Miriam E. Tucker

Transplantation of cadaveric pancreatic islet cells resulted in graft survival and function with acceptable safety for up to 8 years in selected individuals with type 1 diabetes, new research finds.

The study is a long-term follow-up of two phase 3 pivotal trials from the Clinical Islet Transplantation Consortium of a purified human pancreatic islet cell product for treating people with type 1 diabetes.

One trial involved islet transplantation in 48 people who experienced severe hypoglycemia and hypoglycemic unawareness, and the other trial included 24 people who also experienced those complications and were already receiving immunosuppression following kidney transplant. The trials, both registered with the U.S. Food and Drug Administration (FDA), met their primary efficacy and safety endpoints at 2- and 3-year timepoints.

The follow-up data have now been published in Diabetes Care by Michael Rickels, MD, and colleagues.

The procedure involved infusion through the hepatic portal vein of one or more purified human pancreatic islet products under standardized immunosuppression using methods that Dr. Rickels and colleagues have been developing since 2004. The approach involves multiple modalities to protect the islets prior to transplantation.

Among the 34 islet-alone and eight islet-after–kidney transplant recipients who entered the extended follow-up, durable graft survival allowing for achievement of glycemic targets occurred without severe hypoglycemia or adverse effects from immunosuppression.

The primary outcome, actuarial survival of graft islet function, was 56% at the maximum follow-up of 8.3 years for the islet-only transplantation group and 49% at 7.3 years for the islet-after–kidney transplantation group (P = .004).

The findings suggest that “in the long run, islet transplantation has efficacy, including among those who have had kidney transplants ... Most type 1 diabetes patients are improved tremendously with current insulin delivery systems ... but for those having the most difficulty controlling their blood sugar – and those whose diabetes has already been complicated by needing a kidney transplant – the outcomes we saw in this study are what we’ve been hoping to achieve for more than 20 years,” said Dr. Rickels in a statement from his institution, the University of Pennsylvania, Philadelphia.

In the initial trials at day 75 after the initial transplant, 87.5% of the islet-alone and 71% of the islet-after–kidney transplant group achieved hemoglobin A1c under 7%, and 85% and 54%, respectively, achieved A1c at or under 6.5%. At the end of maximal follow-up, 49% of islet-only transplant recipients maintained A1c under 7%, although none had A1c at or under 6.5%. For the islet-after–kidney transplant group, these proportions were 35% and 17%, respectively (P = .0017 for A1c under 7.0% and P < .0001 for A1c ≤ 6.5%, respectively, between the groups).

There were 12 severe hypoglycemic episodes in five patients (three islet-alone and two islet-after–kidney transplant group) during the initial trials, but no additional episodes occurred in either group during long-term follow-up.  

Overall, 53 individuals – 37 in the islet-alone and 16 in the islet-after–kidney transplant group – or 74% of the total, achieved a period of insulin independence with A1c under 7%, ranging from 36 to 481 days. The range of time to achieving insulin independence reflects individuals who received one, two, or three islet infusions.

The fact that most patients achieved insulin independence following just one (n = 20) or two (n = 30) infusions and only three patients required three infusions was notable, Dr. Rickels said.

“Currently, around the world, there’s an expectation of two to three donor pancreases being needed. Here, it’s one, maybe two. It’s a much more efficient protocol and opens up access for more islet transplantation as a hoped-for alternative to pancreas transplants.”

Of those who achieved insulin independence, 30 (57%) remained insulin-independent throughout follow-up (20 of 37 islet-alone and 10 of 16 islet-after–kidney transplant patients), with no difference in duration of insulin independence between the groups.

There were no deaths during post-transplant follow-up. Rates of serious adverse events were 0.31 and 0.43 per patient-year for the islet-after–kidney and islet-alone transplant groups, respectively. Of a total of 104 serious adverse events, 65 occurred during the initial trials and had been previously reported. Of the additional 39 serious adverse events that occurred during long-term follow-up, 11 were possibly due to immunosuppression and 27 were deemed unrelated to the procedures.

According to Dr. Rickels, “These are the most seriously affected patients, and you’d be expecting to see some hospitalizations in a population managed on immunosuppression therapy ... It’s important to note that none of the adverse events were related to the actual islet product. Also, kidney function remained stable during long-term follow-up in both cohorts, in fact, improving in those who had kidney transplants.”

Overall, he said, “This is a much less invasive procedure that opens itself up to significantly fewer complications than what many of these patients would otherwise require, a pancreas transplant, which involves major abdominal surgery.”

The investigators plan to submit these data as part of a biologic license application (BLA) to the FDA.

The research was supported by grants from JDRF, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute of Allergy and Infectious Diseases. Dr. Rickels has reported receiving consulting fees from Sernova and Vertex Pharmaceuticals.

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

Transplantation of cadaveric pancreatic islet cells resulted in graft survival and function with acceptable safety for up to 8 years in selected individuals with type 1 diabetes, new research finds.

The study is a long-term follow-up of two phase 3 pivotal trials from the Clinical Islet Transplantation Consortium of a purified human pancreatic islet cell product for treating people with type 1 diabetes.

One trial involved islet transplantation in 48 people who experienced severe hypoglycemia and hypoglycemic unawareness, and the other trial included 24 people who also experienced those complications and were already receiving immunosuppression following kidney transplant. The trials, both registered with the U.S. Food and Drug Administration (FDA), met their primary efficacy and safety endpoints at 2- and 3-year timepoints.

The follow-up data have now been published in Diabetes Care by Michael Rickels, MD, and colleagues.

The procedure involved infusion through the hepatic portal vein of one or more purified human pancreatic islet products under standardized immunosuppression using methods that Dr. Rickels and colleagues have been developing since 2004. The approach involves multiple modalities to protect the islets prior to transplantation.

Among the 34 islet-alone and eight islet-after–kidney transplant recipients who entered the extended follow-up, durable graft survival allowing for achievement of glycemic targets occurred without severe hypoglycemia or adverse effects from immunosuppression.

The primary outcome, actuarial survival of graft islet function, was 56% at the maximum follow-up of 8.3 years for the islet-only transplantation group and 49% at 7.3 years for the islet-after–kidney transplantation group (P = .004).

The findings suggest that “in the long run, islet transplantation has efficacy, including among those who have had kidney transplants ... Most type 1 diabetes patients are improved tremendously with current insulin delivery systems ... but for those having the most difficulty controlling their blood sugar – and those whose diabetes has already been complicated by needing a kidney transplant – the outcomes we saw in this study are what we’ve been hoping to achieve for more than 20 years,” said Dr. Rickels in a statement from his institution, the University of Pennsylvania, Philadelphia.

In the initial trials at day 75 after the initial transplant, 87.5% of the islet-alone and 71% of the islet-after–kidney transplant group achieved hemoglobin A1c under 7%, and 85% and 54%, respectively, achieved A1c at or under 6.5%. At the end of maximal follow-up, 49% of islet-only transplant recipients maintained A1c under 7%, although none had A1c at or under 6.5%. For the islet-after–kidney transplant group, these proportions were 35% and 17%, respectively (P = .0017 for A1c under 7.0% and P < .0001 for A1c ≤ 6.5%, respectively, between the groups).

There were 12 severe hypoglycemic episodes in five patients (three islet-alone and two islet-after–kidney transplant group) during the initial trials, but no additional episodes occurred in either group during long-term follow-up.  

Overall, 53 individuals – 37 in the islet-alone and 16 in the islet-after–kidney transplant group – or 74% of the total, achieved a period of insulin independence with A1c under 7%, ranging from 36 to 481 days. The range of time to achieving insulin independence reflects individuals who received one, two, or three islet infusions.

The fact that most patients achieved insulin independence following just one (n = 20) or two (n = 30) infusions and only three patients required three infusions was notable, Dr. Rickels said.

“Currently, around the world, there’s an expectation of two to three donor pancreases being needed. Here, it’s one, maybe two. It’s a much more efficient protocol and opens up access for more islet transplantation as a hoped-for alternative to pancreas transplants.”

Of those who achieved insulin independence, 30 (57%) remained insulin-independent throughout follow-up (20 of 37 islet-alone and 10 of 16 islet-after–kidney transplant patients), with no difference in duration of insulin independence between the groups.

There were no deaths during post-transplant follow-up. Rates of serious adverse events were 0.31 and 0.43 per patient-year for the islet-after–kidney and islet-alone transplant groups, respectively. Of a total of 104 serious adverse events, 65 occurred during the initial trials and had been previously reported. Of the additional 39 serious adverse events that occurred during long-term follow-up, 11 were possibly due to immunosuppression and 27 were deemed unrelated to the procedures.

According to Dr. Rickels, “These are the most seriously affected patients, and you’d be expecting to see some hospitalizations in a population managed on immunosuppression therapy ... It’s important to note that none of the adverse events were related to the actual islet product. Also, kidney function remained stable during long-term follow-up in both cohorts, in fact, improving in those who had kidney transplants.”

Overall, he said, “This is a much less invasive procedure that opens itself up to significantly fewer complications than what many of these patients would otherwise require, a pancreas transplant, which involves major abdominal surgery.”

The investigators plan to submit these data as part of a biologic license application (BLA) to the FDA.

The research was supported by grants from JDRF, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute of Allergy and Infectious Diseases. Dr. Rickels has reported receiving consulting fees from Sernova and Vertex Pharmaceuticals.

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

Transplantation of cadaveric pancreatic islet cells resulted in graft survival and function with acceptable safety for up to 8 years in selected individuals with type 1 diabetes, new research finds.

The study is a long-term follow-up of two phase 3 pivotal trials from the Clinical Islet Transplantation Consortium of a purified human pancreatic islet cell product for treating people with type 1 diabetes.

One trial involved islet transplantation in 48 people who experienced severe hypoglycemia and hypoglycemic unawareness, and the other trial included 24 people who also experienced those complications and were already receiving immunosuppression following kidney transplant. The trials, both registered with the U.S. Food and Drug Administration (FDA), met their primary efficacy and safety endpoints at 2- and 3-year timepoints.

The follow-up data have now been published in Diabetes Care by Michael Rickels, MD, and colleagues.

The procedure involved infusion through the hepatic portal vein of one or more purified human pancreatic islet products under standardized immunosuppression using methods that Dr. Rickels and colleagues have been developing since 2004. The approach involves multiple modalities to protect the islets prior to transplantation.

Among the 34 islet-alone and eight islet-after–kidney transplant recipients who entered the extended follow-up, durable graft survival allowing for achievement of glycemic targets occurred without severe hypoglycemia or adverse effects from immunosuppression.

The primary outcome, actuarial survival of graft islet function, was 56% at the maximum follow-up of 8.3 years for the islet-only transplantation group and 49% at 7.3 years for the islet-after–kidney transplantation group (P = .004).

The findings suggest that “in the long run, islet transplantation has efficacy, including among those who have had kidney transplants ... Most type 1 diabetes patients are improved tremendously with current insulin delivery systems ... but for those having the most difficulty controlling their blood sugar – and those whose diabetes has already been complicated by needing a kidney transplant – the outcomes we saw in this study are what we’ve been hoping to achieve for more than 20 years,” said Dr. Rickels in a statement from his institution, the University of Pennsylvania, Philadelphia.

In the initial trials at day 75 after the initial transplant, 87.5% of the islet-alone and 71% of the islet-after–kidney transplant group achieved hemoglobin A1c under 7%, and 85% and 54%, respectively, achieved A1c at or under 6.5%. At the end of maximal follow-up, 49% of islet-only transplant recipients maintained A1c under 7%, although none had A1c at or under 6.5%. For the islet-after–kidney transplant group, these proportions were 35% and 17%, respectively (P = .0017 for A1c under 7.0% and P < .0001 for A1c ≤ 6.5%, respectively, between the groups).

There were 12 severe hypoglycemic episodes in five patients (three islet-alone and two islet-after–kidney transplant group) during the initial trials, but no additional episodes occurred in either group during long-term follow-up.  

Overall, 53 individuals – 37 in the islet-alone and 16 in the islet-after–kidney transplant group – or 74% of the total, achieved a period of insulin independence with A1c under 7%, ranging from 36 to 481 days. The range of time to achieving insulin independence reflects individuals who received one, two, or three islet infusions.

The fact that most patients achieved insulin independence following just one (n = 20) or two (n = 30) infusions and only three patients required three infusions was notable, Dr. Rickels said.

“Currently, around the world, there’s an expectation of two to three donor pancreases being needed. Here, it’s one, maybe two. It’s a much more efficient protocol and opens up access for more islet transplantation as a hoped-for alternative to pancreas transplants.”

Of those who achieved insulin independence, 30 (57%) remained insulin-independent throughout follow-up (20 of 37 islet-alone and 10 of 16 islet-after–kidney transplant patients), with no difference in duration of insulin independence between the groups.

There were no deaths during post-transplant follow-up. Rates of serious adverse events were 0.31 and 0.43 per patient-year for the islet-after–kidney and islet-alone transplant groups, respectively. Of a total of 104 serious adverse events, 65 occurred during the initial trials and had been previously reported. Of the additional 39 serious adverse events that occurred during long-term follow-up, 11 were possibly due to immunosuppression and 27 were deemed unrelated to the procedures.

According to Dr. Rickels, “These are the most seriously affected patients, and you’d be expecting to see some hospitalizations in a population managed on immunosuppression therapy ... It’s important to note that none of the adverse events were related to the actual islet product. Also, kidney function remained stable during long-term follow-up in both cohorts, in fact, improving in those who had kidney transplants.”

Overall, he said, “This is a much less invasive procedure that opens itself up to significantly fewer complications than what many of these patients would otherwise require, a pancreas transplant, which involves major abdominal surgery.”

The investigators plan to submit these data as part of a biologic license application (BLA) to the FDA.

The research was supported by grants from JDRF, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute of Allergy and Infectious Diseases. Dr. Rickels has reported receiving consulting fees from Sernova and Vertex Pharmaceuticals.

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

Insulin rationing due to cost in the United States is common even among people with diabetes who have private health insurance, new data show.

The findings from the 2021 National Health Interview Survey (NHIS) suggest that about one in six people with insulin-treated diabetes in the United States practice insulin rationing – skipping doses, taking less insulin than needed, or delaying the purchase of insulin – because of the price.

Not surprisingly, those without insurance had the highest rationing rate, at nearly a third. However, those with private insurance also had higher rates, at nearly one in five, than those of the overall diabetes population. And those with public insurance – Medicare and Medicaid – had lower rates.

The finding regarding privately insured individuals was “somewhat surprising,” lead author Adam Gaffney, MD, told this news organization. But he noted that the finding likely reflects issues such as copays and deductibles, along with other barriers patients experience within the private health insurance system.

The authors pointed out that the $35 copay cap on insulin included in the Inflation Reduction Act of 2022 might improve insulin access for Medicare beneficiaries but a similar cap for privately insured people was removed from the bill. Moreover, copay caps don’t help people who are uninsured.

And, although some states have also passed insulin copay caps that apply to privately insured people, “even a monthly cost of $35 can be a lot of money for people with low incomes. That isn’t negligible. It’s important to keep that in mind,” said Dr. Gaffney, a pulmonary and critical care physician at Harvard Medical School, Boston, and Cambridge (Mass.) Health Alliance.

“Insulin rationing is frequently harmful and sometimes deadly. In the ICU, I have cared for patients who have life-threatening complications of diabetes because they couldn’t afford this life-saving drug. Universal access to insulin, without cost barriers, is urgently needed,” Dr. Gaffney said in a Public Citizen statement.

Senior author Steffie Woolhandler, MD, agrees. “Drug companies have ramped up prices on insulin year after year, even for products that remain completely unchanged,” she noted.

“Drug firms are making vast profits at the expense of the health, and even the lives, of patients,” noted Dr. Woolhandler, a distinguished professor at Hunter College, City University of New York, a lecturer in medicine at Harvard, and a research associate at Public Citizen.
 

Uninsured, privately insured, and younger people more likely to ration

Dr. Gaffney and colleagues’ findings were published online in Annals of Internal Medicine.

The study is the first to examine insulin rationing across the United States among people with all diabetes types treated with insulin using the nationally representative NHIS data.

The results are consistent with those of previous studies, which have found similar rates of insulin rationing at a single U.S. institution and internationally among just those with type 1 diabetes, Dr. Gaffney noted.

In 2021, questions about insulin rationing were added to the NHIS for the first time.

The sample included 982 insulin users with diabetes, representing about 1.4 million U.S. adults with type 1 diabetes, 5.8 million with type 2 diabetes, and 0.4 million with other/unknown types.

Overall, 16.5% of participants – 1.3 million nationwide – reported skipping or reducing insulin doses or delaying the purchase of it in the past year. Delaying purchase was the most common type of rationing, reported by 14.2%, while taking less than needed was the most common practice among those with type 1 diabetes (16.5%).

Age made a difference, with 11.2% of adults aged 65 or older versus 20.4% of younger people reporting rationing. And by income level, even among those at the top level examined – 400% or higher of the federal poverty line – 10.8% reported rationing.

“The high-income group is not necessarily rich. Many would be considered middle-income,” Dr. Gaffney pointed out.  

By race, 23.2% of Black participants reported rationing compared with 16.0% of White and Hispanic individuals.

People without insurance had the highest rationing rate (29.2%), followed by those with private insurance (18.8%), other coverage (16.1%), Medicare (13.5%), and Medicaid (11.6%).
 

‘It’s a complicated system’

Dr. Gaffney noted that even when the patient has private insurance, it’s challenging for the clinician to know in advance whether there are formulary restrictions on what type of insulin can be prescribed or what the patient’s copay or deductible will be.

“Often the prescription gets written without clear knowledge of coverage beforehand ... Coverage differs from patient to patient, from insurance to insurance. It’s a complicated system.”

He added, though, that some electronic health records (EHRs) incorporate this information. “Currently, some EHRs give real-time feedback. I see no reason why, for all the money we plug into these EHRs, there couldn’t be real-time feedback for every patient so you know what the copay is and whether it’s covered at the time you’re prescribing it. To me that’s a very straightforward technological fix that we could achieve. We have the information, but it’s hard to act on it.”

But beyond the EHR, “there are also problems when the patient’s insurance changes or their network changes, and what insulin is covered changes. And they don’t necessarily get that new prescription in time. And suddenly they have a gap. Gaps can be dangerous.”  

What’s more, Dr. Gaffney noted: “The study raises concerning questions about what happens when the public health emergency ends and millions of people with Medicaid lose their coverage. Where are they going to get insulin? That’s another population we have to be worried about.”

All of this puts clinicians in a difficult spot, he said.

“They want the best for their patients but they’re working in a system that’s not letting them focus on practicing medicine and instead is forcing them to think about these economic issues that are in large part out of their control.”

Dr. Gaffney is a member of Physicians for a National Health Program, which advocates for a single-payer health system in the United States.

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

Insulin rationing due to cost in the United States is common even among people with diabetes who have private health insurance, new data show.

The findings from the 2021 National Health Interview Survey (NHIS) suggest that about one in six people with insulin-treated diabetes in the United States practice insulin rationing – skipping doses, taking less insulin than needed, or delaying the purchase of insulin – because of the price.

Not surprisingly, those without insurance had the highest rationing rate, at nearly a third. However, those with private insurance also had higher rates, at nearly one in five, than those of the overall diabetes population. And those with public insurance – Medicare and Medicaid – had lower rates.

The finding regarding privately insured individuals was “somewhat surprising,” lead author Adam Gaffney, MD, told this news organization. But he noted that the finding likely reflects issues such as copays and deductibles, along with other barriers patients experience within the private health insurance system.

The authors pointed out that the $35 copay cap on insulin included in the Inflation Reduction Act of 2022 might improve insulin access for Medicare beneficiaries but a similar cap for privately insured people was removed from the bill. Moreover, copay caps don’t help people who are uninsured.

And, although some states have also passed insulin copay caps that apply to privately insured people, “even a monthly cost of $35 can be a lot of money for people with low incomes. That isn’t negligible. It’s important to keep that in mind,” said Dr. Gaffney, a pulmonary and critical care physician at Harvard Medical School, Boston, and Cambridge (Mass.) Health Alliance.

“Insulin rationing is frequently harmful and sometimes deadly. In the ICU, I have cared for patients who have life-threatening complications of diabetes because they couldn’t afford this life-saving drug. Universal access to insulin, without cost barriers, is urgently needed,” Dr. Gaffney said in a Public Citizen statement.

Senior author Steffie Woolhandler, MD, agrees. “Drug companies have ramped up prices on insulin year after year, even for products that remain completely unchanged,” she noted.

“Drug firms are making vast profits at the expense of the health, and even the lives, of patients,” noted Dr. Woolhandler, a distinguished professor at Hunter College, City University of New York, a lecturer in medicine at Harvard, and a research associate at Public Citizen.
 

Uninsured, privately insured, and younger people more likely to ration

Dr. Gaffney and colleagues’ findings were published online in Annals of Internal Medicine.

The study is the first to examine insulin rationing across the United States among people with all diabetes types treated with insulin using the nationally representative NHIS data.

The results are consistent with those of previous studies, which have found similar rates of insulin rationing at a single U.S. institution and internationally among just those with type 1 diabetes, Dr. Gaffney noted.

In 2021, questions about insulin rationing were added to the NHIS for the first time.

The sample included 982 insulin users with diabetes, representing about 1.4 million U.S. adults with type 1 diabetes, 5.8 million with type 2 diabetes, and 0.4 million with other/unknown types.

Overall, 16.5% of participants – 1.3 million nationwide – reported skipping or reducing insulin doses or delaying the purchase of it in the past year. Delaying purchase was the most common type of rationing, reported by 14.2%, while taking less than needed was the most common practice among those with type 1 diabetes (16.5%).

Age made a difference, with 11.2% of adults aged 65 or older versus 20.4% of younger people reporting rationing. And by income level, even among those at the top level examined – 400% or higher of the federal poverty line – 10.8% reported rationing.

“The high-income group is not necessarily rich. Many would be considered middle-income,” Dr. Gaffney pointed out.  

By race, 23.2% of Black participants reported rationing compared with 16.0% of White and Hispanic individuals.

People without insurance had the highest rationing rate (29.2%), followed by those with private insurance (18.8%), other coverage (16.1%), Medicare (13.5%), and Medicaid (11.6%).
 

‘It’s a complicated system’

Dr. Gaffney noted that even when the patient has private insurance, it’s challenging for the clinician to know in advance whether there are formulary restrictions on what type of insulin can be prescribed or what the patient’s copay or deductible will be.

“Often the prescription gets written without clear knowledge of coverage beforehand ... Coverage differs from patient to patient, from insurance to insurance. It’s a complicated system.”

He added, though, that some electronic health records (EHRs) incorporate this information. “Currently, some EHRs give real-time feedback. I see no reason why, for all the money we plug into these EHRs, there couldn’t be real-time feedback for every patient so you know what the copay is and whether it’s covered at the time you’re prescribing it. To me that’s a very straightforward technological fix that we could achieve. We have the information, but it’s hard to act on it.”

But beyond the EHR, “there are also problems when the patient’s insurance changes or their network changes, and what insulin is covered changes. And they don’t necessarily get that new prescription in time. And suddenly they have a gap. Gaps can be dangerous.”  

What’s more, Dr. Gaffney noted: “The study raises concerning questions about what happens when the public health emergency ends and millions of people with Medicaid lose their coverage. Where are they going to get insulin? That’s another population we have to be worried about.”

All of this puts clinicians in a difficult spot, he said.

“They want the best for their patients but they’re working in a system that’s not letting them focus on practicing medicine and instead is forcing them to think about these economic issues that are in large part out of their control.”

Dr. Gaffney is a member of Physicians for a National Health Program, which advocates for a single-payer health system in the United States.

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

Insulin rationing due to cost in the United States is common even among people with diabetes who have private health insurance, new data show.

The findings from the 2021 National Health Interview Survey (NHIS) suggest that about one in six people with insulin-treated diabetes in the United States practice insulin rationing – skipping doses, taking less insulin than needed, or delaying the purchase of insulin – because of the price.

Not surprisingly, those without insurance had the highest rationing rate, at nearly a third. However, those with private insurance also had higher rates, at nearly one in five, than those of the overall diabetes population. And those with public insurance – Medicare and Medicaid – had lower rates.

The finding regarding privately insured individuals was “somewhat surprising,” lead author Adam Gaffney, MD, told this news organization. But he noted that the finding likely reflects issues such as copays and deductibles, along with other barriers patients experience within the private health insurance system.

The authors pointed out that the $35 copay cap on insulin included in the Inflation Reduction Act of 2022 might improve insulin access for Medicare beneficiaries but a similar cap for privately insured people was removed from the bill. Moreover, copay caps don’t help people who are uninsured.

And, although some states have also passed insulin copay caps that apply to privately insured people, “even a monthly cost of $35 can be a lot of money for people with low incomes. That isn’t negligible. It’s important to keep that in mind,” said Dr. Gaffney, a pulmonary and critical care physician at Harvard Medical School, Boston, and Cambridge (Mass.) Health Alliance.

“Insulin rationing is frequently harmful and sometimes deadly. In the ICU, I have cared for patients who have life-threatening complications of diabetes because they couldn’t afford this life-saving drug. Universal access to insulin, without cost barriers, is urgently needed,” Dr. Gaffney said in a Public Citizen statement.

Senior author Steffie Woolhandler, MD, agrees. “Drug companies have ramped up prices on insulin year after year, even for products that remain completely unchanged,” she noted.

“Drug firms are making vast profits at the expense of the health, and even the lives, of patients,” noted Dr. Woolhandler, a distinguished professor at Hunter College, City University of New York, a lecturer in medicine at Harvard, and a research associate at Public Citizen.
 

Uninsured, privately insured, and younger people more likely to ration

Dr. Gaffney and colleagues’ findings were published online in Annals of Internal Medicine.

The study is the first to examine insulin rationing across the United States among people with all diabetes types treated with insulin using the nationally representative NHIS data.

The results are consistent with those of previous studies, which have found similar rates of insulin rationing at a single U.S. institution and internationally among just those with type 1 diabetes, Dr. Gaffney noted.

In 2021, questions about insulin rationing were added to the NHIS for the first time.

The sample included 982 insulin users with diabetes, representing about 1.4 million U.S. adults with type 1 diabetes, 5.8 million with type 2 diabetes, and 0.4 million with other/unknown types.

Overall, 16.5% of participants – 1.3 million nationwide – reported skipping or reducing insulin doses or delaying the purchase of it in the past year. Delaying purchase was the most common type of rationing, reported by 14.2%, while taking less than needed was the most common practice among those with type 1 diabetes (16.5%).

Age made a difference, with 11.2% of adults aged 65 or older versus 20.4% of younger people reporting rationing. And by income level, even among those at the top level examined – 400% or higher of the federal poverty line – 10.8% reported rationing.

“The high-income group is not necessarily rich. Many would be considered middle-income,” Dr. Gaffney pointed out.  

By race, 23.2% of Black participants reported rationing compared with 16.0% of White and Hispanic individuals.

People without insurance had the highest rationing rate (29.2%), followed by those with private insurance (18.8%), other coverage (16.1%), Medicare (13.5%), and Medicaid (11.6%).
 

‘It’s a complicated system’

Dr. Gaffney noted that even when the patient has private insurance, it’s challenging for the clinician to know in advance whether there are formulary restrictions on what type of insulin can be prescribed or what the patient’s copay or deductible will be.

“Often the prescription gets written without clear knowledge of coverage beforehand ... Coverage differs from patient to patient, from insurance to insurance. It’s a complicated system.”

He added, though, that some electronic health records (EHRs) incorporate this information. “Currently, some EHRs give real-time feedback. I see no reason why, for all the money we plug into these EHRs, there couldn’t be real-time feedback for every patient so you know what the copay is and whether it’s covered at the time you’re prescribing it. To me that’s a very straightforward technological fix that we could achieve. We have the information, but it’s hard to act on it.”

But beyond the EHR, “there are also problems when the patient’s insurance changes or their network changes, and what insulin is covered changes. And they don’t necessarily get that new prescription in time. And suddenly they have a gap. Gaps can be dangerous.”  

What’s more, Dr. Gaffney noted: “The study raises concerning questions about what happens when the public health emergency ends and millions of people with Medicaid lose their coverage. Where are they going to get insulin? That’s another population we have to be worried about.”

All of this puts clinicians in a difficult spot, he said.

“They want the best for their patients but they’re working in a system that’s not letting them focus on practicing medicine and instead is forcing them to think about these economic issues that are in large part out of their control.”

Dr. Gaffney is a member of Physicians for a National Health Program, which advocates for a single-payer health system in the United States.

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

Thiazolidinediones (TZDs), such as pioglitazone, appear to be protective against dementia whereas sulfonylureas appear to increase the risk, a new observational study in patients with type 2 diabetes suggests.

The data, obtained from nationwide electronic medical records from the Department of Veterans Affairs, yielded a 22% lower risk of dementia with TZD monotherapy and a 12% elevated risk with sulfonylurea monotherapy, compared with metformin monotherapy. The apparent protective effects of TZDs were greater among individuals with overweight or obesity.

“Our findings provide additional information to aid clinicians’ selection of [glucose-lowering medications] for patients with mild or moderate type 2 diabetes and [who] are at high risk of dementia,” Xin Tang and colleagues wrote in their article, published online in BMJ Open Diabetes Research & Care.

The results “add substantially to the literature concerning the effects of [glucose-lowering medications] on dementia where previous findings have been inconsistent. Studies with a follow-up time of less than 3 years have mainly reported null associations, while studies with longer a follow-up time typically yielded protective findings. With a mean follow-up time of 6.8 years, we had a sufficient duration to detect treatment differences,” the investigators wrote.

“Supplementing [a] sulfonylurea with either metformin or [a] TZD may partially offset its prodementia effects. These findings may help inform medication selection for elderly patients with T2D at high risk of dementia,” they added.
 

Randomized trials needed to determine cause and effect

Ivan Koychev, PhD, a senior clinical researcher in the department of psychiatry at the University of Oxford (England), told the UK Science Media Centre: “This is a large, well-conducted real-world data study that highlights the importance of checking whether already prescribed medications may be useful for preventing dementia.”

The findings regarding TZDs, also known as glitazones, are in line with existing literature suggesting dementia protection with other drugs prescribed for type 2 diabetes that weren’t examined in the current study, such as newer agents like glucagonlike peptide–1 (GLP-1) agonists and sodium-glucose cotransporter 2 (SGLT2) inhibitors, Dr. Koychev said.

“The main limitations of this study is that following the initial 2-year period the authors were interested in, the participants may have been prescribed one of the other type 2 diabetes drugs [GLP-1 agonists or SGLT2 inhibitors] that have been found to reduce dementia risk, thus potentially making the direct glitazone [TZD] effect more difficult to discern,” Dr. Koychev noted.

And, he pointed out that the study design limits attribution of causality. “It is also important to note that people with type 2 diabetes do run a higher risk of both dementia and cognitive deficits and that these medications are only prescribed in these patients, so all this data is from this patient group rather than the general population.”

James Connell, PhD, head of translational science at Alzheimer’s Research UK, agreed. “While this observational study found that those with type 2 diabetes taking thiazolidinedione had a lower dementia risk than those on the most common medication for type 2 diabetes, it only shows an association between taking the drug and dementia risk and not a causal relationship.

“Double-blind and placebo-controlled clinical trials are needed to see whether the drug [TDZ] could help lower dementia risk in people with and without diabetes. Anyone with any questions about what treatments they are receiving should speak to their doctor,” he told the UK Science Media Centre.
 

Opposite effects of sulfonylureas, TZDs versus metformin

The study authors analyzed 559,106 VA patients with type 2 diabetes who initiated glucose-lowering medication during 2001-2017 and took it for at least a year. They were aged 60 years or older and did not have dementia at baseline. Most were White (76.8%) and male (96.9%), two-thirds (63.1%) had obesity, and mean hemoglobin A1c was 6.8%.

Overall, 31,125 developed all-cause dementia. The incidence rate was 8.2 cases per 1,000 person-years, ranging from 6.2 cases per 1,000 person-years among those taking metformin monotherapy to 13.4 cases per 1,000 person-years in those taking both sulfonylurea and a TZD.

Compared with metformin monotherapy, the hazard ratio for all-cause dementia for sulfonylurea monotherapy was a significant 1.12. The increased risk was also seen for vascular dementia, with an HR of 1.14.

In contrast, TZD monotherapy was associated with a significantly lower risk for all-cause dementia (HR, 0.78), as well as for Alzheimer’s disease (HR, 0.89) and vascular dementia (HR, 0.43), compared with metformin monotherapy.

The combination of metformin and TZD also lowered the risk of all-cause dementia, while regimens including sulfonylureas raised the risks for all-cause and vascular dementia.

Most of the results didn’t change significantly when the drug exposure window was extended to 2 years.
 

Effects more pronounced in those with obesity

The protective 1-year effects of TZD monotherapy and of metformin plus TZD, compared with metformin alone, were more significant among participants aged 75 or younger and with a body mass index above 25 kg/m², compared with those who were older than 75 years and with normal BMIs, respectively.

On the other hand, the greater risk for dementia incurred with sulfonylureas was further increased among those with higher BMI.

This research was partially funded by grants from the National Human Genome Research Institute, the National Science Foundation, the National Institute of Diabetes and Digestive and Kidney Disease, and the National Heart, Lung, and Blood Institute. Dr. Koychev is chief investigator for a trial, sponsored by Oxford University and funded by Novo Nordisk, testing whether the GLP-1 agonist semaglutide reduces the risk for dementia in aging adults.

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

Thiazolidinediones (TZDs), such as pioglitazone, appear to be protective against dementia whereas sulfonylureas appear to increase the risk, a new observational study in patients with type 2 diabetes suggests.

The data, obtained from nationwide electronic medical records from the Department of Veterans Affairs, yielded a 22% lower risk of dementia with TZD monotherapy and a 12% elevated risk with sulfonylurea monotherapy, compared with metformin monotherapy. The apparent protective effects of TZDs were greater among individuals with overweight or obesity.

“Our findings provide additional information to aid clinicians’ selection of [glucose-lowering medications] for patients with mild or moderate type 2 diabetes and [who] are at high risk of dementia,” Xin Tang and colleagues wrote in their article, published online in BMJ Open Diabetes Research & Care.

The results “add substantially to the literature concerning the effects of [glucose-lowering medications] on dementia where previous findings have been inconsistent. Studies with a follow-up time of less than 3 years have mainly reported null associations, while studies with longer a follow-up time typically yielded protective findings. With a mean follow-up time of 6.8 years, we had a sufficient duration to detect treatment differences,” the investigators wrote.

“Supplementing [a] sulfonylurea with either metformin or [a] TZD may partially offset its prodementia effects. These findings may help inform medication selection for elderly patients with T2D at high risk of dementia,” they added.
 

Randomized trials needed to determine cause and effect

Ivan Koychev, PhD, a senior clinical researcher in the department of psychiatry at the University of Oxford (England), told the UK Science Media Centre: “This is a large, well-conducted real-world data study that highlights the importance of checking whether already prescribed medications may be useful for preventing dementia.”

The findings regarding TZDs, also known as glitazones, are in line with existing literature suggesting dementia protection with other drugs prescribed for type 2 diabetes that weren’t examined in the current study, such as newer agents like glucagonlike peptide–1 (GLP-1) agonists and sodium-glucose cotransporter 2 (SGLT2) inhibitors, Dr. Koychev said.

“The main limitations of this study is that following the initial 2-year period the authors were interested in, the participants may have been prescribed one of the other type 2 diabetes drugs [GLP-1 agonists or SGLT2 inhibitors] that have been found to reduce dementia risk, thus potentially making the direct glitazone [TZD] effect more difficult to discern,” Dr. Koychev noted.

And, he pointed out that the study design limits attribution of causality. “It is also important to note that people with type 2 diabetes do run a higher risk of both dementia and cognitive deficits and that these medications are only prescribed in these patients, so all this data is from this patient group rather than the general population.”

James Connell, PhD, head of translational science at Alzheimer’s Research UK, agreed. “While this observational study found that those with type 2 diabetes taking thiazolidinedione had a lower dementia risk than those on the most common medication for type 2 diabetes, it only shows an association between taking the drug and dementia risk and not a causal relationship.

“Double-blind and placebo-controlled clinical trials are needed to see whether the drug [TDZ] could help lower dementia risk in people with and without diabetes. Anyone with any questions about what treatments they are receiving should speak to their doctor,” he told the UK Science Media Centre.
 

Opposite effects of sulfonylureas, TZDs versus metformin

The study authors analyzed 559,106 VA patients with type 2 diabetes who initiated glucose-lowering medication during 2001-2017 and took it for at least a year. They were aged 60 years or older and did not have dementia at baseline. Most were White (76.8%) and male (96.9%), two-thirds (63.1%) had obesity, and mean hemoglobin A1c was 6.8%.

Overall, 31,125 developed all-cause dementia. The incidence rate was 8.2 cases per 1,000 person-years, ranging from 6.2 cases per 1,000 person-years among those taking metformin monotherapy to 13.4 cases per 1,000 person-years in those taking both sulfonylurea and a TZD.

Compared with metformin monotherapy, the hazard ratio for all-cause dementia for sulfonylurea monotherapy was a significant 1.12. The increased risk was also seen for vascular dementia, with an HR of 1.14.

In contrast, TZD monotherapy was associated with a significantly lower risk for all-cause dementia (HR, 0.78), as well as for Alzheimer’s disease (HR, 0.89) and vascular dementia (HR, 0.43), compared with metformin monotherapy.

The combination of metformin and TZD also lowered the risk of all-cause dementia, while regimens including sulfonylureas raised the risks for all-cause and vascular dementia.

Most of the results didn’t change significantly when the drug exposure window was extended to 2 years.
 

Effects more pronounced in those with obesity

The protective 1-year effects of TZD monotherapy and of metformin plus TZD, compared with metformin alone, were more significant among participants aged 75 or younger and with a body mass index above 25 kg/m², compared with those who were older than 75 years and with normal BMIs, respectively.

On the other hand, the greater risk for dementia incurred with sulfonylureas was further increased among those with higher BMI.

This research was partially funded by grants from the National Human Genome Research Institute, the National Science Foundation, the National Institute of Diabetes and Digestive and Kidney Disease, and the National Heart, Lung, and Blood Institute. Dr. Koychev is chief investigator for a trial, sponsored by Oxford University and funded by Novo Nordisk, testing whether the GLP-1 agonist semaglutide reduces the risk for dementia in aging adults.

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

Thiazolidinediones (TZDs), such as pioglitazone, appear to be protective against dementia whereas sulfonylureas appear to increase the risk, a new observational study in patients with type 2 diabetes suggests.

The data, obtained from nationwide electronic medical records from the Department of Veterans Affairs, yielded a 22% lower risk of dementia with TZD monotherapy and a 12% elevated risk with sulfonylurea monotherapy, compared with metformin monotherapy. The apparent protective effects of TZDs were greater among individuals with overweight or obesity.

“Our findings provide additional information to aid clinicians’ selection of [glucose-lowering medications] for patients with mild or moderate type 2 diabetes and [who] are at high risk of dementia,” Xin Tang and colleagues wrote in their article, published online in BMJ Open Diabetes Research & Care.

The results “add substantially to the literature concerning the effects of [glucose-lowering medications] on dementia where previous findings have been inconsistent. Studies with a follow-up time of less than 3 years have mainly reported null associations, while studies with longer a follow-up time typically yielded protective findings. With a mean follow-up time of 6.8 years, we had a sufficient duration to detect treatment differences,” the investigators wrote.

“Supplementing [a] sulfonylurea with either metformin or [a] TZD may partially offset its prodementia effects. These findings may help inform medication selection for elderly patients with T2D at high risk of dementia,” they added.
 

Randomized trials needed to determine cause and effect

Ivan Koychev, PhD, a senior clinical researcher in the department of psychiatry at the University of Oxford (England), told the UK Science Media Centre: “This is a large, well-conducted real-world data study that highlights the importance of checking whether already prescribed medications may be useful for preventing dementia.”

The findings regarding TZDs, also known as glitazones, are in line with existing literature suggesting dementia protection with other drugs prescribed for type 2 diabetes that weren’t examined in the current study, such as newer agents like glucagonlike peptide–1 (GLP-1) agonists and sodium-glucose cotransporter 2 (SGLT2) inhibitors, Dr. Koychev said.

“The main limitations of this study is that following the initial 2-year period the authors were interested in, the participants may have been prescribed one of the other type 2 diabetes drugs [GLP-1 agonists or SGLT2 inhibitors] that have been found to reduce dementia risk, thus potentially making the direct glitazone [TZD] effect more difficult to discern,” Dr. Koychev noted.

And, he pointed out that the study design limits attribution of causality. “It is also important to note that people with type 2 diabetes do run a higher risk of both dementia and cognitive deficits and that these medications are only prescribed in these patients, so all this data is from this patient group rather than the general population.”

James Connell, PhD, head of translational science at Alzheimer’s Research UK, agreed. “While this observational study found that those with type 2 diabetes taking thiazolidinedione had a lower dementia risk than those on the most common medication for type 2 diabetes, it only shows an association between taking the drug and dementia risk and not a causal relationship.

“Double-blind and placebo-controlled clinical trials are needed to see whether the drug [TDZ] could help lower dementia risk in people with and without diabetes. Anyone with any questions about what treatments they are receiving should speak to their doctor,” he told the UK Science Media Centre.
 

Opposite effects of sulfonylureas, TZDs versus metformin

The study authors analyzed 559,106 VA patients with type 2 diabetes who initiated glucose-lowering medication during 2001-2017 and took it for at least a year. They were aged 60 years or older and did not have dementia at baseline. Most were White (76.8%) and male (96.9%), two-thirds (63.1%) had obesity, and mean hemoglobin A1c was 6.8%.

Overall, 31,125 developed all-cause dementia. The incidence rate was 8.2 cases per 1,000 person-years, ranging from 6.2 cases per 1,000 person-years among those taking metformin monotherapy to 13.4 cases per 1,000 person-years in those taking both sulfonylurea and a TZD.

Compared with metformin monotherapy, the hazard ratio for all-cause dementia for sulfonylurea monotherapy was a significant 1.12. The increased risk was also seen for vascular dementia, with an HR of 1.14.

In contrast, TZD monotherapy was associated with a significantly lower risk for all-cause dementia (HR, 0.78), as well as for Alzheimer’s disease (HR, 0.89) and vascular dementia (HR, 0.43), compared with metformin monotherapy.

The combination of metformin and TZD also lowered the risk of all-cause dementia, while regimens including sulfonylureas raised the risks for all-cause and vascular dementia.

Most of the results didn’t change significantly when the drug exposure window was extended to 2 years.
 

Effects more pronounced in those with obesity

The protective 1-year effects of TZD monotherapy and of metformin plus TZD, compared with metformin alone, were more significant among participants aged 75 or younger and with a body mass index above 25 kg/m², compared with those who were older than 75 years and with normal BMIs, respectively.

On the other hand, the greater risk for dementia incurred with sulfonylureas was further increased among those with higher BMI.

This research was partially funded by grants from the National Human Genome Research Institute, the National Science Foundation, the National Institute of Diabetes and Digestive and Kidney Disease, and the National Heart, Lung, and Blood Institute. Dr. Koychev is chief investigator for a trial, sponsored by Oxford University and funded by Novo Nordisk, testing whether the GLP-1 agonist semaglutide reduces the risk for dementia in aging adults.

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

A new consensus statement summarizes the benefits, limitations, and challenges of using automated insulin delivery (AID) systems and provides recommendations for use by people with diabetes.  

“Automated insulin delivery systems” is becoming the standard terminology – including by the U.S. Food and Drug Administration – to refer to systems that integrate data from a continuous glucose monitoring (CGM) system via a control algorithm into an insulin pump in order to automate subcutaneous insulin delivery. “Hybrid AID” or “hybrid closed-loop” refers to the current status of these systems, which still require some degree of user input to control glucose levels.

The term “artificial pancreas” was used interchangeably with AID in the past, but it doesn’t take into account exocrine pancreatic function. The term “bionic pancreas” refers to a specific system in development that would ultimately include glucagon along with insulin.

The new consensus report, titled “Automated insulin delivery: Benefits, challenges, and recommendations,” was published online in Diabetes Care and Diabetologia.  

The document is geared toward not only diabetologists and other specialists, but also diabetes nurses and specialist dietitians. Colleagues working at regulatory agencies, health care organizations, and related media might also benefit from reading it.

It is endorsed by two professional societies – the European Association for the Study of Diabetes and the American Diabetes Association – and contrasts with other statements about AID systems that are sponsored by their manufacturers, noted document co-author Mark Evans, PhD, professor of diabetic medicine, University of Cambridge, England, in a statement.

“Many clinically relevant aspects, including safety, are addressed in this report. The aim ... is to encourage ongoing improvement of this technology, its safe and effective use, and its accessibility to all who can benefit from it,” Dr. Evans said.

Lead author Jennifer Sherr, MD, PhD, pediatric endocrinology, Yale University, New Haven, Conn., commented that the report “addresses the clinical usage of AID systems from a practical point of view rather than as ... a meta-analysis or a review of all relevant clinical studies. ... As such, the benefits and limitations of systems are discussed while also considering safety, regulatory pathways, and access to this technology.”
 

AID systems do not mean diabetes is “cured”

Separate recommendations provided at the end of the document are aimed at specific stakeholders, including health care providers, patients and their caregivers, manufacturers, regulatory agencies, and the research community.  

The authors make clear in the introduction that, while representing “a significant movement toward optimizing glucose management for individuals with diabetes,” the use of AID systems doesn’t mean that diabetes is “cured.” Rather, “expectations need to be set adequately so that individuals with diabetes and providers understand what such systems can and cannot do.”

In particular, current commercially available AID systems require user input for mealtime insulin dosing and sometimes for correction doses of high blood glucose levels, although the systems at least partially automate that.

“When integrated into care, AID systems hold promise to relieve some of the daily burdens of diabetes care,” the authors write.

The statement also details problems that may arise with the physical devices, including skin irritation from adhesives, occlusion of insulin infusion sets, early CGM sensor failure, and inadequate dosing algorithms.

“Individuals with diabetes who are considering this type of advanced diabetes therapy should not only have appropriate technical understanding of the system but also be able to revert to standard diabetes treatment (that is, nonautomated subcutaneous insulin delivery by pump or injections) in case the AID system fails. They should be able to independently troubleshoot and have access to their health care provider if needed.”

To monitor the impact of the technology, the authors emphasize the importance of the time-in-range metric derived from CGM, with the goal of achieving 70% or greater time in target blood glucose range.

Separate sections of the document address the benefits and limitations of AID systems, education and expectations for both patients and providers, and patient and provider perspectives, including how to handle urgent questions.

Other sections cover special populations such as pregnant women and people with type 2 diabetes, considerations for patient selection for current AID systems, safety, improving access to the technology, liability, and do-it-yourself systems.
 

Recommendations for health care professionals

A table near the end of the document provides specific recommendations for health care professionals, including the following:

• Be knowledgeable about AID systems and nuances of different systems, including their distinguishing features as well as strengths and weaknesses.
• Inform patients with diabetes about AID systems, including review of currently available systems, and create realistic expectations for device use.
• Involve patients with diabetes in shared decision-making when considering use of AID systems.
• Share information with patients with diabetes, as well as their peers, about general standards set by national and international guidelines on AID systems.
• Provide an on-call number or method by which a person with diabetes can always access support from a health care provider at the practice, including weekends and nights.
• Implement, potentially, protocols on times when AID systems should not be used.
• Use an individual’s health data to improve quality of care and health outcomes.

Most members of the ADA/EASD Diabetes Technology Working Group work with industry, but industry had no input on the project. Dr. Sherr has reported conducting clinical trials for Eli Lilly, Insulet, and Medtronic, and has received in-kind support for research studies from Dexcom and Medtronic. She has also reported consulting for Eli Lilly, Lexicon, Medtronic, and Sanofi, and being an advisory board member for Bigfoot Biomedical, Cecelia Health, Eli Lilly, Insulet, T1D Fund, and Vertex Pharmaceuticals. Dr. Evans has reported conducting clinical trials or research collaborations for, serving on advisory boards for, or receiving speakers fees or travel support from Medtronic, Roche, Abbott Diabetes Care, Dexcom, Novo Nordisk, Eli Lilly, Sanofi, Zucara Therapeutics, Pila Pharma, and AstraZeneca. The University of Cambridge has received salary support for Dr. Evans from the National Health Service.

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

A new consensus statement summarizes the benefits, limitations, and challenges of using automated insulin delivery (AID) systems and provides recommendations for use by people with diabetes.  

“Automated insulin delivery systems” is becoming the standard terminology – including by the U.S. Food and Drug Administration – to refer to systems that integrate data from a continuous glucose monitoring (CGM) system via a control algorithm into an insulin pump in order to automate subcutaneous insulin delivery. “Hybrid AID” or “hybrid closed-loop” refers to the current status of these systems, which still require some degree of user input to control glucose levels.

The term “artificial pancreas” was used interchangeably with AID in the past, but it doesn’t take into account exocrine pancreatic function. The term “bionic pancreas” refers to a specific system in development that would ultimately include glucagon along with insulin.

The new consensus report, titled “Automated insulin delivery: Benefits, challenges, and recommendations,” was published online in Diabetes Care and Diabetologia.  

The document is geared toward not only diabetologists and other specialists, but also diabetes nurses and specialist dietitians. Colleagues working at regulatory agencies, health care organizations, and related media might also benefit from reading it.

It is endorsed by two professional societies – the European Association for the Study of Diabetes and the American Diabetes Association – and contrasts with other statements about AID systems that are sponsored by their manufacturers, noted document co-author Mark Evans, PhD, professor of diabetic medicine, University of Cambridge, England, in a statement.

“Many clinically relevant aspects, including safety, are addressed in this report. The aim ... is to encourage ongoing improvement of this technology, its safe and effective use, and its accessibility to all who can benefit from it,” Dr. Evans said.

Lead author Jennifer Sherr, MD, PhD, pediatric endocrinology, Yale University, New Haven, Conn., commented that the report “addresses the clinical usage of AID systems from a practical point of view rather than as ... a meta-analysis or a review of all relevant clinical studies. ... As such, the benefits and limitations of systems are discussed while also considering safety, regulatory pathways, and access to this technology.”
 

AID systems do not mean diabetes is “cured”

Separate recommendations provided at the end of the document are aimed at specific stakeholders, including health care providers, patients and their caregivers, manufacturers, regulatory agencies, and the research community.  

The authors make clear in the introduction that, while representing “a significant movement toward optimizing glucose management for individuals with diabetes,” the use of AID systems doesn’t mean that diabetes is “cured.” Rather, “expectations need to be set adequately so that individuals with diabetes and providers understand what such systems can and cannot do.”

In particular, current commercially available AID systems require user input for mealtime insulin dosing and sometimes for correction doses of high blood glucose levels, although the systems at least partially automate that.

“When integrated into care, AID systems hold promise to relieve some of the daily burdens of diabetes care,” the authors write.

The statement also details problems that may arise with the physical devices, including skin irritation from adhesives, occlusion of insulin infusion sets, early CGM sensor failure, and inadequate dosing algorithms.

“Individuals with diabetes who are considering this type of advanced diabetes therapy should not only have appropriate technical understanding of the system but also be able to revert to standard diabetes treatment (that is, nonautomated subcutaneous insulin delivery by pump or injections) in case the AID system fails. They should be able to independently troubleshoot and have access to their health care provider if needed.”

To monitor the impact of the technology, the authors emphasize the importance of the time-in-range metric derived from CGM, with the goal of achieving 70% or greater time in target blood glucose range.

Separate sections of the document address the benefits and limitations of AID systems, education and expectations for both patients and providers, and patient and provider perspectives, including how to handle urgent questions.

Other sections cover special populations such as pregnant women and people with type 2 diabetes, considerations for patient selection for current AID systems, safety, improving access to the technology, liability, and do-it-yourself systems.
 

Recommendations for health care professionals

A table near the end of the document provides specific recommendations for health care professionals, including the following:

• Be knowledgeable about AID systems and nuances of different systems, including their distinguishing features as well as strengths and weaknesses.
• Inform patients with diabetes about AID systems, including review of currently available systems, and create realistic expectations for device use.
• Involve patients with diabetes in shared decision-making when considering use of AID systems.
• Share information with patients with diabetes, as well as their peers, about general standards set by national and international guidelines on AID systems.
• Provide an on-call number or method by which a person with diabetes can always access support from a health care provider at the practice, including weekends and nights.
• Implement, potentially, protocols on times when AID systems should not be used.
• Use an individual’s health data to improve quality of care and health outcomes.

Most members of the ADA/EASD Diabetes Technology Working Group work with industry, but industry had no input on the project. Dr. Sherr has reported conducting clinical trials for Eli Lilly, Insulet, and Medtronic, and has received in-kind support for research studies from Dexcom and Medtronic. She has also reported consulting for Eli Lilly, Lexicon, Medtronic, and Sanofi, and being an advisory board member for Bigfoot Biomedical, Cecelia Health, Eli Lilly, Insulet, T1D Fund, and Vertex Pharmaceuticals. Dr. Evans has reported conducting clinical trials or research collaborations for, serving on advisory boards for, or receiving speakers fees or travel support from Medtronic, Roche, Abbott Diabetes Care, Dexcom, Novo Nordisk, Eli Lilly, Sanofi, Zucara Therapeutics, Pila Pharma, and AstraZeneca. The University of Cambridge has received salary support for Dr. Evans from the National Health Service.

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

A new consensus statement summarizes the benefits, limitations, and challenges of using automated insulin delivery (AID) systems and provides recommendations for use by people with diabetes.  

“Automated insulin delivery systems” is becoming the standard terminology – including by the U.S. Food and Drug Administration – to refer to systems that integrate data from a continuous glucose monitoring (CGM) system via a control algorithm into an insulin pump in order to automate subcutaneous insulin delivery. “Hybrid AID” or “hybrid closed-loop” refers to the current status of these systems, which still require some degree of user input to control glucose levels.

The term “artificial pancreas” was used interchangeably with AID in the past, but it doesn’t take into account exocrine pancreatic function. The term “bionic pancreas” refers to a specific system in development that would ultimately include glucagon along with insulin.

The new consensus report, titled “Automated insulin delivery: Benefits, challenges, and recommendations,” was published online in Diabetes Care and Diabetologia.  

The document is geared toward not only diabetologists and other specialists, but also diabetes nurses and specialist dietitians. Colleagues working at regulatory agencies, health care organizations, and related media might also benefit from reading it.

It is endorsed by two professional societies – the European Association for the Study of Diabetes and the American Diabetes Association – and contrasts with other statements about AID systems that are sponsored by their manufacturers, noted document co-author Mark Evans, PhD, professor of diabetic medicine, University of Cambridge, England, in a statement.

“Many clinically relevant aspects, including safety, are addressed in this report. The aim ... is to encourage ongoing improvement of this technology, its safe and effective use, and its accessibility to all who can benefit from it,” Dr. Evans said.

Lead author Jennifer Sherr, MD, PhD, pediatric endocrinology, Yale University, New Haven, Conn., commented that the report “addresses the clinical usage of AID systems from a practical point of view rather than as ... a meta-analysis or a review of all relevant clinical studies. ... As such, the benefits and limitations of systems are discussed while also considering safety, regulatory pathways, and access to this technology.”
 

AID systems do not mean diabetes is “cured”

Separate recommendations provided at the end of the document are aimed at specific stakeholders, including health care providers, patients and their caregivers, manufacturers, regulatory agencies, and the research community.  

The authors make clear in the introduction that, while representing “a significant movement toward optimizing glucose management for individuals with diabetes,” the use of AID systems doesn’t mean that diabetes is “cured.” Rather, “expectations need to be set adequately so that individuals with diabetes and providers understand what such systems can and cannot do.”

In particular, current commercially available AID systems require user input for mealtime insulin dosing and sometimes for correction doses of high blood glucose levels, although the systems at least partially automate that.

“When integrated into care, AID systems hold promise to relieve some of the daily burdens of diabetes care,” the authors write.

The statement also details problems that may arise with the physical devices, including skin irritation from adhesives, occlusion of insulin infusion sets, early CGM sensor failure, and inadequate dosing algorithms.

“Individuals with diabetes who are considering this type of advanced diabetes therapy should not only have appropriate technical understanding of the system but also be able to revert to standard diabetes treatment (that is, nonautomated subcutaneous insulin delivery by pump or injections) in case the AID system fails. They should be able to independently troubleshoot and have access to their health care provider if needed.”

To monitor the impact of the technology, the authors emphasize the importance of the time-in-range metric derived from CGM, with the goal of achieving 70% or greater time in target blood glucose range.

Separate sections of the document address the benefits and limitations of AID systems, education and expectations for both patients and providers, and patient and provider perspectives, including how to handle urgent questions.

Other sections cover special populations such as pregnant women and people with type 2 diabetes, considerations for patient selection for current AID systems, safety, improving access to the technology, liability, and do-it-yourself systems.
 

Recommendations for health care professionals

A table near the end of the document provides specific recommendations for health care professionals, including the following:

• Be knowledgeable about AID systems and nuances of different systems, including their distinguishing features as well as strengths and weaknesses.
• Inform patients with diabetes about AID systems, including review of currently available systems, and create realistic expectations for device use.
• Involve patients with diabetes in shared decision-making when considering use of AID systems.
• Share information with patients with diabetes, as well as their peers, about general standards set by national and international guidelines on AID systems.
• Provide an on-call number or method by which a person with diabetes can always access support from a health care provider at the practice, including weekends and nights.
• Implement, potentially, protocols on times when AID systems should not be used.
• Use an individual’s health data to improve quality of care and health outcomes.

Most members of the ADA/EASD Diabetes Technology Working Group work with industry, but industry had no input on the project. Dr. Sherr has reported conducting clinical trials for Eli Lilly, Insulet, and Medtronic, and has received in-kind support for research studies from Dexcom and Medtronic. She has also reported consulting for Eli Lilly, Lexicon, Medtronic, and Sanofi, and being an advisory board member for Bigfoot Biomedical, Cecelia Health, Eli Lilly, Insulet, T1D Fund, and Vertex Pharmaceuticals. Dr. Evans has reported conducting clinical trials or research collaborations for, serving on advisory boards for, or receiving speakers fees or travel support from Medtronic, Roche, Abbott Diabetes Care, Dexcom, Novo Nordisk, Eli Lilly, Sanofi, Zucara Therapeutics, Pila Pharma, and AstraZeneca. The University of Cambridge has received salary support for Dr. Evans from the National Health Service.

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

STOCKHOLM – Enterovirus infection appears to be strongly linked to both type 1 diabetes and islet cell autoantibodies, new research suggests.

The strength of the relationship, particularly within the first month of type 1 diabetes diagnosis, “further supports the rationale for development of enterovirus-targeted vaccines and antiviral therapy to prevent and reduce the impact of type 1 diabetes,” according to lead investigator Sonia Isaacs, MD, of the department of pediatrics and child health at the University of New South Wales, Sydney, Australia.

Enteroviruses are a large family of viruses responsible for many infections in children. These live in the intestinal tract but can cause a wide variety of illnesses. There are more than 70 different strains, which include the group A and group B coxsackieviruses, the polioviruses, hepatitis A virus, and several strains that just go by the name enterovirus. 

Dr. Isaacs presented the data, from a meta-analysis of studies using modern molecular techniques, at the annual meeting of the European Association for the Study of Diabetes.

The findings raise the question of whether people should be routinely tested for enterovirus at the time of type 1 diabetes diagnosis, she said during her presentation.

Asked by this news organization about the implications for first-degree relatives of people with type 1 diabetes, Dr. Isaacs said that they are “definitely a population to watch out for,” with regard to enteroviral infections. “Type 1 diabetes is very diverse and has different endotypes. Different environmental factors may be implicated in these different endotypes, and it may be that the enteroviruses are quite important in the first-degree relative group.”  

Asked to comment, session moderator Kamlesh Khunti, MD, PhD, told this news organization that the data were “compelling,” particularly in the short term after type 1 diabetes diagnosis. “It seems that there may be plausibility for enterovirus associated with the development of type 1 diabetes ... Are there methods by which we can reduce this risk with either antivirals or vaccinations? I think that needs to be tested.”

And in regard to first-degree relatives, “I think that’s the group to go for because the association is so highly correlated. I think that’s the group worth testing with any interventions,” said Dr. Khunti, professor of primary care diabetes and vascular medicine at the University of Leicester, England.

Link stronger a month after diagnosis, in close relatives, in Europe

The new meta-analysis is an update to a prior review published in 2011 by Dr. Isaacs’ group, which found that people with islet cell autoimmunity were more than four times as likely as were controls to have an enterovirus infection, and people with type 1 diabetes were almost 10 times as likely.

This new analysis focuses on studies using more modern molecular techniques for detecting viruses, including high throughput sequencing and single-cell technologies.

The analysis identified 60 studies with a total of 12,077 participants, of whom 900 had islet autoimmunity, 5,081 had type 1 diabetes, and 6,096 were controls. Thirty-five of the studies were from Europe, while others were from the United States, Asia, and the Middle East.

Of 16 studies examining enterovirus infection in islet autoimmunity, cases with islet autoimmunity were twice as likely to have an enterovirus infection at any time point compared to controls, a significant difference (odds ratio [OR], 2.07, P = .002.)

Among 48 studies reporting enterovirus infection in type 1 diabetes, those with type 1 diabetes were eight times as likely to have an enterovirus infection compared with controls (OR, 8.0, P < .00001).

In 25 studies including 2,977 participants with onset of type 1 diabetes within the prior month, those individuals were more than 16 times more likely to present with an enterovirus infection (OR, 16.2, P < .00001).

“The strength of this is association is greater than previously reported by both us and others,” Dr. Isaacs noted.

The association between enterovirus infection and islet autoimmunity was greater in individuals who later progressed to type 1 diabetes, with odds ratio 5.1 vs. 2.0 for those who didn’t. The association was most evident at or shortly after seroconversion (5.1), was stronger in Europe (3.2) than in other regions (1.9), and was stronger among those with a first-degree relative with type 1 diabetes (9.8) than those recruited via a high-risk human leukocyte antigen (HLA), in whom the relationship wasn’t significant.

Having multiple or consecutive enteroviral infections was also associated with islet autoimmunity (2.0).

With type 1 diabetes, the relationship with enterovirus was greater in children (9.0) than in adults (4.1), and was greater for type 1 diabetes onset within 1 year (13.8) and within 1 month (16.2) than for those with established type 1 diabetes (7.0). Here, too, the relationship was stronger in Europe (10.2) than outside Europe (7.5).

The link with type 1 diabetes and enterovirus was particularly strong for those with both a first-degree relative and a high-risk HLA (141.4).

The relationship with type 1 diabetes was significant for enterovirus species A (3.7), B (12.7) and C (13.8), including coxsackie virus genotypes, but not D.

“Future studies should focus on characterizing enterovirus genomes in at-risk cohorts rather than just the presence or absence of the virus,” Dr. Isaacs said.

However, she added, “type 1 diabetes is such a heterogenous condition, viruses may be implicated more in one type than another. It’s important that we start to look into this.”

Dr. Isaacs reports no relevant financial relationships. Dr. Khunti disclosed ties with AstraZeneca, Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Boehringer Ingelheim, Bayer, Berlin-Chemie AG / Menarini Group, Janssen, and Napp.

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

STOCKHOLM – Enterovirus infection appears to be strongly linked to both type 1 diabetes and islet cell autoantibodies, new research suggests.

The strength of the relationship, particularly within the first month of type 1 diabetes diagnosis, “further supports the rationale for development of enterovirus-targeted vaccines and antiviral therapy to prevent and reduce the impact of type 1 diabetes,” according to lead investigator Sonia Isaacs, MD, of the department of pediatrics and child health at the University of New South Wales, Sydney, Australia.

Enteroviruses are a large family of viruses responsible for many infections in children. These live in the intestinal tract but can cause a wide variety of illnesses. There are more than 70 different strains, which include the group A and group B coxsackieviruses, the polioviruses, hepatitis A virus, and several strains that just go by the name enterovirus. 

Dr. Isaacs presented the data, from a meta-analysis of studies using modern molecular techniques, at the annual meeting of the European Association for the Study of Diabetes.

The findings raise the question of whether people should be routinely tested for enterovirus at the time of type 1 diabetes diagnosis, she said during her presentation.

Asked by this news organization about the implications for first-degree relatives of people with type 1 diabetes, Dr. Isaacs said that they are “definitely a population to watch out for,” with regard to enteroviral infections. “Type 1 diabetes is very diverse and has different endotypes. Different environmental factors may be implicated in these different endotypes, and it may be that the enteroviruses are quite important in the first-degree relative group.”  

Asked to comment, session moderator Kamlesh Khunti, MD, PhD, told this news organization that the data were “compelling,” particularly in the short term after type 1 diabetes diagnosis. “It seems that there may be plausibility for enterovirus associated with the development of type 1 diabetes ... Are there methods by which we can reduce this risk with either antivirals or vaccinations? I think that needs to be tested.”

And in regard to first-degree relatives, “I think that’s the group to go for because the association is so highly correlated. I think that’s the group worth testing with any interventions,” said Dr. Khunti, professor of primary care diabetes and vascular medicine at the University of Leicester, England.

Link stronger a month after diagnosis, in close relatives, in Europe

The new meta-analysis is an update to a prior review published in 2011 by Dr. Isaacs’ group, which found that people with islet cell autoimmunity were more than four times as likely as were controls to have an enterovirus infection, and people with type 1 diabetes were almost 10 times as likely.

This new analysis focuses on studies using more modern molecular techniques for detecting viruses, including high throughput sequencing and single-cell technologies.

The analysis identified 60 studies with a total of 12,077 participants, of whom 900 had islet autoimmunity, 5,081 had type 1 diabetes, and 6,096 were controls. Thirty-five of the studies were from Europe, while others were from the United States, Asia, and the Middle East.

Of 16 studies examining enterovirus infection in islet autoimmunity, cases with islet autoimmunity were twice as likely to have an enterovirus infection at any time point compared to controls, a significant difference (odds ratio [OR], 2.07, P = .002.)

Among 48 studies reporting enterovirus infection in type 1 diabetes, those with type 1 diabetes were eight times as likely to have an enterovirus infection compared with controls (OR, 8.0, P < .00001).

In 25 studies including 2,977 participants with onset of type 1 diabetes within the prior month, those individuals were more than 16 times more likely to present with an enterovirus infection (OR, 16.2, P < .00001).

“The strength of this is association is greater than previously reported by both us and others,” Dr. Isaacs noted.

The association between enterovirus infection and islet autoimmunity was greater in individuals who later progressed to type 1 diabetes, with odds ratio 5.1 vs. 2.0 for those who didn’t. The association was most evident at or shortly after seroconversion (5.1), was stronger in Europe (3.2) than in other regions (1.9), and was stronger among those with a first-degree relative with type 1 diabetes (9.8) than those recruited via a high-risk human leukocyte antigen (HLA), in whom the relationship wasn’t significant.

Having multiple or consecutive enteroviral infections was also associated with islet autoimmunity (2.0).

With type 1 diabetes, the relationship with enterovirus was greater in children (9.0) than in adults (4.1), and was greater for type 1 diabetes onset within 1 year (13.8) and within 1 month (16.2) than for those with established type 1 diabetes (7.0). Here, too, the relationship was stronger in Europe (10.2) than outside Europe (7.5).

The link with type 1 diabetes and enterovirus was particularly strong for those with both a first-degree relative and a high-risk HLA (141.4).

The relationship with type 1 diabetes was significant for enterovirus species A (3.7), B (12.7) and C (13.8), including coxsackie virus genotypes, but not D.

“Future studies should focus on characterizing enterovirus genomes in at-risk cohorts rather than just the presence or absence of the virus,” Dr. Isaacs said.

However, she added, “type 1 diabetes is such a heterogenous condition, viruses may be implicated more in one type than another. It’s important that we start to look into this.”

Dr. Isaacs reports no relevant financial relationships. Dr. Khunti disclosed ties with AstraZeneca, Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Boehringer Ingelheim, Bayer, Berlin-Chemie AG / Menarini Group, Janssen, and Napp.

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

STOCKHOLM – Enterovirus infection appears to be strongly linked to both type 1 diabetes and islet cell autoantibodies, new research suggests.

The strength of the relationship, particularly within the first month of type 1 diabetes diagnosis, “further supports the rationale for development of enterovirus-targeted vaccines and antiviral therapy to prevent and reduce the impact of type 1 diabetes,” according to lead investigator Sonia Isaacs, MD, of the department of pediatrics and child health at the University of New South Wales, Sydney, Australia.

Enteroviruses are a large family of viruses responsible for many infections in children. These live in the intestinal tract but can cause a wide variety of illnesses. There are more than 70 different strains, which include the group A and group B coxsackieviruses, the polioviruses, hepatitis A virus, and several strains that just go by the name enterovirus. 

Dr. Isaacs presented the data, from a meta-analysis of studies using modern molecular techniques, at the annual meeting of the European Association for the Study of Diabetes.

The findings raise the question of whether people should be routinely tested for enterovirus at the time of type 1 diabetes diagnosis, she said during her presentation.

Asked by this news organization about the implications for first-degree relatives of people with type 1 diabetes, Dr. Isaacs said that they are “definitely a population to watch out for,” with regard to enteroviral infections. “Type 1 diabetes is very diverse and has different endotypes. Different environmental factors may be implicated in these different endotypes, and it may be that the enteroviruses are quite important in the first-degree relative group.”  

Asked to comment, session moderator Kamlesh Khunti, MD, PhD, told this news organization that the data were “compelling,” particularly in the short term after type 1 diabetes diagnosis. “It seems that there may be plausibility for enterovirus associated with the development of type 1 diabetes ... Are there methods by which we can reduce this risk with either antivirals or vaccinations? I think that needs to be tested.”

And in regard to first-degree relatives, “I think that’s the group to go for because the association is so highly correlated. I think that’s the group worth testing with any interventions,” said Dr. Khunti, professor of primary care diabetes and vascular medicine at the University of Leicester, England.

Link stronger a month after diagnosis, in close relatives, in Europe

The new meta-analysis is an update to a prior review published in 2011 by Dr. Isaacs’ group, which found that people with islet cell autoimmunity were more than four times as likely as were controls to have an enterovirus infection, and people with type 1 diabetes were almost 10 times as likely.

This new analysis focuses on studies using more modern molecular techniques for detecting viruses, including high throughput sequencing and single-cell technologies.

The analysis identified 60 studies with a total of 12,077 participants, of whom 900 had islet autoimmunity, 5,081 had type 1 diabetes, and 6,096 were controls. Thirty-five of the studies were from Europe, while others were from the United States, Asia, and the Middle East.

Of 16 studies examining enterovirus infection in islet autoimmunity, cases with islet autoimmunity were twice as likely to have an enterovirus infection at any time point compared to controls, a significant difference (odds ratio [OR], 2.07, P = .002.)

Among 48 studies reporting enterovirus infection in type 1 diabetes, those with type 1 diabetes were eight times as likely to have an enterovirus infection compared with controls (OR, 8.0, P < .00001).

In 25 studies including 2,977 participants with onset of type 1 diabetes within the prior month, those individuals were more than 16 times more likely to present with an enterovirus infection (OR, 16.2, P < .00001).

“The strength of this is association is greater than previously reported by both us and others,” Dr. Isaacs noted.

The association between enterovirus infection and islet autoimmunity was greater in individuals who later progressed to type 1 diabetes, with odds ratio 5.1 vs. 2.0 for those who didn’t. The association was most evident at or shortly after seroconversion (5.1), was stronger in Europe (3.2) than in other regions (1.9), and was stronger among those with a first-degree relative with type 1 diabetes (9.8) than those recruited via a high-risk human leukocyte antigen (HLA), in whom the relationship wasn’t significant.

Having multiple or consecutive enteroviral infections was also associated with islet autoimmunity (2.0).

With type 1 diabetes, the relationship with enterovirus was greater in children (9.0) than in adults (4.1), and was greater for type 1 diabetes onset within 1 year (13.8) and within 1 month (16.2) than for those with established type 1 diabetes (7.0). Here, too, the relationship was stronger in Europe (10.2) than outside Europe (7.5).

The link with type 1 diabetes and enterovirus was particularly strong for those with both a first-degree relative and a high-risk HLA (141.4).

The relationship with type 1 diabetes was significant for enterovirus species A (3.7), B (12.7) and C (13.8), including coxsackie virus genotypes, but not D.

“Future studies should focus on characterizing enterovirus genomes in at-risk cohorts rather than just the presence or absence of the virus,” Dr. Isaacs said.

However, she added, “type 1 diabetes is such a heterogenous condition, viruses may be implicated more in one type than another. It’s important that we start to look into this.”

Dr. Isaacs reports no relevant financial relationships. Dr. Khunti disclosed ties with AstraZeneca, Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Boehringer Ingelheim, Bayer, Berlin-Chemie AG / Menarini Group, Janssen, and Napp.

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

STOCKHOLM – The investigational once-weekly insulin icodec (Novo Nordisk) significantly reduces A1c without increasing hypoglycemia in people with type 2 diabetes, the first phase 3 data of such an insulin formulation suggest. The data are from one of six trials in the company’s ONWARDS program.

“Once-weekly insulin may redefine diabetes management,” enthused Athena Philis-Tsimikas, MD, who presented the findings at a session during the European Association for the Study of Diabetes (EASD) 2022 Annual Meeting, which also included a summary of previously reported top-line data from other ONWARDS trials as well as phase 2 data for Lilly›s investigational once-weekly Basal Insulin Fc (BIF).

Phase 2 data for icodec were published in 2020 in the New England Journal of Medicine and in 2021 in Diabetes Care, as reported by this news organization.

The capacity for reducing the number of basal insulin injections from at least 365 to just 52 per year means that once-weekly insulin “has the potential to facilitate insulin initiation and improve treatment adherence and persistence in diabetes,” noted Dr. Philis-Tsimikas, corporate vice president of Scripps Whittier Diabetes Institute, San Diego.

Asked to comment, independent diabetes industry consultant Charles Alexander, MD, told this news organization that the new data from ONWARDS 2 of patients switching from daily to once-weekly basal insulin were reassuring with regard to hypoglycemia, at least for people with type 2 diabetes.

“For type 2, I think there’s enough data now to feel comfortable that it’s going to be good, especially for people who are on once-weekly [glucagon-like peptide-1 (GLP-1) agonists].”

However, for type 1 diabetes, the company reported top-line ONWARDS 6 data earlier this year, in which icodec was associated with significantly increased rates of hypoglycemia compared with daily degludec. “In type 1, even the basal needs are [often] changing. That kind of person would want to stay away from once-weekly insulin,” Dr. Alexander said.

And he noted, for any patient who adjusts their insulin dose frequently, “obviously, you’re not going to be able to do that with a once-weekly.”
 

Similar A1c reduction as daily basal without increased hypoglycemia

In ONWARDS 2, 526 adults with type 2 diabetes were randomized to switch from their current once- or twice-daily basal insulin to either once-weekly icodec or once-daily insulin degludec (Tresiba) for 26 weeks. The study was open-label, with a treat-to-glucose target of 80-130 mg/dL design.

Participants had A1c levels of 7.0%-10.0% and were also taking stable doses of other noninsulin glucose-lowering medications. Over 80% were taking metformin, a third were taking an SGLT2 inhibitor, and about a quarter each were taking a GLP-1 agonist or DPP-4 inhibitor. Those medications were continued, but sulfonylureas were discontinued in the 22% taking those at baseline.

The basal insulin used at baseline was glargine U100 for 42%, degludec for 28%, and glargine U300 for 16%, “so, a very typical presentation of patients we see in our practices today,” Dr. Philis-Tsimikas noted.

The primary endpoint, change in A1c from baseline to week 26, dropped from 8.17% to 7.20% with icodec and from 8.10% to 7.42% with degludec. The estimated treatment difference of –0.22 percentage points met the margins for both noninferiority (P < .0001) and superiority (P = .0028). Those taking icodec were significantly more likely to achieve an A1c under 7% compared with degludec, at 40.3% versus 26.5% (P = .0019).

Continuous glucose monitoring parameters during weeks 22-26 showed time in glucose range of 70-180 mg/dL (3.9-10.0 mmol/L) was 63.1% for icodec and 59.5% for degludec, which was not significantly different, Dr. Philis-Tsimikas reported.

Body weight increased by 1.4 kg (3 lb) with icodec but dropped slightly by 0.30 kg with degludec, which was significantly different (P < .001).

When asked about the body weight results, Dr. Alexander said: “It’s really hard to say. We know that insulin generally causes weight gain. A 1.4-kg weight gain over 6 months isn’t really surprising. Why there wasn’t with degludec, I don’t know.”

There was just one episode of severe hypoglycemia (requiring assistance) in the trial in the degludec group. Rates of combined severe or clinically significant hypoglycemic events (glucose < 54 mg/dL / < 3.0 mmol/L) per patient-year exposed were 0.73 for icodec versus 0.27 for degludec, which was not significantly different (P = .0782). Similar findings were seen for nocturnal hypoglycemia.

Significantly more patients achieved an A1c under 7% without significant hypoglycemia with icodec than degludec, at 36.7% versus 26.8% (P = .0223). Other adverse events were equivalent between the two groups, Dr. Philis-Tsimikas reported.

Scores on the diabetes treatment satisfaction questionnaire, which addresses convenience, flexibility, satisfaction, and willingness to recommend treatment to others, were significantly higher for icodec than degludec, at 4.22 versus 2.96 (P = .0036).

“For me, this is one of the most important outcomes,” she commented.  
 

Benefit in type 2 diabetes, potential concern in type 1 diabetes

Top-line results from ONWARDS 1, a phase 3a 78-week trial in 984 drug-naive people with type 2 diabetes and ONWARDS 6, a 52-week trial in 583 people with type 1 diabetes, were presented earlier this year at the American Diabetes Association 81st Scientific Sessions.

In ONWARDS 1, icodec achieved noninferiority to daily insulin glargine, reducing A1c by 1.55 versus 1.35 percentage points, with superior time in range and no significant differences in hypoglycemia rates.

However, in ONWARDS 6, while noninferiority in A1c lowering compared with daily degludec was achieved, with reductions of 0.47 versus 0.51 percentage points from a baseline A1c of 7.6%, there was a significantly greater rate of severe or clinically significant hypoglycemia with icodec, at 19.93 versus 10.37 events per patient-year with degludec.

Dr. Philis-Tsimikas has reported performing research and serving as an advisor on behalf of her employer for Abbott, Bayer, Dexcom, Eli Lilly, Medtronic, Merck, Novo Nordisk, and Sanofi. All reimbursements go to her employer. Dr. Alexander has reported being a nonpaid advisor for diaTribe and a consultant for Kinexum.

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

STOCKHOLM – The investigational once-weekly insulin icodec (Novo Nordisk) significantly reduces A1c without increasing hypoglycemia in people with type 2 diabetes, the first phase 3 data of such an insulin formulation suggest. The data are from one of six trials in the company’s ONWARDS program.

“Once-weekly insulin may redefine diabetes management,” enthused Athena Philis-Tsimikas, MD, who presented the findings at a session during the European Association for the Study of Diabetes (EASD) 2022 Annual Meeting, which also included a summary of previously reported top-line data from other ONWARDS trials as well as phase 2 data for Lilly›s investigational once-weekly Basal Insulin Fc (BIF).

Phase 2 data for icodec were published in 2020 in the New England Journal of Medicine and in 2021 in Diabetes Care, as reported by this news organization.

The capacity for reducing the number of basal insulin injections from at least 365 to just 52 per year means that once-weekly insulin “has the potential to facilitate insulin initiation and improve treatment adherence and persistence in diabetes,” noted Dr. Philis-Tsimikas, corporate vice president of Scripps Whittier Diabetes Institute, San Diego.

Asked to comment, independent diabetes industry consultant Charles Alexander, MD, told this news organization that the new data from ONWARDS 2 of patients switching from daily to once-weekly basal insulin were reassuring with regard to hypoglycemia, at least for people with type 2 diabetes.

“For type 2, I think there’s enough data now to feel comfortable that it’s going to be good, especially for people who are on once-weekly [glucagon-like peptide-1 (GLP-1) agonists].”

However, for type 1 diabetes, the company reported top-line ONWARDS 6 data earlier this year, in which icodec was associated with significantly increased rates of hypoglycemia compared with daily degludec. “In type 1, even the basal needs are [often] changing. That kind of person would want to stay away from once-weekly insulin,” Dr. Alexander said.

And he noted, for any patient who adjusts their insulin dose frequently, “obviously, you’re not going to be able to do that with a once-weekly.”
 

Similar A1c reduction as daily basal without increased hypoglycemia

In ONWARDS 2, 526 adults with type 2 diabetes were randomized to switch from their current once- or twice-daily basal insulin to either once-weekly icodec or once-daily insulin degludec (Tresiba) for 26 weeks. The study was open-label, with a treat-to-glucose target of 80-130 mg/dL design.

Participants had A1c levels of 7.0%-10.0% and were also taking stable doses of other noninsulin glucose-lowering medications. Over 80% were taking metformin, a third were taking an SGLT2 inhibitor, and about a quarter each were taking a GLP-1 agonist or DPP-4 inhibitor. Those medications were continued, but sulfonylureas were discontinued in the 22% taking those at baseline.

The basal insulin used at baseline was glargine U100 for 42%, degludec for 28%, and glargine U300 for 16%, “so, a very typical presentation of patients we see in our practices today,” Dr. Philis-Tsimikas noted.

The primary endpoint, change in A1c from baseline to week 26, dropped from 8.17% to 7.20% with icodec and from 8.10% to 7.42% with degludec. The estimated treatment difference of –0.22 percentage points met the margins for both noninferiority (P < .0001) and superiority (P = .0028). Those taking icodec were significantly more likely to achieve an A1c under 7% compared with degludec, at 40.3% versus 26.5% (P = .0019).

Continuous glucose monitoring parameters during weeks 22-26 showed time in glucose range of 70-180 mg/dL (3.9-10.0 mmol/L) was 63.1% for icodec and 59.5% for degludec, which was not significantly different, Dr. Philis-Tsimikas reported.

Body weight increased by 1.4 kg (3 lb) with icodec but dropped slightly by 0.30 kg with degludec, which was significantly different (P < .001).

When asked about the body weight results, Dr. Alexander said: “It’s really hard to say. We know that insulin generally causes weight gain. A 1.4-kg weight gain over 6 months isn’t really surprising. Why there wasn’t with degludec, I don’t know.”

There was just one episode of severe hypoglycemia (requiring assistance) in the trial in the degludec group. Rates of combined severe or clinically significant hypoglycemic events (glucose < 54 mg/dL / < 3.0 mmol/L) per patient-year exposed were 0.73 for icodec versus 0.27 for degludec, which was not significantly different (P = .0782). Similar findings were seen for nocturnal hypoglycemia.

Significantly more patients achieved an A1c under 7% without significant hypoglycemia with icodec than degludec, at 36.7% versus 26.8% (P = .0223). Other adverse events were equivalent between the two groups, Dr. Philis-Tsimikas reported.

Scores on the diabetes treatment satisfaction questionnaire, which addresses convenience, flexibility, satisfaction, and willingness to recommend treatment to others, were significantly higher for icodec than degludec, at 4.22 versus 2.96 (P = .0036).

“For me, this is one of the most important outcomes,” she commented.  
 

Benefit in type 2 diabetes, potential concern in type 1 diabetes

Top-line results from ONWARDS 1, a phase 3a 78-week trial in 984 drug-naive people with type 2 diabetes and ONWARDS 6, a 52-week trial in 583 people with type 1 diabetes, were presented earlier this year at the American Diabetes Association 81st Scientific Sessions.

In ONWARDS 1, icodec achieved noninferiority to daily insulin glargine, reducing A1c by 1.55 versus 1.35 percentage points, with superior time in range and no significant differences in hypoglycemia rates.

However, in ONWARDS 6, while noninferiority in A1c lowering compared with daily degludec was achieved, with reductions of 0.47 versus 0.51 percentage points from a baseline A1c of 7.6%, there was a significantly greater rate of severe or clinically significant hypoglycemia with icodec, at 19.93 versus 10.37 events per patient-year with degludec.

Dr. Philis-Tsimikas has reported performing research and serving as an advisor on behalf of her employer for Abbott, Bayer, Dexcom, Eli Lilly, Medtronic, Merck, Novo Nordisk, and Sanofi. All reimbursements go to her employer. Dr. Alexander has reported being a nonpaid advisor for diaTribe and a consultant for Kinexum.

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

STOCKHOLM – The investigational once-weekly insulin icodec (Novo Nordisk) significantly reduces A1c without increasing hypoglycemia in people with type 2 diabetes, the first phase 3 data of such an insulin formulation suggest. The data are from one of six trials in the company’s ONWARDS program.

“Once-weekly insulin may redefine diabetes management,” enthused Athena Philis-Tsimikas, MD, who presented the findings at a session during the European Association for the Study of Diabetes (EASD) 2022 Annual Meeting, which also included a summary of previously reported top-line data from other ONWARDS trials as well as phase 2 data for Lilly›s investigational once-weekly Basal Insulin Fc (BIF).

Phase 2 data for icodec were published in 2020 in the New England Journal of Medicine and in 2021 in Diabetes Care, as reported by this news organization.

The capacity for reducing the number of basal insulin injections from at least 365 to just 52 per year means that once-weekly insulin “has the potential to facilitate insulin initiation and improve treatment adherence and persistence in diabetes,” noted Dr. Philis-Tsimikas, corporate vice president of Scripps Whittier Diabetes Institute, San Diego.

Asked to comment, independent diabetes industry consultant Charles Alexander, MD, told this news organization that the new data from ONWARDS 2 of patients switching from daily to once-weekly basal insulin were reassuring with regard to hypoglycemia, at least for people with type 2 diabetes.

“For type 2, I think there’s enough data now to feel comfortable that it’s going to be good, especially for people who are on once-weekly [glucagon-like peptide-1 (GLP-1) agonists].”

However, for type 1 diabetes, the company reported top-line ONWARDS 6 data earlier this year, in which icodec was associated with significantly increased rates of hypoglycemia compared with daily degludec. “In type 1, even the basal needs are [often] changing. That kind of person would want to stay away from once-weekly insulin,” Dr. Alexander said.

And he noted, for any patient who adjusts their insulin dose frequently, “obviously, you’re not going to be able to do that with a once-weekly.”
 

Similar A1c reduction as daily basal without increased hypoglycemia

In ONWARDS 2, 526 adults with type 2 diabetes were randomized to switch from their current once- or twice-daily basal insulin to either once-weekly icodec or once-daily insulin degludec (Tresiba) for 26 weeks. The study was open-label, with a treat-to-glucose target of 80-130 mg/dL design.

Participants had A1c levels of 7.0%-10.0% and were also taking stable doses of other noninsulin glucose-lowering medications. Over 80% were taking metformin, a third were taking an SGLT2 inhibitor, and about a quarter each were taking a GLP-1 agonist or DPP-4 inhibitor. Those medications were continued, but sulfonylureas were discontinued in the 22% taking those at baseline.

The basal insulin used at baseline was glargine U100 for 42%, degludec for 28%, and glargine U300 for 16%, “so, a very typical presentation of patients we see in our practices today,” Dr. Philis-Tsimikas noted.

The primary endpoint, change in A1c from baseline to week 26, dropped from 8.17% to 7.20% with icodec and from 8.10% to 7.42% with degludec. The estimated treatment difference of –0.22 percentage points met the margins for both noninferiority (P < .0001) and superiority (P = .0028). Those taking icodec were significantly more likely to achieve an A1c under 7% compared with degludec, at 40.3% versus 26.5% (P = .0019).

Continuous glucose monitoring parameters during weeks 22-26 showed time in glucose range of 70-180 mg/dL (3.9-10.0 mmol/L) was 63.1% for icodec and 59.5% for degludec, which was not significantly different, Dr. Philis-Tsimikas reported.

Body weight increased by 1.4 kg (3 lb) with icodec but dropped slightly by 0.30 kg with degludec, which was significantly different (P < .001).

When asked about the body weight results, Dr. Alexander said: “It’s really hard to say. We know that insulin generally causes weight gain. A 1.4-kg weight gain over 6 months isn’t really surprising. Why there wasn’t with degludec, I don’t know.”

There was just one episode of severe hypoglycemia (requiring assistance) in the trial in the degludec group. Rates of combined severe or clinically significant hypoglycemic events (glucose < 54 mg/dL / < 3.0 mmol/L) per patient-year exposed were 0.73 for icodec versus 0.27 for degludec, which was not significantly different (P = .0782). Similar findings were seen for nocturnal hypoglycemia.

Significantly more patients achieved an A1c under 7% without significant hypoglycemia with icodec than degludec, at 36.7% versus 26.8% (P = .0223). Other adverse events were equivalent between the two groups, Dr. Philis-Tsimikas reported.

Scores on the diabetes treatment satisfaction questionnaire, which addresses convenience, flexibility, satisfaction, and willingness to recommend treatment to others, were significantly higher for icodec than degludec, at 4.22 versus 2.96 (P = .0036).

“For me, this is one of the most important outcomes,” she commented.  
 

Benefit in type 2 diabetes, potential concern in type 1 diabetes

Top-line results from ONWARDS 1, a phase 3a 78-week trial in 984 drug-naive people with type 2 diabetes and ONWARDS 6, a 52-week trial in 583 people with type 1 diabetes, were presented earlier this year at the American Diabetes Association 81st Scientific Sessions.

In ONWARDS 1, icodec achieved noninferiority to daily insulin glargine, reducing A1c by 1.55 versus 1.35 percentage points, with superior time in range and no significant differences in hypoglycemia rates.

However, in ONWARDS 6, while noninferiority in A1c lowering compared with daily degludec was achieved, with reductions of 0.47 versus 0.51 percentage points from a baseline A1c of 7.6%, there was a significantly greater rate of severe or clinically significant hypoglycemia with icodec, at 19.93 versus 10.37 events per patient-year with degludec.

Dr. Philis-Tsimikas has reported performing research and serving as an advisor on behalf of her employer for Abbott, Bayer, Dexcom, Eli Lilly, Medtronic, Merck, Novo Nordisk, and Sanofi. All reimbursements go to her employer. Dr. Alexander has reported being a nonpaid advisor for diaTribe and a consultant for Kinexum.

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

STOCKHOLM – The number of people living with type 1 diabetes worldwide is expected to double by 2040, with most new cases among adults living in low- and middle-income countries, new modeling data suggest.

The forecast, developed from available data collected in the newly established open-source Type 1 Diabetes Index, provides estimates for type 1 diabetes prevalence, incidence, associated mortality, and life expectancy for 201 countries for 2021.

The model also projects estimates for prevalent cases in 2040. It is the first type 1 diabetes dataset to account for the lack of prevalence because of premature mortality, particularly in low- and middle-income countries.

“The worldwide prevalence of type 1 diabetes is substantial and growing. Improved surveillance – particularly in adults who make up most of the population living with type 1 diabetes – is essential to enable improvements to care and outcomes. There is an opportunity to save millions of lives in the coming decades by raising the standard of care (including ensuring universal access to insulin and other essential supplies) and increasing awareness of the signs and symptoms of type 1 diabetes to enable a 100% rate of diagnosis in all countries,” the authors write.

“This work spells out the need for early diagnosis of type 1 diabetes and timely access to quality care,” said Chantal Mathieu, MD, at the European Association for the Study of Diabetes annual meeting.
 

One in five deaths from type 1 diabetes in under 25s

The new findings were published in Lancet Diabetes & Endocrinology by Gabriel A. Gregory, MD, of Life for a Child Program, New South Wales, Australia, and colleagues. The T1D Index Project database was published Sept. 21, 2022.

According to the model, about 8.4 million people were living with type 1 diabetes in 2021, with one-fifth from low- and middle-income countries. An additional 3.7 million died prematurely and would have been added to that count had they lived. One in five of all deaths caused by type 1 diabetes in 2021 is estimated to have occurred in people younger than age 25 years because of nondiagnosis.

“It is unacceptable that, in 2022, some 35,000 people worldwide are dying undiagnosed within a year of onset of symptoms. There also continues to be a huge disparity in life expectancy for people with type 1 diabetes, hitting those in the poorest countries hardest,” noted Dr. Mathieu, who is senior vice-president of EASD and an endocrinologist based at KU Leuven, Belgium.

By 2040, the model predicts that between 13.5 million and 17.4 million people will be living with the condition, with the largest relative increase from 2021 in low-income and lower-middle-income countries. The majority of incident and prevalent cases of type 1 diabetes are in adults, with an estimated 62% of 510,000 new diagnoses worldwide in 2021 occurring in people aged 20 years and older.
 

Type 1 diabetes is not predominantly a disease of childhood

Dr. Mathieu also noted that the data dispute the long-held view of type 1 diabetes as a predominantly pediatric condition. Indeed, worldwide, the median age for a person living with type 1 diabetes is 37 years.

“While type 1 diabetes is often referred to as ‘child-onset’ diabetes, this important study shows that only around one in five living with the condition are aged 20 years or younger, two-thirds are aged 20-64 years, and a further one in five are aged 65 years or older.”

“This condition does not stop at age 18 years – the children become adults, and the adults become elderly. All countries must examine and strengthen their diagnosis and care pathways for people of all ages living with type 1 diabetes,” Dr. Mathieu emphasized.

And in an accompanying editorial, Serena Jingchuan Guo, MD, PhD, and Hui Shao, MD, PhD, point out that most studies that estimate diabetes burden have focused on type 2 diabetes, noting, “type 1 diabetes faces the challenges of misdiagnosis, underdiagnosis, high risk of complications, and premature mortality.”

The insulin affordability issue is central, point out Dr. Guo and Dr. Shao of the Center for Drug Evaluation and Safety, department of pharmaceutical evaluation and policy, University of Florida College of Pharmacy, Gainesville.

“Countries need to strengthen the price regulation and reimbursement policy for insulin while building subsidy programs to ensure insulin access and to cope with the growing demand for insulin. Meanwhile, optimizing the insulin supply chain between manufacturers and patients while seeking alternative treatment options (for example, biosimilar products) will also improve the current situation,” they conclude.   

The study was funded by JDRF, of which four coauthors are employees. The editorialists have reported no relevant financial relationships.

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

STOCKHOLM – The number of people living with type 1 diabetes worldwide is expected to double by 2040, with most new cases among adults living in low- and middle-income countries, new modeling data suggest.

The forecast, developed from available data collected in the newly established open-source Type 1 Diabetes Index, provides estimates for type 1 diabetes prevalence, incidence, associated mortality, and life expectancy for 201 countries for 2021.

The model also projects estimates for prevalent cases in 2040. It is the first type 1 diabetes dataset to account for the lack of prevalence because of premature mortality, particularly in low- and middle-income countries.

“The worldwide prevalence of type 1 diabetes is substantial and growing. Improved surveillance – particularly in adults who make up most of the population living with type 1 diabetes – is essential to enable improvements to care and outcomes. There is an opportunity to save millions of lives in the coming decades by raising the standard of care (including ensuring universal access to insulin and other essential supplies) and increasing awareness of the signs and symptoms of type 1 diabetes to enable a 100% rate of diagnosis in all countries,” the authors write.

“This work spells out the need for early diagnosis of type 1 diabetes and timely access to quality care,” said Chantal Mathieu, MD, at the European Association for the Study of Diabetes annual meeting.
 

One in five deaths from type 1 diabetes in under 25s

The new findings were published in Lancet Diabetes & Endocrinology by Gabriel A. Gregory, MD, of Life for a Child Program, New South Wales, Australia, and colleagues. The T1D Index Project database was published Sept. 21, 2022.

According to the model, about 8.4 million people were living with type 1 diabetes in 2021, with one-fifth from low- and middle-income countries. An additional 3.7 million died prematurely and would have been added to that count had they lived. One in five of all deaths caused by type 1 diabetes in 2021 is estimated to have occurred in people younger than age 25 years because of nondiagnosis.

“It is unacceptable that, in 2022, some 35,000 people worldwide are dying undiagnosed within a year of onset of symptoms. There also continues to be a huge disparity in life expectancy for people with type 1 diabetes, hitting those in the poorest countries hardest,” noted Dr. Mathieu, who is senior vice-president of EASD and an endocrinologist based at KU Leuven, Belgium.

By 2040, the model predicts that between 13.5 million and 17.4 million people will be living with the condition, with the largest relative increase from 2021 in low-income and lower-middle-income countries. The majority of incident and prevalent cases of type 1 diabetes are in adults, with an estimated 62% of 510,000 new diagnoses worldwide in 2021 occurring in people aged 20 years and older.
 

Type 1 diabetes is not predominantly a disease of childhood

Dr. Mathieu also noted that the data dispute the long-held view of type 1 diabetes as a predominantly pediatric condition. Indeed, worldwide, the median age for a person living with type 1 diabetes is 37 years.

“While type 1 diabetes is often referred to as ‘child-onset’ diabetes, this important study shows that only around one in five living with the condition are aged 20 years or younger, two-thirds are aged 20-64 years, and a further one in five are aged 65 years or older.”

“This condition does not stop at age 18 years – the children become adults, and the adults become elderly. All countries must examine and strengthen their diagnosis and care pathways for people of all ages living with type 1 diabetes,” Dr. Mathieu emphasized.

And in an accompanying editorial, Serena Jingchuan Guo, MD, PhD, and Hui Shao, MD, PhD, point out that most studies that estimate diabetes burden have focused on type 2 diabetes, noting, “type 1 diabetes faces the challenges of misdiagnosis, underdiagnosis, high risk of complications, and premature mortality.”

The insulin affordability issue is central, point out Dr. Guo and Dr. Shao of the Center for Drug Evaluation and Safety, department of pharmaceutical evaluation and policy, University of Florida College of Pharmacy, Gainesville.

“Countries need to strengthen the price regulation and reimbursement policy for insulin while building subsidy programs to ensure insulin access and to cope with the growing demand for insulin. Meanwhile, optimizing the insulin supply chain between manufacturers and patients while seeking alternative treatment options (for example, biosimilar products) will also improve the current situation,” they conclude.   

The study was funded by JDRF, of which four coauthors are employees. The editorialists have reported no relevant financial relationships.

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

STOCKHOLM – The number of people living with type 1 diabetes worldwide is expected to double by 2040, with most new cases among adults living in low- and middle-income countries, new modeling data suggest.

The forecast, developed from available data collected in the newly established open-source Type 1 Diabetes Index, provides estimates for type 1 diabetes prevalence, incidence, associated mortality, and life expectancy for 201 countries for 2021.

The model also projects estimates for prevalent cases in 2040. It is the first type 1 diabetes dataset to account for the lack of prevalence because of premature mortality, particularly in low- and middle-income countries.

“The worldwide prevalence of type 1 diabetes is substantial and growing. Improved surveillance – particularly in adults who make up most of the population living with type 1 diabetes – is essential to enable improvements to care and outcomes. There is an opportunity to save millions of lives in the coming decades by raising the standard of care (including ensuring universal access to insulin and other essential supplies) and increasing awareness of the signs and symptoms of type 1 diabetes to enable a 100% rate of diagnosis in all countries,” the authors write.

“This work spells out the need for early diagnosis of type 1 diabetes and timely access to quality care,” said Chantal Mathieu, MD, at the European Association for the Study of Diabetes annual meeting.
 

One in five deaths from type 1 diabetes in under 25s

The new findings were published in Lancet Diabetes & Endocrinology by Gabriel A. Gregory, MD, of Life for a Child Program, New South Wales, Australia, and colleagues. The T1D Index Project database was published Sept. 21, 2022.

According to the model, about 8.4 million people were living with type 1 diabetes in 2021, with one-fifth from low- and middle-income countries. An additional 3.7 million died prematurely and would have been added to that count had they lived. One in five of all deaths caused by type 1 diabetes in 2021 is estimated to have occurred in people younger than age 25 years because of nondiagnosis.

“It is unacceptable that, in 2022, some 35,000 people worldwide are dying undiagnosed within a year of onset of symptoms. There also continues to be a huge disparity in life expectancy for people with type 1 diabetes, hitting those in the poorest countries hardest,” noted Dr. Mathieu, who is senior vice-president of EASD and an endocrinologist based at KU Leuven, Belgium.

By 2040, the model predicts that between 13.5 million and 17.4 million people will be living with the condition, with the largest relative increase from 2021 in low-income and lower-middle-income countries. The majority of incident and prevalent cases of type 1 diabetes are in adults, with an estimated 62% of 510,000 new diagnoses worldwide in 2021 occurring in people aged 20 years and older.
 

Type 1 diabetes is not predominantly a disease of childhood

Dr. Mathieu also noted that the data dispute the long-held view of type 1 diabetes as a predominantly pediatric condition. Indeed, worldwide, the median age for a person living with type 1 diabetes is 37 years.

“While type 1 diabetes is often referred to as ‘child-onset’ diabetes, this important study shows that only around one in five living with the condition are aged 20 years or younger, two-thirds are aged 20-64 years, and a further one in five are aged 65 years or older.”

“This condition does not stop at age 18 years – the children become adults, and the adults become elderly. All countries must examine and strengthen their diagnosis and care pathways for people of all ages living with type 1 diabetes,” Dr. Mathieu emphasized.

And in an accompanying editorial, Serena Jingchuan Guo, MD, PhD, and Hui Shao, MD, PhD, point out that most studies that estimate diabetes burden have focused on type 2 diabetes, noting, “type 1 diabetes faces the challenges of misdiagnosis, underdiagnosis, high risk of complications, and premature mortality.”

The insulin affordability issue is central, point out Dr. Guo and Dr. Shao of the Center for Drug Evaluation and Safety, department of pharmaceutical evaluation and policy, University of Florida College of Pharmacy, Gainesville.

“Countries need to strengthen the price regulation and reimbursement policy for insulin while building subsidy programs to ensure insulin access and to cope with the growing demand for insulin. Meanwhile, optimizing the insulin supply chain between manufacturers and patients while seeking alternative treatment options (for example, biosimilar products) will also improve the current situation,” they conclude.   

The study was funded by JDRF, of which four coauthors are employees. The editorialists have reported no relevant financial relationships.

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

STOCKHOLM – Weight loss should be a co–primary management goal for type 2 diabetes in adults, according to a new comprehensive joint consensus report from the European Association for the Study of Diabetes and the American Diabetes Association.

And while metformin is still recommended as first-line therapy for patients with type 2 diabetes with no other comorbidities, the statement expands the indications for use of other agents or combinations of agents as initial therapy for subgroups of patients, as part of individualized and patient-centered decision-making.

Last updated in 2019, the new “Management of Hyperglycemia in Type 2 Diabetes” statement also places increased emphasis on social determinants of health, incorporates recent clinical trial data for cardiovascular and kidney outcomes for sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagonlike peptide–1 (GLP-1) agonists to broaden recommendations for cardiorenal protection, and discusses health behaviors such as sleep and sitting. It also targets a wider audience than in the past by addressing health system organization to optimize delivery of diabetes care.

The new statement was presented during a 90-minute session at the annual meeting of the EASD, with 12 of its 14 European and American authors as presenters. The document was simultaneously published in Diabetologia and Diabetes Care.

During the discussion, panel member Jennifer Brigitte Green, MD, commented: “Many of these recommendations are not new. They’re modest revisions of recommendations that have been in place for years, but we know that actual implementation rates of use of these drugs in patients with established comorbidities are very low.”

“I think it’s time for communities, health care systems, etc, to actually introduce these as expectations of care... to assess quality because unless it’s considered formally to be a requirement of care I just don’t think we’re going to move that needle very much,” added Dr. Green, who is professor of medicine at Duke University, Durham, N.C.

Vanita R. Aroda, MD, of the division of endocrinology, diabetes, and hypertension at Brigham and Women’s Hospital, Boston, commented: “In the past, sometimes these recommendations created fodder for debate, but I don’t think this one will. It’s just really solidly evidence based, with the rationales presented throughout, including the figures. I think just having very clear evidence-based directions should support their dissemination and use.”
 

Weight management plays a prominent role in treatment

In an interview, writing panel cochair John B. Buse, MD, PhD, said: “We are saying that the four major components of type 2 diabetes care are glycemic management, cardiovascular risk management, weight management, and prevention of end-organ damage, particularly with regard to cardiorenal risk.”

“The weight management piece is much more explicit now,” said Dr. Buse, director of the Diabetes Center at the University of North Carolina at Chapel Hill.

He noted that recent evidence from the intensive lifestyle trial DiRECT, conducted in the United Kingdom, the bariatric surgery literature, and the emergence of potent weight-loss drugs have meant that “achieving 10%-15% body weight loss is now possible.

“So, aiming for remission is something that might be attractive to patients and providers. This could be based on weight management, with the [chosen] method based on shared decision-making.”

According to the new report: “Weight loss of 5%-10% confers metabolic improvement; weight loss of 10%-15% or more can have a disease-modifying effect and lead to remission of diabetes, defined as normal blood glucose levels for 3 months or more in the absence of pharmacological therapy in a 2021 consensus report.”

“Weight loss may exert benefits that extend beyond glycemic management to improve risk factors for cardiometabolic disease and quality of life,” it adds.
 

Individualization featured throughout

The report’s sections cover principles of care, including the importance of diabetes self-management education and support and avoidance of therapeutic inertia. Detailed guidance addresses therapeutic options including lifestyle, weight management, and pharmacotherapy for treating type 2 diabetes.

Another entire section is devoted to personalizing treatment approaches based on individual characteristics, including new evidence from cardiorenal outcomes studies for SGLT2 inhibitors and GLP-1 agonists that have come out since the last consensus report.

The document advises: “Consider initial combination therapy with glucose-lowering agents, especially in those with high [hemoglobin] A1c at diagnosis (that is, > 70 mmol/mol [> 8.5%]), in younger people with type 2 diabetes (regardless of A1c), and in those in whom a stepwise approach would delay access to agents that provide cardiorenal protection beyond their glucose-lowering effects.”
 

Designed to be used and user-friendly

Under the “Putting it all together: strategies for implementation” section, several lists of “practical tips for clinicians” are provided for many of the topics covered.

A series of colorful infographics are included as well, addressing the “decision cycle for person-centered glycemic management in type 2 diabetes,” including a chart summarizing characteristics of available glucose-lowering medications, including cardiorenal protection.

Also mentioned is the importance of 24-hour physical behaviors (including sleep, sitting, and sweating) and the impact on cardiometabolic health, use of a “holistic person-centered approach” to type 2 diabetes management, and an algorithm on insulin use.

Dr. Buse has financial ties to numerous drug and device companies. Dr. Green is a consultant for AstraZeneca, Pfizer, Boehringer Ingelheim/Lilly, Bayer, Sanofi, Anji, Vertex/ICON, and Valo. Dr. Aroda has served as a consultant for Applied Therapeutics, Duke, Fractyl, Novo Nordisk, Pfizer, and Sanofi.

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

STOCKHOLM – Weight loss should be a co–primary management goal for type 2 diabetes in adults, according to a new comprehensive joint consensus report from the European Association for the Study of Diabetes and the American Diabetes Association.

And while metformin is still recommended as first-line therapy for patients with type 2 diabetes with no other comorbidities, the statement expands the indications for use of other agents or combinations of agents as initial therapy for subgroups of patients, as part of individualized and patient-centered decision-making.

Last updated in 2019, the new “Management of Hyperglycemia in Type 2 Diabetes” statement also places increased emphasis on social determinants of health, incorporates recent clinical trial data for cardiovascular and kidney outcomes for sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagonlike peptide–1 (GLP-1) agonists to broaden recommendations for cardiorenal protection, and discusses health behaviors such as sleep and sitting. It also targets a wider audience than in the past by addressing health system organization to optimize delivery of diabetes care.

The new statement was presented during a 90-minute session at the annual meeting of the EASD, with 12 of its 14 European and American authors as presenters. The document was simultaneously published in Diabetologia and Diabetes Care.

During the discussion, panel member Jennifer Brigitte Green, MD, commented: “Many of these recommendations are not new. They’re modest revisions of recommendations that have been in place for years, but we know that actual implementation rates of use of these drugs in patients with established comorbidities are very low.”

“I think it’s time for communities, health care systems, etc, to actually introduce these as expectations of care... to assess quality because unless it’s considered formally to be a requirement of care I just don’t think we’re going to move that needle very much,” added Dr. Green, who is professor of medicine at Duke University, Durham, N.C.

Vanita R. Aroda, MD, of the division of endocrinology, diabetes, and hypertension at Brigham and Women’s Hospital, Boston, commented: “In the past, sometimes these recommendations created fodder for debate, but I don’t think this one will. It’s just really solidly evidence based, with the rationales presented throughout, including the figures. I think just having very clear evidence-based directions should support their dissemination and use.”
 

Weight management plays a prominent role in treatment

In an interview, writing panel cochair John B. Buse, MD, PhD, said: “We are saying that the four major components of type 2 diabetes care are glycemic management, cardiovascular risk management, weight management, and prevention of end-organ damage, particularly with regard to cardiorenal risk.”

“The weight management piece is much more explicit now,” said Dr. Buse, director of the Diabetes Center at the University of North Carolina at Chapel Hill.

He noted that recent evidence from the intensive lifestyle trial DiRECT, conducted in the United Kingdom, the bariatric surgery literature, and the emergence of potent weight-loss drugs have meant that “achieving 10%-15% body weight loss is now possible.

“So, aiming for remission is something that might be attractive to patients and providers. This could be based on weight management, with the [chosen] method based on shared decision-making.”

According to the new report: “Weight loss of 5%-10% confers metabolic improvement; weight loss of 10%-15% or more can have a disease-modifying effect and lead to remission of diabetes, defined as normal blood glucose levels for 3 months or more in the absence of pharmacological therapy in a 2021 consensus report.”

“Weight loss may exert benefits that extend beyond glycemic management to improve risk factors for cardiometabolic disease and quality of life,” it adds.
 

Individualization featured throughout

The report’s sections cover principles of care, including the importance of diabetes self-management education and support and avoidance of therapeutic inertia. Detailed guidance addresses therapeutic options including lifestyle, weight management, and pharmacotherapy for treating type 2 diabetes.

Another entire section is devoted to personalizing treatment approaches based on individual characteristics, including new evidence from cardiorenal outcomes studies for SGLT2 inhibitors and GLP-1 agonists that have come out since the last consensus report.

The document advises: “Consider initial combination therapy with glucose-lowering agents, especially in those with high [hemoglobin] A1c at diagnosis (that is, > 70 mmol/mol [> 8.5%]), in younger people with type 2 diabetes (regardless of A1c), and in those in whom a stepwise approach would delay access to agents that provide cardiorenal protection beyond their glucose-lowering effects.”
 

Designed to be used and user-friendly

Under the “Putting it all together: strategies for implementation” section, several lists of “practical tips for clinicians” are provided for many of the topics covered.

A series of colorful infographics are included as well, addressing the “decision cycle for person-centered glycemic management in type 2 diabetes,” including a chart summarizing characteristics of available glucose-lowering medications, including cardiorenal protection.

Also mentioned is the importance of 24-hour physical behaviors (including sleep, sitting, and sweating) and the impact on cardiometabolic health, use of a “holistic person-centered approach” to type 2 diabetes management, and an algorithm on insulin use.

Dr. Buse has financial ties to numerous drug and device companies. Dr. Green is a consultant for AstraZeneca, Pfizer, Boehringer Ingelheim/Lilly, Bayer, Sanofi, Anji, Vertex/ICON, and Valo. Dr. Aroda has served as a consultant for Applied Therapeutics, Duke, Fractyl, Novo Nordisk, Pfizer, and Sanofi.

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

STOCKHOLM – Weight loss should be a co–primary management goal for type 2 diabetes in adults, according to a new comprehensive joint consensus report from the European Association for the Study of Diabetes and the American Diabetes Association.

And while metformin is still recommended as first-line therapy for patients with type 2 diabetes with no other comorbidities, the statement expands the indications for use of other agents or combinations of agents as initial therapy for subgroups of patients, as part of individualized and patient-centered decision-making.

Last updated in 2019, the new “Management of Hyperglycemia in Type 2 Diabetes” statement also places increased emphasis on social determinants of health, incorporates recent clinical trial data for cardiovascular and kidney outcomes for sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagonlike peptide–1 (GLP-1) agonists to broaden recommendations for cardiorenal protection, and discusses health behaviors such as sleep and sitting. It also targets a wider audience than in the past by addressing health system organization to optimize delivery of diabetes care.

The new statement was presented during a 90-minute session at the annual meeting of the EASD, with 12 of its 14 European and American authors as presenters. The document was simultaneously published in Diabetologia and Diabetes Care.

During the discussion, panel member Jennifer Brigitte Green, MD, commented: “Many of these recommendations are not new. They’re modest revisions of recommendations that have been in place for years, but we know that actual implementation rates of use of these drugs in patients with established comorbidities are very low.”

“I think it’s time for communities, health care systems, etc, to actually introduce these as expectations of care... to assess quality because unless it’s considered formally to be a requirement of care I just don’t think we’re going to move that needle very much,” added Dr. Green, who is professor of medicine at Duke University, Durham, N.C.

Vanita R. Aroda, MD, of the division of endocrinology, diabetes, and hypertension at Brigham and Women’s Hospital, Boston, commented: “In the past, sometimes these recommendations created fodder for debate, but I don’t think this one will. It’s just really solidly evidence based, with the rationales presented throughout, including the figures. I think just having very clear evidence-based directions should support their dissemination and use.”
 

Weight management plays a prominent role in treatment

In an interview, writing panel cochair John B. Buse, MD, PhD, said: “We are saying that the four major components of type 2 diabetes care are glycemic management, cardiovascular risk management, weight management, and prevention of end-organ damage, particularly with regard to cardiorenal risk.”

“The weight management piece is much more explicit now,” said Dr. Buse, director of the Diabetes Center at the University of North Carolina at Chapel Hill.

He noted that recent evidence from the intensive lifestyle trial DiRECT, conducted in the United Kingdom, the bariatric surgery literature, and the emergence of potent weight-loss drugs have meant that “achieving 10%-15% body weight loss is now possible.

“So, aiming for remission is something that might be attractive to patients and providers. This could be based on weight management, with the [chosen] method based on shared decision-making.”

According to the new report: “Weight loss of 5%-10% confers metabolic improvement; weight loss of 10%-15% or more can have a disease-modifying effect and lead to remission of diabetes, defined as normal blood glucose levels for 3 months or more in the absence of pharmacological therapy in a 2021 consensus report.”

“Weight loss may exert benefits that extend beyond glycemic management to improve risk factors for cardiometabolic disease and quality of life,” it adds.
 

Individualization featured throughout

The report’s sections cover principles of care, including the importance of diabetes self-management education and support and avoidance of therapeutic inertia. Detailed guidance addresses therapeutic options including lifestyle, weight management, and pharmacotherapy for treating type 2 diabetes.

Another entire section is devoted to personalizing treatment approaches based on individual characteristics, including new evidence from cardiorenal outcomes studies for SGLT2 inhibitors and GLP-1 agonists that have come out since the last consensus report.

The document advises: “Consider initial combination therapy with glucose-lowering agents, especially in those with high [hemoglobin] A1c at diagnosis (that is, > 70 mmol/mol [> 8.5%]), in younger people with type 2 diabetes (regardless of A1c), and in those in whom a stepwise approach would delay access to agents that provide cardiorenal protection beyond their glucose-lowering effects.”
 

Designed to be used and user-friendly

Under the “Putting it all together: strategies for implementation” section, several lists of “practical tips for clinicians” are provided for many of the topics covered.

A series of colorful infographics are included as well, addressing the “decision cycle for person-centered glycemic management in type 2 diabetes,” including a chart summarizing characteristics of available glucose-lowering medications, including cardiorenal protection.

Also mentioned is the importance of 24-hour physical behaviors (including sleep, sitting, and sweating) and the impact on cardiometabolic health, use of a “holistic person-centered approach” to type 2 diabetes management, and an algorithm on insulin use.

Dr. Buse has financial ties to numerous drug and device companies. Dr. Green is a consultant for AstraZeneca, Pfizer, Boehringer Ingelheim/Lilly, Bayer, Sanofi, Anji, Vertex/ICON, and Valo. Dr. Aroda has served as a consultant for Applied Therapeutics, Duke, Fractyl, Novo Nordisk, Pfizer, and Sanofi.

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

Long-term A1c from the time of type 1 diabetes diagnosis strongly predicts the development of severe retinopathy and nephropathy, new data suggest.

“[Weighted] HbA1c followed from diagnosis is a very strong biomarker for pan-retinal laser-treated diabetic retinopathy (PDR) and nephropathy, [and] the prevalence of both is still increasing 32 years after diagnosis,” say Hans J. Arnqvist, MD, and colleagues in their study published online Sept. 12 in Diabetes Care.

The results are from a 32-year follow-up of 447 patients from time of diagnosis of type 1 diabetes at age 0-34 in the Vascular Diabetic Complications in Southeast Sweden study.

“To avoid PDR and macroalbuminuria in patients with type 1 diabetes, A1c less than 7.0% (53 mmol/mol) and as normal as possible should be recommended when achievable without severe hypoglycemia and with good quality of life,” stress Dr. Arnqvist, department of endocrinology, Linköping University (Sweden), and coauthors.

At the time of the 20- to 24-year VISS follow-up, severe eye complications, defined as PDR, or nephropathy, defined as macroalbuminuria, were not present in participants with a long-term weighted mean A1c less than 7.6% (60 mmol/mol), they write.
 

Is explanation an increase in glycemic burden with diabetes duration?

By years 32-36, the prevalence of PDR had risen from 14% to 27%, and macroalbuminuria from 4% to 8%, with prevalence strongly correlated with A1c levels. At the same time, the threshold for the appearance of those severe complications dropped, with the lowest A1c values for appearance of PDR decreasing from 7.6% to 7.3% and for macroalbuminuria from 8.4% to 8.1%.

“A possible explanation for the lowered threshold for development of severe microangiopathy is the increase in ‘glycemic burden’ with diabetes duration,” the authors speculate.

In all A1c categories above 6.7% (> 50 mmol/mol), the cumulative proportion with PDR and/or macroproteinuria continued to increase up to at least 32 years of diabetes duration.

At the highest A1c quintile, greater than 9.5% (> 80mmol/mol), 75% had developed PDR and 44.2% had macroalbuminuria.

These findings align with guidelines from both the International Society for Pediatric and Adolescent Diabetes, which recommend A1c less than 7% (53 mmol/mol) as a treatment goal, and the UK National Institute for Health and Care Excellence, which advises a target A1c of 6.5% (48 mmol/mol) or lower in children and adults with type 1 diabetes.

The American Diabetes Association recommends individualized A1c targets ranging from 6.5% to 8.0%.

The study was supported by Barndiabetesfonden (Swedish Children’s Diabetes Foundation) and Region Ostergotlands Stiftelsefonder. The authors reported no further disclosures.

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

Long-term A1c from the time of type 1 diabetes diagnosis strongly predicts the development of severe retinopathy and nephropathy, new data suggest.

“[Weighted] HbA1c followed from diagnosis is a very strong biomarker for pan-retinal laser-treated diabetic retinopathy (PDR) and nephropathy, [and] the prevalence of both is still increasing 32 years after diagnosis,” say Hans J. Arnqvist, MD, and colleagues in their study published online Sept. 12 in Diabetes Care.

The results are from a 32-year follow-up of 447 patients from time of diagnosis of type 1 diabetes at age 0-34 in the Vascular Diabetic Complications in Southeast Sweden study.

“To avoid PDR and macroalbuminuria in patients with type 1 diabetes, A1c less than 7.0% (53 mmol/mol) and as normal as possible should be recommended when achievable without severe hypoglycemia and with good quality of life,” stress Dr. Arnqvist, department of endocrinology, Linköping University (Sweden), and coauthors.

At the time of the 20- to 24-year VISS follow-up, severe eye complications, defined as PDR, or nephropathy, defined as macroalbuminuria, were not present in participants with a long-term weighted mean A1c less than 7.6% (60 mmol/mol), they write.
 

Is explanation an increase in glycemic burden with diabetes duration?

By years 32-36, the prevalence of PDR had risen from 14% to 27%, and macroalbuminuria from 4% to 8%, with prevalence strongly correlated with A1c levels. At the same time, the threshold for the appearance of those severe complications dropped, with the lowest A1c values for appearance of PDR decreasing from 7.6% to 7.3% and for macroalbuminuria from 8.4% to 8.1%.

“A possible explanation for the lowered threshold for development of severe microangiopathy is the increase in ‘glycemic burden’ with diabetes duration,” the authors speculate.

In all A1c categories above 6.7% (> 50 mmol/mol), the cumulative proportion with PDR and/or macroproteinuria continued to increase up to at least 32 years of diabetes duration.

At the highest A1c quintile, greater than 9.5% (> 80mmol/mol), 75% had developed PDR and 44.2% had macroalbuminuria.

These findings align with guidelines from both the International Society for Pediatric and Adolescent Diabetes, which recommend A1c less than 7% (53 mmol/mol) as a treatment goal, and the UK National Institute for Health and Care Excellence, which advises a target A1c of 6.5% (48 mmol/mol) or lower in children and adults with type 1 diabetes.

The American Diabetes Association recommends individualized A1c targets ranging from 6.5% to 8.0%.

The study was supported by Barndiabetesfonden (Swedish Children’s Diabetes Foundation) and Region Ostergotlands Stiftelsefonder. The authors reported no further disclosures.

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

Long-term A1c from the time of type 1 diabetes diagnosis strongly predicts the development of severe retinopathy and nephropathy, new data suggest.

“[Weighted] HbA1c followed from diagnosis is a very strong biomarker for pan-retinal laser-treated diabetic retinopathy (PDR) and nephropathy, [and] the prevalence of both is still increasing 32 years after diagnosis,” say Hans J. Arnqvist, MD, and colleagues in their study published online Sept. 12 in Diabetes Care.

The results are from a 32-year follow-up of 447 patients from time of diagnosis of type 1 diabetes at age 0-34 in the Vascular Diabetic Complications in Southeast Sweden study.

“To avoid PDR and macroalbuminuria in patients with type 1 diabetes, A1c less than 7.0% (53 mmol/mol) and as normal as possible should be recommended when achievable without severe hypoglycemia and with good quality of life,” stress Dr. Arnqvist, department of endocrinology, Linköping University (Sweden), and coauthors.

At the time of the 20- to 24-year VISS follow-up, severe eye complications, defined as PDR, or nephropathy, defined as macroalbuminuria, were not present in participants with a long-term weighted mean A1c less than 7.6% (60 mmol/mol), they write.
 

Is explanation an increase in glycemic burden with diabetes duration?

By years 32-36, the prevalence of PDR had risen from 14% to 27%, and macroalbuminuria from 4% to 8%, with prevalence strongly correlated with A1c levels. At the same time, the threshold for the appearance of those severe complications dropped, with the lowest A1c values for appearance of PDR decreasing from 7.6% to 7.3% and for macroalbuminuria from 8.4% to 8.1%.

“A possible explanation for the lowered threshold for development of severe microangiopathy is the increase in ‘glycemic burden’ with diabetes duration,” the authors speculate.

In all A1c categories above 6.7% (> 50 mmol/mol), the cumulative proportion with PDR and/or macroproteinuria continued to increase up to at least 32 years of diabetes duration.

At the highest A1c quintile, greater than 9.5% (> 80mmol/mol), 75% had developed PDR and 44.2% had macroalbuminuria.

These findings align with guidelines from both the International Society for Pediatric and Adolescent Diabetes, which recommend A1c less than 7% (53 mmol/mol) as a treatment goal, and the UK National Institute for Health and Care Excellence, which advises a target A1c of 6.5% (48 mmol/mol) or lower in children and adults with type 1 diabetes.

The American Diabetes Association recommends individualized A1c targets ranging from 6.5% to 8.0%.

The study was supported by Barndiabetesfonden (Swedish Children’s Diabetes Foundation) and Region Ostergotlands Stiftelsefonder. The authors reported no further disclosures.

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

STOCKHOLM – Among animal protein foods, low-fat dairy consumption may minimize the risk of developing type 2 diabetes while red meat raises that risk, a new analysis finds.

“A plant-based dietary pattern with limited intake of meat, moderate intake of fish, eggs, and full-fat dairy, and habitual consumption of yogurt, milk, or low-fat dairy, might represent the most feasible, sustainable, and successful population strategy to optimize the prevention of type 2 diabetes,” lead author Annalisa Giosuè, MD, of the University of Naples (Italy) Federico II, told this news organization.

baibaz/iStock/Getty Images

She presented the findings from an umbrella review of 13 dose-response meta-analyses of prospective cohort studies at the annual meeting of the European Association for the Study of Diabetes.

The study is believed to be the first comprehensive overview of the available evidence from all published meta-analyses on the relationship between well-defined amounts of animal-origin foods and the risk of type 2 diabetes.

Dr. Giosuè and colleagues focused on animal-based foods because they represent a gap in most guidelines for type 2 diabetes prevention, she explained.

“The existing evidence and dietary recommendations for type 2 diabetes prevention are mainly based on the appropriate consumption of plant foods: high amounts of the fiber-rich ones and low consumption of the refined ones as well as those rich in free sugars. And also on the adequate choice among fat sources – reduction of saturated fat sources like butter and cream and replacement with plant-based poly- and monounsaturated fat sources like nontropical vegetable oils. But not on the most suitable choices among different animal foods for the prevention of type 2 diabetes,” she explained.

The new findings are in line with the Mediterranean diet in that, while plant based, it also limits red-meat consumption, but not all animal-based foods, and has consistently been associated with a reduced risk of type 2 diabetes. Vegetarian diets have also been associated with a reduced risk of type 2 diabetes, but far less evidence is available for that, she said.

Asked for comment, session moderator Matthias Schulze, MD, head of the department of molecular epidemiology at the German Institute of Human Nutrition, Berlin, said: “Decreasing intake of red and processed meat is already a strong recommendation, and these data support that. You have to make choices for and against [certain] foods. So, if you decide to eat less red meat, then the question is what do you eat instead? This study shows that specifically other animal products, like dairy and ... fish or white meat sources ... are healthy among the animal-based foods. But you could also obviously look at plant-based foods as protein sources as well.”

And Dr. Schulze noted that the data suggest another dimension to type 2 diabetes prevention beyond simply focusing on weight loss.

“You can achieve weight loss with very different diets. Diet quality plays an important role. These data support that if you look at diabetes prevention, then you would focus on people with high intakes of specific animal-based foods, besides looking at overweight and obesity. Then you could intervene to reduce this intake, with potential substitutions with other animal foods like fish or white meat, or plant-based sources of proteins.”
 

Red meat damages, dairy protects

The 13 meta-analyses included 175 summary risk ratios for type 2 diabetes incidence for the consumption of total meat, red meat, white meat, processed meats, fish, total dairy, full-fat dairy, low-fat dairy, milk, cheese, yogurt, or eggs.

Significant increases in the risk of developing type 2 diabetes were found for consumption of 100 g/day of total meat (SRR, 1.20; 20% increase) and red meat (SRR, 1.22, 22% increase) and with 50 g/day of processed meats (SRR, 1.30; 30% increase). A borderline increased risk was also seen for 50 g/day of white meat (SRR, 1.04; 4% increase).

The opposite was found for dairy foods. Inverse associations for type 2 diabetes development were found for an intake of 200 g/day of total dairy (SRR, 0.95; 5% reduction), low-fat dairy (SRR, 0.96; 4% reduction), milk (SRR, 0.90; 10% reduction), and for 100 g/day of yogurt (SRR, 0.94, 6% reduction).

Neutral (nonsignificant) effects were found for 200 g/day of full-fat dairy (SRR, 0.98) and for 30 g/day of cheese (SRR, 0.97). Fish consumption also had a neutral association with type 2 diabetes risk (SRR, 1.04 for 100 g/day) as did one egg per day (SRR, 1.07), but evidence quality was low.

And, Dr. Giosuè noted during her presentation, these relationships could change with alterations in the amounts consumed.

Dr. Schulze commented: “Fish is more clearly related to reduced cardiovascular risk than for preventing type 2 diabetes, where we’ve had mixed results. They might not always be the same.”
 

What are the mechanisms?

The reasons for these positive and negative associations aren’t entirely clear, but Dr. Giosuè noted that dairy products contain several nutrients, vitamins, and other components, such as calcium and vitamin D, that have potential beneficial effects on glucose metabolism.

In particular, she said, “Whey proteins in milk have a well-known beneficial effect on the regulation of the rise of glucose levels in the blood after meals, and also on the control of appetite and body weight.”

Moreover, probiotics found in yogurt have been linked to protective effects against weight gain and obesity, which “may in part [explain] the beneficial role of yogurt in type 2 diabetes prevention.”

Meat, in contrast, is full of cholesterol, saturated fatty acids, and heme iron, which can promote subclinical inflammation and oxidative stress, which may in turn, affect insulin sensitivity, Dr. Giosuè explained. What’s more, “processed meats also contain nitrates, nitrites, and sodium that can contribute to pancreatic cell damage and vascular dysfunction, thus affecting insulin sensitivity.”

And white meat (poultry) has a lower fat content than red meats such as beef, lamb, and pork, as well as a more favorable fatty acid profile and a lower heme-iron content, she said in an interview.

What about vegan diets? The devil is in the details

Asked about the relative health benefits of diets that completely eliminate animal-based foods, Dr. Giosuè replied: “What is important to keep in mind when hearing about the potential of vegan diets to prevent, or manage, or induce the remission of type 2 diabetes, is that the inclusion in the diet of solely foods of plant origin does not mean ‘automatically’ to eat only foods that are good for diabetes prevention.”

“Just like the exclusion of all foods of animal origin is not equivalent to reduce the risk of type 2 diabetes ... Solid evidence has demonstrated that plant foods which are refined and/or rich in free sugars like white bread, biscuits, and sweetened beverages are as harmful as red and processed meats for diabetes incidence and progression.”

Dr. Giosuè and Dr. Schulze have reported no relevant financial relationships.

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

STOCKHOLM – Among animal protein foods, low-fat dairy consumption may minimize the risk of developing type 2 diabetes while red meat raises that risk, a new analysis finds.

“A plant-based dietary pattern with limited intake of meat, moderate intake of fish, eggs, and full-fat dairy, and habitual consumption of yogurt, milk, or low-fat dairy, might represent the most feasible, sustainable, and successful population strategy to optimize the prevention of type 2 diabetes,” lead author Annalisa Giosuè, MD, of the University of Naples (Italy) Federico II, told this news organization.

baibaz/iStock/Getty Images

She presented the findings from an umbrella review of 13 dose-response meta-analyses of prospective cohort studies at the annual meeting of the European Association for the Study of Diabetes.

The study is believed to be the first comprehensive overview of the available evidence from all published meta-analyses on the relationship between well-defined amounts of animal-origin foods and the risk of type 2 diabetes.

Dr. Giosuè and colleagues focused on animal-based foods because they represent a gap in most guidelines for type 2 diabetes prevention, she explained.

“The existing evidence and dietary recommendations for type 2 diabetes prevention are mainly based on the appropriate consumption of plant foods: high amounts of the fiber-rich ones and low consumption of the refined ones as well as those rich in free sugars. And also on the adequate choice among fat sources – reduction of saturated fat sources like butter and cream and replacement with plant-based poly- and monounsaturated fat sources like nontropical vegetable oils. But not on the most suitable choices among different animal foods for the prevention of type 2 diabetes,” she explained.

The new findings are in line with the Mediterranean diet in that, while plant based, it also limits red-meat consumption, but not all animal-based foods, and has consistently been associated with a reduced risk of type 2 diabetes. Vegetarian diets have also been associated with a reduced risk of type 2 diabetes, but far less evidence is available for that, she said.

Asked for comment, session moderator Matthias Schulze, MD, head of the department of molecular epidemiology at the German Institute of Human Nutrition, Berlin, said: “Decreasing intake of red and processed meat is already a strong recommendation, and these data support that. You have to make choices for and against [certain] foods. So, if you decide to eat less red meat, then the question is what do you eat instead? This study shows that specifically other animal products, like dairy and ... fish or white meat sources ... are healthy among the animal-based foods. But you could also obviously look at plant-based foods as protein sources as well.”

And Dr. Schulze noted that the data suggest another dimension to type 2 diabetes prevention beyond simply focusing on weight loss.

“You can achieve weight loss with very different diets. Diet quality plays an important role. These data support that if you look at diabetes prevention, then you would focus on people with high intakes of specific animal-based foods, besides looking at overweight and obesity. Then you could intervene to reduce this intake, with potential substitutions with other animal foods like fish or white meat, or plant-based sources of proteins.”
 

Red meat damages, dairy protects

The 13 meta-analyses included 175 summary risk ratios for type 2 diabetes incidence for the consumption of total meat, red meat, white meat, processed meats, fish, total dairy, full-fat dairy, low-fat dairy, milk, cheese, yogurt, or eggs.

Significant increases in the risk of developing type 2 diabetes were found for consumption of 100 g/day of total meat (SRR, 1.20; 20% increase) and red meat (SRR, 1.22, 22% increase) and with 50 g/day of processed meats (SRR, 1.30; 30% increase). A borderline increased risk was also seen for 50 g/day of white meat (SRR, 1.04; 4% increase).

The opposite was found for dairy foods. Inverse associations for type 2 diabetes development were found for an intake of 200 g/day of total dairy (SRR, 0.95; 5% reduction), low-fat dairy (SRR, 0.96; 4% reduction), milk (SRR, 0.90; 10% reduction), and for 100 g/day of yogurt (SRR, 0.94, 6% reduction).

Neutral (nonsignificant) effects were found for 200 g/day of full-fat dairy (SRR, 0.98) and for 30 g/day of cheese (SRR, 0.97). Fish consumption also had a neutral association with type 2 diabetes risk (SRR, 1.04 for 100 g/day) as did one egg per day (SRR, 1.07), but evidence quality was low.

And, Dr. Giosuè noted during her presentation, these relationships could change with alterations in the amounts consumed.

Dr. Schulze commented: “Fish is more clearly related to reduced cardiovascular risk than for preventing type 2 diabetes, where we’ve had mixed results. They might not always be the same.”
 

What are the mechanisms?

The reasons for these positive and negative associations aren’t entirely clear, but Dr. Giosuè noted that dairy products contain several nutrients, vitamins, and other components, such as calcium and vitamin D, that have potential beneficial effects on glucose metabolism.

In particular, she said, “Whey proteins in milk have a well-known beneficial effect on the regulation of the rise of glucose levels in the blood after meals, and also on the control of appetite and body weight.”

Moreover, probiotics found in yogurt have been linked to protective effects against weight gain and obesity, which “may in part [explain] the beneficial role of yogurt in type 2 diabetes prevention.”

Meat, in contrast, is full of cholesterol, saturated fatty acids, and heme iron, which can promote subclinical inflammation and oxidative stress, which may in turn, affect insulin sensitivity, Dr. Giosuè explained. What’s more, “processed meats also contain nitrates, nitrites, and sodium that can contribute to pancreatic cell damage and vascular dysfunction, thus affecting insulin sensitivity.”

And white meat (poultry) has a lower fat content than red meats such as beef, lamb, and pork, as well as a more favorable fatty acid profile and a lower heme-iron content, she said in an interview.

What about vegan diets? The devil is in the details

Asked about the relative health benefits of diets that completely eliminate animal-based foods, Dr. Giosuè replied: “What is important to keep in mind when hearing about the potential of vegan diets to prevent, or manage, or induce the remission of type 2 diabetes, is that the inclusion in the diet of solely foods of plant origin does not mean ‘automatically’ to eat only foods that are good for diabetes prevention.”

“Just like the exclusion of all foods of animal origin is not equivalent to reduce the risk of type 2 diabetes ... Solid evidence has demonstrated that plant foods which are refined and/or rich in free sugars like white bread, biscuits, and sweetened beverages are as harmful as red and processed meats for diabetes incidence and progression.”

Dr. Giosuè and Dr. Schulze have reported no relevant financial relationships.

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

STOCKHOLM – Among animal protein foods, low-fat dairy consumption may minimize the risk of developing type 2 diabetes while red meat raises that risk, a new analysis finds.

“A plant-based dietary pattern with limited intake of meat, moderate intake of fish, eggs, and full-fat dairy, and habitual consumption of yogurt, milk, or low-fat dairy, might represent the most feasible, sustainable, and successful population strategy to optimize the prevention of type 2 diabetes,” lead author Annalisa Giosuè, MD, of the University of Naples (Italy) Federico II, told this news organization.

baibaz/iStock/Getty Images

She presented the findings from an umbrella review of 13 dose-response meta-analyses of prospective cohort studies at the annual meeting of the European Association for the Study of Diabetes.

The study is believed to be the first comprehensive overview of the available evidence from all published meta-analyses on the relationship between well-defined amounts of animal-origin foods and the risk of type 2 diabetes.

Dr. Giosuè and colleagues focused on animal-based foods because they represent a gap in most guidelines for type 2 diabetes prevention, she explained.

“The existing evidence and dietary recommendations for type 2 diabetes prevention are mainly based on the appropriate consumption of plant foods: high amounts of the fiber-rich ones and low consumption of the refined ones as well as those rich in free sugars. And also on the adequate choice among fat sources – reduction of saturated fat sources like butter and cream and replacement with plant-based poly- and monounsaturated fat sources like nontropical vegetable oils. But not on the most suitable choices among different animal foods for the prevention of type 2 diabetes,” she explained.

The new findings are in line with the Mediterranean diet in that, while plant based, it also limits red-meat consumption, but not all animal-based foods, and has consistently been associated with a reduced risk of type 2 diabetes. Vegetarian diets have also been associated with a reduced risk of type 2 diabetes, but far less evidence is available for that, she said.

Asked for comment, session moderator Matthias Schulze, MD, head of the department of molecular epidemiology at the German Institute of Human Nutrition, Berlin, said: “Decreasing intake of red and processed meat is already a strong recommendation, and these data support that. You have to make choices for and against [certain] foods. So, if you decide to eat less red meat, then the question is what do you eat instead? This study shows that specifically other animal products, like dairy and ... fish or white meat sources ... are healthy among the animal-based foods. But you could also obviously look at plant-based foods as protein sources as well.”

And Dr. Schulze noted that the data suggest another dimension to type 2 diabetes prevention beyond simply focusing on weight loss.

“You can achieve weight loss with very different diets. Diet quality plays an important role. These data support that if you look at diabetes prevention, then you would focus on people with high intakes of specific animal-based foods, besides looking at overweight and obesity. Then you could intervene to reduce this intake, with potential substitutions with other animal foods like fish or white meat, or plant-based sources of proteins.”
 

Red meat damages, dairy protects

The 13 meta-analyses included 175 summary risk ratios for type 2 diabetes incidence for the consumption of total meat, red meat, white meat, processed meats, fish, total dairy, full-fat dairy, low-fat dairy, milk, cheese, yogurt, or eggs.

Significant increases in the risk of developing type 2 diabetes were found for consumption of 100 g/day of total meat (SRR, 1.20; 20% increase) and red meat (SRR, 1.22, 22% increase) and with 50 g/day of processed meats (SRR, 1.30; 30% increase). A borderline increased risk was also seen for 50 g/day of white meat (SRR, 1.04; 4% increase).

The opposite was found for dairy foods. Inverse associations for type 2 diabetes development were found for an intake of 200 g/day of total dairy (SRR, 0.95; 5% reduction), low-fat dairy (SRR, 0.96; 4% reduction), milk (SRR, 0.90; 10% reduction), and for 100 g/day of yogurt (SRR, 0.94, 6% reduction).

Neutral (nonsignificant) effects were found for 200 g/day of full-fat dairy (SRR, 0.98) and for 30 g/day of cheese (SRR, 0.97). Fish consumption also had a neutral association with type 2 diabetes risk (SRR, 1.04 for 100 g/day) as did one egg per day (SRR, 1.07), but evidence quality was low.

And, Dr. Giosuè noted during her presentation, these relationships could change with alterations in the amounts consumed.

Dr. Schulze commented: “Fish is more clearly related to reduced cardiovascular risk than for preventing type 2 diabetes, where we’ve had mixed results. They might not always be the same.”
 

What are the mechanisms?

The reasons for these positive and negative associations aren’t entirely clear, but Dr. Giosuè noted that dairy products contain several nutrients, vitamins, and other components, such as calcium and vitamin D, that have potential beneficial effects on glucose metabolism.

In particular, she said, “Whey proteins in milk have a well-known beneficial effect on the regulation of the rise of glucose levels in the blood after meals, and also on the control of appetite and body weight.”

Moreover, probiotics found in yogurt have been linked to protective effects against weight gain and obesity, which “may in part [explain] the beneficial role of yogurt in type 2 diabetes prevention.”

Meat, in contrast, is full of cholesterol, saturated fatty acids, and heme iron, which can promote subclinical inflammation and oxidative stress, which may in turn, affect insulin sensitivity, Dr. Giosuè explained. What’s more, “processed meats also contain nitrates, nitrites, and sodium that can contribute to pancreatic cell damage and vascular dysfunction, thus affecting insulin sensitivity.”

And white meat (poultry) has a lower fat content than red meats such as beef, lamb, and pork, as well as a more favorable fatty acid profile and a lower heme-iron content, she said in an interview.

What about vegan diets? The devil is in the details

Asked about the relative health benefits of diets that completely eliminate animal-based foods, Dr. Giosuè replied: “What is important to keep in mind when hearing about the potential of vegan diets to prevent, or manage, or induce the remission of type 2 diabetes, is that the inclusion in the diet of solely foods of plant origin does not mean ‘automatically’ to eat only foods that are good for diabetes prevention.”

“Just like the exclusion of all foods of animal origin is not equivalent to reduce the risk of type 2 diabetes ... Solid evidence has demonstrated that plant foods which are refined and/or rich in free sugars like white bread, biscuits, and sweetened beverages are as harmful as red and processed meats for diabetes incidence and progression.”

Dr. Giosuè and Dr. Schulze have reported no relevant financial relationships.

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