Miriam E. Tucker

More than half of patients taking the two highest doses of tirzepatide as a once-weekly injection lost at least 20% of their body weight in the first phase 3 trial to examine this agent in patients with obesity, but without diabetes, according to preliminary top-line results from the SURMOUNT-1 trial announced by Lilly.  

The full results will be reported at an upcoming medical conference and published at a later date, Lilly added.

There was much excitement in response to the news, but others have urged caution and noted that, even if tirzepatide is eventually approved for obesity, one of the major barriers to use in the United States will be insurance coverage.

“Wow (and a double Wow!) 52lb weight loss (22.5%) at highest dose of tirzepatide,” tweeted Sek Kathiresan, MD, a cardiologist who is cofounder of Verve Therapeutics and on leave from Harvard (@skathire).

“Thus far the challenge with GLP-1s [agonists] for management of obesity is that insurance usually isn’t covering them. This makes them unaffordable for most people,” replied James Marroquin, MD, of the University of Texas at Austin. (@Jamesmarroquin).

Yoni Freedhoff, MD, of the University of Ottawa (Ont.) who writes a column for this news organization on obesity, said if tirzepatide pans out, along with other similar agents already on the market for this indication, “the next few decades should see the pharmaceutical management of obesity rival its surgical management.”

Would compete with ‘game-changer’ semaglutide?

Tirzepatide has been dubbed a “twincretin” because it works not only as an agonist of the glucagonlike peptide-1 (GLP-1) receptor, but also of the glucose-dependent insulinotropic polypeptide (GIP) receptor. It has been much hyped based on the results of the series of SURPASS clinical trials, which have formed the basis of the application for type 2 diabetes approval, about which the U.S. Food and Drug Administration is expected to make a decision soon.

Several GLP-1 agonists are on the market for both type 2 diabetes and for obesity indications separately, including semaglutide (marketed as Wegovy for obesity, also a once-weekly injection) and liraglutide (Saxenda for obesity, a daily injection), both Novo Nordisk agents.

Wegovy was approved for weight loss in the United States last year, with doctors telling this news organization then that a third of patients who take the drug are likely to lose 20% or more of their starting weight, an outcome that approaches reductions seen with bariatric surgery.

Dr. Freedhoff said he’d like to see “reimbursement by insurers who will see these drugs serving as important ancillary treatments for the myriad of weight-responsive conditions they’re already covering.”

SURMOUNT-1 data: ‘Impressive body weight’ reductions

The new tirzepatide data come from the multicenter, randomized, double-blind, placebo-controlled SURMOUNT-1 trial, which included 2539 participants from the United States, Argentina, Brazil, China, India, Japan Mexico, Russia, and Taiwan. They had obesity or overweight plus at least one comorbidity but not diabetes. They were randomized to 5-mg, 10-mg, or 15-mg once-weekly tirzepatide or placebo injections for 18 months (72 weeks).

Efficacy was analyzed in two ways. Prior to factoring in drug discontinuation, participants taking tirzepatide experienced weight loss of 16.0% (35 lb/16 kg) with 5 mg, 21.4% (49 lb/22 kg) with 10 mg, and 22.5% (52 lb/24 kg) on 15 mg. In contrast, the placebo group lost just 2.4% of body weight (5 lb/2 kg).  

But treatment discontinuation rates because of adverse events were 4.3%, 7.1%, 6.2%, and 2.6%, for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively. Overall treatment discontinuation rates were 14.3%, 16.4%, 15.1%, and 26.4%, respectively.  

When efficacy was assessed regardless of treatment discontinuation, average body weight reductions were 15.0%, 19.5%, 20.9%, and 3.1% for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively.  

More than half of patients taking tirzepatide 10 mg and 15 mg (55% and 63%, respectively) lost at least 20% of their body weight, compared with just 1.3% taking placebo.

Overall safety and tolerability were similar to those of other GLP-1 agonists, with adverse events being gastrointestinal in nature and increasing with higher doses. Nausea affected 24.6%, 33.3%, and 31.0% of the tirzepatide 5-mg, 10-mg, and 15-mg dose groups, respectively, and vomiting was experienced by 8.3%, 10.7%, and 12.2% of patients, respectively. Diarrhea and constipation were also reported more often with the drug than placebo.

“Tirzepatide delivered impressive body weight reductions in SURMOUNT-1, which could represent an important step forward for helping the patient and physician partnership treat this complex disease,” said study investigator Louis J. Aronne, MD, director of the Comprehensive Weight Control Center and the Sanford I. Weill Professor of Metabolic Research at Weill Cornell Medicine, New York, in a press release.

Further studies are ongoing for tirzepatide as a potential treatment for obesity or overweight, according to the Lilly statement. SURMOUNT is a phase 3 global clinical development program for tirzepatide that began in late 2019 with over 5,000 people with obesity or overweight across six clinical trials. Results from SURMOUNT-2, SURMOUNT-3, and SURMOUNT-4 are expected in 2023.

Tirzepatide is also being studied as a potential treatment for nonalcoholic fatty liver disease and heart failure with preserved ejection fraction. Studies of tirzepatide in obstructive sleep apnea and of morbidity/mortality in obesity are also planned.

Dr. Aronne is cofounder, chief scientific advisor, and a member of the board of directors for Intellihealth. He is also a paid scientific advisory board member for Eli Lilly. Dr. Freedhoff has served or is serving as a director, officer, partner, employee, adviser, consultant, or trustee for the Bariatric Medical Institute and Constant Health and has received a research grant from Novo Nordisk.

A version of this article first appeared on Medscape.com.

More than half of patients taking the two highest doses of tirzepatide as a once-weekly injection lost at least 20% of their body weight in the first phase 3 trial to examine this agent in patients with obesity, but without diabetes, according to preliminary top-line results from the SURMOUNT-1 trial announced by Lilly.  

The full results will be reported at an upcoming medical conference and published at a later date, Lilly added.

There was much excitement in response to the news, but others have urged caution and noted that, even if tirzepatide is eventually approved for obesity, one of the major barriers to use in the United States will be insurance coverage.

“Wow (and a double Wow!) 52lb weight loss (22.5%) at highest dose of tirzepatide,” tweeted Sek Kathiresan, MD, a cardiologist who is cofounder of Verve Therapeutics and on leave from Harvard (@skathire).

“Thus far the challenge with GLP-1s [agonists] for management of obesity is that insurance usually isn’t covering them. This makes them unaffordable for most people,” replied James Marroquin, MD, of the University of Texas at Austin. (@Jamesmarroquin).

Yoni Freedhoff, MD, of the University of Ottawa (Ont.) who writes a column for this news organization on obesity, said if tirzepatide pans out, along with other similar agents already on the market for this indication, “the next few decades should see the pharmaceutical management of obesity rival its surgical management.”

Would compete with ‘game-changer’ semaglutide?

Tirzepatide has been dubbed a “twincretin” because it works not only as an agonist of the glucagonlike peptide-1 (GLP-1) receptor, but also of the glucose-dependent insulinotropic polypeptide (GIP) receptor. It has been much hyped based on the results of the series of SURPASS clinical trials, which have formed the basis of the application for type 2 diabetes approval, about which the U.S. Food and Drug Administration is expected to make a decision soon.

Several GLP-1 agonists are on the market for both type 2 diabetes and for obesity indications separately, including semaglutide (marketed as Wegovy for obesity, also a once-weekly injection) and liraglutide (Saxenda for obesity, a daily injection), both Novo Nordisk agents.

Wegovy was approved for weight loss in the United States last year, with doctors telling this news organization then that a third of patients who take the drug are likely to lose 20% or more of their starting weight, an outcome that approaches reductions seen with bariatric surgery.

Dr. Freedhoff said he’d like to see “reimbursement by insurers who will see these drugs serving as important ancillary treatments for the myriad of weight-responsive conditions they’re already covering.”

SURMOUNT-1 data: ‘Impressive body weight’ reductions

The new tirzepatide data come from the multicenter, randomized, double-blind, placebo-controlled SURMOUNT-1 trial, which included 2539 participants from the United States, Argentina, Brazil, China, India, Japan Mexico, Russia, and Taiwan. They had obesity or overweight plus at least one comorbidity but not diabetes. They were randomized to 5-mg, 10-mg, or 15-mg once-weekly tirzepatide or placebo injections for 18 months (72 weeks).

Efficacy was analyzed in two ways. Prior to factoring in drug discontinuation, participants taking tirzepatide experienced weight loss of 16.0% (35 lb/16 kg) with 5 mg, 21.4% (49 lb/22 kg) with 10 mg, and 22.5% (52 lb/24 kg) on 15 mg. In contrast, the placebo group lost just 2.4% of body weight (5 lb/2 kg).  

But treatment discontinuation rates because of adverse events were 4.3%, 7.1%, 6.2%, and 2.6%, for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively. Overall treatment discontinuation rates were 14.3%, 16.4%, 15.1%, and 26.4%, respectively.  

When efficacy was assessed regardless of treatment discontinuation, average body weight reductions were 15.0%, 19.5%, 20.9%, and 3.1% for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively.  

More than half of patients taking tirzepatide 10 mg and 15 mg (55% and 63%, respectively) lost at least 20% of their body weight, compared with just 1.3% taking placebo.

Overall safety and tolerability were similar to those of other GLP-1 agonists, with adverse events being gastrointestinal in nature and increasing with higher doses. Nausea affected 24.6%, 33.3%, and 31.0% of the tirzepatide 5-mg, 10-mg, and 15-mg dose groups, respectively, and vomiting was experienced by 8.3%, 10.7%, and 12.2% of patients, respectively. Diarrhea and constipation were also reported more often with the drug than placebo.

“Tirzepatide delivered impressive body weight reductions in SURMOUNT-1, which could represent an important step forward for helping the patient and physician partnership treat this complex disease,” said study investigator Louis J. Aronne, MD, director of the Comprehensive Weight Control Center and the Sanford I. Weill Professor of Metabolic Research at Weill Cornell Medicine, New York, in a press release.

Further studies are ongoing for tirzepatide as a potential treatment for obesity or overweight, according to the Lilly statement. SURMOUNT is a phase 3 global clinical development program for tirzepatide that began in late 2019 with over 5,000 people with obesity or overweight across six clinical trials. Results from SURMOUNT-2, SURMOUNT-3, and SURMOUNT-4 are expected in 2023.

Tirzepatide is also being studied as a potential treatment for nonalcoholic fatty liver disease and heart failure with preserved ejection fraction. Studies of tirzepatide in obstructive sleep apnea and of morbidity/mortality in obesity are also planned.

Dr. Aronne is cofounder, chief scientific advisor, and a member of the board of directors for Intellihealth. He is also a paid scientific advisory board member for Eli Lilly. Dr. Freedhoff has served or is serving as a director, officer, partner, employee, adviser, consultant, or trustee for the Bariatric Medical Institute and Constant Health and has received a research grant from Novo Nordisk.

A version of this article first appeared on Medscape.com.

More than half of patients taking the two highest doses of tirzepatide as a once-weekly injection lost at least 20% of their body weight in the first phase 3 trial to examine this agent in patients with obesity, but without diabetes, according to preliminary top-line results from the SURMOUNT-1 trial announced by Lilly.  

The full results will be reported at an upcoming medical conference and published at a later date, Lilly added.

There was much excitement in response to the news, but others have urged caution and noted that, even if tirzepatide is eventually approved for obesity, one of the major barriers to use in the United States will be insurance coverage.

“Wow (and a double Wow!) 52lb weight loss (22.5%) at highest dose of tirzepatide,” tweeted Sek Kathiresan, MD, a cardiologist who is cofounder of Verve Therapeutics and on leave from Harvard (@skathire).

“Thus far the challenge with GLP-1s [agonists] for management of obesity is that insurance usually isn’t covering them. This makes them unaffordable for most people,” replied James Marroquin, MD, of the University of Texas at Austin. (@Jamesmarroquin).

Yoni Freedhoff, MD, of the University of Ottawa (Ont.) who writes a column for this news organization on obesity, said if tirzepatide pans out, along with other similar agents already on the market for this indication, “the next few decades should see the pharmaceutical management of obesity rival its surgical management.”

Would compete with ‘game-changer’ semaglutide?

Tirzepatide has been dubbed a “twincretin” because it works not only as an agonist of the glucagonlike peptide-1 (GLP-1) receptor, but also of the glucose-dependent insulinotropic polypeptide (GIP) receptor. It has been much hyped based on the results of the series of SURPASS clinical trials, which have formed the basis of the application for type 2 diabetes approval, about which the U.S. Food and Drug Administration is expected to make a decision soon.

Several GLP-1 agonists are on the market for both type 2 diabetes and for obesity indications separately, including semaglutide (marketed as Wegovy for obesity, also a once-weekly injection) and liraglutide (Saxenda for obesity, a daily injection), both Novo Nordisk agents.

Wegovy was approved for weight loss in the United States last year, with doctors telling this news organization then that a third of patients who take the drug are likely to lose 20% or more of their starting weight, an outcome that approaches reductions seen with bariatric surgery.

Dr. Freedhoff said he’d like to see “reimbursement by insurers who will see these drugs serving as important ancillary treatments for the myriad of weight-responsive conditions they’re already covering.”

SURMOUNT-1 data: ‘Impressive body weight’ reductions

The new tirzepatide data come from the multicenter, randomized, double-blind, placebo-controlled SURMOUNT-1 trial, which included 2539 participants from the United States, Argentina, Brazil, China, India, Japan Mexico, Russia, and Taiwan. They had obesity or overweight plus at least one comorbidity but not diabetes. They were randomized to 5-mg, 10-mg, or 15-mg once-weekly tirzepatide or placebo injections for 18 months (72 weeks).

Efficacy was analyzed in two ways. Prior to factoring in drug discontinuation, participants taking tirzepatide experienced weight loss of 16.0% (35 lb/16 kg) with 5 mg, 21.4% (49 lb/22 kg) with 10 mg, and 22.5% (52 lb/24 kg) on 15 mg. In contrast, the placebo group lost just 2.4% of body weight (5 lb/2 kg).  

But treatment discontinuation rates because of adverse events were 4.3%, 7.1%, 6.2%, and 2.6%, for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively. Overall treatment discontinuation rates were 14.3%, 16.4%, 15.1%, and 26.4%, respectively.  

When efficacy was assessed regardless of treatment discontinuation, average body weight reductions were 15.0%, 19.5%, 20.9%, and 3.1% for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively.  

More than half of patients taking tirzepatide 10 mg and 15 mg (55% and 63%, respectively) lost at least 20% of their body weight, compared with just 1.3% taking placebo.

Overall safety and tolerability were similar to those of other GLP-1 agonists, with adverse events being gastrointestinal in nature and increasing with higher doses. Nausea affected 24.6%, 33.3%, and 31.0% of the tirzepatide 5-mg, 10-mg, and 15-mg dose groups, respectively, and vomiting was experienced by 8.3%, 10.7%, and 12.2% of patients, respectively. Diarrhea and constipation were also reported more often with the drug than placebo.

“Tirzepatide delivered impressive body weight reductions in SURMOUNT-1, which could represent an important step forward for helping the patient and physician partnership treat this complex disease,” said study investigator Louis J. Aronne, MD, director of the Comprehensive Weight Control Center and the Sanford I. Weill Professor of Metabolic Research at Weill Cornell Medicine, New York, in a press release.

Further studies are ongoing for tirzepatide as a potential treatment for obesity or overweight, according to the Lilly statement. SURMOUNT is a phase 3 global clinical development program for tirzepatide that began in late 2019 with over 5,000 people with obesity or overweight across six clinical trials. Results from SURMOUNT-2, SURMOUNT-3, and SURMOUNT-4 are expected in 2023.

Tirzepatide is also being studied as a potential treatment for nonalcoholic fatty liver disease and heart failure with preserved ejection fraction. Studies of tirzepatide in obstructive sleep apnea and of morbidity/mortality in obesity are also planned.

Dr. Aronne is cofounder, chief scientific advisor, and a member of the board of directors for Intellihealth. He is also a paid scientific advisory board member for Eli Lilly. Dr. Freedhoff has served or is serving as a director, officer, partner, employee, adviser, consultant, or trustee for the Bariatric Medical Institute and Constant Health and has received a research grant from Novo Nordisk.

A version of this article first appeared on Medscape.com.

COVID-19 infection appears to significantly raise the risk for diabetes by about 40% at 1 year, indicate new data from a very large Veterans Administration population.

“If patients have a prior history of COVID-19, that’s a risk factor for diabetes and they should certainly be screened for diabetes,” study coauthor Ziyad Al-Aly, MD, a nephrologist and chief of research and development at VA St. Louis Health Care, told this news organization.

“It’s still premature to make guidelines. I think we have to process the data landscape to understand what this all really means, but it’s really, really clear that all these roads are pointing in one direction, that COVID-19 increases the risk of diabetes up to a year later. The risk is small but not negligible,” he said.

The database includes over 8 million people and 180,000 with a prior COVID-19 diagnosis. Significantly increased diabetes risks compared to those not infected ranging from 31% to more than double were found in an analysis of subgroups based on diabetes risk score, body mass index, age, race, prediabetes status, and deprivation level, even after adjustment for confounding factors.

There was a gradient of diabetes risk by COVID-19 severity – i.e., whether patients had not been hospitalized, had been hospitalized, or stayed in intensive care – but a significant excess diabetes burden was seen even among those with “mild” COVID-19. The diabetes risk was also elevated compared to both contemporary and historical controls.

The study was published March 21 in The Lancet Diabetes & Endocrinology, by Yan Xie, MPH, also of VA St Louis Health Care, along with Dr. Al-Aly.

The data align with those from another study just published from a nationwide German primary care database. That study was smaller and of shorter duration than the new VA study but consistent, said Dr. Al-Aly, a clinical epidemiologist at Washington University, St. Louis.

Millions more with new diabetes as late manifestation of COVID-19

“Millions of people in the U.S. have had COVID-19, so this is going to translate to literally millions more people with new-onset diabetes. Better to identify them early so they can be adequately treated,” Dr. Al-Aly said in an interview.

“The long-term implications of SARS-CoV-2 infection increasing diabetes risk are profound,” Venkat Narayan, MD, and Lisa R. Staimez, PhD, both of the Rollins School of Public Health and Emory Global Diabetes Research Center at Emory University, Atlanta, said in an accompanying editorial.

“With large and growing numbers of people worldwide infected with SARS-CoV-2 (434,154,739 cumulative cases by Feb. 28, 2022), any COVID-19-related increases in diabetes incidence could lead to unprecedented cases of diabetes worldwide – wreaking havoc on already over-stretched and under-resourced clinical and public health systems globally, with devastating tolls in terms of deaths and suffering,” they added.

Medscape Medical News contributor Eric Topol MD, of Scripps Research Institute, La Jolla, Calif., agrees. He said these new data “are most profound. The researchers found a 40% increase in diabetes that wasn’t present at 1 month after COVID-19 but at 1 year, it was. Some kind of late manifestation is happening here.”  

Dr. Al-Aly told this news organization that the mechanisms for the association are unknown and likely to be heterogeneous. Among the people who already had risk factors for type 2 diabetes, such as obesity or metabolic syndrome, SARS-CoV-2 could simply accelerate that process and “put them over the edge” to overt diabetes.

However, for those without diabetes risk factors, “COVID-19 with all the inflammation it provokes in the body could be leading to de novo disease.” (Diabetes status was ascertained by ICD-10 codes and only about 0.70% of the total were recorded as type 1 diabetes. But, since autoantibody testing wasn’t routinely conducted, it’s unknown how many of the cases may have been type 1 misclassified as type 2, Dr. Al-Aly acknowledged.)
 

Diabetes risk significantly increased after COVID-19 in all analyses

The analysis included 181,280 patients in the U.S. Department of Veterans Affairs health care database with a COVID-19 diagnosis who survived for at least 30 days afterward during March 2020 through Sept. 30, 2021, with 4,118,441 contemporary controls without COVID-19 seen during 2019, and a historical control group of 4,286,911 people seen at the VA in 2017. Average follow-up was about a year.

Compared with the contemporary controls, the COVID-19 group had an excess diabetes burden of 13.46 per 1,000 person-years with a hazard ratio of 1.40. They had an increased 12.35 per 1,000 person-year risk for incident use of glucose-lowering medications, with a hazard ratio of 1.85. Similar results were seen with the historical controls.

Subgroup analyses showed an increased risk for diabetes following COVID-19 infection by age (≤ 65 years and > 65 years), race (White and Black), sex (male and female), BMI categories (> 18.5 to ≤ 25 kg/m², > 25 to ≤ 30 kg/m², and > 30 kg/m²), and area deprivation index quartiles. The increased risk was also seen across diabetes risk score quartiles.

Notably, COVID-19 significantly elevated the diabetes risk by 59% even for the subgroup with BMI between 18 and 25 kg/m², and by 38% among those with the lowest diabetes risk score quartile.

The COVID-19 population included 162,096 who were not hospitalized, 15,078 hospitalized, and 4,106 admitted to intensive care. Here, the hazard ratios for diabetes compared to the contemporary controls were 1.25, 2.73, and 3.76, respectively, all significant.  

Dr. Al-Aly said that his group is now further analyzing the VA data for other outcomes including cardiovascular disease and kidney disease, as well as the now well-documented long COVID symptoms including fatigue, pain, and neurocognitive dysfunction.

They’re also investigating the impact of the COVID-19 vaccine to see whether the risks are mitigated in the case of breakthrough infections: “We’re doing a broad systematic assessment. The next paper will be more comprehensive.”

Dr. Narayan and Dr. Staimez wrote: “The potential connection between COVID-19 and diabetes highlights that infectious diseases (eg, SARS-CoV-2) and chronic diseases (eg, diabetes) cannot be viewed in siloes. When we emerge out of the pandemic, the much-neglected non-communicable diseases, such as type 2 diabetes, will continue their relentless trajectory, possibly in an accelerated manner, as the leading burdens of global health.” 

Dr. Al-Aly declared support from the U.S. Department of Veterans Affairs for the submitted work. He has received consultation fees from Gilead Sciences and funding (unrelated to this work) from Tonix Pharmaceuticals. He is a member of the board of directors for Veterans Research and Education Foundation of Saint Louis, associate editor for the Journal of the American Society of Nephrology, and a member of multiple editorial boards. Dr. Narayan and Dr. Staimez have received support from the National Institutes of Health.

A version of this article first appeared on Medscape.com.

COVID-19 infection appears to significantly raise the risk for diabetes by about 40% at 1 year, indicate new data from a very large Veterans Administration population.

“If patients have a prior history of COVID-19, that’s a risk factor for diabetes and they should certainly be screened for diabetes,” study coauthor Ziyad Al-Aly, MD, a nephrologist and chief of research and development at VA St. Louis Health Care, told this news organization.

“It’s still premature to make guidelines. I think we have to process the data landscape to understand what this all really means, but it’s really, really clear that all these roads are pointing in one direction, that COVID-19 increases the risk of diabetes up to a year later. The risk is small but not negligible,” he said.

The database includes over 8 million people and 180,000 with a prior COVID-19 diagnosis. Significantly increased diabetes risks compared to those not infected ranging from 31% to more than double were found in an analysis of subgroups based on diabetes risk score, body mass index, age, race, prediabetes status, and deprivation level, even after adjustment for confounding factors.

There was a gradient of diabetes risk by COVID-19 severity – i.e., whether patients had not been hospitalized, had been hospitalized, or stayed in intensive care – but a significant excess diabetes burden was seen even among those with “mild” COVID-19. The diabetes risk was also elevated compared to both contemporary and historical controls.

The study was published March 21 in The Lancet Diabetes & Endocrinology, by Yan Xie, MPH, also of VA St Louis Health Care, along with Dr. Al-Aly.

The data align with those from another study just published from a nationwide German primary care database. That study was smaller and of shorter duration than the new VA study but consistent, said Dr. Al-Aly, a clinical epidemiologist at Washington University, St. Louis.

Millions more with new diabetes as late manifestation of COVID-19

“Millions of people in the U.S. have had COVID-19, so this is going to translate to literally millions more people with new-onset diabetes. Better to identify them early so they can be adequately treated,” Dr. Al-Aly said in an interview.

“The long-term implications of SARS-CoV-2 infection increasing diabetes risk are profound,” Venkat Narayan, MD, and Lisa R. Staimez, PhD, both of the Rollins School of Public Health and Emory Global Diabetes Research Center at Emory University, Atlanta, said in an accompanying editorial.

“With large and growing numbers of people worldwide infected with SARS-CoV-2 (434,154,739 cumulative cases by Feb. 28, 2022), any COVID-19-related increases in diabetes incidence could lead to unprecedented cases of diabetes worldwide – wreaking havoc on already over-stretched and under-resourced clinical and public health systems globally, with devastating tolls in terms of deaths and suffering,” they added.

Medscape Medical News contributor Eric Topol MD, of Scripps Research Institute, La Jolla, Calif., agrees. He said these new data “are most profound. The researchers found a 40% increase in diabetes that wasn’t present at 1 month after COVID-19 but at 1 year, it was. Some kind of late manifestation is happening here.”  

Dr. Al-Aly told this news organization that the mechanisms for the association are unknown and likely to be heterogeneous. Among the people who already had risk factors for type 2 diabetes, such as obesity or metabolic syndrome, SARS-CoV-2 could simply accelerate that process and “put them over the edge” to overt diabetes.

However, for those without diabetes risk factors, “COVID-19 with all the inflammation it provokes in the body could be leading to de novo disease.” (Diabetes status was ascertained by ICD-10 codes and only about 0.70% of the total were recorded as type 1 diabetes. But, since autoantibody testing wasn’t routinely conducted, it’s unknown how many of the cases may have been type 1 misclassified as type 2, Dr. Al-Aly acknowledged.)
 

Diabetes risk significantly increased after COVID-19 in all analyses

The analysis included 181,280 patients in the U.S. Department of Veterans Affairs health care database with a COVID-19 diagnosis who survived for at least 30 days afterward during March 2020 through Sept. 30, 2021, with 4,118,441 contemporary controls without COVID-19 seen during 2019, and a historical control group of 4,286,911 people seen at the VA in 2017. Average follow-up was about a year.

Compared with the contemporary controls, the COVID-19 group had an excess diabetes burden of 13.46 per 1,000 person-years with a hazard ratio of 1.40. They had an increased 12.35 per 1,000 person-year risk for incident use of glucose-lowering medications, with a hazard ratio of 1.85. Similar results were seen with the historical controls.

Subgroup analyses showed an increased risk for diabetes following COVID-19 infection by age (≤ 65 years and > 65 years), race (White and Black), sex (male and female), BMI categories (> 18.5 to ≤ 25 kg/m², > 25 to ≤ 30 kg/m², and > 30 kg/m²), and area deprivation index quartiles. The increased risk was also seen across diabetes risk score quartiles.

Notably, COVID-19 significantly elevated the diabetes risk by 59% even for the subgroup with BMI between 18 and 25 kg/m², and by 38% among those with the lowest diabetes risk score quartile.

The COVID-19 population included 162,096 who were not hospitalized, 15,078 hospitalized, and 4,106 admitted to intensive care. Here, the hazard ratios for diabetes compared to the contemporary controls were 1.25, 2.73, and 3.76, respectively, all significant.  

Dr. Al-Aly said that his group is now further analyzing the VA data for other outcomes including cardiovascular disease and kidney disease, as well as the now well-documented long COVID symptoms including fatigue, pain, and neurocognitive dysfunction.

They’re also investigating the impact of the COVID-19 vaccine to see whether the risks are mitigated in the case of breakthrough infections: “We’re doing a broad systematic assessment. The next paper will be more comprehensive.”

Dr. Narayan and Dr. Staimez wrote: “The potential connection between COVID-19 and diabetes highlights that infectious diseases (eg, SARS-CoV-2) and chronic diseases (eg, diabetes) cannot be viewed in siloes. When we emerge out of the pandemic, the much-neglected non-communicable diseases, such as type 2 diabetes, will continue their relentless trajectory, possibly in an accelerated manner, as the leading burdens of global health.” 

Dr. Al-Aly declared support from the U.S. Department of Veterans Affairs for the submitted work. He has received consultation fees from Gilead Sciences and funding (unrelated to this work) from Tonix Pharmaceuticals. He is a member of the board of directors for Veterans Research and Education Foundation of Saint Louis, associate editor for the Journal of the American Society of Nephrology, and a member of multiple editorial boards. Dr. Narayan and Dr. Staimez have received support from the National Institutes of Health.

A version of this article first appeared on Medscape.com.

COVID-19 infection appears to significantly raise the risk for diabetes by about 40% at 1 year, indicate new data from a very large Veterans Administration population.

“If patients have a prior history of COVID-19, that’s a risk factor for diabetes and they should certainly be screened for diabetes,” study coauthor Ziyad Al-Aly, MD, a nephrologist and chief of research and development at VA St. Louis Health Care, told this news organization.

“It’s still premature to make guidelines. I think we have to process the data landscape to understand what this all really means, but it’s really, really clear that all these roads are pointing in one direction, that COVID-19 increases the risk of diabetes up to a year later. The risk is small but not negligible,” he said.

The database includes over 8 million people and 180,000 with a prior COVID-19 diagnosis. Significantly increased diabetes risks compared to those not infected ranging from 31% to more than double were found in an analysis of subgroups based on diabetes risk score, body mass index, age, race, prediabetes status, and deprivation level, even after adjustment for confounding factors.

There was a gradient of diabetes risk by COVID-19 severity – i.e., whether patients had not been hospitalized, had been hospitalized, or stayed in intensive care – but a significant excess diabetes burden was seen even among those with “mild” COVID-19. The diabetes risk was also elevated compared to both contemporary and historical controls.

The study was published March 21 in The Lancet Diabetes & Endocrinology, by Yan Xie, MPH, also of VA St Louis Health Care, along with Dr. Al-Aly.

The data align with those from another study just published from a nationwide German primary care database. That study was smaller and of shorter duration than the new VA study but consistent, said Dr. Al-Aly, a clinical epidemiologist at Washington University, St. Louis.

Millions more with new diabetes as late manifestation of COVID-19

“Millions of people in the U.S. have had COVID-19, so this is going to translate to literally millions more people with new-onset diabetes. Better to identify them early so they can be adequately treated,” Dr. Al-Aly said in an interview.

“The long-term implications of SARS-CoV-2 infection increasing diabetes risk are profound,” Venkat Narayan, MD, and Lisa R. Staimez, PhD, both of the Rollins School of Public Health and Emory Global Diabetes Research Center at Emory University, Atlanta, said in an accompanying editorial.

“With large and growing numbers of people worldwide infected with SARS-CoV-2 (434,154,739 cumulative cases by Feb. 28, 2022), any COVID-19-related increases in diabetes incidence could lead to unprecedented cases of diabetes worldwide – wreaking havoc on already over-stretched and under-resourced clinical and public health systems globally, with devastating tolls in terms of deaths and suffering,” they added.

Medscape Medical News contributor Eric Topol MD, of Scripps Research Institute, La Jolla, Calif., agrees. He said these new data “are most profound. The researchers found a 40% increase in diabetes that wasn’t present at 1 month after COVID-19 but at 1 year, it was. Some kind of late manifestation is happening here.”  

Dr. Al-Aly told this news organization that the mechanisms for the association are unknown and likely to be heterogeneous. Among the people who already had risk factors for type 2 diabetes, such as obesity or metabolic syndrome, SARS-CoV-2 could simply accelerate that process and “put them over the edge” to overt diabetes.

However, for those without diabetes risk factors, “COVID-19 with all the inflammation it provokes in the body could be leading to de novo disease.” (Diabetes status was ascertained by ICD-10 codes and only about 0.70% of the total were recorded as type 1 diabetes. But, since autoantibody testing wasn’t routinely conducted, it’s unknown how many of the cases may have been type 1 misclassified as type 2, Dr. Al-Aly acknowledged.)
 

Diabetes risk significantly increased after COVID-19 in all analyses

The analysis included 181,280 patients in the U.S. Department of Veterans Affairs health care database with a COVID-19 diagnosis who survived for at least 30 days afterward during March 2020 through Sept. 30, 2021, with 4,118,441 contemporary controls without COVID-19 seen during 2019, and a historical control group of 4,286,911 people seen at the VA in 2017. Average follow-up was about a year.

Compared with the contemporary controls, the COVID-19 group had an excess diabetes burden of 13.46 per 1,000 person-years with a hazard ratio of 1.40. They had an increased 12.35 per 1,000 person-year risk for incident use of glucose-lowering medications, with a hazard ratio of 1.85. Similar results were seen with the historical controls.

Subgroup analyses showed an increased risk for diabetes following COVID-19 infection by age (≤ 65 years and > 65 years), race (White and Black), sex (male and female), BMI categories (> 18.5 to ≤ 25 kg/m², > 25 to ≤ 30 kg/m², and > 30 kg/m²), and area deprivation index quartiles. The increased risk was also seen across diabetes risk score quartiles.

Notably, COVID-19 significantly elevated the diabetes risk by 59% even for the subgroup with BMI between 18 and 25 kg/m², and by 38% among those with the lowest diabetes risk score quartile.

The COVID-19 population included 162,096 who were not hospitalized, 15,078 hospitalized, and 4,106 admitted to intensive care. Here, the hazard ratios for diabetes compared to the contemporary controls were 1.25, 2.73, and 3.76, respectively, all significant.  

Dr. Al-Aly said that his group is now further analyzing the VA data for other outcomes including cardiovascular disease and kidney disease, as well as the now well-documented long COVID symptoms including fatigue, pain, and neurocognitive dysfunction.

They’re also investigating the impact of the COVID-19 vaccine to see whether the risks are mitigated in the case of breakthrough infections: “We’re doing a broad systematic assessment. The next paper will be more comprehensive.”

Dr. Narayan and Dr. Staimez wrote: “The potential connection between COVID-19 and diabetes highlights that infectious diseases (eg, SARS-CoV-2) and chronic diseases (eg, diabetes) cannot be viewed in siloes. When we emerge out of the pandemic, the much-neglected non-communicable diseases, such as type 2 diabetes, will continue their relentless trajectory, possibly in an accelerated manner, as the leading burdens of global health.” 

Dr. Al-Aly declared support from the U.S. Department of Veterans Affairs for the submitted work. He has received consultation fees from Gilead Sciences and funding (unrelated to this work) from Tonix Pharmaceuticals. He is a member of the board of directors for Veterans Research and Education Foundation of Saint Louis, associate editor for the Journal of the American Society of Nephrology, and a member of multiple editorial boards. Dr. Narayan and Dr. Staimez have received support from the National Institutes of Health.

A version of this article first appeared on Medscape.com.

People who recover from a mild case of COVID-19 appear to have an increased risk for subsequent new-onset type 2 diabetes but not other types of diabetes, new data suggest.

“If confirmed, the results of the present study indicate that diabetes screening in individuals who have recovered from even mild COVID-19 should be recommended,” say Wolfgang Rathmann, MD, of the Leibniz Center for Diabetes Research at Heinrich Heine University, Düsseldorf, Germany, and colleagues.

The findings, from a nationwide primary care database in Germany, were recently published in Diabetologia.

These primary care data align with those from other studies of more seriously ill patients with COVID-19 that found increased rates of type 2 diabetes diagnoses in the subsequent months following illness, they point out.

“COVID-19 infection may lead to diabetes by upregulation of the immune system after remission, which may induce pancreatic beta-cell dysfunction and insulin resistance, or patients may have been at risk for developing diabetes due to having obesity or prediabetes, and the stress COVID-19 put on their bodies sped it up,” said Dr. Rathmann in a press release.

However, because the patients with COVID-19 in the study were only followed for about 3 months, “further follow-up is needed to understand whether type 2 diabetes after mild COVID-19 is just temporary and can be reversed after they have fully recovered or whether it leads to a chronic condition,” he noted.
 

Increase in type 2 diabetes 3 months after mild COVID-19

The retrospective cohort analysis was performed using data from the Disease Analyzer, a representative panel of 1,171 physician practices in Germany, from March 2020 to January 2021, with follow-up through July 2021.

Individuals with a history of COVID-19 or diabetes and those taking corticosteroids within 30 days after the index dates were excluded.

A total of 35,865 patients with confirmed SARS-CoV-2 infection were propensity score-matched on a one-to-one basis for sex, age, health insurance, and comorbidities with those who had acute respiratory tract infections (controls) but were COVID-19 negative. Median follow-up was 119 days for the COVID-19 group and 161 days for controls.

There was a 28% increased risk of type 2 diabetes for those who had COVID-19 versus controls (15.8 per 1,000 person-years vs. 12.3 per 1,000 person-years, respectively, which was significantly different, and an incidence rate ratio of 1.28).

The incidence of other types of diabetes or unspecified diabetes for the COVID-19 and control groups did not differ significantly (4.3 per 1,000 person-years vs. 3.7 per 1,000 person-years; IRR, 1.17).

Similar findings were seen in sensitivity analyses by glucose-lowering medication prescriptions and by ICD-10 codes.

Although type 2 diabetes is not likely to be a problem for the vast majority of people who have mild COVID-19, the authors recommend that anyone who has recovered from COVID-19 be aware of the warning signs and symptoms such as fatigue, frequent urination, and increased thirst, and seek treatment right away.

CoviDiab registry tracking type 1 and type 2 diabetes

Over the course of the pandemic, there have been conflicting data on whether COVID-19 induces or reveals a propensity for type 1 and type 2 diabetes.

The CoviDiab global registry is tracking this and will include diabetes type for adults and children.

The aim is to have “as many as possible cases of new-onset diabetes for which we can have also a minimum set of clinical data including type of diabetes and A1c,” coprincipal investigator Francesco Rubino, MD, of King’s College London, previously told this news organization.

“By looking at this information we can infer whether a role of COVID-19 in triggering diabetes is clinically plausible – or not – and what type of diabetes is most frequently associated with COVID-19.”

Rubino said that the CoviDiab team is approaching the data with the assumption that, at least in adults diagnosed with type 2 diabetes, the explanation might be that the person already had undiagnosed diabetes or the hyperglycemia may be stress-induced and temporary.

The German Diabetes Center is funded by the German Federal Ministry of Health and the Ministry of Culture and Science of the State of North Rhine-Westphalia. Dr. Rathmann has reported receiving consulting fees for attending educational sessions or advisory boards for AstraZeneca, Boehringer Ingelheim, and Novo Nordisk and institutional research grants from Novo Nordisk outside of the topic of the current work.

A version of this article first appeared on Medscape.com.

People who recover from a mild case of COVID-19 appear to have an increased risk for subsequent new-onset type 2 diabetes but not other types of diabetes, new data suggest.

“If confirmed, the results of the present study indicate that diabetes screening in individuals who have recovered from even mild COVID-19 should be recommended,” say Wolfgang Rathmann, MD, of the Leibniz Center for Diabetes Research at Heinrich Heine University, Düsseldorf, Germany, and colleagues.

The findings, from a nationwide primary care database in Germany, were recently published in Diabetologia.

These primary care data align with those from other studies of more seriously ill patients with COVID-19 that found increased rates of type 2 diabetes diagnoses in the subsequent months following illness, they point out.

“COVID-19 infection may lead to diabetes by upregulation of the immune system after remission, which may induce pancreatic beta-cell dysfunction and insulin resistance, or patients may have been at risk for developing diabetes due to having obesity or prediabetes, and the stress COVID-19 put on their bodies sped it up,” said Dr. Rathmann in a press release.

However, because the patients with COVID-19 in the study were only followed for about 3 months, “further follow-up is needed to understand whether type 2 diabetes after mild COVID-19 is just temporary and can be reversed after they have fully recovered or whether it leads to a chronic condition,” he noted.
 

Increase in type 2 diabetes 3 months after mild COVID-19

The retrospective cohort analysis was performed using data from the Disease Analyzer, a representative panel of 1,171 physician practices in Germany, from March 2020 to January 2021, with follow-up through July 2021.

Individuals with a history of COVID-19 or diabetes and those taking corticosteroids within 30 days after the index dates were excluded.

A total of 35,865 patients with confirmed SARS-CoV-2 infection were propensity score-matched on a one-to-one basis for sex, age, health insurance, and comorbidities with those who had acute respiratory tract infections (controls) but were COVID-19 negative. Median follow-up was 119 days for the COVID-19 group and 161 days for controls.

There was a 28% increased risk of type 2 diabetes for those who had COVID-19 versus controls (15.8 per 1,000 person-years vs. 12.3 per 1,000 person-years, respectively, which was significantly different, and an incidence rate ratio of 1.28).

The incidence of other types of diabetes or unspecified diabetes for the COVID-19 and control groups did not differ significantly (4.3 per 1,000 person-years vs. 3.7 per 1,000 person-years; IRR, 1.17).

Similar findings were seen in sensitivity analyses by glucose-lowering medication prescriptions and by ICD-10 codes.

Although type 2 diabetes is not likely to be a problem for the vast majority of people who have mild COVID-19, the authors recommend that anyone who has recovered from COVID-19 be aware of the warning signs and symptoms such as fatigue, frequent urination, and increased thirst, and seek treatment right away.

CoviDiab registry tracking type 1 and type 2 diabetes

Over the course of the pandemic, there have been conflicting data on whether COVID-19 induces or reveals a propensity for type 1 and type 2 diabetes.

The CoviDiab global registry is tracking this and will include diabetes type for adults and children.

The aim is to have “as many as possible cases of new-onset diabetes for which we can have also a minimum set of clinical data including type of diabetes and A1c,” coprincipal investigator Francesco Rubino, MD, of King’s College London, previously told this news organization.

“By looking at this information we can infer whether a role of COVID-19 in triggering diabetes is clinically plausible – or not – and what type of diabetes is most frequently associated with COVID-19.”

Rubino said that the CoviDiab team is approaching the data with the assumption that, at least in adults diagnosed with type 2 diabetes, the explanation might be that the person already had undiagnosed diabetes or the hyperglycemia may be stress-induced and temporary.

The German Diabetes Center is funded by the German Federal Ministry of Health and the Ministry of Culture and Science of the State of North Rhine-Westphalia. Dr. Rathmann has reported receiving consulting fees for attending educational sessions or advisory boards for AstraZeneca, Boehringer Ingelheim, and Novo Nordisk and institutional research grants from Novo Nordisk outside of the topic of the current work.

A version of this article first appeared on Medscape.com.

People who recover from a mild case of COVID-19 appear to have an increased risk for subsequent new-onset type 2 diabetes but not other types of diabetes, new data suggest.

“If confirmed, the results of the present study indicate that diabetes screening in individuals who have recovered from even mild COVID-19 should be recommended,” say Wolfgang Rathmann, MD, of the Leibniz Center for Diabetes Research at Heinrich Heine University, Düsseldorf, Germany, and colleagues.

The findings, from a nationwide primary care database in Germany, were recently published in Diabetologia.

These primary care data align with those from other studies of more seriously ill patients with COVID-19 that found increased rates of type 2 diabetes diagnoses in the subsequent months following illness, they point out.

“COVID-19 infection may lead to diabetes by upregulation of the immune system after remission, which may induce pancreatic beta-cell dysfunction and insulin resistance, or patients may have been at risk for developing diabetes due to having obesity or prediabetes, and the stress COVID-19 put on their bodies sped it up,” said Dr. Rathmann in a press release.

However, because the patients with COVID-19 in the study were only followed for about 3 months, “further follow-up is needed to understand whether type 2 diabetes after mild COVID-19 is just temporary and can be reversed after they have fully recovered or whether it leads to a chronic condition,” he noted.
 

Increase in type 2 diabetes 3 months after mild COVID-19

The retrospective cohort analysis was performed using data from the Disease Analyzer, a representative panel of 1,171 physician practices in Germany, from March 2020 to January 2021, with follow-up through July 2021.

Individuals with a history of COVID-19 or diabetes and those taking corticosteroids within 30 days after the index dates were excluded.

A total of 35,865 patients with confirmed SARS-CoV-2 infection were propensity score-matched on a one-to-one basis for sex, age, health insurance, and comorbidities with those who had acute respiratory tract infections (controls) but were COVID-19 negative. Median follow-up was 119 days for the COVID-19 group and 161 days for controls.

There was a 28% increased risk of type 2 diabetes for those who had COVID-19 versus controls (15.8 per 1,000 person-years vs. 12.3 per 1,000 person-years, respectively, which was significantly different, and an incidence rate ratio of 1.28).

The incidence of other types of diabetes or unspecified diabetes for the COVID-19 and control groups did not differ significantly (4.3 per 1,000 person-years vs. 3.7 per 1,000 person-years; IRR, 1.17).

Similar findings were seen in sensitivity analyses by glucose-lowering medication prescriptions and by ICD-10 codes.

Although type 2 diabetes is not likely to be a problem for the vast majority of people who have mild COVID-19, the authors recommend that anyone who has recovered from COVID-19 be aware of the warning signs and symptoms such as fatigue, frequent urination, and increased thirst, and seek treatment right away.

CoviDiab registry tracking type 1 and type 2 diabetes

Over the course of the pandemic, there have been conflicting data on whether COVID-19 induces or reveals a propensity for type 1 and type 2 diabetes.

The CoviDiab global registry is tracking this and will include diabetes type for adults and children.

The aim is to have “as many as possible cases of new-onset diabetes for which we can have also a minimum set of clinical data including type of diabetes and A1c,” coprincipal investigator Francesco Rubino, MD, of King’s College London, previously told this news organization.

“By looking at this information we can infer whether a role of COVID-19 in triggering diabetes is clinically plausible – or not – and what type of diabetes is most frequently associated with COVID-19.”

Rubino said that the CoviDiab team is approaching the data with the assumption that, at least in adults diagnosed with type 2 diabetes, the explanation might be that the person already had undiagnosed diabetes or the hyperglycemia may be stress-induced and temporary.

The German Diabetes Center is funded by the German Federal Ministry of Health and the Ministry of Culture and Science of the State of North Rhine-Westphalia. Dr. Rathmann has reported receiving consulting fees for attending educational sessions or advisory boards for AstraZeneca, Boehringer Ingelheim, and Novo Nordisk and institutional research grants from Novo Nordisk outside of the topic of the current work.

A version of this article first appeared on Medscape.com.

Key takeaways

Results from a retrospective, observational, case-control study of more than 20,000 people from a single U.S. medical center showed a statistically significant but clinically insignificant increase in A1c in people following COVID-19 infection, in both those with and without diabetes.

After people received a diagnosis of COVID-19 infection, they were 40% more likely to also receive a diagnosis of type 2 diabetes, compared with people who tested negative for COVID-19, a difference that was significant and could be explained by the increased medical care received by people who test positive for COVID-19.

The risk of incident diabetic ketoacidosis (DKA) among people who tested positive for COVID-19 was significantly higher among those with pre-existing type 2 diabetes, those using insulin, and among Black individuals.
 

Why this matters

The authors said that their study is the first report of evidence that infection with COVID-19 affects A1c levels in a large, real-world clinical cohort.

Until now, the impact of COVID-19 infection on A1c remained unclear. Results from previous studies indicated that COVID-19 infection may increase A1c levels, but the studied cohorts were small and lacked uninfected controls.

The current study included 8,755 people infected with COVID-19, had data from both before and after the infection on diabetes status and A1c levels, and also included many matched, uninfected people who served as controls.
 

Study design

Data came from a Cleveland Clinic registry that included 81,093 people who tested positive for COVID-19 between March 2020 and May 2021 and 153,034 matched individuals who tested negative for COVID-19 during the same period.

The researchers retrospectively selected patients with an A1c recorded within 12 months before their COVID-19 test, as well as a second A1c value recorded within 12 months after COVID-19 testing. This produced a study cohort of 8,755 COVID-positive people and 11,998 matched people who tested negative for COVID-19.

To evaluate the risk of DKA onset after COVID-19 infection, the authors identified two sub-cohorts that excluded those with a history of DKA. The sub-cohorts were 701 people with type 1 diabetes and 21,830 with type 2 diabetes.
 

Key results

The investigators found a statistically significant but clinically insignificant A1c increase following a positive COVID-19 test, an average A1c increase of 0.06 percentage points. Those who tested negative for COVID-19 had a clinically insignificant change in their average A1c level that was of borderline statistical significance, an average increase of 0.02 percentage points (P = .05).

The statistically significant but clinically insignificant increase in A1c following infection with COVID-19 was similar in people with and without type 2 diabetes prior to infection.

In patients with type 2 diabetes who became infected with COVID-19, the researchers saw significant positive associations between higher A1c levels before infection and time to hospitalization (hazard ratio, 1.07), need for assisted breathing (HR, 1.06), and ICU admission (HR, 1.07).

Following a COVID-19 infection, people were 40% more likely to receive a diagnosis of incident type 2 diabetes, compared with matched uninfected people. The authors said a possible explanation is that after diagnosis of COVID-19, infected people in general received more intensified care that led to better identification of those with underlying type 2 diabetes.

The 701 people included with pre-existing type 1 diabetes showed no significant difference in their rate of developing DKA between those infected and not infected with COVID-19.

Among the 21,830 people with pre-existing type 2 diabetes, the DKA risk was a significant 35% greater for those who were infected with COVID-19, compared with those who were uninfected. The magnitude of this increased relative risk was even higher among the patients with type 2 diabetes who used insulin as part of their treatment.  

The difference in DKA risk didn’t differ between Black and White patients who were not infected with COVID-19, but among those infected by COVID-19, Black patients were more than twice as likely to be diagnosed with DKA, compared with White patients, a significant difference.

Black patients with type 2 diabetes who became infected with COVID-19 had a significant (63%) increased rate of DKA compared with Black patients with type 2 diabetes who remained uninfected.
 

Limitations

The study included patients with A1c measurements made up to 12 months prior to their COVID-19 test, and hence comorbid conditions, medication changes during this period, or other factors may have affected subsequent A1c levels. To address this, the authors also assessed outcomes at 3- and 6-month intervals, which produced results consistent with the 12-month findings.

The researchers did not have A1c values for many of the more than 234,000 people in the entire registry who underwent COVID-19 testing from March 2020-May 2021 at the Cleveland Clinic, omissions that may have biased the study cohort.

This was a single-center study. Some patients may have received care outside of the center, hence records of those episodes could not be included.
 

Disclosures

The study received no commercial funding. Four authors received consulting and speaker honoraria and research funding from AstraZeneca, Bayer, Boehringer Ingelheim, Corcept Therapeutics, Diasome, Eli Lilly, Merck, Novo Nordisk, and Sanofi. Three authors have intellectual property related to treatment decisionmaking in the context of type 2 diabetes.

This is a summary of a preprint research study “Impacts of COVID-19 on glycemia and risk of diabetic ketoacidosis,” written by researchers at the Cleveland Clinic on medRxiv. The study has not yet been peer reviewed. The full text of the study can be found on medRxiv.org.

A version of this article first appeared on Medscape.com.

Key takeaways

Results from a retrospective, observational, case-control study of more than 20,000 people from a single U.S. medical center showed a statistically significant but clinically insignificant increase in A1c in people following COVID-19 infection, in both those with and without diabetes.

After people received a diagnosis of COVID-19 infection, they were 40% more likely to also receive a diagnosis of type 2 diabetes, compared with people who tested negative for COVID-19, a difference that was significant and could be explained by the increased medical care received by people who test positive for COVID-19.

The risk of incident diabetic ketoacidosis (DKA) among people who tested positive for COVID-19 was significantly higher among those with pre-existing type 2 diabetes, those using insulin, and among Black individuals.
 

Why this matters

The authors said that their study is the first report of evidence that infection with COVID-19 affects A1c levels in a large, real-world clinical cohort.

Until now, the impact of COVID-19 infection on A1c remained unclear. Results from previous studies indicated that COVID-19 infection may increase A1c levels, but the studied cohorts were small and lacked uninfected controls.

The current study included 8,755 people infected with COVID-19, had data from both before and after the infection on diabetes status and A1c levels, and also included many matched, uninfected people who served as controls.
 

Study design

Data came from a Cleveland Clinic registry that included 81,093 people who tested positive for COVID-19 between March 2020 and May 2021 and 153,034 matched individuals who tested negative for COVID-19 during the same period.

The researchers retrospectively selected patients with an A1c recorded within 12 months before their COVID-19 test, as well as a second A1c value recorded within 12 months after COVID-19 testing. This produced a study cohort of 8,755 COVID-positive people and 11,998 matched people who tested negative for COVID-19.

To evaluate the risk of DKA onset after COVID-19 infection, the authors identified two sub-cohorts that excluded those with a history of DKA. The sub-cohorts were 701 people with type 1 diabetes and 21,830 with type 2 diabetes.
 

Key results

The investigators found a statistically significant but clinically insignificant A1c increase following a positive COVID-19 test, an average A1c increase of 0.06 percentage points. Those who tested negative for COVID-19 had a clinically insignificant change in their average A1c level that was of borderline statistical significance, an average increase of 0.02 percentage points (P = .05).

The statistically significant but clinically insignificant increase in A1c following infection with COVID-19 was similar in people with and without type 2 diabetes prior to infection.

In patients with type 2 diabetes who became infected with COVID-19, the researchers saw significant positive associations between higher A1c levels before infection and time to hospitalization (hazard ratio, 1.07), need for assisted breathing (HR, 1.06), and ICU admission (HR, 1.07).

Following a COVID-19 infection, people were 40% more likely to receive a diagnosis of incident type 2 diabetes, compared with matched uninfected people. The authors said a possible explanation is that after diagnosis of COVID-19, infected people in general received more intensified care that led to better identification of those with underlying type 2 diabetes.

The 701 people included with pre-existing type 1 diabetes showed no significant difference in their rate of developing DKA between those infected and not infected with COVID-19.

Among the 21,830 people with pre-existing type 2 diabetes, the DKA risk was a significant 35% greater for those who were infected with COVID-19, compared with those who were uninfected. The magnitude of this increased relative risk was even higher among the patients with type 2 diabetes who used insulin as part of their treatment.  

The difference in DKA risk didn’t differ between Black and White patients who were not infected with COVID-19, but among those infected by COVID-19, Black patients were more than twice as likely to be diagnosed with DKA, compared with White patients, a significant difference.

Black patients with type 2 diabetes who became infected with COVID-19 had a significant (63%) increased rate of DKA compared with Black patients with type 2 diabetes who remained uninfected.
 

Limitations

The study included patients with A1c measurements made up to 12 months prior to their COVID-19 test, and hence comorbid conditions, medication changes during this period, or other factors may have affected subsequent A1c levels. To address this, the authors also assessed outcomes at 3- and 6-month intervals, which produced results consistent with the 12-month findings.

The researchers did not have A1c values for many of the more than 234,000 people in the entire registry who underwent COVID-19 testing from March 2020-May 2021 at the Cleveland Clinic, omissions that may have biased the study cohort.

This was a single-center study. Some patients may have received care outside of the center, hence records of those episodes could not be included.
 

Disclosures

The study received no commercial funding. Four authors received consulting and speaker honoraria and research funding from AstraZeneca, Bayer, Boehringer Ingelheim, Corcept Therapeutics, Diasome, Eli Lilly, Merck, Novo Nordisk, and Sanofi. Three authors have intellectual property related to treatment decisionmaking in the context of type 2 diabetes.

This is a summary of a preprint research study “Impacts of COVID-19 on glycemia and risk of diabetic ketoacidosis,” written by researchers at the Cleveland Clinic on medRxiv. The study has not yet been peer reviewed. The full text of the study can be found on medRxiv.org.

A version of this article first appeared on Medscape.com.

Key takeaways

Results from a retrospective, observational, case-control study of more than 20,000 people from a single U.S. medical center showed a statistically significant but clinically insignificant increase in A1c in people following COVID-19 infection, in both those with and without diabetes.

After people received a diagnosis of COVID-19 infection, they were 40% more likely to also receive a diagnosis of type 2 diabetes, compared with people who tested negative for COVID-19, a difference that was significant and could be explained by the increased medical care received by people who test positive for COVID-19.

The risk of incident diabetic ketoacidosis (DKA) among people who tested positive for COVID-19 was significantly higher among those with pre-existing type 2 diabetes, those using insulin, and among Black individuals.
 

Why this matters

The authors said that their study is the first report of evidence that infection with COVID-19 affects A1c levels in a large, real-world clinical cohort.

Until now, the impact of COVID-19 infection on A1c remained unclear. Results from previous studies indicated that COVID-19 infection may increase A1c levels, but the studied cohorts were small and lacked uninfected controls.

The current study included 8,755 people infected with COVID-19, had data from both before and after the infection on diabetes status and A1c levels, and also included many matched, uninfected people who served as controls.
 

Study design

Data came from a Cleveland Clinic registry that included 81,093 people who tested positive for COVID-19 between March 2020 and May 2021 and 153,034 matched individuals who tested negative for COVID-19 during the same period.

The researchers retrospectively selected patients with an A1c recorded within 12 months before their COVID-19 test, as well as a second A1c value recorded within 12 months after COVID-19 testing. This produced a study cohort of 8,755 COVID-positive people and 11,998 matched people who tested negative for COVID-19.

To evaluate the risk of DKA onset after COVID-19 infection, the authors identified two sub-cohorts that excluded those with a history of DKA. The sub-cohorts were 701 people with type 1 diabetes and 21,830 with type 2 diabetes.
 

Key results

The investigators found a statistically significant but clinically insignificant A1c increase following a positive COVID-19 test, an average A1c increase of 0.06 percentage points. Those who tested negative for COVID-19 had a clinically insignificant change in their average A1c level that was of borderline statistical significance, an average increase of 0.02 percentage points (P = .05).

The statistically significant but clinically insignificant increase in A1c following infection with COVID-19 was similar in people with and without type 2 diabetes prior to infection.

In patients with type 2 diabetes who became infected with COVID-19, the researchers saw significant positive associations between higher A1c levels before infection and time to hospitalization (hazard ratio, 1.07), need for assisted breathing (HR, 1.06), and ICU admission (HR, 1.07).

Following a COVID-19 infection, people were 40% more likely to receive a diagnosis of incident type 2 diabetes, compared with matched uninfected people. The authors said a possible explanation is that after diagnosis of COVID-19, infected people in general received more intensified care that led to better identification of those with underlying type 2 diabetes.

The 701 people included with pre-existing type 1 diabetes showed no significant difference in their rate of developing DKA between those infected and not infected with COVID-19.

Among the 21,830 people with pre-existing type 2 diabetes, the DKA risk was a significant 35% greater for those who were infected with COVID-19, compared with those who were uninfected. The magnitude of this increased relative risk was even higher among the patients with type 2 diabetes who used insulin as part of their treatment.  

The difference in DKA risk didn’t differ between Black and White patients who were not infected with COVID-19, but among those infected by COVID-19, Black patients were more than twice as likely to be diagnosed with DKA, compared with White patients, a significant difference.

Black patients with type 2 diabetes who became infected with COVID-19 had a significant (63%) increased rate of DKA compared with Black patients with type 2 diabetes who remained uninfected.
 

Limitations

The study included patients with A1c measurements made up to 12 months prior to their COVID-19 test, and hence comorbid conditions, medication changes during this period, or other factors may have affected subsequent A1c levels. To address this, the authors also assessed outcomes at 3- and 6-month intervals, which produced results consistent with the 12-month findings.

The researchers did not have A1c values for many of the more than 234,000 people in the entire registry who underwent COVID-19 testing from March 2020-May 2021 at the Cleveland Clinic, omissions that may have biased the study cohort.

This was a single-center study. Some patients may have received care outside of the center, hence records of those episodes could not be included.
 

Disclosures

The study received no commercial funding. Four authors received consulting and speaker honoraria and research funding from AstraZeneca, Bayer, Boehringer Ingelheim, Corcept Therapeutics, Diasome, Eli Lilly, Merck, Novo Nordisk, and Sanofi. Three authors have intellectual property related to treatment decisionmaking in the context of type 2 diabetes.

This is a summary of a preprint research study “Impacts of COVID-19 on glycemia and risk of diabetic ketoacidosis,” written by researchers at the Cleveland Clinic on medRxiv. The study has not yet been peer reviewed. The full text of the study can be found on medRxiv.org.

A version of this article first appeared on Medscape.com.

Diabetes care and access to insulin and other medications in Ukraine have been “severely disrupted” since Russia’s invasion, with shortages resulting more from distribution problems than supply itself, according to multiple sources.

In 2021, there were about 2.3 million people with diabetes in Ukraine, roughly 7% of the total population. Of those, about 120,000 have type 1 diabetes and depend on insulin to live, while a similar number have insulin-treated type 2 diabetes.

Donations of insulin, other medications, and supplies have been pouring in since late February from sources including the Ukrainian diaspora, nongovernmental organizations, other European governments, universities, and product manufacturers. “The main problem now is logistic,” Boris Mankovsky, MD, president of the Ukrainian Diabetology Association, said in an interview.

Insulin manufacturer Novo Nordisk’s warehouse continues to operate, although deliveries have been curtailed because of shortages in delivery staff. The company is working to get medications to patients either through pharmacies or humanitarian organizations and has funded refugee support efforts, they said in a March 8 statement.

But even if the supplies reach the pharmacies, they may not reach patients for a variety of logistical reasons, noted Dr. Mankovsky, who is head of the department of diabetology at the P.L. Shupyk National Medical Academy for Postgraduate Education in Kyiv. “So, there are a lot of problems. I don’t know exactly where the main bottleneck is, but there are shortages, definitely.”

Insulin supplies have also been distributed very unequally by region and type, with various shipments containing long-acting, short-acting, analog, or human insulins. “We’re very grateful for all of it. But it’s not centrally coordinated, which of course is understandable, but it means that a lot of donations go to one place and no supply goes to another,” Dr. Mankovsky said.

Most of the donated supplies have been going to western Ukraine, where the capital Kyiv is located. “But the main problem now is the eastern part of Ukraine. It’s difficult and dangerous to deliver any supplies there, especially [with] the terrible situation in Mariupol. Eastern Ukraine now suffers the most, at least at this minute,” he said.  
 

Diabetes specialists continue to work, at least for now  

Ivan Smirnov, MD, PhD, head of the endocrinology department at Kharkiv Regional Hospital, in the northeastern part of the country, said in an email to this news organization: “I continue to stay in Kharkiv, in spite of the situation. A lot of people are killed, many people are wounded. My hospital is full of wounded civilians ... a lot of buildings are destroyed partly and some completely.”

Dr. Smirnov said that he and his colleagues “find the way to overcome the fear ... in constant work. Part of the work is online consulting assistance for routine patients. ... But the main time now is dedicated to providing the diabetes patients with insulin. This is a heavy job to do indeed.”

Dr. Mankovsky, who practices adult diabetology and endocrinology in Kyiv, continues to manage patients, but mostly remotely. “Practice is severely disrupted. I’m willing to see patients but it’s extremely difficult and dangerous for them and probably not possible to travel to see me. So that’s why all our communications now is distant, through phone or internet. ... We can communicate and I’m able to provide some recommendations for changes in treatment or some corrections in insulin therapy.”

Despite the Russians closing in on Kyiv, Dr. Mankovsky said, “I’ve decided to stay as long as possible. Then, nobody knows of course but I think I have to. ... We hear explosions every day. ... I’m in the center of the city and the streets are empty. It’s heartbreaking.”
 

Supplies are reaching refugees

Dr. Mankovsky said: “Now we have huge movement of refugees. Among them are a lot of people with diabetes who moved out of their place and nobody knows where they are. It’s really a huge disruption.”

According to the type 1 diabetes advocacy organization JDRF, many men with diabetes aged 18-60 are remaining in Ukraine to fight, despite the increased risk with the disease. But an estimated 15,000 children with type 1 diabetes and their families are attempting to escape the conflict by moving to the western regions of the country or over the borders.

“Those who make it to Hungary, Moldova, Poland, or Romania are being received with wonderful generosity. We have heard stories ranging from governments making it possible to pick up insulin free without a script to individuals emptying their cupboards of insulin for those whose need is urgent,” JDRF said in a statement on March 2.  

For its part, Novo Nordisk has donated 55 million Danish kroner (about 7.3 million Euros, or $8.2 million U.S. dollars) to support international relief organizations in assisting refugees.

Ivan Tkac, MD, PhD, professor of medicine at Safárik University in Kosice, Slovakia, is assisting refugees, including those with diabetes. Slovakia is predominantly a transit country for refugees from Ukraine, he said in an interview. 

“However, in solidarity with Ukraine, we are providing emergency medical care for both Ukrainians and refugees from third countries leaving Ukraine,” he said, noting that those individuals are primarily foreign students who had been studying there.

“Asylum seekers receive full medical insurance paid by the government of the Slovak Republic. As part of this care, the refugees are provided with the necessary amount of insulin and other antidiabetic drugs, as well as medical devices needed for the treatment of diabetes. The European Commission has pledged to supply Slovakia with the necessary quantities of medicines for the treatment of diabetes in the coming weeks as part of its assistance to the countries bordering Ukraine. In addition, some humanitarian organizations are organizing supplies of insulin and other medicines for soldiers fighting in the Ukrainian army,” Dr. Tkac said.
 

How you can help

A number of organizations are providing assistance specifically to people with diabetes, as well as broader medical assistance to people remaining in Ukraine and to refugees.

A collaboration between the Ministry of Health of Ukraine, the humanitarian agency Direct Relief, and the International Diabetes Federation is working to determine where supplies are short, to secure donations within Europe, and to open up “green corridors” within Ukraine to deliver them quickly to where they’re needed. They have asked those who wish to help to donate to Direct Relief and direct donations to the “Ukraine crisis.”

Another effort organized by IDF Europe is Connect Solidarity, a program that “aims to facilitate support from IDF Europe member associations across Europe wishing to help other national diabetes associations in Ukraine’s neighboring countries, provide advice, medicines, and supplies to Ukrainian refugees.”

IDF President Andrew Boulton, MD, told this news organization that he has been in almost daily contact with senior colleagues working in diabetes in Ukraine, and that he is working with the organization’s affiliated charity Life for a Child in addition to the other charitable agencies. “We will continue to do our utmost best to help those with diabetes living in Ukraine. However, this is, of course, very challenging, and we hope that we are doing the best we can in such a difficult situation. We all hope and pray that this situation is soon resolved.”

The European Association for the Study of Diabetes is taking a somewhat different approach, by encouraging its members to “support people with ill health, including diabetes, with donations through established [nongovernmental organizations] that have the capacity to help on site, such as United Nations High Commissioner for Refugees or International Committee of the Red Cross.”

Dr. Mankovsky told this news organization that he is very grateful for all the support from around the world: “Just thanks. I’ve got so much support, so many phone calls, so many letters ... not just me, all of us. People wise and friendship wise we feel support. It’s really important, emotionally and with insulin supply and other medications. Without that, it would be much more difficult.”
 

Pandemic-prompted changes enable wartime diabetes care

Dramatic changes in diabetes care delivery in Ukraine necessitated by the COVID-19 pandemic have proved indispensable during the Russian invasion.

In a piece published May 29, 2020, in the Journal of Diabetes Science and Technology, Dr. Mankovsky described how the pandemic hit just as Ukraine’s health system was pivoting from government controlled to insurance based.

Prior to the pandemic, patients with both type 1 and type 2 diabetes were regularly admitted to hospital for routine checkups, insulin dose management, and other treatments, a “remnant of the Soviet-era medical practice, which emphasized heavily on hospital admissions,” Dr. Mankovsky said in an interview.

This was the case, he wrote in the article, “despite the common understanding that such a system was a waste of resources ... this policy was changing much slower than we wanted.”

But the COVID-19 pandemic changed that practice “abruptly and dramatically,” so that all hospitalizations for patients with diabetes were stopped unless there was a real metabolic emergency.

Subsequently, Dr. Mankovsky wrote, “almost every health professional recognizes the particular importance of the new ways of communications with patients and with other colleagues.”

Indeed, in his email to this news organization, Dr. Smirnov mentioned that the routine diabetes management work he is still able to do remotely despite the extreme disruption in his region “is easy because of long-term COVID-period experience.”

Also because of the pandemic, insulin prescriptions were switched from traditional paper to electronic transfer, so that patients could easily pick them up at the pharmacy. “This new ... system proved to be not just very convenient for all parties involved, but in the current situation, it allowed us to prevent so many medically unnecessary visits to the clinics, which otherwise would have presented the real threat to the patients’ health and risk to get them infected,” Dr. Mankovsky wrote in 2020.

Now with the new danger, he said, “the inability to see patients is probably the least of our problems.”

A version of this article first appeared on Medscape.com.

Diabetes care and access to insulin and other medications in Ukraine have been “severely disrupted” since Russia’s invasion, with shortages resulting more from distribution problems than supply itself, according to multiple sources.

In 2021, there were about 2.3 million people with diabetes in Ukraine, roughly 7% of the total population. Of those, about 120,000 have type 1 diabetes and depend on insulin to live, while a similar number have insulin-treated type 2 diabetes.

Donations of insulin, other medications, and supplies have been pouring in since late February from sources including the Ukrainian diaspora, nongovernmental organizations, other European governments, universities, and product manufacturers. “The main problem now is logistic,” Boris Mankovsky, MD, president of the Ukrainian Diabetology Association, said in an interview.

Insulin manufacturer Novo Nordisk’s warehouse continues to operate, although deliveries have been curtailed because of shortages in delivery staff. The company is working to get medications to patients either through pharmacies or humanitarian organizations and has funded refugee support efforts, they said in a March 8 statement.

But even if the supplies reach the pharmacies, they may not reach patients for a variety of logistical reasons, noted Dr. Mankovsky, who is head of the department of diabetology at the P.L. Shupyk National Medical Academy for Postgraduate Education in Kyiv. “So, there are a lot of problems. I don’t know exactly where the main bottleneck is, but there are shortages, definitely.”

Insulin supplies have also been distributed very unequally by region and type, with various shipments containing long-acting, short-acting, analog, or human insulins. “We’re very grateful for all of it. But it’s not centrally coordinated, which of course is understandable, but it means that a lot of donations go to one place and no supply goes to another,” Dr. Mankovsky said.

Most of the donated supplies have been going to western Ukraine, where the capital Kyiv is located. “But the main problem now is the eastern part of Ukraine. It’s difficult and dangerous to deliver any supplies there, especially [with] the terrible situation in Mariupol. Eastern Ukraine now suffers the most, at least at this minute,” he said.  
 

Diabetes specialists continue to work, at least for now  

Ivan Smirnov, MD, PhD, head of the endocrinology department at Kharkiv Regional Hospital, in the northeastern part of the country, said in an email to this news organization: “I continue to stay in Kharkiv, in spite of the situation. A lot of people are killed, many people are wounded. My hospital is full of wounded civilians ... a lot of buildings are destroyed partly and some completely.”

Dr. Smirnov said that he and his colleagues “find the way to overcome the fear ... in constant work. Part of the work is online consulting assistance for routine patients. ... But the main time now is dedicated to providing the diabetes patients with insulin. This is a heavy job to do indeed.”

Dr. Mankovsky, who practices adult diabetology and endocrinology in Kyiv, continues to manage patients, but mostly remotely. “Practice is severely disrupted. I’m willing to see patients but it’s extremely difficult and dangerous for them and probably not possible to travel to see me. So that’s why all our communications now is distant, through phone or internet. ... We can communicate and I’m able to provide some recommendations for changes in treatment or some corrections in insulin therapy.”

Despite the Russians closing in on Kyiv, Dr. Mankovsky said, “I’ve decided to stay as long as possible. Then, nobody knows of course but I think I have to. ... We hear explosions every day. ... I’m in the center of the city and the streets are empty. It’s heartbreaking.”
 

Supplies are reaching refugees

Dr. Mankovsky said: “Now we have huge movement of refugees. Among them are a lot of people with diabetes who moved out of their place and nobody knows where they are. It’s really a huge disruption.”

According to the type 1 diabetes advocacy organization JDRF, many men with diabetes aged 18-60 are remaining in Ukraine to fight, despite the increased risk with the disease. But an estimated 15,000 children with type 1 diabetes and their families are attempting to escape the conflict by moving to the western regions of the country or over the borders.

“Those who make it to Hungary, Moldova, Poland, or Romania are being received with wonderful generosity. We have heard stories ranging from governments making it possible to pick up insulin free without a script to individuals emptying their cupboards of insulin for those whose need is urgent,” JDRF said in a statement on March 2.  

For its part, Novo Nordisk has donated 55 million Danish kroner (about 7.3 million Euros, or $8.2 million U.S. dollars) to support international relief organizations in assisting refugees.

Ivan Tkac, MD, PhD, professor of medicine at Safárik University in Kosice, Slovakia, is assisting refugees, including those with diabetes. Slovakia is predominantly a transit country for refugees from Ukraine, he said in an interview. 

“However, in solidarity with Ukraine, we are providing emergency medical care for both Ukrainians and refugees from third countries leaving Ukraine,” he said, noting that those individuals are primarily foreign students who had been studying there.

“Asylum seekers receive full medical insurance paid by the government of the Slovak Republic. As part of this care, the refugees are provided with the necessary amount of insulin and other antidiabetic drugs, as well as medical devices needed for the treatment of diabetes. The European Commission has pledged to supply Slovakia with the necessary quantities of medicines for the treatment of diabetes in the coming weeks as part of its assistance to the countries bordering Ukraine. In addition, some humanitarian organizations are organizing supplies of insulin and other medicines for soldiers fighting in the Ukrainian army,” Dr. Tkac said.
 

How you can help

A number of organizations are providing assistance specifically to people with diabetes, as well as broader medical assistance to people remaining in Ukraine and to refugees.

A collaboration between the Ministry of Health of Ukraine, the humanitarian agency Direct Relief, and the International Diabetes Federation is working to determine where supplies are short, to secure donations within Europe, and to open up “green corridors” within Ukraine to deliver them quickly to where they’re needed. They have asked those who wish to help to donate to Direct Relief and direct donations to the “Ukraine crisis.”

Another effort organized by IDF Europe is Connect Solidarity, a program that “aims to facilitate support from IDF Europe member associations across Europe wishing to help other national diabetes associations in Ukraine’s neighboring countries, provide advice, medicines, and supplies to Ukrainian refugees.”

IDF President Andrew Boulton, MD, told this news organization that he has been in almost daily contact with senior colleagues working in diabetes in Ukraine, and that he is working with the organization’s affiliated charity Life for a Child in addition to the other charitable agencies. “We will continue to do our utmost best to help those with diabetes living in Ukraine. However, this is, of course, very challenging, and we hope that we are doing the best we can in such a difficult situation. We all hope and pray that this situation is soon resolved.”

The European Association for the Study of Diabetes is taking a somewhat different approach, by encouraging its members to “support people with ill health, including diabetes, with donations through established [nongovernmental organizations] that have the capacity to help on site, such as United Nations High Commissioner for Refugees or International Committee of the Red Cross.”

Dr. Mankovsky told this news organization that he is very grateful for all the support from around the world: “Just thanks. I’ve got so much support, so many phone calls, so many letters ... not just me, all of us. People wise and friendship wise we feel support. It’s really important, emotionally and with insulin supply and other medications. Without that, it would be much more difficult.”
 

Pandemic-prompted changes enable wartime diabetes care

Dramatic changes in diabetes care delivery in Ukraine necessitated by the COVID-19 pandemic have proved indispensable during the Russian invasion.

In a piece published May 29, 2020, in the Journal of Diabetes Science and Technology, Dr. Mankovsky described how the pandemic hit just as Ukraine’s health system was pivoting from government controlled to insurance based.

Prior to the pandemic, patients with both type 1 and type 2 diabetes were regularly admitted to hospital for routine checkups, insulin dose management, and other treatments, a “remnant of the Soviet-era medical practice, which emphasized heavily on hospital admissions,” Dr. Mankovsky said in an interview.

This was the case, he wrote in the article, “despite the common understanding that such a system was a waste of resources ... this policy was changing much slower than we wanted.”

But the COVID-19 pandemic changed that practice “abruptly and dramatically,” so that all hospitalizations for patients with diabetes were stopped unless there was a real metabolic emergency.

Subsequently, Dr. Mankovsky wrote, “almost every health professional recognizes the particular importance of the new ways of communications with patients and with other colleagues.”

Indeed, in his email to this news organization, Dr. Smirnov mentioned that the routine diabetes management work he is still able to do remotely despite the extreme disruption in his region “is easy because of long-term COVID-period experience.”

Also because of the pandemic, insulin prescriptions were switched from traditional paper to electronic transfer, so that patients could easily pick them up at the pharmacy. “This new ... system proved to be not just very convenient for all parties involved, but in the current situation, it allowed us to prevent so many medically unnecessary visits to the clinics, which otherwise would have presented the real threat to the patients’ health and risk to get them infected,” Dr. Mankovsky wrote in 2020.

Now with the new danger, he said, “the inability to see patients is probably the least of our problems.”

A version of this article first appeared on Medscape.com.

Diabetes care and access to insulin and other medications in Ukraine have been “severely disrupted” since Russia’s invasion, with shortages resulting more from distribution problems than supply itself, according to multiple sources.

In 2021, there were about 2.3 million people with diabetes in Ukraine, roughly 7% of the total population. Of those, about 120,000 have type 1 diabetes and depend on insulin to live, while a similar number have insulin-treated type 2 diabetes.

Donations of insulin, other medications, and supplies have been pouring in since late February from sources including the Ukrainian diaspora, nongovernmental organizations, other European governments, universities, and product manufacturers. “The main problem now is logistic,” Boris Mankovsky, MD, president of the Ukrainian Diabetology Association, said in an interview.

Insulin manufacturer Novo Nordisk’s warehouse continues to operate, although deliveries have been curtailed because of shortages in delivery staff. The company is working to get medications to patients either through pharmacies or humanitarian organizations and has funded refugee support efforts, they said in a March 8 statement.

But even if the supplies reach the pharmacies, they may not reach patients for a variety of logistical reasons, noted Dr. Mankovsky, who is head of the department of diabetology at the P.L. Shupyk National Medical Academy for Postgraduate Education in Kyiv. “So, there are a lot of problems. I don’t know exactly where the main bottleneck is, but there are shortages, definitely.”

Insulin supplies have also been distributed very unequally by region and type, with various shipments containing long-acting, short-acting, analog, or human insulins. “We’re very grateful for all of it. But it’s not centrally coordinated, which of course is understandable, but it means that a lot of donations go to one place and no supply goes to another,” Dr. Mankovsky said.

Most of the donated supplies have been going to western Ukraine, where the capital Kyiv is located. “But the main problem now is the eastern part of Ukraine. It’s difficult and dangerous to deliver any supplies there, especially [with] the terrible situation in Mariupol. Eastern Ukraine now suffers the most, at least at this minute,” he said.  
 

Diabetes specialists continue to work, at least for now  

Ivan Smirnov, MD, PhD, head of the endocrinology department at Kharkiv Regional Hospital, in the northeastern part of the country, said in an email to this news organization: “I continue to stay in Kharkiv, in spite of the situation. A lot of people are killed, many people are wounded. My hospital is full of wounded civilians ... a lot of buildings are destroyed partly and some completely.”

Dr. Smirnov said that he and his colleagues “find the way to overcome the fear ... in constant work. Part of the work is online consulting assistance for routine patients. ... But the main time now is dedicated to providing the diabetes patients with insulin. This is a heavy job to do indeed.”

Dr. Mankovsky, who practices adult diabetology and endocrinology in Kyiv, continues to manage patients, but mostly remotely. “Practice is severely disrupted. I’m willing to see patients but it’s extremely difficult and dangerous for them and probably not possible to travel to see me. So that’s why all our communications now is distant, through phone or internet. ... We can communicate and I’m able to provide some recommendations for changes in treatment or some corrections in insulin therapy.”

Despite the Russians closing in on Kyiv, Dr. Mankovsky said, “I’ve decided to stay as long as possible. Then, nobody knows of course but I think I have to. ... We hear explosions every day. ... I’m in the center of the city and the streets are empty. It’s heartbreaking.”
 

Supplies are reaching refugees

Dr. Mankovsky said: “Now we have huge movement of refugees. Among them are a lot of people with diabetes who moved out of their place and nobody knows where they are. It’s really a huge disruption.”

According to the type 1 diabetes advocacy organization JDRF, many men with diabetes aged 18-60 are remaining in Ukraine to fight, despite the increased risk with the disease. But an estimated 15,000 children with type 1 diabetes and their families are attempting to escape the conflict by moving to the western regions of the country or over the borders.

“Those who make it to Hungary, Moldova, Poland, or Romania are being received with wonderful generosity. We have heard stories ranging from governments making it possible to pick up insulin free without a script to individuals emptying their cupboards of insulin for those whose need is urgent,” JDRF said in a statement on March 2.  

For its part, Novo Nordisk has donated 55 million Danish kroner (about 7.3 million Euros, or $8.2 million U.S. dollars) to support international relief organizations in assisting refugees.

Ivan Tkac, MD, PhD, professor of medicine at Safárik University in Kosice, Slovakia, is assisting refugees, including those with diabetes. Slovakia is predominantly a transit country for refugees from Ukraine, he said in an interview. 

“However, in solidarity with Ukraine, we are providing emergency medical care for both Ukrainians and refugees from third countries leaving Ukraine,” he said, noting that those individuals are primarily foreign students who had been studying there.

“Asylum seekers receive full medical insurance paid by the government of the Slovak Republic. As part of this care, the refugees are provided with the necessary amount of insulin and other antidiabetic drugs, as well as medical devices needed for the treatment of diabetes. The European Commission has pledged to supply Slovakia with the necessary quantities of medicines for the treatment of diabetes in the coming weeks as part of its assistance to the countries bordering Ukraine. In addition, some humanitarian organizations are organizing supplies of insulin and other medicines for soldiers fighting in the Ukrainian army,” Dr. Tkac said.
 

How you can help

A number of organizations are providing assistance specifically to people with diabetes, as well as broader medical assistance to people remaining in Ukraine and to refugees.

A collaboration between the Ministry of Health of Ukraine, the humanitarian agency Direct Relief, and the International Diabetes Federation is working to determine where supplies are short, to secure donations within Europe, and to open up “green corridors” within Ukraine to deliver them quickly to where they’re needed. They have asked those who wish to help to donate to Direct Relief and direct donations to the “Ukraine crisis.”

Another effort organized by IDF Europe is Connect Solidarity, a program that “aims to facilitate support from IDF Europe member associations across Europe wishing to help other national diabetes associations in Ukraine’s neighboring countries, provide advice, medicines, and supplies to Ukrainian refugees.”

IDF President Andrew Boulton, MD, told this news organization that he has been in almost daily contact with senior colleagues working in diabetes in Ukraine, and that he is working with the organization’s affiliated charity Life for a Child in addition to the other charitable agencies. “We will continue to do our utmost best to help those with diabetes living in Ukraine. However, this is, of course, very challenging, and we hope that we are doing the best we can in such a difficult situation. We all hope and pray that this situation is soon resolved.”

The European Association for the Study of Diabetes is taking a somewhat different approach, by encouraging its members to “support people with ill health, including diabetes, with donations through established [nongovernmental organizations] that have the capacity to help on site, such as United Nations High Commissioner for Refugees or International Committee of the Red Cross.”

Dr. Mankovsky told this news organization that he is very grateful for all the support from around the world: “Just thanks. I’ve got so much support, so many phone calls, so many letters ... not just me, all of us. People wise and friendship wise we feel support. It’s really important, emotionally and with insulin supply and other medications. Without that, it would be much more difficult.”
 

Pandemic-prompted changes enable wartime diabetes care

Dramatic changes in diabetes care delivery in Ukraine necessitated by the COVID-19 pandemic have proved indispensable during the Russian invasion.

In a piece published May 29, 2020, in the Journal of Diabetes Science and Technology, Dr. Mankovsky described how the pandemic hit just as Ukraine’s health system was pivoting from government controlled to insurance based.

Prior to the pandemic, patients with both type 1 and type 2 diabetes were regularly admitted to hospital for routine checkups, insulin dose management, and other treatments, a “remnant of the Soviet-era medical practice, which emphasized heavily on hospital admissions,” Dr. Mankovsky said in an interview.

This was the case, he wrote in the article, “despite the common understanding that such a system was a waste of resources ... this policy was changing much slower than we wanted.”

But the COVID-19 pandemic changed that practice “abruptly and dramatically,” so that all hospitalizations for patients with diabetes were stopped unless there was a real metabolic emergency.

Subsequently, Dr. Mankovsky wrote, “almost every health professional recognizes the particular importance of the new ways of communications with patients and with other colleagues.”

Indeed, in his email to this news organization, Dr. Smirnov mentioned that the routine diabetes management work he is still able to do remotely despite the extreme disruption in his region “is easy because of long-term COVID-period experience.”

Also because of the pandemic, insulin prescriptions were switched from traditional paper to electronic transfer, so that patients could easily pick them up at the pharmacy. “This new ... system proved to be not just very convenient for all parties involved, but in the current situation, it allowed us to prevent so many medically unnecessary visits to the clinics, which otherwise would have presented the real threat to the patients’ health and risk to get them infected,” Dr. Mankovsky wrote in 2020.

Now with the new danger, he said, “the inability to see patients is probably the least of our problems.”

A version of this article first appeared on Medscape.com.

As public attention continues to focus on making insulin affordable, a new online guide is available to help clinicians approach discussions with patients about diabetes medication affordability and access.

The resource, “Having Healthcare Cost Conversations to Improve Patient Outcomes: A Practical Guide,” was jointly developed by the Association of Diabetes Care & Education Specialists and Beyond Type 1, the nonprofit patient advocacy organization.

Indeed, the guide appeared as President Biden discussed his proposal to cap insulin costs at $35 per insulin vial during the State of the Union address, during which he introduced a young boy with type 1 diabetes in the guest box, as reported by this news organization. On March 3, Civica, a nonprofit coalition of health systems and philanthropies, announced it plans to manufacture generic insulin at a deeply discounted price, as reported by this news organization.

“Just to see diabetes front and center at the State of the Union followed by these announcements is certainly reflective of our own advocacy effort to make sure that people have affordable options for insulin, diabetes medications, services,” Kate Thomas, ADCES chief advocacy and external affairs officer, said in an interview. She added that ADCES has also pushed for legislation in Congress that would expand access to diabetes self-management training under the Medicare program.

The guide includes advice about overcoming barriers to discussing treatment costs with patients, suggested questions to ask patients about specific costs, and determinants of health and conversational approaches. Links are provided to resources for obtaining affordable insulin, other diabetes medications, and continuous glucose monitoring and insulin pump equipment.

“We know that, especially during primary care visits, there is limited time along with numbers of issues to talk about, so I think our challenge is how do we prioritize these conversations with something that can lead to action, not just saying you should do this but how do you actually do it,” Ms. Thomas said.

The introduction summarizes results from a 2021 Beyond Type 1 survey confirming prior findings reported by this news organization that cost is a frequent barrier for many individuals living with diabetes. “Especially right now where we are in terms of the impact of the pandemic and with peoples’ job statuses changing, I think it’s worthwhile to raise this in patient encounters,” Ms. Thomas said.
 

Overcoming conversational barriers

The first of three tables in the guide provides a list of “barriers to having a cost conversation” in the first column and “suggested solutions” in the second. For example, for the barrier, “You have insufficient time and/or knowledge about cost,” the suggestion is, “request and share available faculty and resources, including benefits coordinators, social workers, and community-based organizations. Work with the pharmacists and other members of the diabetes care team to identify resources that lower cost of medications.”

And for another barrier, “patients are often embarrassed or ashamed to initiate discussions of affordability,” the suggested solution is: “Normalize the issue of cost of care barriers for patients.”

A second table offers specific questions to ask patients about costs of medications and care, determinants of health, and financial barriers. These include: “What are some challenges you’ve had to accessing your medications or taking them as prescribed? What are some out-of-pocket health care costs you need help with? What challenges do you have accessing healthy food for you and your family?”

A link to a screening tool for social determinants of health is also included.

Language suggestions include talking about “cost of care” rather than “money,” asking patients if they’ve understood everything correctly by repeating back what they’ve said, and asking for confirmation and discussing follow-up.

Overall, the tool is designed to be a “broad conversation starter,” and not just about medications, Ms. Thomas said. “This is for all audiences and it’s meant to be something that the provider can tailor depending on who they’re speaking to. ... It’s about medications, but also the entire cost of care, including services and devices, transportation to appointments, access to food. ... Diabetes care isn’t just taking medication. It’s so many more factors.”

Ms. Thomas reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

As public attention continues to focus on making insulin affordable, a new online guide is available to help clinicians approach discussions with patients about diabetes medication affordability and access.

The resource, “Having Healthcare Cost Conversations to Improve Patient Outcomes: A Practical Guide,” was jointly developed by the Association of Diabetes Care & Education Specialists and Beyond Type 1, the nonprofit patient advocacy organization.

Indeed, the guide appeared as President Biden discussed his proposal to cap insulin costs at $35 per insulin vial during the State of the Union address, during which he introduced a young boy with type 1 diabetes in the guest box, as reported by this news organization. On March 3, Civica, a nonprofit coalition of health systems and philanthropies, announced it plans to manufacture generic insulin at a deeply discounted price, as reported by this news organization.

“Just to see diabetes front and center at the State of the Union followed by these announcements is certainly reflective of our own advocacy effort to make sure that people have affordable options for insulin, diabetes medications, services,” Kate Thomas, ADCES chief advocacy and external affairs officer, said in an interview. She added that ADCES has also pushed for legislation in Congress that would expand access to diabetes self-management training under the Medicare program.

The guide includes advice about overcoming barriers to discussing treatment costs with patients, suggested questions to ask patients about specific costs, and determinants of health and conversational approaches. Links are provided to resources for obtaining affordable insulin, other diabetes medications, and continuous glucose monitoring and insulin pump equipment.

“We know that, especially during primary care visits, there is limited time along with numbers of issues to talk about, so I think our challenge is how do we prioritize these conversations with something that can lead to action, not just saying you should do this but how do you actually do it,” Ms. Thomas said.

The introduction summarizes results from a 2021 Beyond Type 1 survey confirming prior findings reported by this news organization that cost is a frequent barrier for many individuals living with diabetes. “Especially right now where we are in terms of the impact of the pandemic and with peoples’ job statuses changing, I think it’s worthwhile to raise this in patient encounters,” Ms. Thomas said.
 

Overcoming conversational barriers

The first of three tables in the guide provides a list of “barriers to having a cost conversation” in the first column and “suggested solutions” in the second. For example, for the barrier, “You have insufficient time and/or knowledge about cost,” the suggestion is, “request and share available faculty and resources, including benefits coordinators, social workers, and community-based organizations. Work with the pharmacists and other members of the diabetes care team to identify resources that lower cost of medications.”

And for another barrier, “patients are often embarrassed or ashamed to initiate discussions of affordability,” the suggested solution is: “Normalize the issue of cost of care barriers for patients.”

A second table offers specific questions to ask patients about costs of medications and care, determinants of health, and financial barriers. These include: “What are some challenges you’ve had to accessing your medications or taking them as prescribed? What are some out-of-pocket health care costs you need help with? What challenges do you have accessing healthy food for you and your family?”

A link to a screening tool for social determinants of health is also included.

Language suggestions include talking about “cost of care” rather than “money,” asking patients if they’ve understood everything correctly by repeating back what they’ve said, and asking for confirmation and discussing follow-up.

Overall, the tool is designed to be a “broad conversation starter,” and not just about medications, Ms. Thomas said. “This is for all audiences and it’s meant to be something that the provider can tailor depending on who they’re speaking to. ... It’s about medications, but also the entire cost of care, including services and devices, transportation to appointments, access to food. ... Diabetes care isn’t just taking medication. It’s so many more factors.”

Ms. Thomas reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

As public attention continues to focus on making insulin affordable, a new online guide is available to help clinicians approach discussions with patients about diabetes medication affordability and access.

The resource, “Having Healthcare Cost Conversations to Improve Patient Outcomes: A Practical Guide,” was jointly developed by the Association of Diabetes Care & Education Specialists and Beyond Type 1, the nonprofit patient advocacy organization.

Indeed, the guide appeared as President Biden discussed his proposal to cap insulin costs at $35 per insulin vial during the State of the Union address, during which he introduced a young boy with type 1 diabetes in the guest box, as reported by this news organization. On March 3, Civica, a nonprofit coalition of health systems and philanthropies, announced it plans to manufacture generic insulin at a deeply discounted price, as reported by this news organization.

“Just to see diabetes front and center at the State of the Union followed by these announcements is certainly reflective of our own advocacy effort to make sure that people have affordable options for insulin, diabetes medications, services,” Kate Thomas, ADCES chief advocacy and external affairs officer, said in an interview. She added that ADCES has also pushed for legislation in Congress that would expand access to diabetes self-management training under the Medicare program.

The guide includes advice about overcoming barriers to discussing treatment costs with patients, suggested questions to ask patients about specific costs, and determinants of health and conversational approaches. Links are provided to resources for obtaining affordable insulin, other diabetes medications, and continuous glucose monitoring and insulin pump equipment.

“We know that, especially during primary care visits, there is limited time along with numbers of issues to talk about, so I think our challenge is how do we prioritize these conversations with something that can lead to action, not just saying you should do this but how do you actually do it,” Ms. Thomas said.

The introduction summarizes results from a 2021 Beyond Type 1 survey confirming prior findings reported by this news organization that cost is a frequent barrier for many individuals living with diabetes. “Especially right now where we are in terms of the impact of the pandemic and with peoples’ job statuses changing, I think it’s worthwhile to raise this in patient encounters,” Ms. Thomas said.
 

Overcoming conversational barriers

The first of three tables in the guide provides a list of “barriers to having a cost conversation” in the first column and “suggested solutions” in the second. For example, for the barrier, “You have insufficient time and/or knowledge about cost,” the suggestion is, “request and share available faculty and resources, including benefits coordinators, social workers, and community-based organizations. Work with the pharmacists and other members of the diabetes care team to identify resources that lower cost of medications.”

And for another barrier, “patients are often embarrassed or ashamed to initiate discussions of affordability,” the suggested solution is: “Normalize the issue of cost of care barriers for patients.”

A second table offers specific questions to ask patients about costs of medications and care, determinants of health, and financial barriers. These include: “What are some challenges you’ve had to accessing your medications or taking them as prescribed? What are some out-of-pocket health care costs you need help with? What challenges do you have accessing healthy food for you and your family?”

A link to a screening tool for social determinants of health is also included.

Language suggestions include talking about “cost of care” rather than “money,” asking patients if they’ve understood everything correctly by repeating back what they’ve said, and asking for confirmation and discussing follow-up.

Overall, the tool is designed to be a “broad conversation starter,” and not just about medications, Ms. Thomas said. “This is for all audiences and it’s meant to be something that the provider can tailor depending on who they’re speaking to. ... It’s about medications, but also the entire cost of care, including services and devices, transportation to appointments, access to food. ... Diabetes care isn’t just taking medication. It’s so many more factors.”

Ms. Thomas reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Universal screening for presymptomatic type 1 diabetes among schoolchildren would cost approximately 22 euros (about $25) per child screened, and about 7,000 euros (about $7,900) per child diagnosed, a new analysis of data from a German program finds.

The data come from the Fr1da study, in which a blood test for type 1 diabetes–associated islet autoantibodies is offered to all children aged 21 months to 6 years old in Bavaria.

Families of those who test positive are offered participation in a program of diabetes education, metabolic staging, psychological evaluation for stress, and prospective follow-up.

The researchers explain that, worldwide, 4 in 1,000 people under the age of 20 years have type 1 diabetes. It is the most common metabolic disease in children and adolescents. Only about 1 in 10 of those affected has a close relative with the disease. This means that type 1 diabetes can affect any child.

However, in many cases, the disease does not become known until a severe to life-threatening metabolic derailment known as diabetic ketoacidosis (DKA) occurs. This often leads to intensive medical treatment, a longer hospitalization, and poorer blood glucose control, which can result in an increased risk of secondary diseases and very high costs for the health care system.

“We want to protect as many children as possible from serious metabolic derailments. This is only possible with type 1 diabetes screenings. Therefore, we strongly support to include early detection tests in standard medical care,” Peter Achenbach, DrMed, senior author of the study, said in a statement from his institution, Helmholtz Zentrum München in Neuherberg, Germany.

The new findings were published in Diabetes Care by Florian M. Karl, also of Helmholtz Zentrum München, and colleagues.

In 2020, the Fr1da investigators reported that, of 90,632 children who participated from February 2015 to May 2019, 0.31% (280) were diagnosed with presymptomatic type 1 diabetes through the presence of two or more islet autoantibodies.

This news organization asked Brett McQueen, PhD, who led a similar study examining cost and cost-effectiveness in the Autoimmunity Screening for Kids (ASK) program, in which Denver-area children aged 2-17 years are offered autoantibody screening for both type 1 diabetes and celiac disease, for comment.

“If we have a chance to change a child’s life from when they’re 2 or 3 years old and there’s even a small chance that this thing potentially improves health outcomes for a decent price, what are we waiting for?” said Dr. McQueen, who is assistant professor in the department of clinical pharmacy at the University of Colorado, Aurora.
 

Is DKA prevention enough to justify universal screening?

Although identifying type 1 diabetes before symptoms arise could help avoid DKA, currently no therapeutic interventions are available to prevent or delay the trajectory from presymptomatic to clinical type 1 diabetes.

A possible future intervention – the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio) – had a setback in July 2021 when the Food and Drug Administration declined to approve it for the delay of type 1 diabetes in at-risk individuals.

However, on Feb. 22 Provention Bio announced that it has resubmitted the Biologics License Application for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals. The FDA now has 30 days to review the resubmission, determine whether it is complete and acceptable for review, and provide a review goal date, according to a company statement.

But even without the ability to forestall the development of type 1 diabetes, screening proponents point to the potential benefit from educating families about early signs of diabetes onset and thereby preventing progression to DKA and both its short-term and possible long-term sequelae.

Prevention of DKA at diagnosis has been linked to improved long-term glycemic control and other potential health benefits.

And the frequency of DKA at the onset of type 1 diabetes has increased in recent years, to more than 20% in Germany and over 45% in the United States.

But, prior data have suggested that universal screening for presymptomatic type 1 diabetes is unlikely to be cost effective if only the health and economic benefits of prevention of DKA at type 1 diabetes onset is considered, unless the screening costs are exceedingly low.
 

What will it take to implement universal screening?

“What this paper does is contribute really to our understanding of more around resource utilization,” noted Dr. McQueen. “As they correctly identify, it’s really hard to compare country prices. It’s easier to compare utilization.”

In Dr. McQueen’s ASK program, the cost per child screened and per case detected in that program were similar to those found in the German study, even though the cost of the antibody testing itself was considerably lower in Germany than in the United States.

Fr1da included more components of screening and monitoring than did ASK, Dr. McQueen told this news organization.

The conclusions of the ASK study were that “presymptomatic type 1 diabetes screening may be cost effective in areas with a high prevalence of DKA and an infrastructure facilitating screening and monitoring if the benefits of avoiding DKA events and improved [hemoglobin] A1c persist over long-run time horizons.”

Nonetheless, Dr. McQueen thinks it’s unlikely that universal screening will be recommended by professional societies or covered by payers in the United States until a pharmacologic intervention to forestall disease progression is available.“Teplizumab approval could move this along. ... We’re just trying to take one factor, the economics of it, to create the most efficient scenario so that if it were to be adopted we would catch the most cases, prevent the most complications, benefit children the most in terms of their lifetime health outcomes – all at the minimum cost possible.”
 

‘A benchmark for the expected implementation cost of screening’

Mr. Karl and colleagues simulated the cost of implementation of this screening as standard care in Germany – assuming the same 0.31% prevalence found in Fr1da – the average cost per child was estimated at 21.73 euros, including 9.34 euros for laboratory costs, 12.25 euros for pediatrician costs, and 0.14 euros for local diabetes clinics to perform metabolic staging and education for children diagnosed with presymptomatic type 1 diabetes.

The model included 50% of the costs incurred in Fr1da for obtaining informed consent. Negative autoantibody results from the initial screening were not communicated to families, and all children with presymptomatic type 1 diabetes received staging and education. The estimated average cost per diagnosed child was 7,035 euros.

“Although our analyses are subject to some level of uncertainty, they provide a benchmark for the expected implementation cost of screening,” said coauthor Michael Laxy, MSc, PhD, also at Helmholtz Zentrum München.

“Next, we aim to evaluate the long-term ratio of screening costs, potential cost savings through the prevention of metabolic derailment and its consequences, and potentially increased quality of life with a type 1 diabetes screening compared to the costs and quality of life without a screening.”

Dr. McQueen is working along similar lines in Colorado, attempting to create a model that incorporates all the different possibilities including DKA monitoring, teplizumab availability, screening children at different ages, and the effect of including blood glucose monitoring in children identified with presymptomatic type 1 diabetes.

“There are so many different potential answers and avenues and no one has really put it all together,” he observed.

But he believes that economics shouldn’t be the only factor used in deciding whether to institute widespread screening.

This study was supported by grants from the German Federal Ministry of Education and Research to the German Center for Diabetes Research (DZD). The Fr1da study was supported by grants from the LifeScience-Stiftung, JDRF International, the Bavarian State Ministry of Health and Care, the Leona M. and Harry B. Helmsley Charitable Trust, Deutsche Diabetes-Stiftung, Landesverband Bayern der Betriebskrankenkassen, B. Braun-Stiftung, Deutsche Diabetes Hilfe, and the German Federal Ministry of Education and Research to the DZD. The authors disclosed no relevant financial relationships. The ASK study was funded by JDRF International, the Leona M. and Harry B. Helmsley Charitable Trust, and Janssen Research and Development. Dr. McQueen has received institutional funding for value assessment applications from the Institute for Clinical and Economic Review, the PhRMA Foundation, and PhRMA.

A version of this article first appeared on Medscape.com.

Universal screening for presymptomatic type 1 diabetes among schoolchildren would cost approximately 22 euros (about $25) per child screened, and about 7,000 euros (about $7,900) per child diagnosed, a new analysis of data from a German program finds.

The data come from the Fr1da study, in which a blood test for type 1 diabetes–associated islet autoantibodies is offered to all children aged 21 months to 6 years old in Bavaria.

Families of those who test positive are offered participation in a program of diabetes education, metabolic staging, psychological evaluation for stress, and prospective follow-up.

The researchers explain that, worldwide, 4 in 1,000 people under the age of 20 years have type 1 diabetes. It is the most common metabolic disease in children and adolescents. Only about 1 in 10 of those affected has a close relative with the disease. This means that type 1 diabetes can affect any child.

However, in many cases, the disease does not become known until a severe to life-threatening metabolic derailment known as diabetic ketoacidosis (DKA) occurs. This often leads to intensive medical treatment, a longer hospitalization, and poorer blood glucose control, which can result in an increased risk of secondary diseases and very high costs for the health care system.

“We want to protect as many children as possible from serious metabolic derailments. This is only possible with type 1 diabetes screenings. Therefore, we strongly support to include early detection tests in standard medical care,” Peter Achenbach, DrMed, senior author of the study, said in a statement from his institution, Helmholtz Zentrum München in Neuherberg, Germany.

The new findings were published in Diabetes Care by Florian M. Karl, also of Helmholtz Zentrum München, and colleagues.

In 2020, the Fr1da investigators reported that, of 90,632 children who participated from February 2015 to May 2019, 0.31% (280) were diagnosed with presymptomatic type 1 diabetes through the presence of two or more islet autoantibodies.

This news organization asked Brett McQueen, PhD, who led a similar study examining cost and cost-effectiveness in the Autoimmunity Screening for Kids (ASK) program, in which Denver-area children aged 2-17 years are offered autoantibody screening for both type 1 diabetes and celiac disease, for comment.

“If we have a chance to change a child’s life from when they’re 2 or 3 years old and there’s even a small chance that this thing potentially improves health outcomes for a decent price, what are we waiting for?” said Dr. McQueen, who is assistant professor in the department of clinical pharmacy at the University of Colorado, Aurora.
 

Is DKA prevention enough to justify universal screening?

Although identifying type 1 diabetes before symptoms arise could help avoid DKA, currently no therapeutic interventions are available to prevent or delay the trajectory from presymptomatic to clinical type 1 diabetes.

A possible future intervention – the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio) – had a setback in July 2021 when the Food and Drug Administration declined to approve it for the delay of type 1 diabetes in at-risk individuals.

However, on Feb. 22 Provention Bio announced that it has resubmitted the Biologics License Application for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals. The FDA now has 30 days to review the resubmission, determine whether it is complete and acceptable for review, and provide a review goal date, according to a company statement.

But even without the ability to forestall the development of type 1 diabetes, screening proponents point to the potential benefit from educating families about early signs of diabetes onset and thereby preventing progression to DKA and both its short-term and possible long-term sequelae.

Prevention of DKA at diagnosis has been linked to improved long-term glycemic control and other potential health benefits.

And the frequency of DKA at the onset of type 1 diabetes has increased in recent years, to more than 20% in Germany and over 45% in the United States.

But, prior data have suggested that universal screening for presymptomatic type 1 diabetes is unlikely to be cost effective if only the health and economic benefits of prevention of DKA at type 1 diabetes onset is considered, unless the screening costs are exceedingly low.
 

What will it take to implement universal screening?

“What this paper does is contribute really to our understanding of more around resource utilization,” noted Dr. McQueen. “As they correctly identify, it’s really hard to compare country prices. It’s easier to compare utilization.”

In Dr. McQueen’s ASK program, the cost per child screened and per case detected in that program were similar to those found in the German study, even though the cost of the antibody testing itself was considerably lower in Germany than in the United States.

Fr1da included more components of screening and monitoring than did ASK, Dr. McQueen told this news organization.

The conclusions of the ASK study were that “presymptomatic type 1 diabetes screening may be cost effective in areas with a high prevalence of DKA and an infrastructure facilitating screening and monitoring if the benefits of avoiding DKA events and improved [hemoglobin] A1c persist over long-run time horizons.”

Nonetheless, Dr. McQueen thinks it’s unlikely that universal screening will be recommended by professional societies or covered by payers in the United States until a pharmacologic intervention to forestall disease progression is available.“Teplizumab approval could move this along. ... We’re just trying to take one factor, the economics of it, to create the most efficient scenario so that if it were to be adopted we would catch the most cases, prevent the most complications, benefit children the most in terms of their lifetime health outcomes – all at the minimum cost possible.”
 

‘A benchmark for the expected implementation cost of screening’

Mr. Karl and colleagues simulated the cost of implementation of this screening as standard care in Germany – assuming the same 0.31% prevalence found in Fr1da – the average cost per child was estimated at 21.73 euros, including 9.34 euros for laboratory costs, 12.25 euros for pediatrician costs, and 0.14 euros for local diabetes clinics to perform metabolic staging and education for children diagnosed with presymptomatic type 1 diabetes.

The model included 50% of the costs incurred in Fr1da for obtaining informed consent. Negative autoantibody results from the initial screening were not communicated to families, and all children with presymptomatic type 1 diabetes received staging and education. The estimated average cost per diagnosed child was 7,035 euros.

“Although our analyses are subject to some level of uncertainty, they provide a benchmark for the expected implementation cost of screening,” said coauthor Michael Laxy, MSc, PhD, also at Helmholtz Zentrum München.

“Next, we aim to evaluate the long-term ratio of screening costs, potential cost savings through the prevention of metabolic derailment and its consequences, and potentially increased quality of life with a type 1 diabetes screening compared to the costs and quality of life without a screening.”

Dr. McQueen is working along similar lines in Colorado, attempting to create a model that incorporates all the different possibilities including DKA monitoring, teplizumab availability, screening children at different ages, and the effect of including blood glucose monitoring in children identified with presymptomatic type 1 diabetes.

“There are so many different potential answers and avenues and no one has really put it all together,” he observed.

But he believes that economics shouldn’t be the only factor used in deciding whether to institute widespread screening.

This study was supported by grants from the German Federal Ministry of Education and Research to the German Center for Diabetes Research (DZD). The Fr1da study was supported by grants from the LifeScience-Stiftung, JDRF International, the Bavarian State Ministry of Health and Care, the Leona M. and Harry B. Helmsley Charitable Trust, Deutsche Diabetes-Stiftung, Landesverband Bayern der Betriebskrankenkassen, B. Braun-Stiftung, Deutsche Diabetes Hilfe, and the German Federal Ministry of Education and Research to the DZD. The authors disclosed no relevant financial relationships. The ASK study was funded by JDRF International, the Leona M. and Harry B. Helmsley Charitable Trust, and Janssen Research and Development. Dr. McQueen has received institutional funding for value assessment applications from the Institute for Clinical and Economic Review, the PhRMA Foundation, and PhRMA.

A version of this article first appeared on Medscape.com.

Universal screening for presymptomatic type 1 diabetes among schoolchildren would cost approximately 22 euros (about $25) per child screened, and about 7,000 euros (about $7,900) per child diagnosed, a new analysis of data from a German program finds.

The data come from the Fr1da study, in which a blood test for type 1 diabetes–associated islet autoantibodies is offered to all children aged 21 months to 6 years old in Bavaria.

Families of those who test positive are offered participation in a program of diabetes education, metabolic staging, psychological evaluation for stress, and prospective follow-up.

The researchers explain that, worldwide, 4 in 1,000 people under the age of 20 years have type 1 diabetes. It is the most common metabolic disease in children and adolescents. Only about 1 in 10 of those affected has a close relative with the disease. This means that type 1 diabetes can affect any child.

However, in many cases, the disease does not become known until a severe to life-threatening metabolic derailment known as diabetic ketoacidosis (DKA) occurs. This often leads to intensive medical treatment, a longer hospitalization, and poorer blood glucose control, which can result in an increased risk of secondary diseases and very high costs for the health care system.

“We want to protect as many children as possible from serious metabolic derailments. This is only possible with type 1 diabetes screenings. Therefore, we strongly support to include early detection tests in standard medical care,” Peter Achenbach, DrMed, senior author of the study, said in a statement from his institution, Helmholtz Zentrum München in Neuherberg, Germany.

The new findings were published in Diabetes Care by Florian M. Karl, also of Helmholtz Zentrum München, and colleagues.

In 2020, the Fr1da investigators reported that, of 90,632 children who participated from February 2015 to May 2019, 0.31% (280) were diagnosed with presymptomatic type 1 diabetes through the presence of two or more islet autoantibodies.

This news organization asked Brett McQueen, PhD, who led a similar study examining cost and cost-effectiveness in the Autoimmunity Screening for Kids (ASK) program, in which Denver-area children aged 2-17 years are offered autoantibody screening for both type 1 diabetes and celiac disease, for comment.

“If we have a chance to change a child’s life from when they’re 2 or 3 years old and there’s even a small chance that this thing potentially improves health outcomes for a decent price, what are we waiting for?” said Dr. McQueen, who is assistant professor in the department of clinical pharmacy at the University of Colorado, Aurora.
 

Is DKA prevention enough to justify universal screening?

Although identifying type 1 diabetes before symptoms arise could help avoid DKA, currently no therapeutic interventions are available to prevent or delay the trajectory from presymptomatic to clinical type 1 diabetes.

A possible future intervention – the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio) – had a setback in July 2021 when the Food and Drug Administration declined to approve it for the delay of type 1 diabetes in at-risk individuals.

However, on Feb. 22 Provention Bio announced that it has resubmitted the Biologics License Application for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals. The FDA now has 30 days to review the resubmission, determine whether it is complete and acceptable for review, and provide a review goal date, according to a company statement.

But even without the ability to forestall the development of type 1 diabetes, screening proponents point to the potential benefit from educating families about early signs of diabetes onset and thereby preventing progression to DKA and both its short-term and possible long-term sequelae.

Prevention of DKA at diagnosis has been linked to improved long-term glycemic control and other potential health benefits.

And the frequency of DKA at the onset of type 1 diabetes has increased in recent years, to more than 20% in Germany and over 45% in the United States.

But, prior data have suggested that universal screening for presymptomatic type 1 diabetes is unlikely to be cost effective if only the health and economic benefits of prevention of DKA at type 1 diabetes onset is considered, unless the screening costs are exceedingly low.
 

What will it take to implement universal screening?

“What this paper does is contribute really to our understanding of more around resource utilization,” noted Dr. McQueen. “As they correctly identify, it’s really hard to compare country prices. It’s easier to compare utilization.”

In Dr. McQueen’s ASK program, the cost per child screened and per case detected in that program were similar to those found in the German study, even though the cost of the antibody testing itself was considerably lower in Germany than in the United States.

Fr1da included more components of screening and monitoring than did ASK, Dr. McQueen told this news organization.

The conclusions of the ASK study were that “presymptomatic type 1 diabetes screening may be cost effective in areas with a high prevalence of DKA and an infrastructure facilitating screening and monitoring if the benefits of avoiding DKA events and improved [hemoglobin] A1c persist over long-run time horizons.”

Nonetheless, Dr. McQueen thinks it’s unlikely that universal screening will be recommended by professional societies or covered by payers in the United States until a pharmacologic intervention to forestall disease progression is available.“Teplizumab approval could move this along. ... We’re just trying to take one factor, the economics of it, to create the most efficient scenario so that if it were to be adopted we would catch the most cases, prevent the most complications, benefit children the most in terms of their lifetime health outcomes – all at the minimum cost possible.”
 

‘A benchmark for the expected implementation cost of screening’

Mr. Karl and colleagues simulated the cost of implementation of this screening as standard care in Germany – assuming the same 0.31% prevalence found in Fr1da – the average cost per child was estimated at 21.73 euros, including 9.34 euros for laboratory costs, 12.25 euros for pediatrician costs, and 0.14 euros for local diabetes clinics to perform metabolic staging and education for children diagnosed with presymptomatic type 1 diabetes.

The model included 50% of the costs incurred in Fr1da for obtaining informed consent. Negative autoantibody results from the initial screening were not communicated to families, and all children with presymptomatic type 1 diabetes received staging and education. The estimated average cost per diagnosed child was 7,035 euros.

“Although our analyses are subject to some level of uncertainty, they provide a benchmark for the expected implementation cost of screening,” said coauthor Michael Laxy, MSc, PhD, also at Helmholtz Zentrum München.

“Next, we aim to evaluate the long-term ratio of screening costs, potential cost savings through the prevention of metabolic derailment and its consequences, and potentially increased quality of life with a type 1 diabetes screening compared to the costs and quality of life without a screening.”

Dr. McQueen is working along similar lines in Colorado, attempting to create a model that incorporates all the different possibilities including DKA monitoring, teplizumab availability, screening children at different ages, and the effect of including blood glucose monitoring in children identified with presymptomatic type 1 diabetes.

“There are so many different potential answers and avenues and no one has really put it all together,” he observed.

But he believes that economics shouldn’t be the only factor used in deciding whether to institute widespread screening.

This study was supported by grants from the German Federal Ministry of Education and Research to the German Center for Diabetes Research (DZD). The Fr1da study was supported by grants from the LifeScience-Stiftung, JDRF International, the Bavarian State Ministry of Health and Care, the Leona M. and Harry B. Helmsley Charitable Trust, Deutsche Diabetes-Stiftung, Landesverband Bayern der Betriebskrankenkassen, B. Braun-Stiftung, Deutsche Diabetes Hilfe, and the German Federal Ministry of Education and Research to the DZD. The authors disclosed no relevant financial relationships. The ASK study was funded by JDRF International, the Leona M. and Harry B. Helmsley Charitable Trust, and Janssen Research and Development. Dr. McQueen has received institutional funding for value assessment applications from the Institute for Clinical and Economic Review, the PhRMA Foundation, and PhRMA.

A version of this article first appeared on Medscape.com.

The Dexcom G7 continuous glucose monitor (CGM) is as accurate or better than other currently marketed CGM devices for measuring glucose in those with diabetes, new data from a pivotal study suggest.  

Currently under review by the U.S. Food and Drug Administration, the G7 is expected to be an improvement over the Dexcom G6 version in several ways.

The on-body size will be 60% smaller, “roughly the size of three stacked quarters,” according to the authors, and will incorporate the sensor with a single-use transmitter, as opposed to the current separate 3-month transmitter used with the G6 sensor. This will eliminate the need for using a transmitter across multiple sensor sessions (as is the case for G6).

The warm-up period after insertion is reduced from 2 hours to 27 minutes, and users are given an extra 12-hour “grace period” after the 10-day wear period to change the device before it stops displaying glucose data. Up to 24 hours of missed data can also be recaptured.

“The enhanced features of G7 may increase clinical adoption, encourage sustained use, and reduce the burden of diabetes management,” write Satish K. Garg, MD, of the University of Colorado, Aurora, and colleagues, in their article, published online Feb. 14 in Diabetes Technology & Therapeutics.  

Several features of the G6 remain unchanged, including factory calibration, but also the capacity for optional user calibrations, use of Bluetooth to transmit data up to 20 feet (approximately 6 meters), and data displays on either a dedicated receiver or a variety of iOS and Android smart devices.

It will also allow for user-customized settings and alerts, as well as the option for real-time remote “share” monitoring with caregivers or providers. The G7 will also not be susceptible to interference by acetaminophen (paracetamol) or ascorbic acid.

And, like the G6, the G7 was submitted for approval to the FDA as an “integrated CGM,” meaning that it will be interoperable with other compatible devices, including insulin pumps, glucose meters, or other electronic devices used for diabetes management.

Accuracy shown on abdomen, arm

The prospective, multicenter, single-arm study reported by Dr. Garg and colleagues was conducted at 12 U.S. sites between February and June 2021.

In-clinic visits were conducted on days 1 or 2, 4 or 7, and one additional day for comparisons with a reference glucose measure (YSI 2300 Stat Plus glucose analyzer). Participants wore blinded G7 sensors concurrently on the upper arm and abdomen while continuing to use their own personal glucose monitoring method (CGM or fingerstick) at home.

A total of 316 insulin-using adults with type 1 or type 2 diabetes contributed data from 308 arm- and 311 abdomen-placed blinded devices, which generated 77,774 matched pairs of data within the blood glucose reportable range of 40-400 mg/dL.  

The overall mean absolute relative difference (MARD) of each CGM-YSI pair (a standard metric for CGM analysis) was 8.2%, with 9.1% for the abdomen and 8.2% for the arm.

Accuracy remained high in both arm- and abdomen-placed sensors across the 10-day wear period through the 12-hour grace period and across glucose ranges. There were no significant differences between G7 accuracy by diabetes type, insulin regimen, or body mass index.

The highest agreement rates and lowest MARDs occurred when CGM readings were increasing or decreasing by no more than 1 mg/dL per minute. However, even at the highest rates of glucose concentration change, MARD values below 10% were found for arm-placed sensors and below 10.5% for abdomen-placed sensors, Dr. Garg and colleagues report.

When the hypoglycemia threshold alert was set to 55 mg/dL, true alert rates for detection of hypoglycemia below 70 mg/dL by sensors worn on the arm and abdomen were 91.3% and 85.2%, respectively. With hyperglycemia threshold alerts set to 300 mg/dL, the true alert rates for detection of hyperglycemia greater than 250 mg/dL by sensors worn on the arm and abdomen were 99.9% and 99.8% respectively.

The overall mean time lag for the sensors was 3.5 minutes, 3.6 minutes for the arm, and 3.4 minutes for the abdomen. There were no serious adverse events during the study.

The study excluded children and adolescents; data from these populations will be reported separately, the authors note.
 

Accuracy at least as good as prior Dexcom versions, competitors

The MARD values of 8.2% on the arm and 9.1% on the abdomen were similar to or better than accuracy measurements of other commercially available CGM systems, note Dr. Garg and colleagues, although they acknowledge that few head-to-head studies at different anatomic locations have been conducted.

A study of an older Dexcom version (G4 Platinum) found MARD estimates of 12.0% on the arm and 12.3% on the abdomen, the authors note.  

The newly FDA-approved implantable Eversense E3 (Senseonics) CGM, worn on the upper arm, has a MARD of 9.1%, while the arm-placed Abbott FreeStyle Libre 2, approved in the U.S. in June 2020, has an overall MARD of 9.3%.

Lag-time differences between the reference and G7 were also similar to or better than time delays in prior-generation Dexcom CGMs, Dr. Garg and colleagues say.

Participants also completed a survey. “The redesigned applicator allows for sensor deployment with one hand, and most participants found G7 easier to insert than their prior CGM system,” the researchers say.

Finally, “unlike G6, G7 allows for temporary silencing of all audible alerts, including Urgent Low. Taken together, these attributes are anticipated to provide for a better end-user experience with G7 and help reduce diabetes burden,” they conclude.

The study was supported by a grant from Dexcom. Dr. Garg has reported receiving consultant fees from Medtronic, Novo Nordisk, Zealand, LifeScan, Roche, and Lilly, as well as research grants through the University of Colorado from Lilly, Novo Nordisk, Medtronic, Dexcom, T1D Exchange, Helmsley Trust, NIDDK, and JDRF.

A version of this article first appeared on Medscape.com.

The Dexcom G7 continuous glucose monitor (CGM) is as accurate or better than other currently marketed CGM devices for measuring glucose in those with diabetes, new data from a pivotal study suggest.  

Currently under review by the U.S. Food and Drug Administration, the G7 is expected to be an improvement over the Dexcom G6 version in several ways.

The on-body size will be 60% smaller, “roughly the size of three stacked quarters,” according to the authors, and will incorporate the sensor with a single-use transmitter, as opposed to the current separate 3-month transmitter used with the G6 sensor. This will eliminate the need for using a transmitter across multiple sensor sessions (as is the case for G6).

The warm-up period after insertion is reduced from 2 hours to 27 minutes, and users are given an extra 12-hour “grace period” after the 10-day wear period to change the device before it stops displaying glucose data. Up to 24 hours of missed data can also be recaptured.

“The enhanced features of G7 may increase clinical adoption, encourage sustained use, and reduce the burden of diabetes management,” write Satish K. Garg, MD, of the University of Colorado, Aurora, and colleagues, in their article, published online Feb. 14 in Diabetes Technology & Therapeutics.  

Several features of the G6 remain unchanged, including factory calibration, but also the capacity for optional user calibrations, use of Bluetooth to transmit data up to 20 feet (approximately 6 meters), and data displays on either a dedicated receiver or a variety of iOS and Android smart devices.

It will also allow for user-customized settings and alerts, as well as the option for real-time remote “share” monitoring with caregivers or providers. The G7 will also not be susceptible to interference by acetaminophen (paracetamol) or ascorbic acid.

And, like the G6, the G7 was submitted for approval to the FDA as an “integrated CGM,” meaning that it will be interoperable with other compatible devices, including insulin pumps, glucose meters, or other electronic devices used for diabetes management.

Accuracy shown on abdomen, arm

The prospective, multicenter, single-arm study reported by Dr. Garg and colleagues was conducted at 12 U.S. sites between February and June 2021.

In-clinic visits were conducted on days 1 or 2, 4 or 7, and one additional day for comparisons with a reference glucose measure (YSI 2300 Stat Plus glucose analyzer). Participants wore blinded G7 sensors concurrently on the upper arm and abdomen while continuing to use their own personal glucose monitoring method (CGM or fingerstick) at home.

A total of 316 insulin-using adults with type 1 or type 2 diabetes contributed data from 308 arm- and 311 abdomen-placed blinded devices, which generated 77,774 matched pairs of data within the blood glucose reportable range of 40-400 mg/dL.  

The overall mean absolute relative difference (MARD) of each CGM-YSI pair (a standard metric for CGM analysis) was 8.2%, with 9.1% for the abdomen and 8.2% for the arm.

Accuracy remained high in both arm- and abdomen-placed sensors across the 10-day wear period through the 12-hour grace period and across glucose ranges. There were no significant differences between G7 accuracy by diabetes type, insulin regimen, or body mass index.

The highest agreement rates and lowest MARDs occurred when CGM readings were increasing or decreasing by no more than 1 mg/dL per minute. However, even at the highest rates of glucose concentration change, MARD values below 10% were found for arm-placed sensors and below 10.5% for abdomen-placed sensors, Dr. Garg and colleagues report.

When the hypoglycemia threshold alert was set to 55 mg/dL, true alert rates for detection of hypoglycemia below 70 mg/dL by sensors worn on the arm and abdomen were 91.3% and 85.2%, respectively. With hyperglycemia threshold alerts set to 300 mg/dL, the true alert rates for detection of hyperglycemia greater than 250 mg/dL by sensors worn on the arm and abdomen were 99.9% and 99.8% respectively.

The overall mean time lag for the sensors was 3.5 minutes, 3.6 minutes for the arm, and 3.4 minutes for the abdomen. There were no serious adverse events during the study.

The study excluded children and adolescents; data from these populations will be reported separately, the authors note.
 

Accuracy at least as good as prior Dexcom versions, competitors

The MARD values of 8.2% on the arm and 9.1% on the abdomen were similar to or better than accuracy measurements of other commercially available CGM systems, note Dr. Garg and colleagues, although they acknowledge that few head-to-head studies at different anatomic locations have been conducted.

A study of an older Dexcom version (G4 Platinum) found MARD estimates of 12.0% on the arm and 12.3% on the abdomen, the authors note.  

The newly FDA-approved implantable Eversense E3 (Senseonics) CGM, worn on the upper arm, has a MARD of 9.1%, while the arm-placed Abbott FreeStyle Libre 2, approved in the U.S. in June 2020, has an overall MARD of 9.3%.

Lag-time differences between the reference and G7 were also similar to or better than time delays in prior-generation Dexcom CGMs, Dr. Garg and colleagues say.

Participants also completed a survey. “The redesigned applicator allows for sensor deployment with one hand, and most participants found G7 easier to insert than their prior CGM system,” the researchers say.

Finally, “unlike G6, G7 allows for temporary silencing of all audible alerts, including Urgent Low. Taken together, these attributes are anticipated to provide for a better end-user experience with G7 and help reduce diabetes burden,” they conclude.

The study was supported by a grant from Dexcom. Dr. Garg has reported receiving consultant fees from Medtronic, Novo Nordisk, Zealand, LifeScan, Roche, and Lilly, as well as research grants through the University of Colorado from Lilly, Novo Nordisk, Medtronic, Dexcom, T1D Exchange, Helmsley Trust, NIDDK, and JDRF.

A version of this article first appeared on Medscape.com.

The Dexcom G7 continuous glucose monitor (CGM) is as accurate or better than other currently marketed CGM devices for measuring glucose in those with diabetes, new data from a pivotal study suggest.  

Currently under review by the U.S. Food and Drug Administration, the G7 is expected to be an improvement over the Dexcom G6 version in several ways.

The on-body size will be 60% smaller, “roughly the size of three stacked quarters,” according to the authors, and will incorporate the sensor with a single-use transmitter, as opposed to the current separate 3-month transmitter used with the G6 sensor. This will eliminate the need for using a transmitter across multiple sensor sessions (as is the case for G6).

The warm-up period after insertion is reduced from 2 hours to 27 minutes, and users are given an extra 12-hour “grace period” after the 10-day wear period to change the device before it stops displaying glucose data. Up to 24 hours of missed data can also be recaptured.

“The enhanced features of G7 may increase clinical adoption, encourage sustained use, and reduce the burden of diabetes management,” write Satish K. Garg, MD, of the University of Colorado, Aurora, and colleagues, in their article, published online Feb. 14 in Diabetes Technology & Therapeutics.  

Several features of the G6 remain unchanged, including factory calibration, but also the capacity for optional user calibrations, use of Bluetooth to transmit data up to 20 feet (approximately 6 meters), and data displays on either a dedicated receiver or a variety of iOS and Android smart devices.

It will also allow for user-customized settings and alerts, as well as the option for real-time remote “share” monitoring with caregivers or providers. The G7 will also not be susceptible to interference by acetaminophen (paracetamol) or ascorbic acid.

And, like the G6, the G7 was submitted for approval to the FDA as an “integrated CGM,” meaning that it will be interoperable with other compatible devices, including insulin pumps, glucose meters, or other electronic devices used for diabetes management.

Accuracy shown on abdomen, arm

The prospective, multicenter, single-arm study reported by Dr. Garg and colleagues was conducted at 12 U.S. sites between February and June 2021.

In-clinic visits were conducted on days 1 or 2, 4 or 7, and one additional day for comparisons with a reference glucose measure (YSI 2300 Stat Plus glucose analyzer). Participants wore blinded G7 sensors concurrently on the upper arm and abdomen while continuing to use their own personal glucose monitoring method (CGM or fingerstick) at home.

A total of 316 insulin-using adults with type 1 or type 2 diabetes contributed data from 308 arm- and 311 abdomen-placed blinded devices, which generated 77,774 matched pairs of data within the blood glucose reportable range of 40-400 mg/dL.  

The overall mean absolute relative difference (MARD) of each CGM-YSI pair (a standard metric for CGM analysis) was 8.2%, with 9.1% for the abdomen and 8.2% for the arm.

Accuracy remained high in both arm- and abdomen-placed sensors across the 10-day wear period through the 12-hour grace period and across glucose ranges. There were no significant differences between G7 accuracy by diabetes type, insulin regimen, or body mass index.

The highest agreement rates and lowest MARDs occurred when CGM readings were increasing or decreasing by no more than 1 mg/dL per minute. However, even at the highest rates of glucose concentration change, MARD values below 10% were found for arm-placed sensors and below 10.5% for abdomen-placed sensors, Dr. Garg and colleagues report.

When the hypoglycemia threshold alert was set to 55 mg/dL, true alert rates for detection of hypoglycemia below 70 mg/dL by sensors worn on the arm and abdomen were 91.3% and 85.2%, respectively. With hyperglycemia threshold alerts set to 300 mg/dL, the true alert rates for detection of hyperglycemia greater than 250 mg/dL by sensors worn on the arm and abdomen were 99.9% and 99.8% respectively.

The overall mean time lag for the sensors was 3.5 minutes, 3.6 minutes for the arm, and 3.4 minutes for the abdomen. There were no serious adverse events during the study.

The study excluded children and adolescents; data from these populations will be reported separately, the authors note.
 

Accuracy at least as good as prior Dexcom versions, competitors

The MARD values of 8.2% on the arm and 9.1% on the abdomen were similar to or better than accuracy measurements of other commercially available CGM systems, note Dr. Garg and colleagues, although they acknowledge that few head-to-head studies at different anatomic locations have been conducted.

A study of an older Dexcom version (G4 Platinum) found MARD estimates of 12.0% on the arm and 12.3% on the abdomen, the authors note.  

The newly FDA-approved implantable Eversense E3 (Senseonics) CGM, worn on the upper arm, has a MARD of 9.1%, while the arm-placed Abbott FreeStyle Libre 2, approved in the U.S. in June 2020, has an overall MARD of 9.3%.

Lag-time differences between the reference and G7 were also similar to or better than time delays in prior-generation Dexcom CGMs, Dr. Garg and colleagues say.

Participants also completed a survey. “The redesigned applicator allows for sensor deployment with one hand, and most participants found G7 easier to insert than their prior CGM system,” the researchers say.

Finally, “unlike G6, G7 allows for temporary silencing of all audible alerts, including Urgent Low. Taken together, these attributes are anticipated to provide for a better end-user experience with G7 and help reduce diabetes burden,” they conclude.

The study was supported by a grant from Dexcom. Dr. Garg has reported receiving consultant fees from Medtronic, Novo Nordisk, Zealand, LifeScan, Roche, and Lilly, as well as research grants through the University of Colorado from Lilly, Novo Nordisk, Medtronic, Dexcom, T1D Exchange, Helmsley Trust, NIDDK, and JDRF.

A version of this article first appeared on Medscape.com.

Estrogen supplementation is associated with a reduced risk of death from COVID-19 among postmenopausal women, new research suggests.

The findings, from a nationwide study using data from Sweden, were published online Feb. 14 in BMJ Open by Malin Sund, MD, PhD, of Umeå (Sweden) University Faculty of Medicine and colleagues.

Among postmenopausal women aged 50-80 years with verified COVID-19, those receiving estrogen as part of hormone replacement therapy for menopausal symptoms were less than half as likely to die from it as those not receiving estrogen, even after adjustment for confounders.

“This study shows an association between estrogen levels and COVID-19 death. Consequently, drugs increasing estrogen levels may have a role in therapeutic efforts to alleviate COVID-19 severity in postmenopausal women and could be studied in randomized control trials,” the investigators write.

However, coauthor Anne-Marie Fors Connolly, MD, PhD, a resident in clinical microbiology at Umeå University, cautioned: “This is an observational study. Further clinical studies are needed to verify these results before recommending clinicians to consider estrogen supplementation.”

Stephen Evans, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, agrees.

He told the U.K. Science and Media Centre: “This is an observational study comparing three groups of women based on whether they used hormonal therapy to boost estrogen levels or who had, as a result of treatment for breast cancer ... reduced estrogen levels or neither. The findings are apparently dramatic.”

“At the very least, great caution should be exercised in thinking that menopausal hormone therapy will have substantial, or even any, benefits in dealing with COVID-19,” he warned.
 

Do women die less frequently from COVID-19 than men?

Studies conducted early in the pandemic suggest women may be protected from poor outcomes of SARS-CoV-2 infection, compared with men, even after adjustment for confounders.

According to more recent data from the Swedish Public Health Agency, of the 16,501 people who have died from COVID-19 since the start of the pandemic, about 45% are women and 55% are men. About 70% who have received intensive care because of COVID-19 are men, although cumulative data suggest that women are nearly as likely to die from COVID-19 as men, Dr. Connolly told this news organization.

For the current study, a total of 14,685 women aged 50-80 years were included, of whom 17.3% (2,535) had received estrogen supplementation, 81.2% (11,923) had native estrogen levels with no breast cancer or estrogen supplementation (controls), and 1.5% (227) had decreased estrogen levels because of breast cancer and antiestrogen treatment.

The group with decreased estrogen levels had a more than twofold risk of dying from COVID-19 compared with controls (odds ratio, 2.35), but this difference was no longer significant after adjustments for potential confounders including age, income, and educational level, and weighted Charlson Comorbidity Index (wCCI).

However, the group with augmented estrogen levels had a decreased risk of dying from COVID-19 before (odds ratio, 0.45) and after (OR, 0.47) adjustment.

The percentages of patients who died of COVID-19 were 4.6% of controls, 10.1% of those with decreased estrogen, and 2.1% with increased estrogen.

Not surprisingly, the risk of dying from COVID-19 also increased with age (OR of 1.15 for every year increase in age) and comorbidities (OR, 1.13 per increase in wCCI). Low income and having only a primary level education also increased the odds of dying from COVID-19.

Data on obesity, a known risk factor for COVID-19 death, weren’t reported.

“Obesity would have been a very relevant variable to include. Unfortunately, this information is not present in the nationwide registry data that we used for our study,” Dr. Connolly told this news organization.

While the data are observational and can’t be used to inform treatment, Dr. Connolly pointed to a U.S. randomized clinical trial currently recruiting patients that will investigate the effect of estradiol and progesterone therapy in 120 adults hospitalized with COVID-19.

In the meantime, she warned doctors and patients: “Please do not consider ending antiestrogen treatment following breast cancer – this is a necessary treatment for the cancer.”

Dr. Evans noted, “There are short-term benefits of menopausal hormone therapy but women should not, based on this or other observational studies, be advised to take HRT [hormone replacement therapy] for a supposed benefit on death from COVID-19.”

The study had several nonpharmaceutical industry funders, including Umeå University and the Knut and Alice Wallenberg Foundation. The authors and Dr. Evans have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Estrogen supplementation is associated with a reduced risk of death from COVID-19 among postmenopausal women, new research suggests.

The findings, from a nationwide study using data from Sweden, were published online Feb. 14 in BMJ Open by Malin Sund, MD, PhD, of Umeå (Sweden) University Faculty of Medicine and colleagues.

Among postmenopausal women aged 50-80 years with verified COVID-19, those receiving estrogen as part of hormone replacement therapy for menopausal symptoms were less than half as likely to die from it as those not receiving estrogen, even after adjustment for confounders.

“This study shows an association between estrogen levels and COVID-19 death. Consequently, drugs increasing estrogen levels may have a role in therapeutic efforts to alleviate COVID-19 severity in postmenopausal women and could be studied in randomized control trials,” the investigators write.

However, coauthor Anne-Marie Fors Connolly, MD, PhD, a resident in clinical microbiology at Umeå University, cautioned: “This is an observational study. Further clinical studies are needed to verify these results before recommending clinicians to consider estrogen supplementation.”

Stephen Evans, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, agrees.

He told the U.K. Science and Media Centre: “This is an observational study comparing three groups of women based on whether they used hormonal therapy to boost estrogen levels or who had, as a result of treatment for breast cancer ... reduced estrogen levels or neither. The findings are apparently dramatic.”

“At the very least, great caution should be exercised in thinking that menopausal hormone therapy will have substantial, or even any, benefits in dealing with COVID-19,” he warned.
 

Do women die less frequently from COVID-19 than men?

Studies conducted early in the pandemic suggest women may be protected from poor outcomes of SARS-CoV-2 infection, compared with men, even after adjustment for confounders.

According to more recent data from the Swedish Public Health Agency, of the 16,501 people who have died from COVID-19 since the start of the pandemic, about 45% are women and 55% are men. About 70% who have received intensive care because of COVID-19 are men, although cumulative data suggest that women are nearly as likely to die from COVID-19 as men, Dr. Connolly told this news organization.

For the current study, a total of 14,685 women aged 50-80 years were included, of whom 17.3% (2,535) had received estrogen supplementation, 81.2% (11,923) had native estrogen levels with no breast cancer or estrogen supplementation (controls), and 1.5% (227) had decreased estrogen levels because of breast cancer and antiestrogen treatment.

The group with decreased estrogen levels had a more than twofold risk of dying from COVID-19 compared with controls (odds ratio, 2.35), but this difference was no longer significant after adjustments for potential confounders including age, income, and educational level, and weighted Charlson Comorbidity Index (wCCI).

However, the group with augmented estrogen levels had a decreased risk of dying from COVID-19 before (odds ratio, 0.45) and after (OR, 0.47) adjustment.

The percentages of patients who died of COVID-19 were 4.6% of controls, 10.1% of those with decreased estrogen, and 2.1% with increased estrogen.

Not surprisingly, the risk of dying from COVID-19 also increased with age (OR of 1.15 for every year increase in age) and comorbidities (OR, 1.13 per increase in wCCI). Low income and having only a primary level education also increased the odds of dying from COVID-19.

Data on obesity, a known risk factor for COVID-19 death, weren’t reported.

“Obesity would have been a very relevant variable to include. Unfortunately, this information is not present in the nationwide registry data that we used for our study,” Dr. Connolly told this news organization.

While the data are observational and can’t be used to inform treatment, Dr. Connolly pointed to a U.S. randomized clinical trial currently recruiting patients that will investigate the effect of estradiol and progesterone therapy in 120 adults hospitalized with COVID-19.

In the meantime, she warned doctors and patients: “Please do not consider ending antiestrogen treatment following breast cancer – this is a necessary treatment for the cancer.”

Dr. Evans noted, “There are short-term benefits of menopausal hormone therapy but women should not, based on this or other observational studies, be advised to take HRT [hormone replacement therapy] for a supposed benefit on death from COVID-19.”

The study had several nonpharmaceutical industry funders, including Umeå University and the Knut and Alice Wallenberg Foundation. The authors and Dr. Evans have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Estrogen supplementation is associated with a reduced risk of death from COVID-19 among postmenopausal women, new research suggests.

The findings, from a nationwide study using data from Sweden, were published online Feb. 14 in BMJ Open by Malin Sund, MD, PhD, of Umeå (Sweden) University Faculty of Medicine and colleagues.

Among postmenopausal women aged 50-80 years with verified COVID-19, those receiving estrogen as part of hormone replacement therapy for menopausal symptoms were less than half as likely to die from it as those not receiving estrogen, even after adjustment for confounders.

“This study shows an association between estrogen levels and COVID-19 death. Consequently, drugs increasing estrogen levels may have a role in therapeutic efforts to alleviate COVID-19 severity in postmenopausal women and could be studied in randomized control trials,” the investigators write.

However, coauthor Anne-Marie Fors Connolly, MD, PhD, a resident in clinical microbiology at Umeå University, cautioned: “This is an observational study. Further clinical studies are needed to verify these results before recommending clinicians to consider estrogen supplementation.”

Stephen Evans, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, agrees.

He told the U.K. Science and Media Centre: “This is an observational study comparing three groups of women based on whether they used hormonal therapy to boost estrogen levels or who had, as a result of treatment for breast cancer ... reduced estrogen levels or neither. The findings are apparently dramatic.”

“At the very least, great caution should be exercised in thinking that menopausal hormone therapy will have substantial, or even any, benefits in dealing with COVID-19,” he warned.
 

Do women die less frequently from COVID-19 than men?

Studies conducted early in the pandemic suggest women may be protected from poor outcomes of SARS-CoV-2 infection, compared with men, even after adjustment for confounders.

According to more recent data from the Swedish Public Health Agency, of the 16,501 people who have died from COVID-19 since the start of the pandemic, about 45% are women and 55% are men. About 70% who have received intensive care because of COVID-19 are men, although cumulative data suggest that women are nearly as likely to die from COVID-19 as men, Dr. Connolly told this news organization.

For the current study, a total of 14,685 women aged 50-80 years were included, of whom 17.3% (2,535) had received estrogen supplementation, 81.2% (11,923) had native estrogen levels with no breast cancer or estrogen supplementation (controls), and 1.5% (227) had decreased estrogen levels because of breast cancer and antiestrogen treatment.

The group with decreased estrogen levels had a more than twofold risk of dying from COVID-19 compared with controls (odds ratio, 2.35), but this difference was no longer significant after adjustments for potential confounders including age, income, and educational level, and weighted Charlson Comorbidity Index (wCCI).

However, the group with augmented estrogen levels had a decreased risk of dying from COVID-19 before (odds ratio, 0.45) and after (OR, 0.47) adjustment.

The percentages of patients who died of COVID-19 were 4.6% of controls, 10.1% of those with decreased estrogen, and 2.1% with increased estrogen.

Not surprisingly, the risk of dying from COVID-19 also increased with age (OR of 1.15 for every year increase in age) and comorbidities (OR, 1.13 per increase in wCCI). Low income and having only a primary level education also increased the odds of dying from COVID-19.

Data on obesity, a known risk factor for COVID-19 death, weren’t reported.

“Obesity would have been a very relevant variable to include. Unfortunately, this information is not present in the nationwide registry data that we used for our study,” Dr. Connolly told this news organization.

While the data are observational and can’t be used to inform treatment, Dr. Connolly pointed to a U.S. randomized clinical trial currently recruiting patients that will investigate the effect of estradiol and progesterone therapy in 120 adults hospitalized with COVID-19.

In the meantime, she warned doctors and patients: “Please do not consider ending antiestrogen treatment following breast cancer – this is a necessary treatment for the cancer.”

Dr. Evans noted, “There are short-term benefits of menopausal hormone therapy but women should not, based on this or other observational studies, be advised to take HRT [hormone replacement therapy] for a supposed benefit on death from COVID-19.”

The study had several nonpharmaceutical industry funders, including Umeå University and the Knut and Alice Wallenberg Foundation. The authors and Dr. Evans have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved a new second-generation version of the implanted continuous glucose monitoring (CGM) system Eversense (Senseonics) that lasts for 6 months.

The Eversense E3 CGM system doubles the wear time from 3 months with the previous Eversense device approved in the United States in 2018. As before, the new system is approved for adults with diabetes aged 18 years and older.

This means that it will be the longest lasting CGM system available in the United States, with essentially two sensor insertion and removal procedures per year, the company said.

Data from the pivotal PROMISE trial of the 6-month version were presented at the American Diabetes Association Scientific Sessions in 2021, as reported by this news organization.

An older 6-month wear time version (Eversense XL) has been available in Europe since 2017. The new second-generation 6-month system is currently under regulatory review there.

The PROMISE trial included 181 participants with diabetes, about two-thirds with type 1 and one-third with type 2 diabetes, at eight clinical research sites.

“We repeatedly hear from our patients with diabetes that what they desire is a long-lasting sensor that is also highly accurate ... The next generation Eversense E3 System delivers on both,” said PROMISE study principal investigator Satish Garg, MD, professor of medicine and director of the adult diabetes program at the Barbara Davis Center, University of Colorado, Aurora, in a company press release.

The Eversense E3 consists of a fluorescence-based sensor, a transmitter, and a smartphone app that displays glucose values, trends, and alerts. The sensor is inserted subcutaneously into the upper arm by a certified health care professional in a brief office procedure. The transmitter is placed on the skin on top of the sensor. Glucose data are sent to the app automatically every 5 minutes.

The system includes an on-body vibratory alert as well as alerts on the app for high and low blood glucose values. Eversense readings may be used for treatment decisions, but users still must perform fingerstick glucose checks for calibration.

The regulatory review for the Eversense E3 was delayed for a year due to the COVID-19 pandemic. It will be distributed in the United States through a partnership with Ascensia Diabetes Care beginning in the second quarter of 2022, according to a Senseonics statement.

In addition, “the company expects the majority of its expenses for 2022 to be for research and development for ongoing feasibility and pivotal clinical trials for additional products in its product pipeline, including the start of its 365-day pivotal trial.”

Health care providers who want to offer the Eversense CGM System to their patients can sign up here or call 844-SENSE4U (844-736-7348).

Patients interested in getting started on Eversense can sign up here and will be among the first to know when Eversense E3 is commercially available.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved a new second-generation version of the implanted continuous glucose monitoring (CGM) system Eversense (Senseonics) that lasts for 6 months.

The Eversense E3 CGM system doubles the wear time from 3 months with the previous Eversense device approved in the United States in 2018. As before, the new system is approved for adults with diabetes aged 18 years and older.

This means that it will be the longest lasting CGM system available in the United States, with essentially two sensor insertion and removal procedures per year, the company said.

Data from the pivotal PROMISE trial of the 6-month version were presented at the American Diabetes Association Scientific Sessions in 2021, as reported by this news organization.

An older 6-month wear time version (Eversense XL) has been available in Europe since 2017. The new second-generation 6-month system is currently under regulatory review there.

The PROMISE trial included 181 participants with diabetes, about two-thirds with type 1 and one-third with type 2 diabetes, at eight clinical research sites.

“We repeatedly hear from our patients with diabetes that what they desire is a long-lasting sensor that is also highly accurate ... The next generation Eversense E3 System delivers on both,” said PROMISE study principal investigator Satish Garg, MD, professor of medicine and director of the adult diabetes program at the Barbara Davis Center, University of Colorado, Aurora, in a company press release.

The Eversense E3 consists of a fluorescence-based sensor, a transmitter, and a smartphone app that displays glucose values, trends, and alerts. The sensor is inserted subcutaneously into the upper arm by a certified health care professional in a brief office procedure. The transmitter is placed on the skin on top of the sensor. Glucose data are sent to the app automatically every 5 minutes.

The system includes an on-body vibratory alert as well as alerts on the app for high and low blood glucose values. Eversense readings may be used for treatment decisions, but users still must perform fingerstick glucose checks for calibration.

The regulatory review for the Eversense E3 was delayed for a year due to the COVID-19 pandemic. It will be distributed in the United States through a partnership with Ascensia Diabetes Care beginning in the second quarter of 2022, according to a Senseonics statement.

In addition, “the company expects the majority of its expenses for 2022 to be for research and development for ongoing feasibility and pivotal clinical trials for additional products in its product pipeline, including the start of its 365-day pivotal trial.”

Health care providers who want to offer the Eversense CGM System to their patients can sign up here or call 844-SENSE4U (844-736-7348).

Patients interested in getting started on Eversense can sign up here and will be among the first to know when Eversense E3 is commercially available.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved a new second-generation version of the implanted continuous glucose monitoring (CGM) system Eversense (Senseonics) that lasts for 6 months.

The Eversense E3 CGM system doubles the wear time from 3 months with the previous Eversense device approved in the United States in 2018. As before, the new system is approved for adults with diabetes aged 18 years and older.

This means that it will be the longest lasting CGM system available in the United States, with essentially two sensor insertion and removal procedures per year, the company said.

Data from the pivotal PROMISE trial of the 6-month version were presented at the American Diabetes Association Scientific Sessions in 2021, as reported by this news organization.

An older 6-month wear time version (Eversense XL) has been available in Europe since 2017. The new second-generation 6-month system is currently under regulatory review there.

The PROMISE trial included 181 participants with diabetes, about two-thirds with type 1 and one-third with type 2 diabetes, at eight clinical research sites.

“We repeatedly hear from our patients with diabetes that what they desire is a long-lasting sensor that is also highly accurate ... The next generation Eversense E3 System delivers on both,” said PROMISE study principal investigator Satish Garg, MD, professor of medicine and director of the adult diabetes program at the Barbara Davis Center, University of Colorado, Aurora, in a company press release.

The Eversense E3 consists of a fluorescence-based sensor, a transmitter, and a smartphone app that displays glucose values, trends, and alerts. The sensor is inserted subcutaneously into the upper arm by a certified health care professional in a brief office procedure. The transmitter is placed on the skin on top of the sensor. Glucose data are sent to the app automatically every 5 minutes.

The system includes an on-body vibratory alert as well as alerts on the app for high and low blood glucose values. Eversense readings may be used for treatment decisions, but users still must perform fingerstick glucose checks for calibration.

The regulatory review for the Eversense E3 was delayed for a year due to the COVID-19 pandemic. It will be distributed in the United States through a partnership with Ascensia Diabetes Care beginning in the second quarter of 2022, according to a Senseonics statement.

In addition, “the company expects the majority of its expenses for 2022 to be for research and development for ongoing feasibility and pivotal clinical trials for additional products in its product pipeline, including the start of its 365-day pivotal trial.”

Health care providers who want to offer the Eversense CGM System to their patients can sign up here or call 844-SENSE4U (844-736-7348).

Patients interested in getting started on Eversense can sign up here and will be among the first to know when Eversense E3 is commercially available.

A version of this article first appeared on Medscape.com.