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COVID-19 linked to increased diabetes risk in youth
SARS-CoV-2 infection was associated with an increased risk for diabetes among youth, whereas other acute respiratory infections were not, new data from the U.S. Centers for Disease Control and Prevention indicate.
The results from two large U.S. health claims databases were published in an early release in the CDC’s Morbidity and Mortality Weekly Report by Catherine E. Barrett, PhD, and colleagues of the CDC’s COVID-19 Emergency Response Team and Division of Diabetes Translation.
Clinicians should monitor individuals younger than 18 years in the months following a SARS-CoV-2 infection for new diabetes onset, they advise.
The findings, which are supported by independent studies in adults, “underscore the importance of COVID-19 prevention among all age groups, including vaccination for all eligible children and adolescents, and chronic disease prevention and treatment,” Dr. Barrett and colleagues say.
Diabetes type couldn’t be reliably distinguished from the databases, which is noted as an important study limitation.
“SARS-CoV-2 infection might lead to type 1 or type 2 diabetes through complex and differing mechanisms,” they say.
Emerging evidence began to suggest, in mid-2020, that COVID-19 may trigger the onset of diabetes in healthy people. A new global registry was subsequently established to collect data on patients with COVID-19–related diabetes, called the CoviDiab registry.
Not clear if diabetes after COVID-19 is transient or permanent
From one of the databases used in the new study, known as IQVIA, 80,893 individuals aged younger than 18 years diagnosed with COVID-19 during March 2020 to February 26, 2021, were compared with age- and sex-matched people during that period who did not have COVID-19 and to prepandemic groups with and without a diagnosis of acute respiratory illness during March 1, 2017, to February 26, 2018.
From the second database, HealthVerity, 439,439 youth diagnosed with COVID-19 during March 1, 2020, to June 28, 2021, were compared with age- and sex-matched youth without COVID-19. Here, there was no prepandemic comparison group.
Diabetes diagnoses were coded in 0.08% with COVID-19 vs. 0.03% without COVID-19 in IQVIA and in 0.25% vs. 0.19% in HealthVerity.
Thus, new diabetes diagnoses were 166% and 31% more likely to occur in those with COVID-19 in IQVIA and HealthVerity, respectively. And in IQVIA, those with COVID-19 were 116% more likely to develop diabetes than were those with prepandemic acute respiratory illnesses. Those differences were all significant, whereas non–SARS-CoV-2 respiratory infections were not associated with diabetes, Dr. Barrett and colleagues say.
In both databases, diabetic ketoacidosis (DKA) was more common at diabetes onset among those with, vs. without, COVID-19: 48.5% vs. 13.6% in IQVIA and 40.2% vs. 29.7% in HealthVerity. In IQVIA, 22.0% with prepandemic acute respiratory illness presented with DKA.
Dr. Barrett and colleagues offer several potential explanations for the observed association between COVID-19 and diabetes, including a direct attack on pancreatic beta cells expressing angiotensin-converting enzyme 2 receptors, or via stress hyperglycemia resulting from cytokine storm and alterations in glucose metabolism.
Another possibility is the precipitation to diabetes from prediabetes; the latter is a condition present in one in five U.S. adolescents.
Steroid treatment during hospitalization might have led to transient hyperglycemia, but only 1.5% to 2.2% of diabetes codes were for drug- or chemical-induced diabetes. The majority were for type 1 or 2.
Alternatively, pandemic-associated weight gain might have also contributed to risks for both severe COVID-19 and type 2 diabetes.
“Although this study can provide information on the risk for diabetes following SARS-CoV-2 infection, additional data are needed to understand underlying pathogenic mechanisms, either those caused by SARS-CoV-2 infection itself or resulting from treatments, and whether a COVID-19–associated diabetes diagnosis is transient or leads to a chronic condition,” Dr. Barrett and colleagues conclude.
A version of this article first appeared on Medscape.com.
SARS-CoV-2 infection was associated with an increased risk for diabetes among youth, whereas other acute respiratory infections were not, new data from the U.S. Centers for Disease Control and Prevention indicate.
The results from two large U.S. health claims databases were published in an early release in the CDC’s Morbidity and Mortality Weekly Report by Catherine E. Barrett, PhD, and colleagues of the CDC’s COVID-19 Emergency Response Team and Division of Diabetes Translation.
Clinicians should monitor individuals younger than 18 years in the months following a SARS-CoV-2 infection for new diabetes onset, they advise.
The findings, which are supported by independent studies in adults, “underscore the importance of COVID-19 prevention among all age groups, including vaccination for all eligible children and adolescents, and chronic disease prevention and treatment,” Dr. Barrett and colleagues say.
Diabetes type couldn’t be reliably distinguished from the databases, which is noted as an important study limitation.
“SARS-CoV-2 infection might lead to type 1 or type 2 diabetes through complex and differing mechanisms,” they say.
Emerging evidence began to suggest, in mid-2020, that COVID-19 may trigger the onset of diabetes in healthy people. A new global registry was subsequently established to collect data on patients with COVID-19–related diabetes, called the CoviDiab registry.
Not clear if diabetes after COVID-19 is transient or permanent
From one of the databases used in the new study, known as IQVIA, 80,893 individuals aged younger than 18 years diagnosed with COVID-19 during March 2020 to February 26, 2021, were compared with age- and sex-matched people during that period who did not have COVID-19 and to prepandemic groups with and without a diagnosis of acute respiratory illness during March 1, 2017, to February 26, 2018.
From the second database, HealthVerity, 439,439 youth diagnosed with COVID-19 during March 1, 2020, to June 28, 2021, were compared with age- and sex-matched youth without COVID-19. Here, there was no prepandemic comparison group.
Diabetes diagnoses were coded in 0.08% with COVID-19 vs. 0.03% without COVID-19 in IQVIA and in 0.25% vs. 0.19% in HealthVerity.
Thus, new diabetes diagnoses were 166% and 31% more likely to occur in those with COVID-19 in IQVIA and HealthVerity, respectively. And in IQVIA, those with COVID-19 were 116% more likely to develop diabetes than were those with prepandemic acute respiratory illnesses. Those differences were all significant, whereas non–SARS-CoV-2 respiratory infections were not associated with diabetes, Dr. Barrett and colleagues say.
In both databases, diabetic ketoacidosis (DKA) was more common at diabetes onset among those with, vs. without, COVID-19: 48.5% vs. 13.6% in IQVIA and 40.2% vs. 29.7% in HealthVerity. In IQVIA, 22.0% with prepandemic acute respiratory illness presented with DKA.
Dr. Barrett and colleagues offer several potential explanations for the observed association between COVID-19 and diabetes, including a direct attack on pancreatic beta cells expressing angiotensin-converting enzyme 2 receptors, or via stress hyperglycemia resulting from cytokine storm and alterations in glucose metabolism.
Another possibility is the precipitation to diabetes from prediabetes; the latter is a condition present in one in five U.S. adolescents.
Steroid treatment during hospitalization might have led to transient hyperglycemia, but only 1.5% to 2.2% of diabetes codes were for drug- or chemical-induced diabetes. The majority were for type 1 or 2.
Alternatively, pandemic-associated weight gain might have also contributed to risks for both severe COVID-19 and type 2 diabetes.
“Although this study can provide information on the risk for diabetes following SARS-CoV-2 infection, additional data are needed to understand underlying pathogenic mechanisms, either those caused by SARS-CoV-2 infection itself or resulting from treatments, and whether a COVID-19–associated diabetes diagnosis is transient or leads to a chronic condition,” Dr. Barrett and colleagues conclude.
A version of this article first appeared on Medscape.com.
SARS-CoV-2 infection was associated with an increased risk for diabetes among youth, whereas other acute respiratory infections were not, new data from the U.S. Centers for Disease Control and Prevention indicate.
The results from two large U.S. health claims databases were published in an early release in the CDC’s Morbidity and Mortality Weekly Report by Catherine E. Barrett, PhD, and colleagues of the CDC’s COVID-19 Emergency Response Team and Division of Diabetes Translation.
Clinicians should monitor individuals younger than 18 years in the months following a SARS-CoV-2 infection for new diabetes onset, they advise.
The findings, which are supported by independent studies in adults, “underscore the importance of COVID-19 prevention among all age groups, including vaccination for all eligible children and adolescents, and chronic disease prevention and treatment,” Dr. Barrett and colleagues say.
Diabetes type couldn’t be reliably distinguished from the databases, which is noted as an important study limitation.
“SARS-CoV-2 infection might lead to type 1 or type 2 diabetes through complex and differing mechanisms,” they say.
Emerging evidence began to suggest, in mid-2020, that COVID-19 may trigger the onset of diabetes in healthy people. A new global registry was subsequently established to collect data on patients with COVID-19–related diabetes, called the CoviDiab registry.
Not clear if diabetes after COVID-19 is transient or permanent
From one of the databases used in the new study, known as IQVIA, 80,893 individuals aged younger than 18 years diagnosed with COVID-19 during March 2020 to February 26, 2021, were compared with age- and sex-matched people during that period who did not have COVID-19 and to prepandemic groups with and without a diagnosis of acute respiratory illness during March 1, 2017, to February 26, 2018.
From the second database, HealthVerity, 439,439 youth diagnosed with COVID-19 during March 1, 2020, to June 28, 2021, were compared with age- and sex-matched youth without COVID-19. Here, there was no prepandemic comparison group.
Diabetes diagnoses were coded in 0.08% with COVID-19 vs. 0.03% without COVID-19 in IQVIA and in 0.25% vs. 0.19% in HealthVerity.
Thus, new diabetes diagnoses were 166% and 31% more likely to occur in those with COVID-19 in IQVIA and HealthVerity, respectively. And in IQVIA, those with COVID-19 were 116% more likely to develop diabetes than were those with prepandemic acute respiratory illnesses. Those differences were all significant, whereas non–SARS-CoV-2 respiratory infections were not associated with diabetes, Dr. Barrett and colleagues say.
In both databases, diabetic ketoacidosis (DKA) was more common at diabetes onset among those with, vs. without, COVID-19: 48.5% vs. 13.6% in IQVIA and 40.2% vs. 29.7% in HealthVerity. In IQVIA, 22.0% with prepandemic acute respiratory illness presented with DKA.
Dr. Barrett and colleagues offer several potential explanations for the observed association between COVID-19 and diabetes, including a direct attack on pancreatic beta cells expressing angiotensin-converting enzyme 2 receptors, or via stress hyperglycemia resulting from cytokine storm and alterations in glucose metabolism.
Another possibility is the precipitation to diabetes from prediabetes; the latter is a condition present in one in five U.S. adolescents.
Steroid treatment during hospitalization might have led to transient hyperglycemia, but only 1.5% to 2.2% of diabetes codes were for drug- or chemical-induced diabetes. The majority were for type 1 or 2.
Alternatively, pandemic-associated weight gain might have also contributed to risks for both severe COVID-19 and type 2 diabetes.
“Although this study can provide information on the risk for diabetes following SARS-CoV-2 infection, additional data are needed to understand underlying pathogenic mechanisms, either those caused by SARS-CoV-2 infection itself or resulting from treatments, and whether a COVID-19–associated diabetes diagnosis is transient or leads to a chronic condition,” Dr. Barrett and colleagues conclude.
A version of this article first appeared on Medscape.com.
FROM MMWR
SGLT2 inhibitors improve cardiovascular outcomes across groups
Sodium-glucose cotransporter 2 (SGLT2) inhibitors show “remarkable consistency of class benefit” for improving cardiovascular outcomes in high-risk people across age, sex, and race/ethnicity categories.
The findings, from a meta-analysis of 10 major randomized clinical trials, were published online Jan. 5, 2021, in JAMA Network Open by Mukul Bhattarai, MD, a cardiology fellow at Southern Illinois University, Springfield, and colleagues.
“Our meta-analysis evaluated a wide spectrum of efficacy outcomes, further characterizing the primary outcome in different subgroups from several well-designed large clinical trials. It supports that SGLT2 inhibitors have emerged as an effective class of drugs for improving cardiovascular morbidity and mortality, including the prevention of [hospitalization for heart failure] and reducing all-cause mortality in selected patients,” Dr. Bhattarai and colleagues wrote.
The cardiovascular outcomes of SGLT2 inhibitor therapy, they noted, “can be compared across all trials, and it demonstrates remarkable consistency of class benefit, despite the variations in populations enrolled.”
However, they also noted that SGLT inhibitors did not reduce the risk of acute MIn overall, and that most of the trials were short term, with a mean follow-up of just 2.3 years.
Ten trials, consistent cardiovascular benefits
Dr. Bhattarai and colleagues searched the literature through Jan. 10, 2021, as well as meeting presentations and other sources. They identified 10 placebo-controlled, randomized clinical trials in which participants had atherosclerotic cardiovascular disease or ASCVD risk factors, diabetes, or heart failure. Among a total of 71,553 high-risk patients, 39,053 received an SGLT2 inhibitor and 32,500 received a placebo.
The primary outcome of cardiovascular death or hospitalization for heart failure occurred in 8.10% randomized to SGLT2 inhibitors, compared with 11.56% in the placebo group, a significant difference with odds ratio 0.67 (P < .001). Both individual outcomes were lower in the SGLT2-inhibitor group, with a number needed to treat of 5.7 (P < .001).
Patients receiving SGLT2 inhibitors also had significantly lower rates of major adverse cardiovascular events, defined as death due to cardiovascular causes, nonfatal MI, or nonfatal stroke. Those events occurred in 9.82% versus 10.22%(OR, 0.90; P = .03).
Hospitalizations and ED visits with heart failure were also reduced with SGLT2 inhibitors (4.37% vs. 6.81%; OR, 0.67; P < .001), as was cardiovascular death (4.65% vs. 5.14%; OR, 0.87; P = .009). The reduction in heart failure is likely caused by a combination of a natriuretic effect and reduced interstitial fluid, along with inhibition of cardiac fibrosis, the authors said.
On the other hand, no reductions were seen in acute MI, evaluated in five of the studies. That event occurred in 4.66% taking SGLT2 inhibitors, compared with 4.70% of the placebo group, a nonsignificant difference with an OR of 0.95 (P = 0.22). This is likely because of the fact that SGLT2 inhibitors don’t have known antianginal properties or vasodilatory effects, they don’t reduce myocardial oxygen consumption, and they don’t prevent cardiac muscle remodeling, they noted.
All-cause mortality was significantly lower with SGLT2 inhibitors, though, at 7.09% versus 7.86% (odds ratio, 0.87; P = .004).
Benefits seen across age, sex, and race/ethnicity subgroups
While no differences in benefit were found between men and women when compared with placebo groups, the rates of cardiovascular death or heart failure hospitalizations were slightly higher in men than in women (9.01% [OR, 0.75; P < .001] vs. 5.34% [OR, 0.78; P = .002]).
By age, SGLT2 inhibitors benefited people both those younger than 65 years and those aged 65 years and older, although the primary outcome was slightly lower in the younger group (6.94% [OR, 0.79; P < 0.001] vs. 10.47% [OR, 0.78; P < .001]).
And by race, similar benefits from SGLT2 inhibitors were seen among individuals who were White, compared with those who were Asian, Black, or of other race/ethnicity, with event rates of 8.77% (OR, 0.82; P < .001) and 8.75% (OR, 0.66; P = .06), respectively.
“Owing to the short-term trial durations, future long-term prospective studies and postmarketing surveillance studies are warranted to discover the rate of cardiovascular outcomes,” Dr. Bhattarai and colleagues concluded.
The authors have no disclosures.
A version of this article first appeared on Medscape.com.
Sodium-glucose cotransporter 2 (SGLT2) inhibitors show “remarkable consistency of class benefit” for improving cardiovascular outcomes in high-risk people across age, sex, and race/ethnicity categories.
The findings, from a meta-analysis of 10 major randomized clinical trials, were published online Jan. 5, 2021, in JAMA Network Open by Mukul Bhattarai, MD, a cardiology fellow at Southern Illinois University, Springfield, and colleagues.
“Our meta-analysis evaluated a wide spectrum of efficacy outcomes, further characterizing the primary outcome in different subgroups from several well-designed large clinical trials. It supports that SGLT2 inhibitors have emerged as an effective class of drugs for improving cardiovascular morbidity and mortality, including the prevention of [hospitalization for heart failure] and reducing all-cause mortality in selected patients,” Dr. Bhattarai and colleagues wrote.
The cardiovascular outcomes of SGLT2 inhibitor therapy, they noted, “can be compared across all trials, and it demonstrates remarkable consistency of class benefit, despite the variations in populations enrolled.”
However, they also noted that SGLT inhibitors did not reduce the risk of acute MIn overall, and that most of the trials were short term, with a mean follow-up of just 2.3 years.
Ten trials, consistent cardiovascular benefits
Dr. Bhattarai and colleagues searched the literature through Jan. 10, 2021, as well as meeting presentations and other sources. They identified 10 placebo-controlled, randomized clinical trials in which participants had atherosclerotic cardiovascular disease or ASCVD risk factors, diabetes, or heart failure. Among a total of 71,553 high-risk patients, 39,053 received an SGLT2 inhibitor and 32,500 received a placebo.
The primary outcome of cardiovascular death or hospitalization for heart failure occurred in 8.10% randomized to SGLT2 inhibitors, compared with 11.56% in the placebo group, a significant difference with odds ratio 0.67 (P < .001). Both individual outcomes were lower in the SGLT2-inhibitor group, with a number needed to treat of 5.7 (P < .001).
Patients receiving SGLT2 inhibitors also had significantly lower rates of major adverse cardiovascular events, defined as death due to cardiovascular causes, nonfatal MI, or nonfatal stroke. Those events occurred in 9.82% versus 10.22%(OR, 0.90; P = .03).
Hospitalizations and ED visits with heart failure were also reduced with SGLT2 inhibitors (4.37% vs. 6.81%; OR, 0.67; P < .001), as was cardiovascular death (4.65% vs. 5.14%; OR, 0.87; P = .009). The reduction in heart failure is likely caused by a combination of a natriuretic effect and reduced interstitial fluid, along with inhibition of cardiac fibrosis, the authors said.
On the other hand, no reductions were seen in acute MI, evaluated in five of the studies. That event occurred in 4.66% taking SGLT2 inhibitors, compared with 4.70% of the placebo group, a nonsignificant difference with an OR of 0.95 (P = 0.22). This is likely because of the fact that SGLT2 inhibitors don’t have known antianginal properties or vasodilatory effects, they don’t reduce myocardial oxygen consumption, and they don’t prevent cardiac muscle remodeling, they noted.
All-cause mortality was significantly lower with SGLT2 inhibitors, though, at 7.09% versus 7.86% (odds ratio, 0.87; P = .004).
Benefits seen across age, sex, and race/ethnicity subgroups
While no differences in benefit were found between men and women when compared with placebo groups, the rates of cardiovascular death or heart failure hospitalizations were slightly higher in men than in women (9.01% [OR, 0.75; P < .001] vs. 5.34% [OR, 0.78; P = .002]).
By age, SGLT2 inhibitors benefited people both those younger than 65 years and those aged 65 years and older, although the primary outcome was slightly lower in the younger group (6.94% [OR, 0.79; P < 0.001] vs. 10.47% [OR, 0.78; P < .001]).
And by race, similar benefits from SGLT2 inhibitors were seen among individuals who were White, compared with those who were Asian, Black, or of other race/ethnicity, with event rates of 8.77% (OR, 0.82; P < .001) and 8.75% (OR, 0.66; P = .06), respectively.
“Owing to the short-term trial durations, future long-term prospective studies and postmarketing surveillance studies are warranted to discover the rate of cardiovascular outcomes,” Dr. Bhattarai and colleagues concluded.
The authors have no disclosures.
A version of this article first appeared on Medscape.com.
Sodium-glucose cotransporter 2 (SGLT2) inhibitors show “remarkable consistency of class benefit” for improving cardiovascular outcomes in high-risk people across age, sex, and race/ethnicity categories.
The findings, from a meta-analysis of 10 major randomized clinical trials, were published online Jan. 5, 2021, in JAMA Network Open by Mukul Bhattarai, MD, a cardiology fellow at Southern Illinois University, Springfield, and colleagues.
“Our meta-analysis evaluated a wide spectrum of efficacy outcomes, further characterizing the primary outcome in different subgroups from several well-designed large clinical trials. It supports that SGLT2 inhibitors have emerged as an effective class of drugs for improving cardiovascular morbidity and mortality, including the prevention of [hospitalization for heart failure] and reducing all-cause mortality in selected patients,” Dr. Bhattarai and colleagues wrote.
The cardiovascular outcomes of SGLT2 inhibitor therapy, they noted, “can be compared across all trials, and it demonstrates remarkable consistency of class benefit, despite the variations in populations enrolled.”
However, they also noted that SGLT inhibitors did not reduce the risk of acute MIn overall, and that most of the trials were short term, with a mean follow-up of just 2.3 years.
Ten trials, consistent cardiovascular benefits
Dr. Bhattarai and colleagues searched the literature through Jan. 10, 2021, as well as meeting presentations and other sources. They identified 10 placebo-controlled, randomized clinical trials in which participants had atherosclerotic cardiovascular disease or ASCVD risk factors, diabetes, or heart failure. Among a total of 71,553 high-risk patients, 39,053 received an SGLT2 inhibitor and 32,500 received a placebo.
The primary outcome of cardiovascular death or hospitalization for heart failure occurred in 8.10% randomized to SGLT2 inhibitors, compared with 11.56% in the placebo group, a significant difference with odds ratio 0.67 (P < .001). Both individual outcomes were lower in the SGLT2-inhibitor group, with a number needed to treat of 5.7 (P < .001).
Patients receiving SGLT2 inhibitors also had significantly lower rates of major adverse cardiovascular events, defined as death due to cardiovascular causes, nonfatal MI, or nonfatal stroke. Those events occurred in 9.82% versus 10.22%(OR, 0.90; P = .03).
Hospitalizations and ED visits with heart failure were also reduced with SGLT2 inhibitors (4.37% vs. 6.81%; OR, 0.67; P < .001), as was cardiovascular death (4.65% vs. 5.14%; OR, 0.87; P = .009). The reduction in heart failure is likely caused by a combination of a natriuretic effect and reduced interstitial fluid, along with inhibition of cardiac fibrosis, the authors said.
On the other hand, no reductions were seen in acute MI, evaluated in five of the studies. That event occurred in 4.66% taking SGLT2 inhibitors, compared with 4.70% of the placebo group, a nonsignificant difference with an OR of 0.95 (P = 0.22). This is likely because of the fact that SGLT2 inhibitors don’t have known antianginal properties or vasodilatory effects, they don’t reduce myocardial oxygen consumption, and they don’t prevent cardiac muscle remodeling, they noted.
All-cause mortality was significantly lower with SGLT2 inhibitors, though, at 7.09% versus 7.86% (odds ratio, 0.87; P = .004).
Benefits seen across age, sex, and race/ethnicity subgroups
While no differences in benefit were found between men and women when compared with placebo groups, the rates of cardiovascular death or heart failure hospitalizations were slightly higher in men than in women (9.01% [OR, 0.75; P < .001] vs. 5.34% [OR, 0.78; P = .002]).
By age, SGLT2 inhibitors benefited people both those younger than 65 years and those aged 65 years and older, although the primary outcome was slightly lower in the younger group (6.94% [OR, 0.79; P < 0.001] vs. 10.47% [OR, 0.78; P < .001]).
And by race, similar benefits from SGLT2 inhibitors were seen among individuals who were White, compared with those who were Asian, Black, or of other race/ethnicity, with event rates of 8.77% (OR, 0.82; P < .001) and 8.75% (OR, 0.66; P = .06), respectively.
“Owing to the short-term trial durations, future long-term prospective studies and postmarketing surveillance studies are warranted to discover the rate of cardiovascular outcomes,” Dr. Bhattarai and colleagues concluded.
The authors have no disclosures.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Medicare expands coverage of continuous glucose monitoring devices for diabetes
Proposed in November 2020, the final CMS rule applies primarily to CGMs that integrate with Medtronic insulin pumps. Those CGMs have not been approved by the Food and Drug Administration to replace the need for fingerstick blood glucose measurements in determining insulin or other glucose-lowering medication dosing.
Other CGM systems, Dexcom G6 and Abbott Libre, have “therapeutic” indications and were already covered under Medicare, as was the combined insulin pump–CGM Tandem Diabetes Care Control-IQ technology system.
The expanded coverage means that people using the Medtronic 770G or 630G hybrid closed-loop insulin delivery systems will receive coverage for all the systems’ components, and that people aging into Medicare won’t lose any coverage for those devices.
Medtronic will continue to offer its CGM Access Discount to all Medicare customers until the ruling takes effect. The proposed rule was finalized on Dec. 21, 2021, and will be effective starting 60 days after official publication.
A version of this article first appeared on Medscape.com.
Proposed in November 2020, the final CMS rule applies primarily to CGMs that integrate with Medtronic insulin pumps. Those CGMs have not been approved by the Food and Drug Administration to replace the need for fingerstick blood glucose measurements in determining insulin or other glucose-lowering medication dosing.
Other CGM systems, Dexcom G6 and Abbott Libre, have “therapeutic” indications and were already covered under Medicare, as was the combined insulin pump–CGM Tandem Diabetes Care Control-IQ technology system.
The expanded coverage means that people using the Medtronic 770G or 630G hybrid closed-loop insulin delivery systems will receive coverage for all the systems’ components, and that people aging into Medicare won’t lose any coverage for those devices.
Medtronic will continue to offer its CGM Access Discount to all Medicare customers until the ruling takes effect. The proposed rule was finalized on Dec. 21, 2021, and will be effective starting 60 days after official publication.
A version of this article first appeared on Medscape.com.
Proposed in November 2020, the final CMS rule applies primarily to CGMs that integrate with Medtronic insulin pumps. Those CGMs have not been approved by the Food and Drug Administration to replace the need for fingerstick blood glucose measurements in determining insulin or other glucose-lowering medication dosing.
Other CGM systems, Dexcom G6 and Abbott Libre, have “therapeutic” indications and were already covered under Medicare, as was the combined insulin pump–CGM Tandem Diabetes Care Control-IQ technology system.
The expanded coverage means that people using the Medtronic 770G or 630G hybrid closed-loop insulin delivery systems will receive coverage for all the systems’ components, and that people aging into Medicare won’t lose any coverage for those devices.
Medtronic will continue to offer its CGM Access Discount to all Medicare customers until the ruling takes effect. The proposed rule was finalized on Dec. 21, 2021, and will be effective starting 60 days after official publication.
A version of this article first appeared on Medscape.com.
FDA approves levoketoconazole for Cushing syndrome
The Food and Drug Administration has approved levoketoconazole (Recorlev, Xeris Biopharma) for the treatment of endogenous hypercortisolemia in adults with Cushing syndrome for whom surgery is not possible or was not curative.
Endogenous Cushing syndrome is a relatively rare condition characterized by chronically elevated cortisol levels, typically arising from a benign pituitary tumor. Left untreated, it can lead to reproductive problems and hirsutism in women, as well as serious complications, including diabetes, hypertension, tissue fragility, and mood disorders. Half of patients will die within 5 years if left untreated.
Levoketoconazole inhibits cortisol synthesis. The FDA approval was based on efficacy and safety data from two phase 3 studies involving a total of 166 patients with endogenous Cushing syndrome. In both the open-label, single-arm SONICS study and the randomized, placebo-controlled LOGICS trial, the drug significantly reduced and normalized mean urinary free cortisol levels and improved several secondary endpoints. The ongoing open-label OPTICS study will gather long-term data.
The Recorlev label includes boxed warnings about the potential for life-threatening hepatotoxicity and QT prolongation. Prior to and during treatment, patients should undergo liver enzyme testing, ECG, and correction of hypokalemia and hypomagnesemia.
The most common adverse reactions (occurring in less than 20%) include nausea/vomiting, hypokalemia, hemorrhage/contusion, systemic hypertension, headache, hepatic injury, abnormal uterine bleeding, erythema, fatigue, abdominal pain/dyspepsia, arthritis, upper respiratory infection, myalgia, arrhythmia, back pain, insomnia/sleep disturbances, and peripheral edema.
“Cushing syndrome is a rare disease that can be physically and emotionally devastating to the patient. Most patients endure years of symptoms prior to obtaining a diagnosis and are then faced with limited effective treatment options ... We are excited to see that the long and complicated path of rare drug development has reached FDA approval on a new therapeutic option for our underserved Cushing’s community,” Leslie Edwin, president of the Cushing’s Support & Research Foundation, said in a Xeris statement.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved levoketoconazole (Recorlev, Xeris Biopharma) for the treatment of endogenous hypercortisolemia in adults with Cushing syndrome for whom surgery is not possible or was not curative.
Endogenous Cushing syndrome is a relatively rare condition characterized by chronically elevated cortisol levels, typically arising from a benign pituitary tumor. Left untreated, it can lead to reproductive problems and hirsutism in women, as well as serious complications, including diabetes, hypertension, tissue fragility, and mood disorders. Half of patients will die within 5 years if left untreated.
Levoketoconazole inhibits cortisol synthesis. The FDA approval was based on efficacy and safety data from two phase 3 studies involving a total of 166 patients with endogenous Cushing syndrome. In both the open-label, single-arm SONICS study and the randomized, placebo-controlled LOGICS trial, the drug significantly reduced and normalized mean urinary free cortisol levels and improved several secondary endpoints. The ongoing open-label OPTICS study will gather long-term data.
The Recorlev label includes boxed warnings about the potential for life-threatening hepatotoxicity and QT prolongation. Prior to and during treatment, patients should undergo liver enzyme testing, ECG, and correction of hypokalemia and hypomagnesemia.
The most common adverse reactions (occurring in less than 20%) include nausea/vomiting, hypokalemia, hemorrhage/contusion, systemic hypertension, headache, hepatic injury, abnormal uterine bleeding, erythema, fatigue, abdominal pain/dyspepsia, arthritis, upper respiratory infection, myalgia, arrhythmia, back pain, insomnia/sleep disturbances, and peripheral edema.
“Cushing syndrome is a rare disease that can be physically and emotionally devastating to the patient. Most patients endure years of symptoms prior to obtaining a diagnosis and are then faced with limited effective treatment options ... We are excited to see that the long and complicated path of rare drug development has reached FDA approval on a new therapeutic option for our underserved Cushing’s community,” Leslie Edwin, president of the Cushing’s Support & Research Foundation, said in a Xeris statement.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved levoketoconazole (Recorlev, Xeris Biopharma) for the treatment of endogenous hypercortisolemia in adults with Cushing syndrome for whom surgery is not possible or was not curative.
Endogenous Cushing syndrome is a relatively rare condition characterized by chronically elevated cortisol levels, typically arising from a benign pituitary tumor. Left untreated, it can lead to reproductive problems and hirsutism in women, as well as serious complications, including diabetes, hypertension, tissue fragility, and mood disorders. Half of patients will die within 5 years if left untreated.
Levoketoconazole inhibits cortisol synthesis. The FDA approval was based on efficacy and safety data from two phase 3 studies involving a total of 166 patients with endogenous Cushing syndrome. In both the open-label, single-arm SONICS study and the randomized, placebo-controlled LOGICS trial, the drug significantly reduced and normalized mean urinary free cortisol levels and improved several secondary endpoints. The ongoing open-label OPTICS study will gather long-term data.
The Recorlev label includes boxed warnings about the potential for life-threatening hepatotoxicity and QT prolongation. Prior to and during treatment, patients should undergo liver enzyme testing, ECG, and correction of hypokalemia and hypomagnesemia.
The most common adverse reactions (occurring in less than 20%) include nausea/vomiting, hypokalemia, hemorrhage/contusion, systemic hypertension, headache, hepatic injury, abnormal uterine bleeding, erythema, fatigue, abdominal pain/dyspepsia, arthritis, upper respiratory infection, myalgia, arrhythmia, back pain, insomnia/sleep disturbances, and peripheral edema.
“Cushing syndrome is a rare disease that can be physically and emotionally devastating to the patient. Most patients endure years of symptoms prior to obtaining a diagnosis and are then faced with limited effective treatment options ... We are excited to see that the long and complicated path of rare drug development has reached FDA approval on a new therapeutic option for our underserved Cushing’s community,” Leslie Edwin, president of the Cushing’s Support & Research Foundation, said in a Xeris statement.
A version of this article first appeared on Medscape.com.
ADA standards of care 2022: Screen more, personalize, use technology
The American Diabetes Association’s updated clinical recommendations for 2022 call for wider population screening, along with furthering the trends toward individualization of care use of diabetes technology.
The summary of changes from 2021 spans four pages. “Diabetes is a really dynamic field so there is a lot to update which is good. It means progress,” ADA chief science and medical officer Robert A. Gabbay, MD, PhD, told this news organization.
The ADA Standards of Medical Care in Diabetes – 2022 was published Dec. 20, 2021, online as a supplement to Diabetes Care.
Screening widened by age, in pregnancy, and for type 1 diabetes
One dramatic change is a drop in age to begin screening all people for prediabetes and diabetes from 45 years to 35 years, regardless of risk factors such as obesity.
“Sadly, there are increasing numbers of people with diabetes and developing diabetes younger,” Dr. Gabbay said.
In August 2021, the U.S. Preventive Services Task Force dropped its recommended age of diabetes screening from 40 to 35 years for people with overweight or obesity, but not universally, as ADA now has.
The ADA made its recommendation independently, Dr. Gabbay noted.
The recommendation for testing pregnant women early in gestation (<15 weeks) for preexisting diabetes was also expanded, from just those with risk factors to consideration of testing all women for undiagnosed diabetes at the time they’re planning pregnancy, and if not then, at the first prenatal visit. Screening for gestational diabetes is then performed at 24-28 weeks.
Again, this is caused by increasing diabetes onset at younger ages, Dr. Gabbay said. “We’re well aware that the number of women who have diabetes and don’t know it and become pregnant is significant and therefore screening early on is important.”
New guidance regarding autoantibody screening in adults suspected of having type 1 diabetes and genetic testing for those who don’t fit typical criteria for either of the two main types are based on the ADA/European Association for the Study of Diabetes joint consensus statement on type 1 diabetes in adults.
Individualization of care based on comorbidities, other factors
The concept of individualization of care in diabetes has been emphasized for several years now, but continues to be enhanced with new data and newly available management tools.
Regarding management of type 2 diabetes, several charts have been included to help guide decision-making.
One lists drug-specific and patient factors, including comorbidities, to consider when selecting glucose-lowering medications. A new table depicts a building with four “pillars,” for complication risk reduction, including management of blood pressure, lipids, and glucose, as well as use of agents with cardiovascular and kidney benefit.
“On the type 2 side, the choice of therapy is really guided by several factors. We lay them out in a nice diagram. ... A lot of useful information there compares classes of drugs in order to help clinicians make decisions on what would be the appropriate therapy for a given individual,” Dr. Gabbay said.
An algorithm for pharmacologic treatment includes considerations of weight, hypoglycemia, and cost. Tables are also provided listing average wholesale prices of insulins and noninsulin medications.
A section now entitled “Obesity and weight management for the prevention and treatment of type 2 diabetes” has added content regarding the importance of addressing obesity in diabetes, particularly in the context of the COVID-19 pandemic, and the addition of semaglutide as an approved obesity treatment.
“What we hope is that this engenders a shared decision-making process with the patient to identify what the goals are and then choose the appropriate therapy for those goals,” Dr. Gabbay said.
New information has also been added about management of nonalcoholic fatty liver disease. “I think that’s one of the unrecognized and unaddressed complications of diabetes that we’ll see in the future, particularly as new therapies come out,” Dr. Gabbay predicted.
The section on cardiovascular disease and risk management, endorsed for the fourth year in a row by the American College of Cardiology, includes several new recommendations, including diagnosis of hypertension at a single visit if blood pressure is 180/110 mm Hg or greater, and individualization of blood pressure targets.
Chronic kidney disease management has now been separated from other microvascular complications into a standalone section, with several new updates. Retinopathy, neuropathy, and foot care remain combined in one section.
Diabetes technology: Rapidly evolving, access an issue
The new technology section “doubles down on the time in [normal glucose] range (TIR) concept,” but also emphasizes the importance of time below range.
“When we see that, we need to make a therapeutic change. We were concerned that as there’s more and more information and numbers, users might not pick up on what’s important,” Dr. Gabbay noted.
The new standards also provides greater affirmation of the value of continuous glucose monitoring (CGM) for people with both type 1 and type 2 diabetes at any age, with individualized choice of devices.
Access to technology is a “big issue, and something the ADA has really been fighting for, particularly in terms of health disparities,” Dr. Gabbay said, noting that ADA has a new Health Equity Now platform, which includes a “bill of rights” calling for all patients with diabetes to have access to state-of-the-art technologies, including CGM.
Overall, he said, “I think the big picture is diabetes continues to evolve and advance. After careful review of the literature, the standards of care identifies at least four big areas where there are some changes that clinicians need to know about: screening, how to individualize treatment, considerations of comorbidities, and the important role that technology plays.”
Dr. Gabbay is an employee of the ADA.
A version of this article first appeared on Medscape.com.
The American Diabetes Association’s updated clinical recommendations for 2022 call for wider population screening, along with furthering the trends toward individualization of care use of diabetes technology.
The summary of changes from 2021 spans four pages. “Diabetes is a really dynamic field so there is a lot to update which is good. It means progress,” ADA chief science and medical officer Robert A. Gabbay, MD, PhD, told this news organization.
The ADA Standards of Medical Care in Diabetes – 2022 was published Dec. 20, 2021, online as a supplement to Diabetes Care.
Screening widened by age, in pregnancy, and for type 1 diabetes
One dramatic change is a drop in age to begin screening all people for prediabetes and diabetes from 45 years to 35 years, regardless of risk factors such as obesity.
“Sadly, there are increasing numbers of people with diabetes and developing diabetes younger,” Dr. Gabbay said.
In August 2021, the U.S. Preventive Services Task Force dropped its recommended age of diabetes screening from 40 to 35 years for people with overweight or obesity, but not universally, as ADA now has.
The ADA made its recommendation independently, Dr. Gabbay noted.
The recommendation for testing pregnant women early in gestation (<15 weeks) for preexisting diabetes was also expanded, from just those with risk factors to consideration of testing all women for undiagnosed diabetes at the time they’re planning pregnancy, and if not then, at the first prenatal visit. Screening for gestational diabetes is then performed at 24-28 weeks.
Again, this is caused by increasing diabetes onset at younger ages, Dr. Gabbay said. “We’re well aware that the number of women who have diabetes and don’t know it and become pregnant is significant and therefore screening early on is important.”
New guidance regarding autoantibody screening in adults suspected of having type 1 diabetes and genetic testing for those who don’t fit typical criteria for either of the two main types are based on the ADA/European Association for the Study of Diabetes joint consensus statement on type 1 diabetes in adults.
Individualization of care based on comorbidities, other factors
The concept of individualization of care in diabetes has been emphasized for several years now, but continues to be enhanced with new data and newly available management tools.
Regarding management of type 2 diabetes, several charts have been included to help guide decision-making.
One lists drug-specific and patient factors, including comorbidities, to consider when selecting glucose-lowering medications. A new table depicts a building with four “pillars,” for complication risk reduction, including management of blood pressure, lipids, and glucose, as well as use of agents with cardiovascular and kidney benefit.
“On the type 2 side, the choice of therapy is really guided by several factors. We lay them out in a nice diagram. ... A lot of useful information there compares classes of drugs in order to help clinicians make decisions on what would be the appropriate therapy for a given individual,” Dr. Gabbay said.
An algorithm for pharmacologic treatment includes considerations of weight, hypoglycemia, and cost. Tables are also provided listing average wholesale prices of insulins and noninsulin medications.
A section now entitled “Obesity and weight management for the prevention and treatment of type 2 diabetes” has added content regarding the importance of addressing obesity in diabetes, particularly in the context of the COVID-19 pandemic, and the addition of semaglutide as an approved obesity treatment.
“What we hope is that this engenders a shared decision-making process with the patient to identify what the goals are and then choose the appropriate therapy for those goals,” Dr. Gabbay said.
New information has also been added about management of nonalcoholic fatty liver disease. “I think that’s one of the unrecognized and unaddressed complications of diabetes that we’ll see in the future, particularly as new therapies come out,” Dr. Gabbay predicted.
The section on cardiovascular disease and risk management, endorsed for the fourth year in a row by the American College of Cardiology, includes several new recommendations, including diagnosis of hypertension at a single visit if blood pressure is 180/110 mm Hg or greater, and individualization of blood pressure targets.
Chronic kidney disease management has now been separated from other microvascular complications into a standalone section, with several new updates. Retinopathy, neuropathy, and foot care remain combined in one section.
Diabetes technology: Rapidly evolving, access an issue
The new technology section “doubles down on the time in [normal glucose] range (TIR) concept,” but also emphasizes the importance of time below range.
“When we see that, we need to make a therapeutic change. We were concerned that as there’s more and more information and numbers, users might not pick up on what’s important,” Dr. Gabbay noted.
The new standards also provides greater affirmation of the value of continuous glucose monitoring (CGM) for people with both type 1 and type 2 diabetes at any age, with individualized choice of devices.
Access to technology is a “big issue, and something the ADA has really been fighting for, particularly in terms of health disparities,” Dr. Gabbay said, noting that ADA has a new Health Equity Now platform, which includes a “bill of rights” calling for all patients with diabetes to have access to state-of-the-art technologies, including CGM.
Overall, he said, “I think the big picture is diabetes continues to evolve and advance. After careful review of the literature, the standards of care identifies at least four big areas where there are some changes that clinicians need to know about: screening, how to individualize treatment, considerations of comorbidities, and the important role that technology plays.”
Dr. Gabbay is an employee of the ADA.
A version of this article first appeared on Medscape.com.
The American Diabetes Association’s updated clinical recommendations for 2022 call for wider population screening, along with furthering the trends toward individualization of care use of diabetes technology.
The summary of changes from 2021 spans four pages. “Diabetes is a really dynamic field so there is a lot to update which is good. It means progress,” ADA chief science and medical officer Robert A. Gabbay, MD, PhD, told this news organization.
The ADA Standards of Medical Care in Diabetes – 2022 was published Dec. 20, 2021, online as a supplement to Diabetes Care.
Screening widened by age, in pregnancy, and for type 1 diabetes
One dramatic change is a drop in age to begin screening all people for prediabetes and diabetes from 45 years to 35 years, regardless of risk factors such as obesity.
“Sadly, there are increasing numbers of people with diabetes and developing diabetes younger,” Dr. Gabbay said.
In August 2021, the U.S. Preventive Services Task Force dropped its recommended age of diabetes screening from 40 to 35 years for people with overweight or obesity, but not universally, as ADA now has.
The ADA made its recommendation independently, Dr. Gabbay noted.
The recommendation for testing pregnant women early in gestation (<15 weeks) for preexisting diabetes was also expanded, from just those with risk factors to consideration of testing all women for undiagnosed diabetes at the time they’re planning pregnancy, and if not then, at the first prenatal visit. Screening for gestational diabetes is then performed at 24-28 weeks.
Again, this is caused by increasing diabetes onset at younger ages, Dr. Gabbay said. “We’re well aware that the number of women who have diabetes and don’t know it and become pregnant is significant and therefore screening early on is important.”
New guidance regarding autoantibody screening in adults suspected of having type 1 diabetes and genetic testing for those who don’t fit typical criteria for either of the two main types are based on the ADA/European Association for the Study of Diabetes joint consensus statement on type 1 diabetes in adults.
Individualization of care based on comorbidities, other factors
The concept of individualization of care in diabetes has been emphasized for several years now, but continues to be enhanced with new data and newly available management tools.
Regarding management of type 2 diabetes, several charts have been included to help guide decision-making.
One lists drug-specific and patient factors, including comorbidities, to consider when selecting glucose-lowering medications. A new table depicts a building with four “pillars,” for complication risk reduction, including management of blood pressure, lipids, and glucose, as well as use of agents with cardiovascular and kidney benefit.
“On the type 2 side, the choice of therapy is really guided by several factors. We lay them out in a nice diagram. ... A lot of useful information there compares classes of drugs in order to help clinicians make decisions on what would be the appropriate therapy for a given individual,” Dr. Gabbay said.
An algorithm for pharmacologic treatment includes considerations of weight, hypoglycemia, and cost. Tables are also provided listing average wholesale prices of insulins and noninsulin medications.
A section now entitled “Obesity and weight management for the prevention and treatment of type 2 diabetes” has added content regarding the importance of addressing obesity in diabetes, particularly in the context of the COVID-19 pandemic, and the addition of semaglutide as an approved obesity treatment.
“What we hope is that this engenders a shared decision-making process with the patient to identify what the goals are and then choose the appropriate therapy for those goals,” Dr. Gabbay said.
New information has also been added about management of nonalcoholic fatty liver disease. “I think that’s one of the unrecognized and unaddressed complications of diabetes that we’ll see in the future, particularly as new therapies come out,” Dr. Gabbay predicted.
The section on cardiovascular disease and risk management, endorsed for the fourth year in a row by the American College of Cardiology, includes several new recommendations, including diagnosis of hypertension at a single visit if blood pressure is 180/110 mm Hg or greater, and individualization of blood pressure targets.
Chronic kidney disease management has now been separated from other microvascular complications into a standalone section, with several new updates. Retinopathy, neuropathy, and foot care remain combined in one section.
Diabetes technology: Rapidly evolving, access an issue
The new technology section “doubles down on the time in [normal glucose] range (TIR) concept,” but also emphasizes the importance of time below range.
“When we see that, we need to make a therapeutic change. We were concerned that as there’s more and more information and numbers, users might not pick up on what’s important,” Dr. Gabbay noted.
The new standards also provides greater affirmation of the value of continuous glucose monitoring (CGM) for people with both type 1 and type 2 diabetes at any age, with individualized choice of devices.
Access to technology is a “big issue, and something the ADA has really been fighting for, particularly in terms of health disparities,” Dr. Gabbay said, noting that ADA has a new Health Equity Now platform, which includes a “bill of rights” calling for all patients with diabetes to have access to state-of-the-art technologies, including CGM.
Overall, he said, “I think the big picture is diabetes continues to evolve and advance. After careful review of the literature, the standards of care identifies at least four big areas where there are some changes that clinicians need to know about: screening, how to individualize treatment, considerations of comorbidities, and the important role that technology plays.”
Dr. Gabbay is an employee of the ADA.
A version of this article first appeared on Medscape.com.
IDF Atlas: 1 in 10 adults worldwide now has diabetes
One in 10 adults worldwide currently has diabetes, accounting for an estimated global health expenditure of $966 billion in U.S. dollars in 2021, according to the new International Diabetes Federation Diabetes Atlas.
The IDF Atlas, 10th edition, was published online Dec. 6, 2021.
Highlights from it were presented during two sessions at the IDF Virtual Congress 2021, covering global diabetes incidence and prevalence, mortality, and costs, as well as new sections in this edition devoted to adult-onset type 1 diabetes, childhood-onset type 2 diabetes, and the interactions between diabetes and COVID-19.
More detailed data from some of the Atlas chapters were also published Dec. 6, 2021, in separate papers in the IDF journal Diabetes Research and Clinical Practice, with more publications planned.
Information for the Atlas comes from peer-reviewed literature, unpublished reports, and national registries. This latest edition includes 219 data sources from 144 countries, with figures for other countries extrapolated.
Atlas cochair Dianna Magliano, PhD, reviewed some of the highlights. Half of those currently with diabetes, or about 240 million adults, are undiagnosed, and another 319 million have impaired fasting glucose. Over three-quarters of all adults with diabetes now live in low- and middle-income countries. And about 6.7 million deaths in 2021 can be attributed to diabetes.
The Atlas also predicts increases in these numbers over the coming decades if current trends continue.
“Our data and projections tell a sobering story. Diabetes prevalence is expected to increase globally. The number of adults with diabetes will rise from 537 million in 2021 to 786 million ... by the year 2045, an increase of 46%. Rises are expected in every region of the world, with the largest increases expected to occur in the regions of Africa, the Middle East, and Southeast Asia,” said Dr. Magliano, head of diabetes and population health at the Baker Heart and Diabetes Institute, Melbourne.
Since 2019, when the last Atlas was published, the 2021 numbers represent increases of 73.6 million more adults with diabetes including 7.8 million more undiagnosed, 2.5 million more deaths attributed to diabetes, and an additional global expenditure of $206 billion.
Increases have also occurred in the number of people with prediabetes, children with type 1 diabetes, and pregnancies affected by diabetes, Dr. Magliano reported.
“There is a strong need for effective intervention strategies and policies to stall the increase in the number of people developing diabetes across the world,” she added.
Projected rise in expenditures for diabetes will be ‘unsustainable’
The current $966 billion global health expenditure caused by diabetes represents a 316% increase from the $232 billion reported in 2006, according to William H. Herman, MD, professor of internal medicine and epidemiology at the University of Michigan, Ann Arbor.
By region, 43% of current diabetes-related global expenditures are in North America, 25% in the Western Pacific, and 20% in Europe, while 12% are from the regions of South and Central America, North Africa, Africa, and Southeast Asia combined, Herman said.
The direct costs of diabetes are projected to grow to $1054 billion in 2045, an increase of just 9% over 25 years. The reason for the far lower increase going forward, compared with the tripling in the 15 years prior, is because of the anticipated diabetes rise in regions of the world where per-person spending on diabetes is low, a situation Dr. Herman called “unsustainable.”
“The keys to controlling the global costs of diabetes care are diabetes prevention and providing effective care to the largest number of people at the lowest possible cost,” he said.
Diabetes-related mortality: Some shifts since 2019
One third of the current 6.7 million diabetes-related deaths in 2021 were in people younger than 60 years, said Elbert S. Huang, MD, professor of medicine and public health sciences at the University of Chicago.
Overall, diabetes accounted for 11.8% of total global deaths in people younger than 60 years, but that varied widely, from 24.5% in the Middle East/North Africa to just 6.9% in Southeast Asia.
The regions with the highest number of diabetes-related deaths in people younger than 60 years in 2021 were the Western Pacific and the Middle East/North Africa, a major change from just 2 years ago, when Southeast Asia and Africa saw the greatest numbers of diabetes-related deaths in working-age adults.
“These findings mirror recent reports on inadequate uptake of diabetes prevention programs as well as stagnant quality of care trends for the past decade and reemphasize the need to address noncommunicable diseases across the globe,” Dr. Huang said.
Diabetes and COVID-19: Other factors partly explain the increased risk
Gillian Booth, MD, summarized the current literature on COVID-19 and diabetes including a meta-analysis her group conducted of 300 studies from around the world, with 58% from high-income countries.
The risk for increased COVID-19 severity in people with diabetes could be at least partly explained by factors such as age, sex, and comorbidities, said Dr. Booth, professor in the department of medicine and the Institute of Health Policy, Management, and Evaluation at the University of Toronto.
For example, the unadjusted pooled odds of hospitalization with COVID-19 in patients with diabetes, compared with those without diabetes, was 3.69, but dropped to 1.73 after adjustment for age, sex, and having one or more comorbidities. For COVID-19–related death, those odds ratios were 2.32 unadjusted versus 1.59 adjusted. In both cases, the values were still significant after adjustment, she emphasized.
Overall, hyperglycemia and hemoglobin A1c at admission emerged as significant independent predictors of severe outcomes.
“Further research is needed to understand the interplay between COVID-19 and diabetes and how best to address the disproportionate burden of COVID-19 among people living with diabetes,” she stressed.
Adult-onset type 1 diabetes: Growing recognition of the burden
Ascertainment of data for both adult-onset type 1 and type 2 diabetes in youth was subject to significant limitations.
For adult-onset type 1 diabetes, Jessica Harding, PhD, pointed to the fact that the epidemiology of adult-onset type 1 diabetes hasn’t been well characterized because of the historical focus on children, the difficulty of distinguishing it from type 2 diabetes in adults, and that many registries simply don’t include incident data across the lifespan for type 1 diabetes.
Nonetheless, she said, “there is growing recognition of the burden of adult-onset type 1,” noting that the American Diabetes Association and European Association for the Study of Diabetes just published a consensus statement addressing the topic.
A systematic review of 46 studies representing 32 countries or regions revealed that countries with the highest incidence of type 1 diabetes onset per population of 100,000 ages 20 or above were Eritrea, at 46.2, followed by Sweden and Ireland, both at 30.6, and Finland, at 0. The lowest rates were in Asian countries.
While the Nordic countries (Finland, Sweden, and Norway) are among the top for incidence of both childhood-onset (0-14 years) and adult-onset type 1 diabetes, Eritrea isn’t even among the top 10 for childhood onset.
The unusual situation in Eritrea is the subject of current study but the reasons aren’t yet clear, noted Dr. Magliano, of Emory University, Atlanta, during the question-and-answer period.
And only seven studies, 15%, used biomarkers to determine type 1 diabetes status, suggesting “there is a pressing need to improve the quality and quantity of information on adult-onset type 1 diabetes, particularly in those low- and middle-income countries,” Dr. Harding said.
Type 2 diabetes in youth: A call for better data
When presenting the data for childhood-onset type 2 diabetes, Andrea Luk, MD, noted: “The onset of advanced complications during the most productive time of life has significant impact on individuals, communities, and health economies.”
In 19 studies, the highest reported prevalence of type 2 diabetes in youth was in Brazil, Mexico, indigenous populations of the United States and Canada, and the Black population in the United States, with rates ranging from 160 per 100,000 to 3300 per 100,000. The lowest prevalence rates of 0.6 per 100,000 to 2.7 per 100,000 were reported in Europe. Incidence data were similar, with the highest rates from 31 per 100,000 to 94 per 100,000 and the lowest 0.1 per 100,000 to 0.8 per 100,000 per year.
Of note, Dr. Luk pointed out that childhood obesity is an important factor but not the only one.
“Some populations that have a low prevalence of obesity, such as East Asians, reported higher incidence rates of youth-onset type 2 diabetes than populations with a greater burden of childhood obesity.”
There was variability in incidence rates for youth of similar ethnic background but from different countries. “Apart from genetic predisposition and background obesogenic environment, disparity in socioeconomic status, access to health care, and cultural practices are other contributors to differences in risk of type 2 diabetes in youth,” noted Dr. Luk, associate professor in the division of endocrinology, Department of Medicine and Therapeutics, Chinese University of Hong Kong.
She also noted that the incidence of type 2 diabetes was extremely low in prepubertal children and rises gradually during puberty, and that the incidence is higher in girls than boys but that reverses in adulthood.
Compared with adults with type 2 diabetes, youth with type 2 diabetes had a more adverse glycemic trajectory and higher rates of metformin failure.
And compared with youth with type 1 diabetes, those with type 2 diabetes had more adverse metabolic profiles and higher rates of vascular complications.
“A strong call must be made for the collection of trend data to assess global burden of type 2 diabetes in youth,” she concluded.
Dr. Luk reported serving as an advisory panel member for and/or receiving research support from Amgen, AstraZeneca, Boehringer Ingelheim, Sanofi, the Asia Diabetes Foundation, Bayer, Lee’s Pharmaceutical, MSD, Novo Nordisk, Roche, Sugardown, and Takeda. The other authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
One in 10 adults worldwide currently has diabetes, accounting for an estimated global health expenditure of $966 billion in U.S. dollars in 2021, according to the new International Diabetes Federation Diabetes Atlas.
The IDF Atlas, 10th edition, was published online Dec. 6, 2021.
Highlights from it were presented during two sessions at the IDF Virtual Congress 2021, covering global diabetes incidence and prevalence, mortality, and costs, as well as new sections in this edition devoted to adult-onset type 1 diabetes, childhood-onset type 2 diabetes, and the interactions between diabetes and COVID-19.
More detailed data from some of the Atlas chapters were also published Dec. 6, 2021, in separate papers in the IDF journal Diabetes Research and Clinical Practice, with more publications planned.
Information for the Atlas comes from peer-reviewed literature, unpublished reports, and national registries. This latest edition includes 219 data sources from 144 countries, with figures for other countries extrapolated.
Atlas cochair Dianna Magliano, PhD, reviewed some of the highlights. Half of those currently with diabetes, or about 240 million adults, are undiagnosed, and another 319 million have impaired fasting glucose. Over three-quarters of all adults with diabetes now live in low- and middle-income countries. And about 6.7 million deaths in 2021 can be attributed to diabetes.
The Atlas also predicts increases in these numbers over the coming decades if current trends continue.
“Our data and projections tell a sobering story. Diabetes prevalence is expected to increase globally. The number of adults with diabetes will rise from 537 million in 2021 to 786 million ... by the year 2045, an increase of 46%. Rises are expected in every region of the world, with the largest increases expected to occur in the regions of Africa, the Middle East, and Southeast Asia,” said Dr. Magliano, head of diabetes and population health at the Baker Heart and Diabetes Institute, Melbourne.
Since 2019, when the last Atlas was published, the 2021 numbers represent increases of 73.6 million more adults with diabetes including 7.8 million more undiagnosed, 2.5 million more deaths attributed to diabetes, and an additional global expenditure of $206 billion.
Increases have also occurred in the number of people with prediabetes, children with type 1 diabetes, and pregnancies affected by diabetes, Dr. Magliano reported.
“There is a strong need for effective intervention strategies and policies to stall the increase in the number of people developing diabetes across the world,” she added.
Projected rise in expenditures for diabetes will be ‘unsustainable’
The current $966 billion global health expenditure caused by diabetes represents a 316% increase from the $232 billion reported in 2006, according to William H. Herman, MD, professor of internal medicine and epidemiology at the University of Michigan, Ann Arbor.
By region, 43% of current diabetes-related global expenditures are in North America, 25% in the Western Pacific, and 20% in Europe, while 12% are from the regions of South and Central America, North Africa, Africa, and Southeast Asia combined, Herman said.
The direct costs of diabetes are projected to grow to $1054 billion in 2045, an increase of just 9% over 25 years. The reason for the far lower increase going forward, compared with the tripling in the 15 years prior, is because of the anticipated diabetes rise in regions of the world where per-person spending on diabetes is low, a situation Dr. Herman called “unsustainable.”
“The keys to controlling the global costs of diabetes care are diabetes prevention and providing effective care to the largest number of people at the lowest possible cost,” he said.
Diabetes-related mortality: Some shifts since 2019
One third of the current 6.7 million diabetes-related deaths in 2021 were in people younger than 60 years, said Elbert S. Huang, MD, professor of medicine and public health sciences at the University of Chicago.
Overall, diabetes accounted for 11.8% of total global deaths in people younger than 60 years, but that varied widely, from 24.5% in the Middle East/North Africa to just 6.9% in Southeast Asia.
The regions with the highest number of diabetes-related deaths in people younger than 60 years in 2021 were the Western Pacific and the Middle East/North Africa, a major change from just 2 years ago, when Southeast Asia and Africa saw the greatest numbers of diabetes-related deaths in working-age adults.
“These findings mirror recent reports on inadequate uptake of diabetes prevention programs as well as stagnant quality of care trends for the past decade and reemphasize the need to address noncommunicable diseases across the globe,” Dr. Huang said.
Diabetes and COVID-19: Other factors partly explain the increased risk
Gillian Booth, MD, summarized the current literature on COVID-19 and diabetes including a meta-analysis her group conducted of 300 studies from around the world, with 58% from high-income countries.
The risk for increased COVID-19 severity in people with diabetes could be at least partly explained by factors such as age, sex, and comorbidities, said Dr. Booth, professor in the department of medicine and the Institute of Health Policy, Management, and Evaluation at the University of Toronto.
For example, the unadjusted pooled odds of hospitalization with COVID-19 in patients with diabetes, compared with those without diabetes, was 3.69, but dropped to 1.73 after adjustment for age, sex, and having one or more comorbidities. For COVID-19–related death, those odds ratios were 2.32 unadjusted versus 1.59 adjusted. In both cases, the values were still significant after adjustment, she emphasized.
Overall, hyperglycemia and hemoglobin A1c at admission emerged as significant independent predictors of severe outcomes.
“Further research is needed to understand the interplay between COVID-19 and diabetes and how best to address the disproportionate burden of COVID-19 among people living with diabetes,” she stressed.
Adult-onset type 1 diabetes: Growing recognition of the burden
Ascertainment of data for both adult-onset type 1 and type 2 diabetes in youth was subject to significant limitations.
For adult-onset type 1 diabetes, Jessica Harding, PhD, pointed to the fact that the epidemiology of adult-onset type 1 diabetes hasn’t been well characterized because of the historical focus on children, the difficulty of distinguishing it from type 2 diabetes in adults, and that many registries simply don’t include incident data across the lifespan for type 1 diabetes.
Nonetheless, she said, “there is growing recognition of the burden of adult-onset type 1,” noting that the American Diabetes Association and European Association for the Study of Diabetes just published a consensus statement addressing the topic.
A systematic review of 46 studies representing 32 countries or regions revealed that countries with the highest incidence of type 1 diabetes onset per population of 100,000 ages 20 or above were Eritrea, at 46.2, followed by Sweden and Ireland, both at 30.6, and Finland, at 0. The lowest rates were in Asian countries.
While the Nordic countries (Finland, Sweden, and Norway) are among the top for incidence of both childhood-onset (0-14 years) and adult-onset type 1 diabetes, Eritrea isn’t even among the top 10 for childhood onset.
The unusual situation in Eritrea is the subject of current study but the reasons aren’t yet clear, noted Dr. Magliano, of Emory University, Atlanta, during the question-and-answer period.
And only seven studies, 15%, used biomarkers to determine type 1 diabetes status, suggesting “there is a pressing need to improve the quality and quantity of information on adult-onset type 1 diabetes, particularly in those low- and middle-income countries,” Dr. Harding said.
Type 2 diabetes in youth: A call for better data
When presenting the data for childhood-onset type 2 diabetes, Andrea Luk, MD, noted: “The onset of advanced complications during the most productive time of life has significant impact on individuals, communities, and health economies.”
In 19 studies, the highest reported prevalence of type 2 diabetes in youth was in Brazil, Mexico, indigenous populations of the United States and Canada, and the Black population in the United States, with rates ranging from 160 per 100,000 to 3300 per 100,000. The lowest prevalence rates of 0.6 per 100,000 to 2.7 per 100,000 were reported in Europe. Incidence data were similar, with the highest rates from 31 per 100,000 to 94 per 100,000 and the lowest 0.1 per 100,000 to 0.8 per 100,000 per year.
Of note, Dr. Luk pointed out that childhood obesity is an important factor but not the only one.
“Some populations that have a low prevalence of obesity, such as East Asians, reported higher incidence rates of youth-onset type 2 diabetes than populations with a greater burden of childhood obesity.”
There was variability in incidence rates for youth of similar ethnic background but from different countries. “Apart from genetic predisposition and background obesogenic environment, disparity in socioeconomic status, access to health care, and cultural practices are other contributors to differences in risk of type 2 diabetes in youth,” noted Dr. Luk, associate professor in the division of endocrinology, Department of Medicine and Therapeutics, Chinese University of Hong Kong.
She also noted that the incidence of type 2 diabetes was extremely low in prepubertal children and rises gradually during puberty, and that the incidence is higher in girls than boys but that reverses in adulthood.
Compared with adults with type 2 diabetes, youth with type 2 diabetes had a more adverse glycemic trajectory and higher rates of metformin failure.
And compared with youth with type 1 diabetes, those with type 2 diabetes had more adverse metabolic profiles and higher rates of vascular complications.
“A strong call must be made for the collection of trend data to assess global burden of type 2 diabetes in youth,” she concluded.
Dr. Luk reported serving as an advisory panel member for and/or receiving research support from Amgen, AstraZeneca, Boehringer Ingelheim, Sanofi, the Asia Diabetes Foundation, Bayer, Lee’s Pharmaceutical, MSD, Novo Nordisk, Roche, Sugardown, and Takeda. The other authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
One in 10 adults worldwide currently has diabetes, accounting for an estimated global health expenditure of $966 billion in U.S. dollars in 2021, according to the new International Diabetes Federation Diabetes Atlas.
The IDF Atlas, 10th edition, was published online Dec. 6, 2021.
Highlights from it were presented during two sessions at the IDF Virtual Congress 2021, covering global diabetes incidence and prevalence, mortality, and costs, as well as new sections in this edition devoted to adult-onset type 1 diabetes, childhood-onset type 2 diabetes, and the interactions between diabetes and COVID-19.
More detailed data from some of the Atlas chapters were also published Dec. 6, 2021, in separate papers in the IDF journal Diabetes Research and Clinical Practice, with more publications planned.
Information for the Atlas comes from peer-reviewed literature, unpublished reports, and national registries. This latest edition includes 219 data sources from 144 countries, with figures for other countries extrapolated.
Atlas cochair Dianna Magliano, PhD, reviewed some of the highlights. Half of those currently with diabetes, or about 240 million adults, are undiagnosed, and another 319 million have impaired fasting glucose. Over three-quarters of all adults with diabetes now live in low- and middle-income countries. And about 6.7 million deaths in 2021 can be attributed to diabetes.
The Atlas also predicts increases in these numbers over the coming decades if current trends continue.
“Our data and projections tell a sobering story. Diabetes prevalence is expected to increase globally. The number of adults with diabetes will rise from 537 million in 2021 to 786 million ... by the year 2045, an increase of 46%. Rises are expected in every region of the world, with the largest increases expected to occur in the regions of Africa, the Middle East, and Southeast Asia,” said Dr. Magliano, head of diabetes and population health at the Baker Heart and Diabetes Institute, Melbourne.
Since 2019, when the last Atlas was published, the 2021 numbers represent increases of 73.6 million more adults with diabetes including 7.8 million more undiagnosed, 2.5 million more deaths attributed to diabetes, and an additional global expenditure of $206 billion.
Increases have also occurred in the number of people with prediabetes, children with type 1 diabetes, and pregnancies affected by diabetes, Dr. Magliano reported.
“There is a strong need for effective intervention strategies and policies to stall the increase in the number of people developing diabetes across the world,” she added.
Projected rise in expenditures for diabetes will be ‘unsustainable’
The current $966 billion global health expenditure caused by diabetes represents a 316% increase from the $232 billion reported in 2006, according to William H. Herman, MD, professor of internal medicine and epidemiology at the University of Michigan, Ann Arbor.
By region, 43% of current diabetes-related global expenditures are in North America, 25% in the Western Pacific, and 20% in Europe, while 12% are from the regions of South and Central America, North Africa, Africa, and Southeast Asia combined, Herman said.
The direct costs of diabetes are projected to grow to $1054 billion in 2045, an increase of just 9% over 25 years. The reason for the far lower increase going forward, compared with the tripling in the 15 years prior, is because of the anticipated diabetes rise in regions of the world where per-person spending on diabetes is low, a situation Dr. Herman called “unsustainable.”
“The keys to controlling the global costs of diabetes care are diabetes prevention and providing effective care to the largest number of people at the lowest possible cost,” he said.
Diabetes-related mortality: Some shifts since 2019
One third of the current 6.7 million diabetes-related deaths in 2021 were in people younger than 60 years, said Elbert S. Huang, MD, professor of medicine and public health sciences at the University of Chicago.
Overall, diabetes accounted for 11.8% of total global deaths in people younger than 60 years, but that varied widely, from 24.5% in the Middle East/North Africa to just 6.9% in Southeast Asia.
The regions with the highest number of diabetes-related deaths in people younger than 60 years in 2021 were the Western Pacific and the Middle East/North Africa, a major change from just 2 years ago, when Southeast Asia and Africa saw the greatest numbers of diabetes-related deaths in working-age adults.
“These findings mirror recent reports on inadequate uptake of diabetes prevention programs as well as stagnant quality of care trends for the past decade and reemphasize the need to address noncommunicable diseases across the globe,” Dr. Huang said.
Diabetes and COVID-19: Other factors partly explain the increased risk
Gillian Booth, MD, summarized the current literature on COVID-19 and diabetes including a meta-analysis her group conducted of 300 studies from around the world, with 58% from high-income countries.
The risk for increased COVID-19 severity in people with diabetes could be at least partly explained by factors such as age, sex, and comorbidities, said Dr. Booth, professor in the department of medicine and the Institute of Health Policy, Management, and Evaluation at the University of Toronto.
For example, the unadjusted pooled odds of hospitalization with COVID-19 in patients with diabetes, compared with those without diabetes, was 3.69, but dropped to 1.73 after adjustment for age, sex, and having one or more comorbidities. For COVID-19–related death, those odds ratios were 2.32 unadjusted versus 1.59 adjusted. In both cases, the values were still significant after adjustment, she emphasized.
Overall, hyperglycemia and hemoglobin A1c at admission emerged as significant independent predictors of severe outcomes.
“Further research is needed to understand the interplay between COVID-19 and diabetes and how best to address the disproportionate burden of COVID-19 among people living with diabetes,” she stressed.
Adult-onset type 1 diabetes: Growing recognition of the burden
Ascertainment of data for both adult-onset type 1 and type 2 diabetes in youth was subject to significant limitations.
For adult-onset type 1 diabetes, Jessica Harding, PhD, pointed to the fact that the epidemiology of adult-onset type 1 diabetes hasn’t been well characterized because of the historical focus on children, the difficulty of distinguishing it from type 2 diabetes in adults, and that many registries simply don’t include incident data across the lifespan for type 1 diabetes.
Nonetheless, she said, “there is growing recognition of the burden of adult-onset type 1,” noting that the American Diabetes Association and European Association for the Study of Diabetes just published a consensus statement addressing the topic.
A systematic review of 46 studies representing 32 countries or regions revealed that countries with the highest incidence of type 1 diabetes onset per population of 100,000 ages 20 or above were Eritrea, at 46.2, followed by Sweden and Ireland, both at 30.6, and Finland, at 0. The lowest rates were in Asian countries.
While the Nordic countries (Finland, Sweden, and Norway) are among the top for incidence of both childhood-onset (0-14 years) and adult-onset type 1 diabetes, Eritrea isn’t even among the top 10 for childhood onset.
The unusual situation in Eritrea is the subject of current study but the reasons aren’t yet clear, noted Dr. Magliano, of Emory University, Atlanta, during the question-and-answer period.
And only seven studies, 15%, used biomarkers to determine type 1 diabetes status, suggesting “there is a pressing need to improve the quality and quantity of information on adult-onset type 1 diabetes, particularly in those low- and middle-income countries,” Dr. Harding said.
Type 2 diabetes in youth: A call for better data
When presenting the data for childhood-onset type 2 diabetes, Andrea Luk, MD, noted: “The onset of advanced complications during the most productive time of life has significant impact on individuals, communities, and health economies.”
In 19 studies, the highest reported prevalence of type 2 diabetes in youth was in Brazil, Mexico, indigenous populations of the United States and Canada, and the Black population in the United States, with rates ranging from 160 per 100,000 to 3300 per 100,000. The lowest prevalence rates of 0.6 per 100,000 to 2.7 per 100,000 were reported in Europe. Incidence data were similar, with the highest rates from 31 per 100,000 to 94 per 100,000 and the lowest 0.1 per 100,000 to 0.8 per 100,000 per year.
Of note, Dr. Luk pointed out that childhood obesity is an important factor but not the only one.
“Some populations that have a low prevalence of obesity, such as East Asians, reported higher incidence rates of youth-onset type 2 diabetes than populations with a greater burden of childhood obesity.”
There was variability in incidence rates for youth of similar ethnic background but from different countries. “Apart from genetic predisposition and background obesogenic environment, disparity in socioeconomic status, access to health care, and cultural practices are other contributors to differences in risk of type 2 diabetes in youth,” noted Dr. Luk, associate professor in the division of endocrinology, Department of Medicine and Therapeutics, Chinese University of Hong Kong.
She also noted that the incidence of type 2 diabetes was extremely low in prepubertal children and rises gradually during puberty, and that the incidence is higher in girls than boys but that reverses in adulthood.
Compared with adults with type 2 diabetes, youth with type 2 diabetes had a more adverse glycemic trajectory and higher rates of metformin failure.
And compared with youth with type 1 diabetes, those with type 2 diabetes had more adverse metabolic profiles and higher rates of vascular complications.
“A strong call must be made for the collection of trend data to assess global burden of type 2 diabetes in youth,” she concluded.
Dr. Luk reported serving as an advisory panel member for and/or receiving research support from Amgen, AstraZeneca, Boehringer Ingelheim, Sanofi, the Asia Diabetes Foundation, Bayer, Lee’s Pharmaceutical, MSD, Novo Nordisk, Roche, Sugardown, and Takeda. The other authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New single-button blood glucose monitor available in U.S.
The POGO Automatic Blood Glucose Monitoring System (Intuity Medical) has been cleared by the U.S. Food and Drug Administration for people with diabetes aged 13 years and older.
It contains a 10-test cartridge, and once loaded and the monitor is turned on, the user only has to press their finger on a button to activate POGO Automatic, which then does all the work of lancing and blood collection, followed by a 4-second countdown and a result. Users only need to carry the monitor and not separate lancets or strips.
An app called Patterns is available for iOS and Android that allows the results from the device to automatically sync via Bluetooth. It visually presents glucose trends and enables data sharing with health care providers.
“We know that people with diabetes are more effective at managing their diabetes when they regularly check their blood glucose and use the information to take action,” said Daniel Einhorn, MD, medical director of Scripps Whittier Diabetes Institute, president of Diabetes and Endocrine Associates, and chairperson of the Intuity Medical Scientific Advisory Board, in a company statement.
“My patients and millions of others with diabetes have struggled for decades with the burden of checking their glucose because it’s complicated, there’s a lot to carry around, and it’s intrusive,” he added. “What they’ve needed is a simple, quick, and truly discreet way to check their blood glucose, so they’ll actually do it.”
How does POGO compare with CGM?
Continuous glucose monitors (CGMs), such as the Abbott FreeStyle Libre, Dexcom G6, and Eversense implant, are increasingly employed by people with type 1 diabetes, and some with type 2 diabetes, to keep a close eye on their blood glucose levels.
Asked how the POGO device compares with CGM systems, Intuity Chief Commercial Officer Dean Zikria said: “While [CGM] is certainly an important option for a subset of people with diabetes, CGM is a very different technology, requiring a user to wear a sensor and transmitter on their body.”
“Patients also need to obtain a prescription in order to use CGM.”
“Conversely, POGO Automatic is available with or without a prescription. POGO Automatic also gives people who do not want to wear a device on their body a new choice other than traditional blood glucose monitoring,” Mr. Zikria added.
The POGO system is available at U.S. pharmacies, including CVS and Walgreens, and can also be purchased online.
The device costs $68 from the company website and a pack of 5 cartridges (each containing 10 tests, with an aim of people performing 1-2 tests per day) costs a further $32 as a one-off, or $32 per month as a subscription.
The product is also eligible for purchase using Flexible Spending Accounts and Health Savings Accounts.
A version of this article first appeared on Medscape.com.
The POGO Automatic Blood Glucose Monitoring System (Intuity Medical) has been cleared by the U.S. Food and Drug Administration for people with diabetes aged 13 years and older.
It contains a 10-test cartridge, and once loaded and the monitor is turned on, the user only has to press their finger on a button to activate POGO Automatic, which then does all the work of lancing and blood collection, followed by a 4-second countdown and a result. Users only need to carry the monitor and not separate lancets or strips.
An app called Patterns is available for iOS and Android that allows the results from the device to automatically sync via Bluetooth. It visually presents glucose trends and enables data sharing with health care providers.
“We know that people with diabetes are more effective at managing their diabetes when they regularly check their blood glucose and use the information to take action,” said Daniel Einhorn, MD, medical director of Scripps Whittier Diabetes Institute, president of Diabetes and Endocrine Associates, and chairperson of the Intuity Medical Scientific Advisory Board, in a company statement.
“My patients and millions of others with diabetes have struggled for decades with the burden of checking their glucose because it’s complicated, there’s a lot to carry around, and it’s intrusive,” he added. “What they’ve needed is a simple, quick, and truly discreet way to check their blood glucose, so they’ll actually do it.”
How does POGO compare with CGM?
Continuous glucose monitors (CGMs), such as the Abbott FreeStyle Libre, Dexcom G6, and Eversense implant, are increasingly employed by people with type 1 diabetes, and some with type 2 diabetes, to keep a close eye on their blood glucose levels.
Asked how the POGO device compares with CGM systems, Intuity Chief Commercial Officer Dean Zikria said: “While [CGM] is certainly an important option for a subset of people with diabetes, CGM is a very different technology, requiring a user to wear a sensor and transmitter on their body.”
“Patients also need to obtain a prescription in order to use CGM.”
“Conversely, POGO Automatic is available with or without a prescription. POGO Automatic also gives people who do not want to wear a device on their body a new choice other than traditional blood glucose monitoring,” Mr. Zikria added.
The POGO system is available at U.S. pharmacies, including CVS and Walgreens, and can also be purchased online.
The device costs $68 from the company website and a pack of 5 cartridges (each containing 10 tests, with an aim of people performing 1-2 tests per day) costs a further $32 as a one-off, or $32 per month as a subscription.
The product is also eligible for purchase using Flexible Spending Accounts and Health Savings Accounts.
A version of this article first appeared on Medscape.com.
The POGO Automatic Blood Glucose Monitoring System (Intuity Medical) has been cleared by the U.S. Food and Drug Administration for people with diabetes aged 13 years and older.
It contains a 10-test cartridge, and once loaded and the monitor is turned on, the user only has to press their finger on a button to activate POGO Automatic, which then does all the work of lancing and blood collection, followed by a 4-second countdown and a result. Users only need to carry the monitor and not separate lancets or strips.
An app called Patterns is available for iOS and Android that allows the results from the device to automatically sync via Bluetooth. It visually presents glucose trends and enables data sharing with health care providers.
“We know that people with diabetes are more effective at managing their diabetes when they regularly check their blood glucose and use the information to take action,” said Daniel Einhorn, MD, medical director of Scripps Whittier Diabetes Institute, president of Diabetes and Endocrine Associates, and chairperson of the Intuity Medical Scientific Advisory Board, in a company statement.
“My patients and millions of others with diabetes have struggled for decades with the burden of checking their glucose because it’s complicated, there’s a lot to carry around, and it’s intrusive,” he added. “What they’ve needed is a simple, quick, and truly discreet way to check their blood glucose, so they’ll actually do it.”
How does POGO compare with CGM?
Continuous glucose monitors (CGMs), such as the Abbott FreeStyle Libre, Dexcom G6, and Eversense implant, are increasingly employed by people with type 1 diabetes, and some with type 2 diabetes, to keep a close eye on their blood glucose levels.
Asked how the POGO device compares with CGM systems, Intuity Chief Commercial Officer Dean Zikria said: “While [CGM] is certainly an important option for a subset of people with diabetes, CGM is a very different technology, requiring a user to wear a sensor and transmitter on their body.”
“Patients also need to obtain a prescription in order to use CGM.”
“Conversely, POGO Automatic is available with or without a prescription. POGO Automatic also gives people who do not want to wear a device on their body a new choice other than traditional blood glucose monitoring,” Mr. Zikria added.
The POGO system is available at U.S. pharmacies, including CVS and Walgreens, and can also be purchased online.
The device costs $68 from the company website and a pack of 5 cartridges (each containing 10 tests, with an aim of people performing 1-2 tests per day) costs a further $32 as a one-off, or $32 per month as a subscription.
The product is also eligible for purchase using Flexible Spending Accounts and Health Savings Accounts.
A version of this article first appeared on Medscape.com.
Neighborhood fast food restaurants linked to type 2 diabetes
new research indicates.
The national study of more than 4 million U.S. veterans also found the opposite association with supermarkets in suburban and rural communities but not others.
“Neighborhood food environment was associated with type 2 diabetes risk among U.S. veterans in multiple community types, suggesting potential avenues for action to address the burden of type 2 diabetes,” say Rania Kanchi, MPH, of the department of population health, New York University Langone Health, and colleagues.
Restriction of fast food establishments could benefit all types of communities, while interventions to increase supermarket availability could help minimize diabetes risk in suburban and rural communities, they stress.
“These actions, combined with increasing awareness of the risk of type 2 diabetes and the importance of healthy diet intake, might be associated with a decrease in the burden of type 2 diabetes among adults in the U.S.,” the researchers add.
The data were published online Oct. 29 in JAMA Network Open.
“The more we learn about the relationship between the food environment and chronic diseases like type 2 diabetes, the more policymakers can act by improving the mix of healthy food options sold in restaurants and food outlets, or by creating better zoning laws that promote optimal food options for residents,” commented Lorna Thorpe, PhD, MPH, professor in the department of population health at NYU Langone and senior author of the study in a press release.
In an accompanying editorial, Elham Hatef, MD, MPH, of the Center for Population Health IT at Johns Hopkins Bloomberg School of Public Health, Baltimore, calls the study “a great example of the capabilities of [health information technology] to provide a comprehensive assessment of a person’s health, which goes beyond just documenting clinical diseases and medical interventions.”
Research has large geographic breadth
The study is notable for its large geographic breadth, say the researchers.
“Most studies that examine the built food environment and its relationship to chronic diseases have been much smaller or conducted in localized areas,” Ms. Kanchi said in the press statement.
“Our study design is national in scope and allowed us to identify the types of communities that people are living in, characterize their food environment, and observe what happens to them over time. The size of our cohort allows for geographic generalizability in a way that other studies do not,” Ms. Kanchi continued.
The research included data for 4,100,650 individuals from the Veterans Affairs electronic health records (EHRs) who didn’t have type 2 diabetes at baseline, between 2008 and 2016. After a median follow-up of 5.5 person-years, 13.2% developed type 2 diabetes. Cumulative incidence was greater among those who were older, those who were non-Hispanic Black compared with other races, and those with disabilities and lower incomes.
The proportion of adults with type 2 diabetes was highest among those living in high-density urban communities (14.3%), followed by low-density urban (13.1%), rural (13.2%), and suburban (12.6%) communities.
Overall, a 10% increase in the number of fast food restaurants compared with other food establishments in a given neighborhood was associated with a 1% increased risk for incident type 2 diabetes in high-density urban, low-density urban, and rural communities and a 2% increased risk in suburban communities.
In contrast, a 10% increase in supermarket density compared with other food stores was associated with a lower risk for type 2 diabetes in suburban and rural communities, but the association wasn’t significant elsewhere.
“Taken together, our findings suggest that policies specific to fast food restaurants, such as [those] ... restricting the siting of fast food restaurants and healthy beverage default laws, may be effective in reducing type 2 diabetes risk in all community types,” say the authors.
“In urban areas where population and retail density are growing, it will be even more important to focus on these policies,” they emphasize.
Great example of capabilities of health information technology
In the editorial, Dr. Hatef notes that methodological advances, such as natural language processing and machine learning, have enabled health systems to use real-world data such as the free-text notes in the EHR to identify patient-level risk factors for diseases or disease complications.
Such methods could be further used to “evaluate the associations between social needs and place-based [social determinants of health] and type 2 diabetes incidence and management,” Dr. Hatef adds.
And linkage of data from the EHR to such community-level data “would help to comprehensively assess and identify patients likely to experience type 2 diabetes and its complications as a result of their risk factors or characteristics of the neighborhoods where they reside.”
“This approach could foster collaborations between the health systems and at-risk communities they serve and help to reallocate health system resources to those in most need in the community to reduce the burden of type 2 diabetes and other chronic conditions among racial minority groups and socioeconomically disadvantaged patients and to advance population health.”
The study was supported by the Centers for Disease Control and Prevention, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Aging, the Commonwealth Universal Research Enhancement program funded by the Pennsylvania Department of Health, the Urban Health Collaborative at Drexel University, and the Built Environment and Health Research Group at Columbia University. Ms. Kanchi and Dr. Hatef have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
new research indicates.
The national study of more than 4 million U.S. veterans also found the opposite association with supermarkets in suburban and rural communities but not others.
“Neighborhood food environment was associated with type 2 diabetes risk among U.S. veterans in multiple community types, suggesting potential avenues for action to address the burden of type 2 diabetes,” say Rania Kanchi, MPH, of the department of population health, New York University Langone Health, and colleagues.
Restriction of fast food establishments could benefit all types of communities, while interventions to increase supermarket availability could help minimize diabetes risk in suburban and rural communities, they stress.
“These actions, combined with increasing awareness of the risk of type 2 diabetes and the importance of healthy diet intake, might be associated with a decrease in the burden of type 2 diabetes among adults in the U.S.,” the researchers add.
The data were published online Oct. 29 in JAMA Network Open.
“The more we learn about the relationship between the food environment and chronic diseases like type 2 diabetes, the more policymakers can act by improving the mix of healthy food options sold in restaurants and food outlets, or by creating better zoning laws that promote optimal food options for residents,” commented Lorna Thorpe, PhD, MPH, professor in the department of population health at NYU Langone and senior author of the study in a press release.
In an accompanying editorial, Elham Hatef, MD, MPH, of the Center for Population Health IT at Johns Hopkins Bloomberg School of Public Health, Baltimore, calls the study “a great example of the capabilities of [health information technology] to provide a comprehensive assessment of a person’s health, which goes beyond just documenting clinical diseases and medical interventions.”
Research has large geographic breadth
The study is notable for its large geographic breadth, say the researchers.
“Most studies that examine the built food environment and its relationship to chronic diseases have been much smaller or conducted in localized areas,” Ms. Kanchi said in the press statement.
“Our study design is national in scope and allowed us to identify the types of communities that people are living in, characterize their food environment, and observe what happens to them over time. The size of our cohort allows for geographic generalizability in a way that other studies do not,” Ms. Kanchi continued.
The research included data for 4,100,650 individuals from the Veterans Affairs electronic health records (EHRs) who didn’t have type 2 diabetes at baseline, between 2008 and 2016. After a median follow-up of 5.5 person-years, 13.2% developed type 2 diabetes. Cumulative incidence was greater among those who were older, those who were non-Hispanic Black compared with other races, and those with disabilities and lower incomes.
The proportion of adults with type 2 diabetes was highest among those living in high-density urban communities (14.3%), followed by low-density urban (13.1%), rural (13.2%), and suburban (12.6%) communities.
Overall, a 10% increase in the number of fast food restaurants compared with other food establishments in a given neighborhood was associated with a 1% increased risk for incident type 2 diabetes in high-density urban, low-density urban, and rural communities and a 2% increased risk in suburban communities.
In contrast, a 10% increase in supermarket density compared with other food stores was associated with a lower risk for type 2 diabetes in suburban and rural communities, but the association wasn’t significant elsewhere.
“Taken together, our findings suggest that policies specific to fast food restaurants, such as [those] ... restricting the siting of fast food restaurants and healthy beverage default laws, may be effective in reducing type 2 diabetes risk in all community types,” say the authors.
“In urban areas where population and retail density are growing, it will be even more important to focus on these policies,” they emphasize.
Great example of capabilities of health information technology
In the editorial, Dr. Hatef notes that methodological advances, such as natural language processing and machine learning, have enabled health systems to use real-world data such as the free-text notes in the EHR to identify patient-level risk factors for diseases or disease complications.
Such methods could be further used to “evaluate the associations between social needs and place-based [social determinants of health] and type 2 diabetes incidence and management,” Dr. Hatef adds.
And linkage of data from the EHR to such community-level data “would help to comprehensively assess and identify patients likely to experience type 2 diabetes and its complications as a result of their risk factors or characteristics of the neighborhoods where they reside.”
“This approach could foster collaborations between the health systems and at-risk communities they serve and help to reallocate health system resources to those in most need in the community to reduce the burden of type 2 diabetes and other chronic conditions among racial minority groups and socioeconomically disadvantaged patients and to advance population health.”
The study was supported by the Centers for Disease Control and Prevention, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Aging, the Commonwealth Universal Research Enhancement program funded by the Pennsylvania Department of Health, the Urban Health Collaborative at Drexel University, and the Built Environment and Health Research Group at Columbia University. Ms. Kanchi and Dr. Hatef have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
new research indicates.
The national study of more than 4 million U.S. veterans also found the opposite association with supermarkets in suburban and rural communities but not others.
“Neighborhood food environment was associated with type 2 diabetes risk among U.S. veterans in multiple community types, suggesting potential avenues for action to address the burden of type 2 diabetes,” say Rania Kanchi, MPH, of the department of population health, New York University Langone Health, and colleagues.
Restriction of fast food establishments could benefit all types of communities, while interventions to increase supermarket availability could help minimize diabetes risk in suburban and rural communities, they stress.
“These actions, combined with increasing awareness of the risk of type 2 diabetes and the importance of healthy diet intake, might be associated with a decrease in the burden of type 2 diabetes among adults in the U.S.,” the researchers add.
The data were published online Oct. 29 in JAMA Network Open.
“The more we learn about the relationship between the food environment and chronic diseases like type 2 diabetes, the more policymakers can act by improving the mix of healthy food options sold in restaurants and food outlets, or by creating better zoning laws that promote optimal food options for residents,” commented Lorna Thorpe, PhD, MPH, professor in the department of population health at NYU Langone and senior author of the study in a press release.
In an accompanying editorial, Elham Hatef, MD, MPH, of the Center for Population Health IT at Johns Hopkins Bloomberg School of Public Health, Baltimore, calls the study “a great example of the capabilities of [health information technology] to provide a comprehensive assessment of a person’s health, which goes beyond just documenting clinical diseases and medical interventions.”
Research has large geographic breadth
The study is notable for its large geographic breadth, say the researchers.
“Most studies that examine the built food environment and its relationship to chronic diseases have been much smaller or conducted in localized areas,” Ms. Kanchi said in the press statement.
“Our study design is national in scope and allowed us to identify the types of communities that people are living in, characterize their food environment, and observe what happens to them over time. The size of our cohort allows for geographic generalizability in a way that other studies do not,” Ms. Kanchi continued.
The research included data for 4,100,650 individuals from the Veterans Affairs electronic health records (EHRs) who didn’t have type 2 diabetes at baseline, between 2008 and 2016. After a median follow-up of 5.5 person-years, 13.2% developed type 2 diabetes. Cumulative incidence was greater among those who were older, those who were non-Hispanic Black compared with other races, and those with disabilities and lower incomes.
The proportion of adults with type 2 diabetes was highest among those living in high-density urban communities (14.3%), followed by low-density urban (13.1%), rural (13.2%), and suburban (12.6%) communities.
Overall, a 10% increase in the number of fast food restaurants compared with other food establishments in a given neighborhood was associated with a 1% increased risk for incident type 2 diabetes in high-density urban, low-density urban, and rural communities and a 2% increased risk in suburban communities.
In contrast, a 10% increase in supermarket density compared with other food stores was associated with a lower risk for type 2 diabetes in suburban and rural communities, but the association wasn’t significant elsewhere.
“Taken together, our findings suggest that policies specific to fast food restaurants, such as [those] ... restricting the siting of fast food restaurants and healthy beverage default laws, may be effective in reducing type 2 diabetes risk in all community types,” say the authors.
“In urban areas where population and retail density are growing, it will be even more important to focus on these policies,” they emphasize.
Great example of capabilities of health information technology
In the editorial, Dr. Hatef notes that methodological advances, such as natural language processing and machine learning, have enabled health systems to use real-world data such as the free-text notes in the EHR to identify patient-level risk factors for diseases or disease complications.
Such methods could be further used to “evaluate the associations between social needs and place-based [social determinants of health] and type 2 diabetes incidence and management,” Dr. Hatef adds.
And linkage of data from the EHR to such community-level data “would help to comprehensively assess and identify patients likely to experience type 2 diabetes and its complications as a result of their risk factors or characteristics of the neighborhoods where they reside.”
“This approach could foster collaborations between the health systems and at-risk communities they serve and help to reallocate health system resources to those in most need in the community to reduce the burden of type 2 diabetes and other chronic conditions among racial minority groups and socioeconomically disadvantaged patients and to advance population health.”
The study was supported by the Centers for Disease Control and Prevention, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Aging, the Commonwealth Universal Research Enhancement program funded by the Pennsylvania Department of Health, the Urban Health Collaborative at Drexel University, and the Built Environment and Health Research Group at Columbia University. Ms. Kanchi and Dr. Hatef have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Stem cell transplant seen as major type 1 diabetes advance
A novel investigational allogeneic stem cell–derived treatment resulted in near reversal of type 1 diabetes in a patient who had lived with the condition for about 40 years.
The patient was the first in Vertex Pharmaceuticals’ phase 1/2 multicenter, single-arm, open-label clinical trial of the insulin-producing islet cell therapy VX-880 for patients with type 1 diabetes who have impaired hypoglycemic awareness and severe hypoglycemia.
The cells are delivered by infusion into the hepatic portal vein. As of now, chronic immunosuppression is required to prevent rejection, but several approaches are being studied to overcome the limitation.
“There’s hope that this is a real advance. It’s been long awaited, and it looks really encouraging,” James Markmann, MD, PhD, the surgeon who performed the procedure, told this news organization.
The use of insulin-producing pancreatic beta cells derived from human pluripotent stem cells, first reported in 2014 by a team at the Harvard Stem Cell Institute, Boston, is seen as a major advance over use of cadaveric donor islet cells because stem cell–derived islets are available in unlimited and uncontaminated supplies.
Cadaveric donor islets are being used in products such as donislecel (CellTrans), which was endorsed by a Food and Drug Administration advisory committee in the summer for the treatment of type 1 diabetes that can’t be managed with current therapies.
The patient in the Vertex trial isn’t the first reported stem cell–derived islet recipient with type 1 diabetes, but these cells are the first to be transplanted into the liver.
“This Vertex patient stood out because the reduction in insulin requirement ... was so striking,” noted Dr. Markmann, chief of the division of transplant surgery at Massachusetts General Hospital, Boston, who has been transplanting islet cells from cadaveric donors into humans via the hepatic portal vein for over 20 years.
“Nobody knew what to expect, as it hadn’t been done before, but certainly the results in this patient are better than what I would have expected from a deceased donor islet transplant,” he added.
Asked to comment, A.M. James Shapiro, MD, agreed. “I think the most important finding is that a stem cell–derived islet is now transplanted into the liver of a patient safely, so far,” he said in an interview.
Dr. Shapiro is clinical director of the living donor and islet cell transplantation programs at the University of Alberta, Edmonton. He pioneered cadaveric donor islet cell transplantation more than 20 years ago with the watershed Edmonton Protocol.
‘Impressive finding ... bodes well for ongoing efforts’
Vertex announced the result by press release. The company plans to transplant another 16 patients, staggering them over time at multiple centers.
The first patient was treated with a single infusion of VX-880 at half the target dose (per protocol for the first two study subjects), along with standard immunosuppressive therapy. At 90 days, the patient’s C-peptide, a measure of endogenous insulin secretion, rose from undetectable to 280 pmol/L fasting and 560 pmol/L post mixed-meal tolerance testing.
Over the same period, the patient’s hemoglobin A1c dropped from 8.6% at baseline to 7.2%. And within 7 days, the individual’s daily exogenous insulin requirement dropped from an average of 34 units to just 2.9 units, a 91% decrease.
The patient had experienced five severe hypoglycemic episodes in the year prior to transplant. They experienced some mild hypoglycemia soon after the procedure while insulin doses were being adjusted, but none thereafter.
Dr. Shapiro said in an interview: “I was absolutely thrilled to see the first patient results with high C-peptide and a 91% reduction in insulin. That’s a pretty impressive finding for half dosing in the very first patient in a trial. I think it bodes really well for ongoing efforts in this area by Vertex and by others that have similar kinds of cells. It’s very exciting.”
However, he cautioned, “we do need some longer-term data to be sure there’s no off-target growth or other concerns. But based on the purity of this product, that risk is likely to be low.”
And he noted, “I think we still have to address the challenges of setting this process up. A huge amount of work has gone into manufacturing the cell product for a single patient. I think it remains to be seen whether the same technology can be delivered at a larger scale ... i.e., being able to treat hundreds or thousands of patients.”
A blog post on the website of diabetes charity JDRF called the result “outstanding.” “It’s a big deal,” they added. However, they also cautioned: “There are a few things to keep in mind while assessing the data. One is that these are only results from a single person. Data are needed from many more to fully evaluate the potential of this therapy. The second is that this person only received half the target dose of cells.”
Dr. Shapiro is working with another company, ViaCyte, which has also developed stem cell–derived islets. In contrast to the Vertex product, which is fully differentiated and delivered to the liver, ViaCyte’s PEC-Direct product is comprised of stem cell-derived pancreatic islet progenitor cells that are implanted subcutaneously in a pouch, allowing for vascularization.
In a late-breaking poster at the annual scientific sessions of the American Diabetes Association in June 2021, ViaCyte reported on a patient given PEC-Direct. In that patient, stimulated C-peptide increased from 0.1 ng/mL at baseline to 0.8 ng/mL at week 39, and there was a drop in A1c from 7.4% to 6.6%, with no adverse events.
Immunosuppression: Which approach will come closer to cure?
Thus far, the requirement for lifelong immunosuppression has meant that any islet cell replacement approach, including with stem cell–derived islets, has been limited to use in people with type 1 diabetes who have hypoglycemic unawareness or severely unpredictable blood glucose levels.
Two broad approaches are simultaneously being explored to overcome the rejection problem: Encapsulation of the cells to protect them from the immune system, and genetic modification of the cells so that they don’t provoke the immune system in the first place.
In 2022, Vertex plans to file an investigational new drug application for an encapsulated islet cell program with the FDA.
Dr. Markmann believes the genetic modification approach is more promising. “I’m not a believer in encapsulation. I think the foreign body response is hard to overcome. I think the answer will ultimately be genetically modifying the [cell] lines. ... The cell could express something that would potentially turn off the lymphocytes or interfere with the lymphocytes trying to attack them.”
Moreover, he said, “you don’t have to get rid of immunosuppression completely. It’s all [a] risk-benefit [equation]. Even if you could get it down to a single less-toxic [immunosuppressive] agent that would be a huge step.”
Dr. Shapiro commented: “All efforts and eyes are laser-focused on developing cells or approaches that will allow transplantation of this kind of stem cell without any immunosuppression or with low-dose immunosuppression that could be regarded as being exceedingly low risk.”
“Then, and only then, I think we could offer this kind of treatment to children who are just diagnosed with diabetes or to [a bigger proportion of] patients with type 1 or type 2 diabetes. ... The science has to be done in a step-wise fashion,” he added.
Microencapsulation, Dr. Shapiro noted, “is a big challenge because the process of capturing the cells and putting them into a device is really injurious to their survival. ... That may or may not work.”
Dr. Shapiro and his Edmonton team are now embarking on a new trial with ViaCyte and CRISPR Therapeutics using gene-edited cells that contain two knock-in genes and two knock-out genes shown to be less immunogenic and anti-inflammatory in rodent models.
“They look to be promising. We’re going to start a first-in-human trial in the next few months with those cells to see if they really are able to withstand a transplant without the need for immunosuppression. That will be a very exciting trial in itself,” Dr. Shapiro said, noting that they expect to enroll the first patients in the next few months.
However, he cautioned, “first we have to make sure that the gene-edited product continues to function in patients in the way that the original product did, that the cells survive, and that the gene modifications are actually effective. ... Maybe other iterations will be needed.”
“I think, as we move forward, we will ultimately have a gene-edited stem cell–derived product that is immune evasive and will survive. So, I’m ... optimistic that this is not as long term as you might think, and it’s ... happening much more rapidly – at least in first-in-human trials to test safety and preliminary efficacy.”
Dr. Shapiro is a consultant for ViaCyte.
A version of this article first appeared on Medscape.com.
A novel investigational allogeneic stem cell–derived treatment resulted in near reversal of type 1 diabetes in a patient who had lived with the condition for about 40 years.
The patient was the first in Vertex Pharmaceuticals’ phase 1/2 multicenter, single-arm, open-label clinical trial of the insulin-producing islet cell therapy VX-880 for patients with type 1 diabetes who have impaired hypoglycemic awareness and severe hypoglycemia.
The cells are delivered by infusion into the hepatic portal vein. As of now, chronic immunosuppression is required to prevent rejection, but several approaches are being studied to overcome the limitation.
“There’s hope that this is a real advance. It’s been long awaited, and it looks really encouraging,” James Markmann, MD, PhD, the surgeon who performed the procedure, told this news organization.
The use of insulin-producing pancreatic beta cells derived from human pluripotent stem cells, first reported in 2014 by a team at the Harvard Stem Cell Institute, Boston, is seen as a major advance over use of cadaveric donor islet cells because stem cell–derived islets are available in unlimited and uncontaminated supplies.
Cadaveric donor islets are being used in products such as donislecel (CellTrans), which was endorsed by a Food and Drug Administration advisory committee in the summer for the treatment of type 1 diabetes that can’t be managed with current therapies.
The patient in the Vertex trial isn’t the first reported stem cell–derived islet recipient with type 1 diabetes, but these cells are the first to be transplanted into the liver.
“This Vertex patient stood out because the reduction in insulin requirement ... was so striking,” noted Dr. Markmann, chief of the division of transplant surgery at Massachusetts General Hospital, Boston, who has been transplanting islet cells from cadaveric donors into humans via the hepatic portal vein for over 20 years.
“Nobody knew what to expect, as it hadn’t been done before, but certainly the results in this patient are better than what I would have expected from a deceased donor islet transplant,” he added.
Asked to comment, A.M. James Shapiro, MD, agreed. “I think the most important finding is that a stem cell–derived islet is now transplanted into the liver of a patient safely, so far,” he said in an interview.
Dr. Shapiro is clinical director of the living donor and islet cell transplantation programs at the University of Alberta, Edmonton. He pioneered cadaveric donor islet cell transplantation more than 20 years ago with the watershed Edmonton Protocol.
‘Impressive finding ... bodes well for ongoing efforts’
Vertex announced the result by press release. The company plans to transplant another 16 patients, staggering them over time at multiple centers.
The first patient was treated with a single infusion of VX-880 at half the target dose (per protocol for the first two study subjects), along with standard immunosuppressive therapy. At 90 days, the patient’s C-peptide, a measure of endogenous insulin secretion, rose from undetectable to 280 pmol/L fasting and 560 pmol/L post mixed-meal tolerance testing.
Over the same period, the patient’s hemoglobin A1c dropped from 8.6% at baseline to 7.2%. And within 7 days, the individual’s daily exogenous insulin requirement dropped from an average of 34 units to just 2.9 units, a 91% decrease.
The patient had experienced five severe hypoglycemic episodes in the year prior to transplant. They experienced some mild hypoglycemia soon after the procedure while insulin doses were being adjusted, but none thereafter.
Dr. Shapiro said in an interview: “I was absolutely thrilled to see the first patient results with high C-peptide and a 91% reduction in insulin. That’s a pretty impressive finding for half dosing in the very first patient in a trial. I think it bodes really well for ongoing efforts in this area by Vertex and by others that have similar kinds of cells. It’s very exciting.”
However, he cautioned, “we do need some longer-term data to be sure there’s no off-target growth or other concerns. But based on the purity of this product, that risk is likely to be low.”
And he noted, “I think we still have to address the challenges of setting this process up. A huge amount of work has gone into manufacturing the cell product for a single patient. I think it remains to be seen whether the same technology can be delivered at a larger scale ... i.e., being able to treat hundreds or thousands of patients.”
A blog post on the website of diabetes charity JDRF called the result “outstanding.” “It’s a big deal,” they added. However, they also cautioned: “There are a few things to keep in mind while assessing the data. One is that these are only results from a single person. Data are needed from many more to fully evaluate the potential of this therapy. The second is that this person only received half the target dose of cells.”
Dr. Shapiro is working with another company, ViaCyte, which has also developed stem cell–derived islets. In contrast to the Vertex product, which is fully differentiated and delivered to the liver, ViaCyte’s PEC-Direct product is comprised of stem cell-derived pancreatic islet progenitor cells that are implanted subcutaneously in a pouch, allowing for vascularization.
In a late-breaking poster at the annual scientific sessions of the American Diabetes Association in June 2021, ViaCyte reported on a patient given PEC-Direct. In that patient, stimulated C-peptide increased from 0.1 ng/mL at baseline to 0.8 ng/mL at week 39, and there was a drop in A1c from 7.4% to 6.6%, with no adverse events.
Immunosuppression: Which approach will come closer to cure?
Thus far, the requirement for lifelong immunosuppression has meant that any islet cell replacement approach, including with stem cell–derived islets, has been limited to use in people with type 1 diabetes who have hypoglycemic unawareness or severely unpredictable blood glucose levels.
Two broad approaches are simultaneously being explored to overcome the rejection problem: Encapsulation of the cells to protect them from the immune system, and genetic modification of the cells so that they don’t provoke the immune system in the first place.
In 2022, Vertex plans to file an investigational new drug application for an encapsulated islet cell program with the FDA.
Dr. Markmann believes the genetic modification approach is more promising. “I’m not a believer in encapsulation. I think the foreign body response is hard to overcome. I think the answer will ultimately be genetically modifying the [cell] lines. ... The cell could express something that would potentially turn off the lymphocytes or interfere with the lymphocytes trying to attack them.”
Moreover, he said, “you don’t have to get rid of immunosuppression completely. It’s all [a] risk-benefit [equation]. Even if you could get it down to a single less-toxic [immunosuppressive] agent that would be a huge step.”
Dr. Shapiro commented: “All efforts and eyes are laser-focused on developing cells or approaches that will allow transplantation of this kind of stem cell without any immunosuppression or with low-dose immunosuppression that could be regarded as being exceedingly low risk.”
“Then, and only then, I think we could offer this kind of treatment to children who are just diagnosed with diabetes or to [a bigger proportion of] patients with type 1 or type 2 diabetes. ... The science has to be done in a step-wise fashion,” he added.
Microencapsulation, Dr. Shapiro noted, “is a big challenge because the process of capturing the cells and putting them into a device is really injurious to their survival. ... That may or may not work.”
Dr. Shapiro and his Edmonton team are now embarking on a new trial with ViaCyte and CRISPR Therapeutics using gene-edited cells that contain two knock-in genes and two knock-out genes shown to be less immunogenic and anti-inflammatory in rodent models.
“They look to be promising. We’re going to start a first-in-human trial in the next few months with those cells to see if they really are able to withstand a transplant without the need for immunosuppression. That will be a very exciting trial in itself,” Dr. Shapiro said, noting that they expect to enroll the first patients in the next few months.
However, he cautioned, “first we have to make sure that the gene-edited product continues to function in patients in the way that the original product did, that the cells survive, and that the gene modifications are actually effective. ... Maybe other iterations will be needed.”
“I think, as we move forward, we will ultimately have a gene-edited stem cell–derived product that is immune evasive and will survive. So, I’m ... optimistic that this is not as long term as you might think, and it’s ... happening much more rapidly – at least in first-in-human trials to test safety and preliminary efficacy.”
Dr. Shapiro is a consultant for ViaCyte.
A version of this article first appeared on Medscape.com.
A novel investigational allogeneic stem cell–derived treatment resulted in near reversal of type 1 diabetes in a patient who had lived with the condition for about 40 years.
The patient was the first in Vertex Pharmaceuticals’ phase 1/2 multicenter, single-arm, open-label clinical trial of the insulin-producing islet cell therapy VX-880 for patients with type 1 diabetes who have impaired hypoglycemic awareness and severe hypoglycemia.
The cells are delivered by infusion into the hepatic portal vein. As of now, chronic immunosuppression is required to prevent rejection, but several approaches are being studied to overcome the limitation.
“There’s hope that this is a real advance. It’s been long awaited, and it looks really encouraging,” James Markmann, MD, PhD, the surgeon who performed the procedure, told this news organization.
The use of insulin-producing pancreatic beta cells derived from human pluripotent stem cells, first reported in 2014 by a team at the Harvard Stem Cell Institute, Boston, is seen as a major advance over use of cadaveric donor islet cells because stem cell–derived islets are available in unlimited and uncontaminated supplies.
Cadaveric donor islets are being used in products such as donislecel (CellTrans), which was endorsed by a Food and Drug Administration advisory committee in the summer for the treatment of type 1 diabetes that can’t be managed with current therapies.
The patient in the Vertex trial isn’t the first reported stem cell–derived islet recipient with type 1 diabetes, but these cells are the first to be transplanted into the liver.
“This Vertex patient stood out because the reduction in insulin requirement ... was so striking,” noted Dr. Markmann, chief of the division of transplant surgery at Massachusetts General Hospital, Boston, who has been transplanting islet cells from cadaveric donors into humans via the hepatic portal vein for over 20 years.
“Nobody knew what to expect, as it hadn’t been done before, but certainly the results in this patient are better than what I would have expected from a deceased donor islet transplant,” he added.
Asked to comment, A.M. James Shapiro, MD, agreed. “I think the most important finding is that a stem cell–derived islet is now transplanted into the liver of a patient safely, so far,” he said in an interview.
Dr. Shapiro is clinical director of the living donor and islet cell transplantation programs at the University of Alberta, Edmonton. He pioneered cadaveric donor islet cell transplantation more than 20 years ago with the watershed Edmonton Protocol.
‘Impressive finding ... bodes well for ongoing efforts’
Vertex announced the result by press release. The company plans to transplant another 16 patients, staggering them over time at multiple centers.
The first patient was treated with a single infusion of VX-880 at half the target dose (per protocol for the first two study subjects), along with standard immunosuppressive therapy. At 90 days, the patient’s C-peptide, a measure of endogenous insulin secretion, rose from undetectable to 280 pmol/L fasting and 560 pmol/L post mixed-meal tolerance testing.
Over the same period, the patient’s hemoglobin A1c dropped from 8.6% at baseline to 7.2%. And within 7 days, the individual’s daily exogenous insulin requirement dropped from an average of 34 units to just 2.9 units, a 91% decrease.
The patient had experienced five severe hypoglycemic episodes in the year prior to transplant. They experienced some mild hypoglycemia soon after the procedure while insulin doses were being adjusted, but none thereafter.
Dr. Shapiro said in an interview: “I was absolutely thrilled to see the first patient results with high C-peptide and a 91% reduction in insulin. That’s a pretty impressive finding for half dosing in the very first patient in a trial. I think it bodes really well for ongoing efforts in this area by Vertex and by others that have similar kinds of cells. It’s very exciting.”
However, he cautioned, “we do need some longer-term data to be sure there’s no off-target growth or other concerns. But based on the purity of this product, that risk is likely to be low.”
And he noted, “I think we still have to address the challenges of setting this process up. A huge amount of work has gone into manufacturing the cell product for a single patient. I think it remains to be seen whether the same technology can be delivered at a larger scale ... i.e., being able to treat hundreds or thousands of patients.”
A blog post on the website of diabetes charity JDRF called the result “outstanding.” “It’s a big deal,” they added. However, they also cautioned: “There are a few things to keep in mind while assessing the data. One is that these are only results from a single person. Data are needed from many more to fully evaluate the potential of this therapy. The second is that this person only received half the target dose of cells.”
Dr. Shapiro is working with another company, ViaCyte, which has also developed stem cell–derived islets. In contrast to the Vertex product, which is fully differentiated and delivered to the liver, ViaCyte’s PEC-Direct product is comprised of stem cell-derived pancreatic islet progenitor cells that are implanted subcutaneously in a pouch, allowing for vascularization.
In a late-breaking poster at the annual scientific sessions of the American Diabetes Association in June 2021, ViaCyte reported on a patient given PEC-Direct. In that patient, stimulated C-peptide increased from 0.1 ng/mL at baseline to 0.8 ng/mL at week 39, and there was a drop in A1c from 7.4% to 6.6%, with no adverse events.
Immunosuppression: Which approach will come closer to cure?
Thus far, the requirement for lifelong immunosuppression has meant that any islet cell replacement approach, including with stem cell–derived islets, has been limited to use in people with type 1 diabetes who have hypoglycemic unawareness or severely unpredictable blood glucose levels.
Two broad approaches are simultaneously being explored to overcome the rejection problem: Encapsulation of the cells to protect them from the immune system, and genetic modification of the cells so that they don’t provoke the immune system in the first place.
In 2022, Vertex plans to file an investigational new drug application for an encapsulated islet cell program with the FDA.
Dr. Markmann believes the genetic modification approach is more promising. “I’m not a believer in encapsulation. I think the foreign body response is hard to overcome. I think the answer will ultimately be genetically modifying the [cell] lines. ... The cell could express something that would potentially turn off the lymphocytes or interfere with the lymphocytes trying to attack them.”
Moreover, he said, “you don’t have to get rid of immunosuppression completely. It’s all [a] risk-benefit [equation]. Even if you could get it down to a single less-toxic [immunosuppressive] agent that would be a huge step.”
Dr. Shapiro commented: “All efforts and eyes are laser-focused on developing cells or approaches that will allow transplantation of this kind of stem cell without any immunosuppression or with low-dose immunosuppression that could be regarded as being exceedingly low risk.”
“Then, and only then, I think we could offer this kind of treatment to children who are just diagnosed with diabetes or to [a bigger proportion of] patients with type 1 or type 2 diabetes. ... The science has to be done in a step-wise fashion,” he added.
Microencapsulation, Dr. Shapiro noted, “is a big challenge because the process of capturing the cells and putting them into a device is really injurious to their survival. ... That may or may not work.”
Dr. Shapiro and his Edmonton team are now embarking on a new trial with ViaCyte and CRISPR Therapeutics using gene-edited cells that contain two knock-in genes and two knock-out genes shown to be less immunogenic and anti-inflammatory in rodent models.
“They look to be promising. We’re going to start a first-in-human trial in the next few months with those cells to see if they really are able to withstand a transplant without the need for immunosuppression. That will be a very exciting trial in itself,” Dr. Shapiro said, noting that they expect to enroll the first patients in the next few months.
However, he cautioned, “first we have to make sure that the gene-edited product continues to function in patients in the way that the original product did, that the cells survive, and that the gene modifications are actually effective. ... Maybe other iterations will be needed.”
“I think, as we move forward, we will ultimately have a gene-edited stem cell–derived product that is immune evasive and will survive. So, I’m ... optimistic that this is not as long term as you might think, and it’s ... happening much more rapidly – at least in first-in-human trials to test safety and preliminary efficacy.”
Dr. Shapiro is a consultant for ViaCyte.
A version of this article first appeared on Medscape.com.
‘Green’ Mediterranean diet benefits may arise from ‘hunger hormone’
A “green” adaptation to the traditional Mediterranean diet could help improve insulin sensitivity and reduce visceral fat by increasing levels of ghrelin, the “hunger hormone,” new research suggests.
The current study is a new analysis of data from the randomized DIRECT-PLUS trial, which showed that the addition of green tea and substitution of red meat for a plant-based (Mankai) protein shake at dinner – dubbed the “green Mediterranean diet” – resulted in further improved cardiometabolic benefits compared with the traditional Mediterranean diet among people with baseline abdominal obesity and/or dyslipidemia, according to the researchers.
They specifically looked at ghrelin, nicknamed the “hunger hormone,” a neuropeptide mainly secreted by the gastric epithelium. It acts on the pituitary gland to release growth hormone. Ghrelin concentrations increase during fasting and decrease after eating. Lower levels are associated with insulin resistance and obesity.
Fasting ghrelin levels were elevated with weight loss, but those increases were associated with improved insulin sensitivity and regression of visceral adipose tissue even beyond weight loss.
Although the caloric restriction and weight loss were comparable with the two Mediterranean diets, the green Mediterranean diet group had double the increase in fasting ghrelin as the traditional Mediterranean diet group, the researchers point out in their report .
‘Hypothesis-generating’ study pushes many hot topic buttons
“This specific study is the first to show that ghrelin levels play an important role in metabolic adaptation to a dietary or lifestyle intervention and that ghrelin is an important player in the axis of adiposity, insulin resistance, and metabolic health,” lead researcher Gal Tsaban, MD, told this news organization.
The data partially explain some of the prior beneficial effects seen with the Green Mediterranean diet, even after adjustment for weight loss, he explained, noting that the revised version of the diet “could be considered as an alternative lifestyle intervention with possible metabolic benefits even beyond the Mediterranean diet, which is what we currently recommend for patients.”
Asked for comment, Christopher Gardner, PhD, was not as enthusiastic.
He took issue with the fact that ghrelin wasn’t a primary or even a prespecified secondary outcome of the DIRECT-PLUS trial and because the specific plant-based ingredients of the green Mediterranean diet used in the study may not be widely available or desirable and therefore limit the study’s generalizability.
Dr. Gardner, who is director of nutrition studies at the Stanford Prevention Research Center, California, also said: “They’re tying lots of interesting things together. The Mediterranean diet is a cool thing, ghrelin is a cool thing, and insulin resistance is hugely important in this day and age, even though we don’t all agree on how to measure it.”
“But it gets tough as you try to link them all together for an exploratory outcome. ... To me it’s an interesting hypothesis-generating study that pushes a lot of interesting buttons that are hot topics in the field.”
Green Mediterranean diet led to higher ghrelin, metabolic benefits
In DIRECT-PLUS, a total of 294 adults (88% men) older than 30 years of age with abdominal obesity (waist circumference >102 cm for men or >88 cm for women), or dyslipidemia (triglycerides >150 mg/dL and HDL-cholesterol ≤40 mg/dL for men or ≤50 mg/dL for women) were included. Half had prediabetes or type 2 diabetes.
They were randomized to one of three diets: a diet based on standard healthy dietary guidelines; a traditional Mediterranean diet low in simple carbohydrates, rich in vegetables, with poultry and fish replacing beef and lamb and 28 g/day of walnuts; or the Green-Mediterranean diet, including 3-4 cups/day of green tea and 100 g/day of a green shake made from the Mankai strain of Wolffia globosa (also known as duckweed) replacing dinner, and 28 g/day of walnuts.
The Green Mediterranean diet included 800 mg more polyphenols than the traditional Mediterranean diet. Both were equally calorie-restricted, at about 1,500-1,800 kcal/day for men and 1,200-1,400 kcal/day for women. All three groups were instructed to engage in regular physical activity and were given free gym memberships.
The retention rate was 98.3% after 6 months and 89.8% after 18 months.
Weight loss was similar between the two Mediterranean diet groups (2.9% and 3.9% for the traditional and green versions, respectively) compared with the standard healthy diet (0.6%) (P < .05 for both Mediterranean diet groups vs. control).
After 6 months, fasting ghrelin increased in the traditional (8.0%; P = .015) and green (10.5%; P = 0.031) Mediterranean groups versus baseline, with no significant change in the control group.
By 18 months, fasting ghrelin was significantly greater compared with baseline only in the green Mediterranean group (P = .012).
Because the differences in fasting ghrelin trajectories were only significant in men – likely due to the small sample size of women – a subsequent 18-month analysis was limited to the men. In a multivariate model adjusted for age, intervention group, baseline biomarker values, and 18-month weight changes, the 18-month change in fasting ghrelin remained a significant predictor for changes in A1c and homeostatic model of insulin resistance (HOMA-IR; P = .022).
Because weight loss remained the most significant predictor of improved insulin resistance, a further analysis examined the association between changes in fasting ghrelin levels with changes in the fraction of insulin resistance marker that were not attributed to weight loss, per se. With the other adjustments, fasting ghrelin was associated with residual reductions in A1c (P = .003), HOMA-IR (P = .021), increased HDL-cholesterol (P = .024), and relative visceral adipose tissue loss (P = .003).
No specific product needed to push Mediterranean diet towards vegan
Dr. Tsaban, a nutritional researcher and cardiologist at Ben-Gurion University and Soroka University Medical Center, Be’er-Sheva, Israel, said the Mankai shake is commonly consumed in Israel but is also available worldwide. The study participants, all employees at an isolated nuclear research facility in the Negev, were particularly motivated. “They didn’t have a satiety problem with the drink. It made them very full,” he said. The manufacturer supplied the shakes but didn’t fund the study, he added.
However, Dr. Tsaban said that the “green Mediterranean diet” doesn’t depend on specific products.
Rather, “the concept is to push the Mediterranean diet a bit further and to replace the animal-based protein with vegetable-based protein, to shift your dietary habits towards a more vegan lifestyle. It’s not completely vegan, but it’s trending there. ... Our main goal was to increase the polyphenol intake, the antioxidant intake from vegetables. ... I think it can be replicated.”
Dr. Gardner said, “At the end of the day, it’s an exploratory study. ... It raises some interesting points that give the rest of us room to follow-up on.”
The study was funded by grants from the German Research Foundation, the Israel Ministry of Health, the Israel Ministry of Science and Technology, and the California Walnut Commission. Dr. Tsaban has reported no further relevant financial relationships. Dr. Gardner has reported receiving study funding from Beyond Meat.
A version of this article first appeared on Medscape.com.
A “green” adaptation to the traditional Mediterranean diet could help improve insulin sensitivity and reduce visceral fat by increasing levels of ghrelin, the “hunger hormone,” new research suggests.
The current study is a new analysis of data from the randomized DIRECT-PLUS trial, which showed that the addition of green tea and substitution of red meat for a plant-based (Mankai) protein shake at dinner – dubbed the “green Mediterranean diet” – resulted in further improved cardiometabolic benefits compared with the traditional Mediterranean diet among people with baseline abdominal obesity and/or dyslipidemia, according to the researchers.
They specifically looked at ghrelin, nicknamed the “hunger hormone,” a neuropeptide mainly secreted by the gastric epithelium. It acts on the pituitary gland to release growth hormone. Ghrelin concentrations increase during fasting and decrease after eating. Lower levels are associated with insulin resistance and obesity.
Fasting ghrelin levels were elevated with weight loss, but those increases were associated with improved insulin sensitivity and regression of visceral adipose tissue even beyond weight loss.
Although the caloric restriction and weight loss were comparable with the two Mediterranean diets, the green Mediterranean diet group had double the increase in fasting ghrelin as the traditional Mediterranean diet group, the researchers point out in their report .
‘Hypothesis-generating’ study pushes many hot topic buttons
“This specific study is the first to show that ghrelin levels play an important role in metabolic adaptation to a dietary or lifestyle intervention and that ghrelin is an important player in the axis of adiposity, insulin resistance, and metabolic health,” lead researcher Gal Tsaban, MD, told this news organization.
The data partially explain some of the prior beneficial effects seen with the Green Mediterranean diet, even after adjustment for weight loss, he explained, noting that the revised version of the diet “could be considered as an alternative lifestyle intervention with possible metabolic benefits even beyond the Mediterranean diet, which is what we currently recommend for patients.”
Asked for comment, Christopher Gardner, PhD, was not as enthusiastic.
He took issue with the fact that ghrelin wasn’t a primary or even a prespecified secondary outcome of the DIRECT-PLUS trial and because the specific plant-based ingredients of the green Mediterranean diet used in the study may not be widely available or desirable and therefore limit the study’s generalizability.
Dr. Gardner, who is director of nutrition studies at the Stanford Prevention Research Center, California, also said: “They’re tying lots of interesting things together. The Mediterranean diet is a cool thing, ghrelin is a cool thing, and insulin resistance is hugely important in this day and age, even though we don’t all agree on how to measure it.”
“But it gets tough as you try to link them all together for an exploratory outcome. ... To me it’s an interesting hypothesis-generating study that pushes a lot of interesting buttons that are hot topics in the field.”
Green Mediterranean diet led to higher ghrelin, metabolic benefits
In DIRECT-PLUS, a total of 294 adults (88% men) older than 30 years of age with abdominal obesity (waist circumference >102 cm for men or >88 cm for women), or dyslipidemia (triglycerides >150 mg/dL and HDL-cholesterol ≤40 mg/dL for men or ≤50 mg/dL for women) were included. Half had prediabetes or type 2 diabetes.
They were randomized to one of three diets: a diet based on standard healthy dietary guidelines; a traditional Mediterranean diet low in simple carbohydrates, rich in vegetables, with poultry and fish replacing beef and lamb and 28 g/day of walnuts; or the Green-Mediterranean diet, including 3-4 cups/day of green tea and 100 g/day of a green shake made from the Mankai strain of Wolffia globosa (also known as duckweed) replacing dinner, and 28 g/day of walnuts.
The Green Mediterranean diet included 800 mg more polyphenols than the traditional Mediterranean diet. Both were equally calorie-restricted, at about 1,500-1,800 kcal/day for men and 1,200-1,400 kcal/day for women. All three groups were instructed to engage in regular physical activity and were given free gym memberships.
The retention rate was 98.3% after 6 months and 89.8% after 18 months.
Weight loss was similar between the two Mediterranean diet groups (2.9% and 3.9% for the traditional and green versions, respectively) compared with the standard healthy diet (0.6%) (P < .05 for both Mediterranean diet groups vs. control).
After 6 months, fasting ghrelin increased in the traditional (8.0%; P = .015) and green (10.5%; P = 0.031) Mediterranean groups versus baseline, with no significant change in the control group.
By 18 months, fasting ghrelin was significantly greater compared with baseline only in the green Mediterranean group (P = .012).
Because the differences in fasting ghrelin trajectories were only significant in men – likely due to the small sample size of women – a subsequent 18-month analysis was limited to the men. In a multivariate model adjusted for age, intervention group, baseline biomarker values, and 18-month weight changes, the 18-month change in fasting ghrelin remained a significant predictor for changes in A1c and homeostatic model of insulin resistance (HOMA-IR; P = .022).
Because weight loss remained the most significant predictor of improved insulin resistance, a further analysis examined the association between changes in fasting ghrelin levels with changes in the fraction of insulin resistance marker that were not attributed to weight loss, per se. With the other adjustments, fasting ghrelin was associated with residual reductions in A1c (P = .003), HOMA-IR (P = .021), increased HDL-cholesterol (P = .024), and relative visceral adipose tissue loss (P = .003).
No specific product needed to push Mediterranean diet towards vegan
Dr. Tsaban, a nutritional researcher and cardiologist at Ben-Gurion University and Soroka University Medical Center, Be’er-Sheva, Israel, said the Mankai shake is commonly consumed in Israel but is also available worldwide. The study participants, all employees at an isolated nuclear research facility in the Negev, were particularly motivated. “They didn’t have a satiety problem with the drink. It made them very full,” he said. The manufacturer supplied the shakes but didn’t fund the study, he added.
However, Dr. Tsaban said that the “green Mediterranean diet” doesn’t depend on specific products.
Rather, “the concept is to push the Mediterranean diet a bit further and to replace the animal-based protein with vegetable-based protein, to shift your dietary habits towards a more vegan lifestyle. It’s not completely vegan, but it’s trending there. ... Our main goal was to increase the polyphenol intake, the antioxidant intake from vegetables. ... I think it can be replicated.”
Dr. Gardner said, “At the end of the day, it’s an exploratory study. ... It raises some interesting points that give the rest of us room to follow-up on.”
The study was funded by grants from the German Research Foundation, the Israel Ministry of Health, the Israel Ministry of Science and Technology, and the California Walnut Commission. Dr. Tsaban has reported no further relevant financial relationships. Dr. Gardner has reported receiving study funding from Beyond Meat.
A version of this article first appeared on Medscape.com.
A “green” adaptation to the traditional Mediterranean diet could help improve insulin sensitivity and reduce visceral fat by increasing levels of ghrelin, the “hunger hormone,” new research suggests.
The current study is a new analysis of data from the randomized DIRECT-PLUS trial, which showed that the addition of green tea and substitution of red meat for a plant-based (Mankai) protein shake at dinner – dubbed the “green Mediterranean diet” – resulted in further improved cardiometabolic benefits compared with the traditional Mediterranean diet among people with baseline abdominal obesity and/or dyslipidemia, according to the researchers.
They specifically looked at ghrelin, nicknamed the “hunger hormone,” a neuropeptide mainly secreted by the gastric epithelium. It acts on the pituitary gland to release growth hormone. Ghrelin concentrations increase during fasting and decrease after eating. Lower levels are associated with insulin resistance and obesity.
Fasting ghrelin levels were elevated with weight loss, but those increases were associated with improved insulin sensitivity and regression of visceral adipose tissue even beyond weight loss.
Although the caloric restriction and weight loss were comparable with the two Mediterranean diets, the green Mediterranean diet group had double the increase in fasting ghrelin as the traditional Mediterranean diet group, the researchers point out in their report .
‘Hypothesis-generating’ study pushes many hot topic buttons
“This specific study is the first to show that ghrelin levels play an important role in metabolic adaptation to a dietary or lifestyle intervention and that ghrelin is an important player in the axis of adiposity, insulin resistance, and metabolic health,” lead researcher Gal Tsaban, MD, told this news organization.
The data partially explain some of the prior beneficial effects seen with the Green Mediterranean diet, even after adjustment for weight loss, he explained, noting that the revised version of the diet “could be considered as an alternative lifestyle intervention with possible metabolic benefits even beyond the Mediterranean diet, which is what we currently recommend for patients.”
Asked for comment, Christopher Gardner, PhD, was not as enthusiastic.
He took issue with the fact that ghrelin wasn’t a primary or even a prespecified secondary outcome of the DIRECT-PLUS trial and because the specific plant-based ingredients of the green Mediterranean diet used in the study may not be widely available or desirable and therefore limit the study’s generalizability.
Dr. Gardner, who is director of nutrition studies at the Stanford Prevention Research Center, California, also said: “They’re tying lots of interesting things together. The Mediterranean diet is a cool thing, ghrelin is a cool thing, and insulin resistance is hugely important in this day and age, even though we don’t all agree on how to measure it.”
“But it gets tough as you try to link them all together for an exploratory outcome. ... To me it’s an interesting hypothesis-generating study that pushes a lot of interesting buttons that are hot topics in the field.”
Green Mediterranean diet led to higher ghrelin, metabolic benefits
In DIRECT-PLUS, a total of 294 adults (88% men) older than 30 years of age with abdominal obesity (waist circumference >102 cm for men or >88 cm for women), or dyslipidemia (triglycerides >150 mg/dL and HDL-cholesterol ≤40 mg/dL for men or ≤50 mg/dL for women) were included. Half had prediabetes or type 2 diabetes.
They were randomized to one of three diets: a diet based on standard healthy dietary guidelines; a traditional Mediterranean diet low in simple carbohydrates, rich in vegetables, with poultry and fish replacing beef and lamb and 28 g/day of walnuts; or the Green-Mediterranean diet, including 3-4 cups/day of green tea and 100 g/day of a green shake made from the Mankai strain of Wolffia globosa (also known as duckweed) replacing dinner, and 28 g/day of walnuts.
The Green Mediterranean diet included 800 mg more polyphenols than the traditional Mediterranean diet. Both were equally calorie-restricted, at about 1,500-1,800 kcal/day for men and 1,200-1,400 kcal/day for women. All three groups were instructed to engage in regular physical activity and were given free gym memberships.
The retention rate was 98.3% after 6 months and 89.8% after 18 months.
Weight loss was similar between the two Mediterranean diet groups (2.9% and 3.9% for the traditional and green versions, respectively) compared with the standard healthy diet (0.6%) (P < .05 for both Mediterranean diet groups vs. control).
After 6 months, fasting ghrelin increased in the traditional (8.0%; P = .015) and green (10.5%; P = 0.031) Mediterranean groups versus baseline, with no significant change in the control group.
By 18 months, fasting ghrelin was significantly greater compared with baseline only in the green Mediterranean group (P = .012).
Because the differences in fasting ghrelin trajectories were only significant in men – likely due to the small sample size of women – a subsequent 18-month analysis was limited to the men. In a multivariate model adjusted for age, intervention group, baseline biomarker values, and 18-month weight changes, the 18-month change in fasting ghrelin remained a significant predictor for changes in A1c and homeostatic model of insulin resistance (HOMA-IR; P = .022).
Because weight loss remained the most significant predictor of improved insulin resistance, a further analysis examined the association between changes in fasting ghrelin levels with changes in the fraction of insulin resistance marker that were not attributed to weight loss, per se. With the other adjustments, fasting ghrelin was associated with residual reductions in A1c (P = .003), HOMA-IR (P = .021), increased HDL-cholesterol (P = .024), and relative visceral adipose tissue loss (P = .003).
No specific product needed to push Mediterranean diet towards vegan
Dr. Tsaban, a nutritional researcher and cardiologist at Ben-Gurion University and Soroka University Medical Center, Be’er-Sheva, Israel, said the Mankai shake is commonly consumed in Israel but is also available worldwide. The study participants, all employees at an isolated nuclear research facility in the Negev, were particularly motivated. “They didn’t have a satiety problem with the drink. It made them very full,” he said. The manufacturer supplied the shakes but didn’t fund the study, he added.
However, Dr. Tsaban said that the “green Mediterranean diet” doesn’t depend on specific products.
Rather, “the concept is to push the Mediterranean diet a bit further and to replace the animal-based protein with vegetable-based protein, to shift your dietary habits towards a more vegan lifestyle. It’s not completely vegan, but it’s trending there. ... Our main goal was to increase the polyphenol intake, the antioxidant intake from vegetables. ... I think it can be replicated.”
Dr. Gardner said, “At the end of the day, it’s an exploratory study. ... It raises some interesting points that give the rest of us room to follow-up on.”
The study was funded by grants from the German Research Foundation, the Israel Ministry of Health, the Israel Ministry of Science and Technology, and the California Walnut Commission. Dr. Tsaban has reported no further relevant financial relationships. Dr. Gardner has reported receiving study funding from Beyond Meat.
A version of this article first appeared on Medscape.com.