Diabetes

Pregnancy termination for medical reasons had been part of the fabric of everyday health care in the United States since the Supreme Court’s 1973 Roe v. Wade decision, which the current high court overturned in a ruling announced on June 24.

That means many clinicians across specialties are entering uncharted territory with the country’s new patchwork of abortion legality. Some specialties, cardiology among them, may feel the impact more than others.

javi_indy/ Thinkstock

“Unfortunately,” Dr. Haythe said, “many of the states that are going to make or have made abortion illegal are not providing that kind of preconception counseling or good prenatal care to women.”

Cardiologists can provide such counseling to their female patients of childbearing age who have high-risk cardiac conditions, “but not everybody knows that they have a heart problem when they get pregnant, and not everybody is getting screened for heart problems when they’re of childbearing age,” Dr. Haythe said.

“Sometimes it’s not clear whether the problems could have been picked up until a woman is pregnant and has started to have symptoms.” For example, “a lot of women with poor access to health care have rheumatic heart disease. They may have no idea that they have severe aortic stenosis, and it’s not until their second trimester that they start to feel really short of breath.” Often that can be treated in the cath lab, “but again, that’s putting the woman and the baby at risk.”

Cardiologists in states where abortion is illegal will still present the option to their patients with high-risk pregnancies, noted Dr. Haythe. But the conversation may sound something like, “you are at very high risk, termination of the pregnancy takes that risk away, but you’ll have to find a state where it’s legal to do that.”

Dr. Park said such a situation, when abortion is recommended but locally unavailable, is much like any other in cardiology for which the patient may want a second opinion. If a center “doesn’t have the capability or the technology to offer a certain treatment, the patient can opt to seek another opinion at another center,” she said. “Patients will often travel out of state to get the care they need.”

A requirement for out-of-state travel to obtain abortions is likely to worsen socioeconomic disparities in health care, Dr. Bond observed, “because we know that those who are low-income won’t be able to afford that travel.”

Dr. Bond is cosignatory on a statement from the Association of Black Cardiologists (ABC) responding to the high court’s ruling in Dobbs v. Jackson. “This decision will isolate the poor, socioeconomically disadvantaged, and minority populations specifically, widening the already large gaps in health care for our most vulnerable communities,” it states.

“The loss of broad protections supporting the medical and often lifesaving procedure of abortions is likely to have a real impact on the maternal mortality rate, especially in those with congenital and/or acquired cardiovascular conditions where evidence-based guidelines advise at times on termination of such high-risk pregnancies.”

The ABC, it states, “believes that every woman, and every person, should be afforded the right to safe, accessible, legal, timely, patient-centered, equitable, and affordable health care.”

The American College of Cardiology (ACC) released a statement on the matter June 24, signed by its president, Edward T.A. Fry, MD, along with five former ACC presidents. “While the ACC has no official policy on abortion, clinical practice guidelines and other clinical guidance tools address the dangers of pregnancy in certain patient populations at higher risk of death or serious cardiac events.”

The college, it states, is “deeply concerned about the potential implications of the Supreme Court decision regarding Roe vs. Wade on the ability of patients and clinicians to engage in important shared discussions about maternal health, or to remove previously available health care options.”

Dr. Bond proposed that a “vocal stance” from medical societies involved in women’s health, “perhaps even a collective stance from our cardiovascular societies and our obstetrics societies,” would also perhaps reach “the masses of doctors in private practice who are dealing with these patients.”

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

Pregnancy termination for medical reasons had been part of the fabric of everyday health care in the United States since the Supreme Court’s 1973 Roe v. Wade decision, which the current high court overturned in a ruling announced on June 24.

That means many clinicians across specialties are entering uncharted territory with the country’s new patchwork of abortion legality. Some specialties, cardiology among them, may feel the impact more than others.

javi_indy/ Thinkstock

“Unfortunately,” Dr. Haythe said, “many of the states that are going to make or have made abortion illegal are not providing that kind of preconception counseling or good prenatal care to women.”

Cardiologists can provide such counseling to their female patients of childbearing age who have high-risk cardiac conditions, “but not everybody knows that they have a heart problem when they get pregnant, and not everybody is getting screened for heart problems when they’re of childbearing age,” Dr. Haythe said.

“Sometimes it’s not clear whether the problems could have been picked up until a woman is pregnant and has started to have symptoms.” For example, “a lot of women with poor access to health care have rheumatic heart disease. They may have no idea that they have severe aortic stenosis, and it’s not until their second trimester that they start to feel really short of breath.” Often that can be treated in the cath lab, “but again, that’s putting the woman and the baby at risk.”

Cardiologists in states where abortion is illegal will still present the option to their patients with high-risk pregnancies, noted Dr. Haythe. But the conversation may sound something like, “you are at very high risk, termination of the pregnancy takes that risk away, but you’ll have to find a state where it’s legal to do that.”

Dr. Park said such a situation, when abortion is recommended but locally unavailable, is much like any other in cardiology for which the patient may want a second opinion. If a center “doesn’t have the capability or the technology to offer a certain treatment, the patient can opt to seek another opinion at another center,” she said. “Patients will often travel out of state to get the care they need.”

A requirement for out-of-state travel to obtain abortions is likely to worsen socioeconomic disparities in health care, Dr. Bond observed, “because we know that those who are low-income won’t be able to afford that travel.”

Dr. Bond is cosignatory on a statement from the Association of Black Cardiologists (ABC) responding to the high court’s ruling in Dobbs v. Jackson. “This decision will isolate the poor, socioeconomically disadvantaged, and minority populations specifically, widening the already large gaps in health care for our most vulnerable communities,” it states.

“The loss of broad protections supporting the medical and often lifesaving procedure of abortions is likely to have a real impact on the maternal mortality rate, especially in those with congenital and/or acquired cardiovascular conditions where evidence-based guidelines advise at times on termination of such high-risk pregnancies.”

The ABC, it states, “believes that every woman, and every person, should be afforded the right to safe, accessible, legal, timely, patient-centered, equitable, and affordable health care.”

The American College of Cardiology (ACC) released a statement on the matter June 24, signed by its president, Edward T.A. Fry, MD, along with five former ACC presidents. “While the ACC has no official policy on abortion, clinical practice guidelines and other clinical guidance tools address the dangers of pregnancy in certain patient populations at higher risk of death or serious cardiac events.”

The college, it states, is “deeply concerned about the potential implications of the Supreme Court decision regarding Roe vs. Wade on the ability of patients and clinicians to engage in important shared discussions about maternal health, or to remove previously available health care options.”

Dr. Bond proposed that a “vocal stance” from medical societies involved in women’s health, “perhaps even a collective stance from our cardiovascular societies and our obstetrics societies,” would also perhaps reach “the masses of doctors in private practice who are dealing with these patients.”

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

Pregnancy termination for medical reasons had been part of the fabric of everyday health care in the United States since the Supreme Court’s 1973 Roe v. Wade decision, which the current high court overturned in a ruling announced on June 24.

That means many clinicians across specialties are entering uncharted territory with the country’s new patchwork of abortion legality. Some specialties, cardiology among them, may feel the impact more than others.

javi_indy/ Thinkstock

“Unfortunately,” Dr. Haythe said, “many of the states that are going to make or have made abortion illegal are not providing that kind of preconception counseling or good prenatal care to women.”

Cardiologists can provide such counseling to their female patients of childbearing age who have high-risk cardiac conditions, “but not everybody knows that they have a heart problem when they get pregnant, and not everybody is getting screened for heart problems when they’re of childbearing age,” Dr. Haythe said.

“Sometimes it’s not clear whether the problems could have been picked up until a woman is pregnant and has started to have symptoms.” For example, “a lot of women with poor access to health care have rheumatic heart disease. They may have no idea that they have severe aortic stenosis, and it’s not until their second trimester that they start to feel really short of breath.” Often that can be treated in the cath lab, “but again, that’s putting the woman and the baby at risk.”

Cardiologists in states where abortion is illegal will still present the option to their patients with high-risk pregnancies, noted Dr. Haythe. But the conversation may sound something like, “you are at very high risk, termination of the pregnancy takes that risk away, but you’ll have to find a state where it’s legal to do that.”

Dr. Park said such a situation, when abortion is recommended but locally unavailable, is much like any other in cardiology for which the patient may want a second opinion. If a center “doesn’t have the capability or the technology to offer a certain treatment, the patient can opt to seek another opinion at another center,” she said. “Patients will often travel out of state to get the care they need.”

A requirement for out-of-state travel to obtain abortions is likely to worsen socioeconomic disparities in health care, Dr. Bond observed, “because we know that those who are low-income won’t be able to afford that travel.”

Dr. Bond is cosignatory on a statement from the Association of Black Cardiologists (ABC) responding to the high court’s ruling in Dobbs v. Jackson. “This decision will isolate the poor, socioeconomically disadvantaged, and minority populations specifically, widening the already large gaps in health care for our most vulnerable communities,” it states.

“The loss of broad protections supporting the medical and often lifesaving procedure of abortions is likely to have a real impact on the maternal mortality rate, especially in those with congenital and/or acquired cardiovascular conditions where evidence-based guidelines advise at times on termination of such high-risk pregnancies.”

The ABC, it states, “believes that every woman, and every person, should be afforded the right to safe, accessible, legal, timely, patient-centered, equitable, and affordable health care.”

The American College of Cardiology (ACC) released a statement on the matter June 24, signed by its president, Edward T.A. Fry, MD, along with five former ACC presidents. “While the ACC has no official policy on abortion, clinical practice guidelines and other clinical guidance tools address the dangers of pregnancy in certain patient populations at higher risk of death or serious cardiac events.”

The college, it states, is “deeply concerned about the potential implications of the Supreme Court decision regarding Roe vs. Wade on the ability of patients and clinicians to engage in important shared discussions about maternal health, or to remove previously available health care options.”

Dr. Bond proposed that a “vocal stance” from medical societies involved in women’s health, “perhaps even a collective stance from our cardiovascular societies and our obstetrics societies,” would also perhaps reach “the masses of doctors in private practice who are dealing with these patients.”

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

Dr George Grunberger, of Wayne State University School of Medicine in Detroit, Michigan, discusses key takeaways on the use of insulin in adults with type 2 diabetes from the 2022 American Diabetes Association Scientific Sessions, held June 3-7 in New Orleans, Louisiana. 

Dr Grunberger highlights presentations that address three challenges among insulin users: cost, hypoglycemia, and the high treatment burden of daily injections. 

On cost, Dr Grunberger reports on a study of Basaglar, a follow-on biologic approved to reference Lantus insulin. After 1 year, Basaglar demonstrated comparable A1c lowering and adverse events, higher adherence, and lower cost. 

Next, on hypoglycemia, Dr Grunberger cites the GRADE trial, which examined adding insulin glargine or the sulfonylurea glimepiride to patients taking metformin. The incidence of severe hypoglycemia proved to be lower in the insulin glargine group. 

Finally, Dr Grunberger reported on studies that explored progress in the development of weekly insulin, with an eye toward decreasing treatment burden. 

--

George Grunberger, MD, Chairman, Grunberger Diabetes Institute, Bloomfield Hills; Clinical Professor, Department of Internal Medicine and Molecular Medicine & Genetics, Wayne State University School of Medicine, Detroit, Michigan; Professor, Department of Internal Medicine, Oakland University William Beaumont School of Medicine, Rochester, Michigan 

George Grunberger, MD, has disclosed the following relevant financial relationships:  

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Nevro; Lifescan  

Serve(d) as a speaker or a member of a speakers bureau for: Eli Lilly; Novo Nordisk 

Dr George Grunberger, of Wayne State University School of Medicine in Detroit, Michigan, discusses key takeaways on the use of insulin in adults with type 2 diabetes from the 2022 American Diabetes Association Scientific Sessions, held June 3-7 in New Orleans, Louisiana. 

Dr Grunberger highlights presentations that address three challenges among insulin users: cost, hypoglycemia, and the high treatment burden of daily injections. 

On cost, Dr Grunberger reports on a study of Basaglar, a follow-on biologic approved to reference Lantus insulin. After 1 year, Basaglar demonstrated comparable A1c lowering and adverse events, higher adherence, and lower cost. 

Next, on hypoglycemia, Dr Grunberger cites the GRADE trial, which examined adding insulin glargine or the sulfonylurea glimepiride to patients taking metformin. The incidence of severe hypoglycemia proved to be lower in the insulin glargine group. 

Finally, Dr Grunberger reported on studies that explored progress in the development of weekly insulin, with an eye toward decreasing treatment burden. 

--

George Grunberger, MD, Chairman, Grunberger Diabetes Institute, Bloomfield Hills; Clinical Professor, Department of Internal Medicine and Molecular Medicine & Genetics, Wayne State University School of Medicine, Detroit, Michigan; Professor, Department of Internal Medicine, Oakland University William Beaumont School of Medicine, Rochester, Michigan 

George Grunberger, MD, has disclosed the following relevant financial relationships:  

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Nevro; Lifescan  

Serve(d) as a speaker or a member of a speakers bureau for: Eli Lilly; Novo Nordisk 

Dr George Grunberger, of Wayne State University School of Medicine in Detroit, Michigan, discusses key takeaways on the use of insulin in adults with type 2 diabetes from the 2022 American Diabetes Association Scientific Sessions, held June 3-7 in New Orleans, Louisiana. 

Dr Grunberger highlights presentations that address three challenges among insulin users: cost, hypoglycemia, and the high treatment burden of daily injections. 

On cost, Dr Grunberger reports on a study of Basaglar, a follow-on biologic approved to reference Lantus insulin. After 1 year, Basaglar demonstrated comparable A1c lowering and adverse events, higher adherence, and lower cost. 

Next, on hypoglycemia, Dr Grunberger cites the GRADE trial, which examined adding insulin glargine or the sulfonylurea glimepiride to patients taking metformin. The incidence of severe hypoglycemia proved to be lower in the insulin glargine group. 

Finally, Dr Grunberger reported on studies that explored progress in the development of weekly insulin, with an eye toward decreasing treatment burden. 

--

George Grunberger, MD, Chairman, Grunberger Diabetes Institute, Bloomfield Hills; Clinical Professor, Department of Internal Medicine and Molecular Medicine & Genetics, Wayne State University School of Medicine, Detroit, Michigan; Professor, Department of Internal Medicine, Oakland University William Beaumont School of Medicine, Rochester, Michigan 

George Grunberger, MD, has disclosed the following relevant financial relationships:  

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Nevro; Lifescan  

Serve(d) as a speaker or a member of a speakers bureau for: Eli Lilly; Novo Nordisk 

New guidelines and key studies in glycemic control from the 2022 annual meeting of the American Diabetes Association (ADA) are highlighted by Dr Ildiko Lingvay, from the University of Texas Southwestern Medical Center.  

Dr Lingvay opens by reporting on forthcoming guidelines by the ADA in joint partnership with the European Association for the Study of Diabetes (EASD) on the treatment of hyperglycemia in type 2 diabetes. This consensus paper, she says, will endorse a holistic, person-centered approach to managing type 2 diabetes. The finalized paper will be presented at the EASD annual meeting in Stockholm in September 2022. Next, Dr Lingvay discusses the yearly update to the ADA Standards of Medical Care in Diabetes, which include the benefits of finerenone, the benefits of SGLT2 inhibitors on heart failure and renal outcomes, and the endorsement of the updated eGFR calculator, which omits patient race from calculations.   

She then looks at the SURMOUNT-1 study, a phase 3 trial investigating tirzepatide, a dual GLP/GLP-1 receptor agonist, for the treatment of obesity. In addition to a demonstration of substantial weight loss, the study indicated that tirzepatide provided impressive glucose-lowering benefit. 

Dr Lingvay also examines post hoc data from the STEP 1 and 4 trials showing that semaglutide, compared with placebo, reduced the risk for type 2 diabetes in patients with obesity by approximately 60%, regardless of their baseline glycemic status.  

Finally, Dr Lingvay discusses a novel triple GIP, GLP-1, and glucagon receptor agonist called LY3437943, currently in phase 1 trials, which demonstrated promising glycemic and body weight lowering efficacy after a short 12-week trial.  

--

Ildiko Lingvay, MD, MPH, Professor, Department of Internal Medicine, Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, Texas 

Ildiko Lingvay, MD, MPH, has disclosed the following relevant financial relationships: 

Received income in an amount equal to or greater than $250 from: NovoNordisk; Sanofi; Eli Lilly; AstraZeneca; Target Pharma; Boehringer Ingelheim; Intercept; Merck; Janssen; Intarcia; Merck  

Received research grant from: NovoNordisk; Mylan; Sanofi; Merck; Pfizer; Boehringer Ingelheim 

New guidelines and key studies in glycemic control from the 2022 annual meeting of the American Diabetes Association (ADA) are highlighted by Dr Ildiko Lingvay, from the University of Texas Southwestern Medical Center.  

Dr Lingvay opens by reporting on forthcoming guidelines by the ADA in joint partnership with the European Association for the Study of Diabetes (EASD) on the treatment of hyperglycemia in type 2 diabetes. This consensus paper, she says, will endorse a holistic, person-centered approach to managing type 2 diabetes. The finalized paper will be presented at the EASD annual meeting in Stockholm in September 2022. Next, Dr Lingvay discusses the yearly update to the ADA Standards of Medical Care in Diabetes, which include the benefits of finerenone, the benefits of SGLT2 inhibitors on heart failure and renal outcomes, and the endorsement of the updated eGFR calculator, which omits patient race from calculations.   

She then looks at the SURMOUNT-1 study, a phase 3 trial investigating tirzepatide, a dual GLP/GLP-1 receptor agonist, for the treatment of obesity. In addition to a demonstration of substantial weight loss, the study indicated that tirzepatide provided impressive glucose-lowering benefit. 

Dr Lingvay also examines post hoc data from the STEP 1 and 4 trials showing that semaglutide, compared with placebo, reduced the risk for type 2 diabetes in patients with obesity by approximately 60%, regardless of their baseline glycemic status.  

Finally, Dr Lingvay discusses a novel triple GIP, GLP-1, and glucagon receptor agonist called LY3437943, currently in phase 1 trials, which demonstrated promising glycemic and body weight lowering efficacy after a short 12-week trial.  

--

Ildiko Lingvay, MD, MPH, Professor, Department of Internal Medicine, Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, Texas 

Ildiko Lingvay, MD, MPH, has disclosed the following relevant financial relationships: 

Received income in an amount equal to or greater than $250 from: NovoNordisk; Sanofi; Eli Lilly; AstraZeneca; Target Pharma; Boehringer Ingelheim; Intercept; Merck; Janssen; Intarcia; Merck  

Received research grant from: NovoNordisk; Mylan; Sanofi; Merck; Pfizer; Boehringer Ingelheim 

New guidelines and key studies in glycemic control from the 2022 annual meeting of the American Diabetes Association (ADA) are highlighted by Dr Ildiko Lingvay, from the University of Texas Southwestern Medical Center.  

Dr Lingvay opens by reporting on forthcoming guidelines by the ADA in joint partnership with the European Association for the Study of Diabetes (EASD) on the treatment of hyperglycemia in type 2 diabetes. This consensus paper, she says, will endorse a holistic, person-centered approach to managing type 2 diabetes. The finalized paper will be presented at the EASD annual meeting in Stockholm in September 2022. Next, Dr Lingvay discusses the yearly update to the ADA Standards of Medical Care in Diabetes, which include the benefits of finerenone, the benefits of SGLT2 inhibitors on heart failure and renal outcomes, and the endorsement of the updated eGFR calculator, which omits patient race from calculations.   

She then looks at the SURMOUNT-1 study, a phase 3 trial investigating tirzepatide, a dual GLP/GLP-1 receptor agonist, for the treatment of obesity. In addition to a demonstration of substantial weight loss, the study indicated that tirzepatide provided impressive glucose-lowering benefit. 

Dr Lingvay also examines post hoc data from the STEP 1 and 4 trials showing that semaglutide, compared with placebo, reduced the risk for type 2 diabetes in patients with obesity by approximately 60%, regardless of their baseline glycemic status.  

Finally, Dr Lingvay discusses a novel triple GIP, GLP-1, and glucagon receptor agonist called LY3437943, currently in phase 1 trials, which demonstrated promising glycemic and body weight lowering efficacy after a short 12-week trial.  

--

Ildiko Lingvay, MD, MPH, Professor, Department of Internal Medicine, Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, Texas 

Ildiko Lingvay, MD, MPH, has disclosed the following relevant financial relationships: 

Received income in an amount equal to or greater than $250 from: NovoNordisk; Sanofi; Eli Lilly; AstraZeneca; Target Pharma; Boehringer Ingelheim; Intercept; Merck; Janssen; Intarcia; Merck  

Received research grant from: NovoNordisk; Mylan; Sanofi; Merck; Pfizer; Boehringer Ingelheim 

Dr Anastassios Pittas, Chief of Endocrinology at Tufts Medical Center in Boston, discusses key data from the American Diabetes Association Scientific Sessions 2022 on the management of common comorbidities in diabetes. 

Dr Pittas looks first at a prespecified analysis of the SURPASS-4 trial, which highlighted the role of tirzepatide on kidney outcomes in patients with type 2 diabetes. 

He then discusses results of the SPLENDID trial in which patients with diabetes who received bariatric surgery for weight loss showed reduced rates of cancer.  

Finally, Dr Pittas reports on a study examining the effect of food insecurity and diet quality on maintaining good cholesterol levels in diabetes.

--

Anastassios G. Pittas, MD, Chief, Division of Endocrinology, Diabetes, and Metabolism; Co-director, Diabetes and Lipid Center; Professor of Medicine, Tufts University School of Medicine, Boston, Massachusetts 

Anastassios G. Pittas, MD, has disclosed no relevant financial relationships. 

Dr Anastassios Pittas, Chief of Endocrinology at Tufts Medical Center in Boston, discusses key data from the American Diabetes Association Scientific Sessions 2022 on the management of common comorbidities in diabetes. 

Dr Pittas looks first at a prespecified analysis of the SURPASS-4 trial, which highlighted the role of tirzepatide on kidney outcomes in patients with type 2 diabetes. 

He then discusses results of the SPLENDID trial in which patients with diabetes who received bariatric surgery for weight loss showed reduced rates of cancer.  

Finally, Dr Pittas reports on a study examining the effect of food insecurity and diet quality on maintaining good cholesterol levels in diabetes.

--

Anastassios G. Pittas, MD, Chief, Division of Endocrinology, Diabetes, and Metabolism; Co-director, Diabetes and Lipid Center; Professor of Medicine, Tufts University School of Medicine, Boston, Massachusetts 

Anastassios G. Pittas, MD, has disclosed no relevant financial relationships. 

Dr Anastassios Pittas, Chief of Endocrinology at Tufts Medical Center in Boston, discusses key data from the American Diabetes Association Scientific Sessions 2022 on the management of common comorbidities in diabetes. 

Dr Pittas looks first at a prespecified analysis of the SURPASS-4 trial, which highlighted the role of tirzepatide on kidney outcomes in patients with type 2 diabetes. 

He then discusses results of the SPLENDID trial in which patients with diabetes who received bariatric surgery for weight loss showed reduced rates of cancer.  

Finally, Dr Pittas reports on a study examining the effect of food insecurity and diet quality on maintaining good cholesterol levels in diabetes.

--

Anastassios G. Pittas, MD, Chief, Division of Endocrinology, Diabetes, and Metabolism; Co-director, Diabetes and Lipid Center; Professor of Medicine, Tufts University School of Medicine, Boston, Massachusetts 

Anastassios G. Pittas, MD, has disclosed no relevant financial relationships. 

Racial residential segregation was significantly associated with poor glycemic control in Black adolescents with type 1 diabetes, according to data from 144 individuals.

Racial residential segregation is considered a form of systemic racism that involves limited access to resources, including health care resources, Deborah A. Ellis, MD, of Wayne State University, Detroit, and colleagues wrote in a poster presented at the annual meeting of the American Diabetes Association.

In the study, the researchers recruited youth aged 10-15 years with type 1 diabetes from seven pediatric clinics in two large U.S. cities. The mean age of the participants was 13.3 years, and the mean hemoglobin A1c was 11.5%.

Diabetes management was based on self-reports using the Diabetes Management Scale (DMS). Racial residential segregation, which refers to the separation of groups within a geographic area, was determined using data from the U.S. Census using Location Quotient (LQ) at the block group level; this showed the ratio of the Black population to the total population, compared with the same ratio in the metropolitan area.

The mean family income was $34,163, and the mean LQ was 3.04, “indicating residence in highly segregated neighborhoods,” the researchers wrote.

Overall, racial residential segregation was significantly associated with A1c (P = .001) but not with DMS (P = .311). The researchers also conducted a stepwise multiple regression analysis including age, insulin delivery method, neighborhood adversity (a 9-item composite with variables including percentage of persons living in poverty, percentage of households with no vehicle), and family income. They found that only age, insulin delivery method, and racial residential segregation had significant impacts of A1c levels.

The study was limited by several factors, including the use of self-reports.

However, the results are consistent with previous studies showing the potential negative health effects of structural racism, the researchers wrote. The findings suggest that racial residential segregation has an independent effect on glycemic control in Black youth with type 1 diabetes, and consequently, “advocacy and policy making to address such inequities could improve diabetes population health.”
 

Location makes a difference

“Poor neighborhoods have been associated with high rates of obesity, hypertension, type 2 diabetes and high cholesterol,” Romesh K. Khardori, MD, professor of medicine at Eastern Virginia Medical School, Norfolk, said in an interview. However, “not much is known about impact of racial segregation on type 1 diabetes,” said Dr. Khardori, who was not involved in the study.

Dr. Khardori was not surprised by the current study findings. “In our practice, Black youth coming from racially segregated or low-income housing projects often tend have poor diabetes control, with repeated admissions to local hospitals for managing acute/chronic complications of type 1 diabetes,” he said.

The current findings reflect Dr. Khardori’s clinical experience and highlight the need for clinicians to recognize the increased risk for poor glycemic control and poor outcomes in this vulnerable population.

More research is needed to expand the observations of the current study, Dr. Khardori said. Future researchers also should “involve community leaders and politicians to educate and garner more support for mitigation efforts.”

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Ellis and Dr. Khardori had no financial conflicts to disclose.

Racial residential segregation was significantly associated with poor glycemic control in Black adolescents with type 1 diabetes, according to data from 144 individuals.

Racial residential segregation is considered a form of systemic racism that involves limited access to resources, including health care resources, Deborah A. Ellis, MD, of Wayne State University, Detroit, and colleagues wrote in a poster presented at the annual meeting of the American Diabetes Association.

In the study, the researchers recruited youth aged 10-15 years with type 1 diabetes from seven pediatric clinics in two large U.S. cities. The mean age of the participants was 13.3 years, and the mean hemoglobin A1c was 11.5%.

Diabetes management was based on self-reports using the Diabetes Management Scale (DMS). Racial residential segregation, which refers to the separation of groups within a geographic area, was determined using data from the U.S. Census using Location Quotient (LQ) at the block group level; this showed the ratio of the Black population to the total population, compared with the same ratio in the metropolitan area.

The mean family income was $34,163, and the mean LQ was 3.04, “indicating residence in highly segregated neighborhoods,” the researchers wrote.

Overall, racial residential segregation was significantly associated with A1c (P = .001) but not with DMS (P = .311). The researchers also conducted a stepwise multiple regression analysis including age, insulin delivery method, neighborhood adversity (a 9-item composite with variables including percentage of persons living in poverty, percentage of households with no vehicle), and family income. They found that only age, insulin delivery method, and racial residential segregation had significant impacts of A1c levels.

The study was limited by several factors, including the use of self-reports.

However, the results are consistent with previous studies showing the potential negative health effects of structural racism, the researchers wrote. The findings suggest that racial residential segregation has an independent effect on glycemic control in Black youth with type 1 diabetes, and consequently, “advocacy and policy making to address such inequities could improve diabetes population health.”
 

Location makes a difference

“Poor neighborhoods have been associated with high rates of obesity, hypertension, type 2 diabetes and high cholesterol,” Romesh K. Khardori, MD, professor of medicine at Eastern Virginia Medical School, Norfolk, said in an interview. However, “not much is known about impact of racial segregation on type 1 diabetes,” said Dr. Khardori, who was not involved in the study.

Dr. Khardori was not surprised by the current study findings. “In our practice, Black youth coming from racially segregated or low-income housing projects often tend have poor diabetes control, with repeated admissions to local hospitals for managing acute/chronic complications of type 1 diabetes,” he said.

The current findings reflect Dr. Khardori’s clinical experience and highlight the need for clinicians to recognize the increased risk for poor glycemic control and poor outcomes in this vulnerable population.

More research is needed to expand the observations of the current study, Dr. Khardori said. Future researchers also should “involve community leaders and politicians to educate and garner more support for mitigation efforts.”

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Ellis and Dr. Khardori had no financial conflicts to disclose.

Racial residential segregation was significantly associated with poor glycemic control in Black adolescents with type 1 diabetes, according to data from 144 individuals.

Racial residential segregation is considered a form of systemic racism that involves limited access to resources, including health care resources, Deborah A. Ellis, MD, of Wayne State University, Detroit, and colleagues wrote in a poster presented at the annual meeting of the American Diabetes Association.

In the study, the researchers recruited youth aged 10-15 years with type 1 diabetes from seven pediatric clinics in two large U.S. cities. The mean age of the participants was 13.3 years, and the mean hemoglobin A1c was 11.5%.

Diabetes management was based on self-reports using the Diabetes Management Scale (DMS). Racial residential segregation, which refers to the separation of groups within a geographic area, was determined using data from the U.S. Census using Location Quotient (LQ) at the block group level; this showed the ratio of the Black population to the total population, compared with the same ratio in the metropolitan area.

The mean family income was $34,163, and the mean LQ was 3.04, “indicating residence in highly segregated neighborhoods,” the researchers wrote.

Overall, racial residential segregation was significantly associated with A1c (P = .001) but not with DMS (P = .311). The researchers also conducted a stepwise multiple regression analysis including age, insulin delivery method, neighborhood adversity (a 9-item composite with variables including percentage of persons living in poverty, percentage of households with no vehicle), and family income. They found that only age, insulin delivery method, and racial residential segregation had significant impacts of A1c levels.

The study was limited by several factors, including the use of self-reports.

However, the results are consistent with previous studies showing the potential negative health effects of structural racism, the researchers wrote. The findings suggest that racial residential segregation has an independent effect on glycemic control in Black youth with type 1 diabetes, and consequently, “advocacy and policy making to address such inequities could improve diabetes population health.”
 

Location makes a difference

“Poor neighborhoods have been associated with high rates of obesity, hypertension, type 2 diabetes and high cholesterol,” Romesh K. Khardori, MD, professor of medicine at Eastern Virginia Medical School, Norfolk, said in an interview. However, “not much is known about impact of racial segregation on type 1 diabetes,” said Dr. Khardori, who was not involved in the study.

Dr. Khardori was not surprised by the current study findings. “In our practice, Black youth coming from racially segregated or low-income housing projects often tend have poor diabetes control, with repeated admissions to local hospitals for managing acute/chronic complications of type 1 diabetes,” he said.

The current findings reflect Dr. Khardori’s clinical experience and highlight the need for clinicians to recognize the increased risk for poor glycemic control and poor outcomes in this vulnerable population.

More research is needed to expand the observations of the current study, Dr. Khardori said. Future researchers also should “involve community leaders and politicians to educate and garner more support for mitigation efforts.”

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Ellis and Dr. Khardori had no financial conflicts to disclose.

New data and a new documentary called “The Human Trial” together illuminate the hard work, sacrifice, and slow, iterative progress in the long search for a biological cure for type 1 diabetes.

Opening in select theaters on June 24, the film was written by Los Angeles filmmaker Lisa Hepner, who has type 1 diabetes, and codirected by Ms. Hepner and her husband Guy Mossman, who also filmed it. The couple co-own a film production company.

Abramorama

“The Human Trial” follows the personal journeys of two of the first participants in ViaCyte’s early phase 2 trial of stem cell–derived islet cell transplants, as well as those of the investigators and Ms. Hepner herself, who narrates and appears in the film, interweaving her own experience with type 1 diabetes while acting as a “bridge” between the trial’s participants and scientists. The film spans 7 years of the trial.

The timing of the film’s opening happens to follow presentations at two major medical meetings in early June of more recent islet cell transplantation data from ViaCyte and two other companies, Sernova and Vertex. Each is taking a different practical approach, with the most effective and safe technique yet to be determined.

But all are pursuing the same goal: A biological “cure” for type 1 diabetes with the aim of restoring fully functioning islet cells that can produce insulin and keep blood sugar levels in target range. Ultimately, the hope is to eliminate the need for both exogenous insulin and immunosuppression for all people with type 1 diabetes.

“Cell therapy is an attempt to drastically and substantially change the paradigm of how we actually treat type 1 diabetes,” Manasi S. Jaiman, MD, pediatric endocrinologist and chief medical officer at ViaCyte, said during a presentation at the annual meeting of the Endocrine Society.

Transplantation of cadaver-derived pancreatic islet cells to treat type 1 diabetes dates back more than 20 years to the landmark Edmonton Protocol, with many refinements since. About 1,500 recipients have received them, and roughly a quarter has maintained insulin independence after 10 years, Dr. Jaiman said.

More recently, islets derived from stem cells – either embryonic or autologous – have been used to address the supply and quality problems that arise from cadaveric (dead) donors.

Still, though, the need for lifelong immune suppression means the only current recipients are people with type 1 diabetes for whom the risk of diabetes outweighs that of immune suppression, such as those with hypoglycemic unawareness or extreme glucose swings.

Abramorama

Many research efforts are underway to counter the need for immune suppression by a variety of techniques including cell encapsulation or gene modification.

While the data thus far are encouraging, most of the reports align with what Ms. Hepner says in the film: “We all want stories with a beginning, middle, and end where all the loose pieces fit together. But clinical research is messy and hard. It doesn’t fit into a tidy headline, no matter how much you want it to.”
 

Companies use different approaches for transplanting islets

At ENDO 2022, Dr. Jaiman presented results for three patients who received pancreatic precursor (PEC-01) cells derived from ViaCyte’s proprietary pluripotent stem cell line. The cells are housed in an open delivery device about the size of a standard bandage to allow direct vascularization and are implanted in a patient’s forearm. An earlier version of the device was used in the two patients in “The Human Trial.”

All three patients experienced improved blood glucose levels with lower daily insulin doses and a rise from undetectable C-peptide to levels above 0.3 ng/mL. Of the three, the best results were seen in a 52-year-old woman with type 1 diabetes for 36 years complicated by hypoglycemic unawareness. At 1-year post transplant, her hemoglobin A1c dropped from 7.4% to 6.9%, and time in range [of ideal blood glucose] from 55% to 94%, plus she had a reduction in daily exogenous insulin use of 70%. However, at 18 months her time-in-range had dropped to about 75%.

“We are watching very closely to see what this means,” Dr. Jaiman said.

Further optimization of the approach is planned. “We’re still waiting on the bulk of the data and analyzing it ... We do realize this is a journey but we’re very excited by where we are,” she enthused.

In February 2022, ViaCyte announced it had teamed up with CRISPR Therapeutics to develop an allogeneic, gene-edited stem cell-derived product designed to produce insulin while at the same time evading the immune system.

Preliminary data from another company, Sernova, using a pouch device were presented at the 2022 annual scientific sessions of the American Diabetes Association by Piotr J. Bachul, MD, of the Transplantation Institute at the University of Chicago.

The Sernova Cell Pouch System containing cadaver islets was successfully transplanted into the abdominal wall of six of seven patients. After waiting a month to allow for vascularization, the cells are then placed into the pouch (as opposed to ViaCyte’s method where they are implanted together). The first three patients achieved islet cell graft function – with positive C-peptide – for up to 1 year, although all also required supplemental transplants into the portal vein to achieve insulin independence.

In May 2022, Sernova announced a partnership with Evotec to develop a product that will combine induced pluripotent stem cell (iPSC)-based beta cells for use with the Cell Pouch System.

Clinical testing is scheduled to begin in 2024, a Sernova representative told this news organization.

And as reported earlier in June, findings from Vertex Pharmaceuticals showed success in two patients who received that company›s investigational allogeneic stem-cell derived islets (VX-880), with the first person completely insulin independent 9 months post transplant.

In contrast to the other two companies, Vertex’s approach is to transplant the cells directly to the hepatic portal vein rather than into a subcutaneous pouch.

“The only space that has ever worked efficiently for islets is the liver because they immediately get blood. ... The subcutaneous space is an interesting place, but the problem is it’s not very well vascularized,” James F. Markmann, MD, PhD, chief of the division of transplant surgery at Massachusetts General Hospital, Boston, who worked on the Vertex trials, told this news organization.

However, the Sernova representative countered: “With the Cell Pouch transplant, not only can surgeons avoid the risks associated with [hepatic] portal vein infusion – including immediate blood-mediated inflammatory reaction, which is known to kill a large proportion of infused islets – but also liver pathologies.”

Furthermore, the cells remaining in the pouch “may be entirely removed from the patient in the event of a subsequently detected cell quality issue,” which isn’t possible with cells delivered into the portal vein.

“I think it will be interesting how it plays out,” Dr. Markmann said, referring to the field as a whole.

‘The Human Trial’ spotlights the real people behind the data

“The Human Trial” ties together the lives of two young adult study participants: a mother named Maren Badger, who qualified for the study because she regularly experienced severe low blood sugar accompanied by seizures, and Greg Romero, a father who has sight-threatening diabetic retinopathy and other complications, as well as financial hardship.

The film chronicles their experiences over 7 years after receiving the transplant. It’s not easy for either of them to undergo all the implantation and explantation procedures as well as cope with the uncertainty as to whether the transplanted cells are working.

At the same time, the researchers’ emotional and sometimes frustrating journey is shown, as are scenes following company executives to Saudi Arabia and Japan in their pursuit of trial funding.

Ms. Hepner herself is featured pursuing the film’s storyline by frequently questioning company executives, in person and virtually, as well as telling her own story.

A visit to the Banting House Historic Site in London, Ontario, with her young son gives Ms. Hepner the opportunity to explain that after Canadian surgeon Frederick Banting discovered insulin, he sold the patent to the University of Toronto for one dollar.

“One hundred years ago, insulin wasn’t a business. It was a medical breakthrough that saved millions of lives. When Banting accepted his Nobel [Prize], he famously said: ‘Insulin doesn’t belong to me, it belongs to the world.’ ... Now, there’s a $245 billion industry designed to manage our disease,” Ms. Hepner says in the film.

But, she adds: “There’s a catch-22: Biotech needs big pharma’s profits to fund clinical trials. Without that support the researchers wouldn’t have gotten this far. Like most relationships, it’s complicated.”

Nonetheless, the film ultimately uplifts. As one company executive says: “Data show the product is producing insulin in patients for the first time. ... This is a big deal. We know now that the cells work.

“We didn’t know that 5 years ago. All the pieces are there, it’s just a matter of completing the puzzle.”

The ViaCyte work presented by Dr. Jaiman received funding from the European Commission Horizon 2020, the California Institute for Regenerative Medicine, and the JDRF. Jaiman is an employee of ViaCyte. The Sernova work was funded by Sernova and JDRF. Dr. Markmann has reported serving on advisory boards for iTolerance, eGenesis, and Qihan Biotech, and being a consultant for Vertex Pharmaceuticals. Ms. Hepner and Mr. Mossman run LA-based Vox Pop Films, a production company specializing in nonfiction content and commercials. “The Human Trial” was made in collaboration with the nonprofit Beyond Type 1.

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

New data and a new documentary called “The Human Trial” together illuminate the hard work, sacrifice, and slow, iterative progress in the long search for a biological cure for type 1 diabetes.

Opening in select theaters on June 24, the film was written by Los Angeles filmmaker Lisa Hepner, who has type 1 diabetes, and codirected by Ms. Hepner and her husband Guy Mossman, who also filmed it. The couple co-own a film production company.

Abramorama

“The Human Trial” follows the personal journeys of two of the first participants in ViaCyte’s early phase 2 trial of stem cell–derived islet cell transplants, as well as those of the investigators and Ms. Hepner herself, who narrates and appears in the film, interweaving her own experience with type 1 diabetes while acting as a “bridge” between the trial’s participants and scientists. The film spans 7 years of the trial.

The timing of the film’s opening happens to follow presentations at two major medical meetings in early June of more recent islet cell transplantation data from ViaCyte and two other companies, Sernova and Vertex. Each is taking a different practical approach, with the most effective and safe technique yet to be determined.

But all are pursuing the same goal: A biological “cure” for type 1 diabetes with the aim of restoring fully functioning islet cells that can produce insulin and keep blood sugar levels in target range. Ultimately, the hope is to eliminate the need for both exogenous insulin and immunosuppression for all people with type 1 diabetes.

“Cell therapy is an attempt to drastically and substantially change the paradigm of how we actually treat type 1 diabetes,” Manasi S. Jaiman, MD, pediatric endocrinologist and chief medical officer at ViaCyte, said during a presentation at the annual meeting of the Endocrine Society.

Transplantation of cadaver-derived pancreatic islet cells to treat type 1 diabetes dates back more than 20 years to the landmark Edmonton Protocol, with many refinements since. About 1,500 recipients have received them, and roughly a quarter has maintained insulin independence after 10 years, Dr. Jaiman said.

More recently, islets derived from stem cells – either embryonic or autologous – have been used to address the supply and quality problems that arise from cadaveric (dead) donors.

Still, though, the need for lifelong immune suppression means the only current recipients are people with type 1 diabetes for whom the risk of diabetes outweighs that of immune suppression, such as those with hypoglycemic unawareness or extreme glucose swings.

Abramorama

Many research efforts are underway to counter the need for immune suppression by a variety of techniques including cell encapsulation or gene modification.

While the data thus far are encouraging, most of the reports align with what Ms. Hepner says in the film: “We all want stories with a beginning, middle, and end where all the loose pieces fit together. But clinical research is messy and hard. It doesn’t fit into a tidy headline, no matter how much you want it to.”
 

Companies use different approaches for transplanting islets

At ENDO 2022, Dr. Jaiman presented results for three patients who received pancreatic precursor (PEC-01) cells derived from ViaCyte’s proprietary pluripotent stem cell line. The cells are housed in an open delivery device about the size of a standard bandage to allow direct vascularization and are implanted in a patient’s forearm. An earlier version of the device was used in the two patients in “The Human Trial.”

All three patients experienced improved blood glucose levels with lower daily insulin doses and a rise from undetectable C-peptide to levels above 0.3 ng/mL. Of the three, the best results were seen in a 52-year-old woman with type 1 diabetes for 36 years complicated by hypoglycemic unawareness. At 1-year post transplant, her hemoglobin A1c dropped from 7.4% to 6.9%, and time in range [of ideal blood glucose] from 55% to 94%, plus she had a reduction in daily exogenous insulin use of 70%. However, at 18 months her time-in-range had dropped to about 75%.

“We are watching very closely to see what this means,” Dr. Jaiman said.

Further optimization of the approach is planned. “We’re still waiting on the bulk of the data and analyzing it ... We do realize this is a journey but we’re very excited by where we are,” she enthused.

In February 2022, ViaCyte announced it had teamed up with CRISPR Therapeutics to develop an allogeneic, gene-edited stem cell-derived product designed to produce insulin while at the same time evading the immune system.

Preliminary data from another company, Sernova, using a pouch device were presented at the 2022 annual scientific sessions of the American Diabetes Association by Piotr J. Bachul, MD, of the Transplantation Institute at the University of Chicago.

The Sernova Cell Pouch System containing cadaver islets was successfully transplanted into the abdominal wall of six of seven patients. After waiting a month to allow for vascularization, the cells are then placed into the pouch (as opposed to ViaCyte’s method where they are implanted together). The first three patients achieved islet cell graft function – with positive C-peptide – for up to 1 year, although all also required supplemental transplants into the portal vein to achieve insulin independence.

In May 2022, Sernova announced a partnership with Evotec to develop a product that will combine induced pluripotent stem cell (iPSC)-based beta cells for use with the Cell Pouch System.

Clinical testing is scheduled to begin in 2024, a Sernova representative told this news organization.

And as reported earlier in June, findings from Vertex Pharmaceuticals showed success in two patients who received that company›s investigational allogeneic stem-cell derived islets (VX-880), with the first person completely insulin independent 9 months post transplant.

In contrast to the other two companies, Vertex’s approach is to transplant the cells directly to the hepatic portal vein rather than into a subcutaneous pouch.

“The only space that has ever worked efficiently for islets is the liver because they immediately get blood. ... The subcutaneous space is an interesting place, but the problem is it’s not very well vascularized,” James F. Markmann, MD, PhD, chief of the division of transplant surgery at Massachusetts General Hospital, Boston, who worked on the Vertex trials, told this news organization.

However, the Sernova representative countered: “With the Cell Pouch transplant, not only can surgeons avoid the risks associated with [hepatic] portal vein infusion – including immediate blood-mediated inflammatory reaction, which is known to kill a large proportion of infused islets – but also liver pathologies.”

Furthermore, the cells remaining in the pouch “may be entirely removed from the patient in the event of a subsequently detected cell quality issue,” which isn’t possible with cells delivered into the portal vein.

“I think it will be interesting how it plays out,” Dr. Markmann said, referring to the field as a whole.

‘The Human Trial’ spotlights the real people behind the data

“The Human Trial” ties together the lives of two young adult study participants: a mother named Maren Badger, who qualified for the study because she regularly experienced severe low blood sugar accompanied by seizures, and Greg Romero, a father who has sight-threatening diabetic retinopathy and other complications, as well as financial hardship.

The film chronicles their experiences over 7 years after receiving the transplant. It’s not easy for either of them to undergo all the implantation and explantation procedures as well as cope with the uncertainty as to whether the transplanted cells are working.

At the same time, the researchers’ emotional and sometimes frustrating journey is shown, as are scenes following company executives to Saudi Arabia and Japan in their pursuit of trial funding.

Ms. Hepner herself is featured pursuing the film’s storyline by frequently questioning company executives, in person and virtually, as well as telling her own story.

A visit to the Banting House Historic Site in London, Ontario, with her young son gives Ms. Hepner the opportunity to explain that after Canadian surgeon Frederick Banting discovered insulin, he sold the patent to the University of Toronto for one dollar.

“One hundred years ago, insulin wasn’t a business. It was a medical breakthrough that saved millions of lives. When Banting accepted his Nobel [Prize], he famously said: ‘Insulin doesn’t belong to me, it belongs to the world.’ ... Now, there’s a $245 billion industry designed to manage our disease,” Ms. Hepner says in the film.

But, she adds: “There’s a catch-22: Biotech needs big pharma’s profits to fund clinical trials. Without that support the researchers wouldn’t have gotten this far. Like most relationships, it’s complicated.”

Nonetheless, the film ultimately uplifts. As one company executive says: “Data show the product is producing insulin in patients for the first time. ... This is a big deal. We know now that the cells work.

“We didn’t know that 5 years ago. All the pieces are there, it’s just a matter of completing the puzzle.”

The ViaCyte work presented by Dr. Jaiman received funding from the European Commission Horizon 2020, the California Institute for Regenerative Medicine, and the JDRF. Jaiman is an employee of ViaCyte. The Sernova work was funded by Sernova and JDRF. Dr. Markmann has reported serving on advisory boards for iTolerance, eGenesis, and Qihan Biotech, and being a consultant for Vertex Pharmaceuticals. Ms. Hepner and Mr. Mossman run LA-based Vox Pop Films, a production company specializing in nonfiction content and commercials. “The Human Trial” was made in collaboration with the nonprofit Beyond Type 1.

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

New data and a new documentary called “The Human Trial” together illuminate the hard work, sacrifice, and slow, iterative progress in the long search for a biological cure for type 1 diabetes.

Opening in select theaters on June 24, the film was written by Los Angeles filmmaker Lisa Hepner, who has type 1 diabetes, and codirected by Ms. Hepner and her husband Guy Mossman, who also filmed it. The couple co-own a film production company.

Abramorama

“The Human Trial” follows the personal journeys of two of the first participants in ViaCyte’s early phase 2 trial of stem cell–derived islet cell transplants, as well as those of the investigators and Ms. Hepner herself, who narrates and appears in the film, interweaving her own experience with type 1 diabetes while acting as a “bridge” between the trial’s participants and scientists. The film spans 7 years of the trial.

The timing of the film’s opening happens to follow presentations at two major medical meetings in early June of more recent islet cell transplantation data from ViaCyte and two other companies, Sernova and Vertex. Each is taking a different practical approach, with the most effective and safe technique yet to be determined.

But all are pursuing the same goal: A biological “cure” for type 1 diabetes with the aim of restoring fully functioning islet cells that can produce insulin and keep blood sugar levels in target range. Ultimately, the hope is to eliminate the need for both exogenous insulin and immunosuppression for all people with type 1 diabetes.

“Cell therapy is an attempt to drastically and substantially change the paradigm of how we actually treat type 1 diabetes,” Manasi S. Jaiman, MD, pediatric endocrinologist and chief medical officer at ViaCyte, said during a presentation at the annual meeting of the Endocrine Society.

Transplantation of cadaver-derived pancreatic islet cells to treat type 1 diabetes dates back more than 20 years to the landmark Edmonton Protocol, with many refinements since. About 1,500 recipients have received them, and roughly a quarter has maintained insulin independence after 10 years, Dr. Jaiman said.

More recently, islets derived from stem cells – either embryonic or autologous – have been used to address the supply and quality problems that arise from cadaveric (dead) donors.

Still, though, the need for lifelong immune suppression means the only current recipients are people with type 1 diabetes for whom the risk of diabetes outweighs that of immune suppression, such as those with hypoglycemic unawareness or extreme glucose swings.

Abramorama

Many research efforts are underway to counter the need for immune suppression by a variety of techniques including cell encapsulation or gene modification.

While the data thus far are encouraging, most of the reports align with what Ms. Hepner says in the film: “We all want stories with a beginning, middle, and end where all the loose pieces fit together. But clinical research is messy and hard. It doesn’t fit into a tidy headline, no matter how much you want it to.”
 

Companies use different approaches for transplanting islets

At ENDO 2022, Dr. Jaiman presented results for three patients who received pancreatic precursor (PEC-01) cells derived from ViaCyte’s proprietary pluripotent stem cell line. The cells are housed in an open delivery device about the size of a standard bandage to allow direct vascularization and are implanted in a patient’s forearm. An earlier version of the device was used in the two patients in “The Human Trial.”

All three patients experienced improved blood glucose levels with lower daily insulin doses and a rise from undetectable C-peptide to levels above 0.3 ng/mL. Of the three, the best results were seen in a 52-year-old woman with type 1 diabetes for 36 years complicated by hypoglycemic unawareness. At 1-year post transplant, her hemoglobin A1c dropped from 7.4% to 6.9%, and time in range [of ideal blood glucose] from 55% to 94%, plus she had a reduction in daily exogenous insulin use of 70%. However, at 18 months her time-in-range had dropped to about 75%.

“We are watching very closely to see what this means,” Dr. Jaiman said.

Further optimization of the approach is planned. “We’re still waiting on the bulk of the data and analyzing it ... We do realize this is a journey but we’re very excited by where we are,” she enthused.

In February 2022, ViaCyte announced it had teamed up with CRISPR Therapeutics to develop an allogeneic, gene-edited stem cell-derived product designed to produce insulin while at the same time evading the immune system.

Preliminary data from another company, Sernova, using a pouch device were presented at the 2022 annual scientific sessions of the American Diabetes Association by Piotr J. Bachul, MD, of the Transplantation Institute at the University of Chicago.

The Sernova Cell Pouch System containing cadaver islets was successfully transplanted into the abdominal wall of six of seven patients. After waiting a month to allow for vascularization, the cells are then placed into the pouch (as opposed to ViaCyte’s method where they are implanted together). The first three patients achieved islet cell graft function – with positive C-peptide – for up to 1 year, although all also required supplemental transplants into the portal vein to achieve insulin independence.

In May 2022, Sernova announced a partnership with Evotec to develop a product that will combine induced pluripotent stem cell (iPSC)-based beta cells for use with the Cell Pouch System.

Clinical testing is scheduled to begin in 2024, a Sernova representative told this news organization.

And as reported earlier in June, findings from Vertex Pharmaceuticals showed success in two patients who received that company›s investigational allogeneic stem-cell derived islets (VX-880), with the first person completely insulin independent 9 months post transplant.

In contrast to the other two companies, Vertex’s approach is to transplant the cells directly to the hepatic portal vein rather than into a subcutaneous pouch.

“The only space that has ever worked efficiently for islets is the liver because they immediately get blood. ... The subcutaneous space is an interesting place, but the problem is it’s not very well vascularized,” James F. Markmann, MD, PhD, chief of the division of transplant surgery at Massachusetts General Hospital, Boston, who worked on the Vertex trials, told this news organization.

However, the Sernova representative countered: “With the Cell Pouch transplant, not only can surgeons avoid the risks associated with [hepatic] portal vein infusion – including immediate blood-mediated inflammatory reaction, which is known to kill a large proportion of infused islets – but also liver pathologies.”

Furthermore, the cells remaining in the pouch “may be entirely removed from the patient in the event of a subsequently detected cell quality issue,” which isn’t possible with cells delivered into the portal vein.

“I think it will be interesting how it plays out,” Dr. Markmann said, referring to the field as a whole.

‘The Human Trial’ spotlights the real people behind the data

“The Human Trial” ties together the lives of two young adult study participants: a mother named Maren Badger, who qualified for the study because she regularly experienced severe low blood sugar accompanied by seizures, and Greg Romero, a father who has sight-threatening diabetic retinopathy and other complications, as well as financial hardship.

The film chronicles their experiences over 7 years after receiving the transplant. It’s not easy for either of them to undergo all the implantation and explantation procedures as well as cope with the uncertainty as to whether the transplanted cells are working.

At the same time, the researchers’ emotional and sometimes frustrating journey is shown, as are scenes following company executives to Saudi Arabia and Japan in their pursuit of trial funding.

Ms. Hepner herself is featured pursuing the film’s storyline by frequently questioning company executives, in person and virtually, as well as telling her own story.

A visit to the Banting House Historic Site in London, Ontario, with her young son gives Ms. Hepner the opportunity to explain that after Canadian surgeon Frederick Banting discovered insulin, he sold the patent to the University of Toronto for one dollar.

“One hundred years ago, insulin wasn’t a business. It was a medical breakthrough that saved millions of lives. When Banting accepted his Nobel [Prize], he famously said: ‘Insulin doesn’t belong to me, it belongs to the world.’ ... Now, there’s a $245 billion industry designed to manage our disease,” Ms. Hepner says in the film.

But, she adds: “There’s a catch-22: Biotech needs big pharma’s profits to fund clinical trials. Without that support the researchers wouldn’t have gotten this far. Like most relationships, it’s complicated.”

Nonetheless, the film ultimately uplifts. As one company executive says: “Data show the product is producing insulin in patients for the first time. ... This is a big deal. We know now that the cells work.

“We didn’t know that 5 years ago. All the pieces are there, it’s just a matter of completing the puzzle.”

The ViaCyte work presented by Dr. Jaiman received funding from the European Commission Horizon 2020, the California Institute for Regenerative Medicine, and the JDRF. Jaiman is an employee of ViaCyte. The Sernova work was funded by Sernova and JDRF. Dr. Markmann has reported serving on advisory boards for iTolerance, eGenesis, and Qihan Biotech, and being a consultant for Vertex Pharmaceuticals. Ms. Hepner and Mr. Mossman run LA-based Vox Pop Films, a production company specializing in nonfiction content and commercials. “The Human Trial” was made in collaboration with the nonprofit Beyond Type 1.

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

How much does the risk of new-onset type 2 diabetes (T2D) increase in patients who have had a mild SARS-CoV-2 (COVID-19) infection?

Dr. Jain: We are now finding many associations between COVID-19 and T2D. Recently, there have been studies, especially from the United States and Germany, showing that even after mild COVID-19, the occurrence of new onset T2D is greater than what we thought previously. For instance, we are now seeing that the rate of new-onset T2D in adults who have had mild COVID-19 is about 18 additional adults per 1000 people. These people have about a 46% higher risk of developing T2D compared to those who did not have COVID-19. This is something we must keep in mind moving forward when it comes to screening for diabetes.

How have you navigated through the diagnostic components of T2D and COVID-19?

Dr. Jain: When people were exclusively doing virtual appointments during the COVID-19 lockdowns, there wasn't enough screening for retinopathy, worsening blood pressure, or even basic lab testing, for instance. We could not perform electrocardiography screenings for our patients with diabetes; we had to defer it unless people were symptomatic. This was not the ideal situation, as many people with diabetes may have “silent” coronary artery disease, making screening crucial even in those patients who are not symptomatic. The impact of this is anyone’s guess at this time. Unfortunately, there is no literature that has looked at the impact of deferred screenings during the pandemic.

However, in my own practice, we are now transitioning back to in-person appointments and making sure that all of these screening visits are being conducted in a timely manner so that we can catch the micro- and macrovascular complications of diabetes sooner.

Although data on the long-term impact are not available, what studies have been done regarding the treatment of T2D during the pandemic?

Dr. Jain: There are some observational studies. There was a claims database analysis that looked at patient visits, screening tests, filling of medications, and glycated hemoglobin (A1C) levels in 2020 vs 2019 in the United States. There was no significant difference between the A1C levels and medication fills. I think one reason for this is that we all were able to adapt to the changes required from us, and we were able to incorporate the virtual appointments. That's reassuring. I think we still need some more data to make any definitive assumptions about what the overall care of diabetes has been as we are coming out of the pandemic.

Have you seen any particular characteristics or disparities in those patients who have been impacted by T2D and COVID-19?

Dr. Jain: With the mask mandate, physical distancing requirements, and differing vaccination rates across parts of the world, we have seen disparities in the impact of COVID-19, especially for those that are the most vulnerable. This includes people with multiple comorbidities.

We also know that, even at baseline, patients with T2D are often prone to multiple cardiovascular issues and dialysis requirements. These individuals still have to be extremely cautious. I have seen that those patients who actually need the most attention are still not able to go out and get the care. It is important that we are inclusive in our understanding of the requirements of people at high risk for T2D and other comorbidities. Necessary requirements to reduce infection risk include following physical distancing and masking requirements as appropriate and ensuring timely screening for retinopathy, nephropathy, and coronary artery disease as well as getting foot exams.

We have to give them all the care and access to healthcare that they need. Expert consensus suggests that we ensure optimization of vaccination status, glycemic control, cardiovascular risk, and weight control. We also need to ensure that these high-risk individuals have not slipped through the cracks and have appropriate appointment follow-ups, labs, etc. booked in a timely manner.

What guidelines and standards do you rely upon to ensure that patients are getting the most out of their treatment?

Dr. Jain: COVID-19 aside, we still want to make sure that the management of T2D is not glucose-centric. We now understand that diabetes requires 360-degree care, and that involves not only controlling the blood sugars but also making sure that we are mitigating risk factors for vascular complications. That includes ensuring blood pressure is well controlled and that cholesterol levels are in target range for patients who either have history of heart attacks, strokes, heart failure, kidney disease, or who are at future risk for these events.

We are using medications that can help protect the heart and the kidneys. Considering that T2D and obesity are so closely interlinked, we are using medications that help with overcoming the weight aspect as well. I think that a patient-centric, multidisciplinary approach is the most crucial and the most reliable way of getting that 360-degree comprehensive care for patients with diabetes.

Is there anything else you would like to share with your colleagues or peers?

Dr. Jain: As we are coming out of the pandemic, we still we need to realize that the repercussions of COVID-19 will still stay with us for a long, long time. We do know that COVID-19 infection leads to a tsunami of inflammation in the body. This can have long-lasting effects, including chronic conditions.

It is important that we continue to screen for diabetes given that there is a higher incidence of T2D in those with even mild COVID-19, and especially those at highest risk, such as people with obesity. We need to make sure that we are not missing any pieces of the puzzle there, especially because diabetes is a silent disease. We should not rely on symptoms to determine when we should screen; instead, we must be proactive about screening and management.

How much does the risk of new-onset type 2 diabetes (T2D) increase in patients who have had a mild SARS-CoV-2 (COVID-19) infection?

Dr. Jain: We are now finding many associations between COVID-19 and T2D. Recently, there have been studies, especially from the United States and Germany, showing that even after mild COVID-19, the occurrence of new onset T2D is greater than what we thought previously. For instance, we are now seeing that the rate of new-onset T2D in adults who have had mild COVID-19 is about 18 additional adults per 1000 people. These people have about a 46% higher risk of developing T2D compared to those who did not have COVID-19. This is something we must keep in mind moving forward when it comes to screening for diabetes.

How have you navigated through the diagnostic components of T2D and COVID-19?

Dr. Jain: When people were exclusively doing virtual appointments during the COVID-19 lockdowns, there wasn't enough screening for retinopathy, worsening blood pressure, or even basic lab testing, for instance. We could not perform electrocardiography screenings for our patients with diabetes; we had to defer it unless people were symptomatic. This was not the ideal situation, as many people with diabetes may have “silent” coronary artery disease, making screening crucial even in those patients who are not symptomatic. The impact of this is anyone’s guess at this time. Unfortunately, there is no literature that has looked at the impact of deferred screenings during the pandemic.

However, in my own practice, we are now transitioning back to in-person appointments and making sure that all of these screening visits are being conducted in a timely manner so that we can catch the micro- and macrovascular complications of diabetes sooner.

Although data on the long-term impact are not available, what studies have been done regarding the treatment of T2D during the pandemic?

Dr. Jain: There are some observational studies. There was a claims database analysis that looked at patient visits, screening tests, filling of medications, and glycated hemoglobin (A1C) levels in 2020 vs 2019 in the United States. There was no significant difference between the A1C levels and medication fills. I think one reason for this is that we all were able to adapt to the changes required from us, and we were able to incorporate the virtual appointments. That's reassuring. I think we still need some more data to make any definitive assumptions about what the overall care of diabetes has been as we are coming out of the pandemic.

Have you seen any particular characteristics or disparities in those patients who have been impacted by T2D and COVID-19?

Dr. Jain: With the mask mandate, physical distancing requirements, and differing vaccination rates across parts of the world, we have seen disparities in the impact of COVID-19, especially for those that are the most vulnerable. This includes people with multiple comorbidities.

We also know that, even at baseline, patients with T2D are often prone to multiple cardiovascular issues and dialysis requirements. These individuals still have to be extremely cautious. I have seen that those patients who actually need the most attention are still not able to go out and get the care. It is important that we are inclusive in our understanding of the requirements of people at high risk for T2D and other comorbidities. Necessary requirements to reduce infection risk include following physical distancing and masking requirements as appropriate and ensuring timely screening for retinopathy, nephropathy, and coronary artery disease as well as getting foot exams.

We have to give them all the care and access to healthcare that they need. Expert consensus suggests that we ensure optimization of vaccination status, glycemic control, cardiovascular risk, and weight control. We also need to ensure that these high-risk individuals have not slipped through the cracks and have appropriate appointment follow-ups, labs, etc. booked in a timely manner.

What guidelines and standards do you rely upon to ensure that patients are getting the most out of their treatment?

Dr. Jain: COVID-19 aside, we still want to make sure that the management of T2D is not glucose-centric. We now understand that diabetes requires 360-degree care, and that involves not only controlling the blood sugars but also making sure that we are mitigating risk factors for vascular complications. That includes ensuring blood pressure is well controlled and that cholesterol levels are in target range for patients who either have history of heart attacks, strokes, heart failure, kidney disease, or who are at future risk for these events.

We are using medications that can help protect the heart and the kidneys. Considering that T2D and obesity are so closely interlinked, we are using medications that help with overcoming the weight aspect as well. I think that a patient-centric, multidisciplinary approach is the most crucial and the most reliable way of getting that 360-degree comprehensive care for patients with diabetes.

Is there anything else you would like to share with your colleagues or peers?

Dr. Jain: As we are coming out of the pandemic, we still we need to realize that the repercussions of COVID-19 will still stay with us for a long, long time. We do know that COVID-19 infection leads to a tsunami of inflammation in the body. This can have long-lasting effects, including chronic conditions.

It is important that we continue to screen for diabetes given that there is a higher incidence of T2D in those with even mild COVID-19, and especially those at highest risk, such as people with obesity. We need to make sure that we are not missing any pieces of the puzzle there, especially because diabetes is a silent disease. We should not rely on symptoms to determine when we should screen; instead, we must be proactive about screening and management.

How much does the risk of new-onset type 2 diabetes (T2D) increase in patients who have had a mild SARS-CoV-2 (COVID-19) infection?

Dr. Jain: We are now finding many associations between COVID-19 and T2D. Recently, there have been studies, especially from the United States and Germany, showing that even after mild COVID-19, the occurrence of new onset T2D is greater than what we thought previously. For instance, we are now seeing that the rate of new-onset T2D in adults who have had mild COVID-19 is about 18 additional adults per 1000 people. These people have about a 46% higher risk of developing T2D compared to those who did not have COVID-19. This is something we must keep in mind moving forward when it comes to screening for diabetes.

How have you navigated through the diagnostic components of T2D and COVID-19?

Dr. Jain: When people were exclusively doing virtual appointments during the COVID-19 lockdowns, there wasn't enough screening for retinopathy, worsening blood pressure, or even basic lab testing, for instance. We could not perform electrocardiography screenings for our patients with diabetes; we had to defer it unless people were symptomatic. This was not the ideal situation, as many people with diabetes may have “silent” coronary artery disease, making screening crucial even in those patients who are not symptomatic. The impact of this is anyone’s guess at this time. Unfortunately, there is no literature that has looked at the impact of deferred screenings during the pandemic.

However, in my own practice, we are now transitioning back to in-person appointments and making sure that all of these screening visits are being conducted in a timely manner so that we can catch the micro- and macrovascular complications of diabetes sooner.

Although data on the long-term impact are not available, what studies have been done regarding the treatment of T2D during the pandemic?

Dr. Jain: There are some observational studies. There was a claims database analysis that looked at patient visits, screening tests, filling of medications, and glycated hemoglobin (A1C) levels in 2020 vs 2019 in the United States. There was no significant difference between the A1C levels and medication fills. I think one reason for this is that we all were able to adapt to the changes required from us, and we were able to incorporate the virtual appointments. That's reassuring. I think we still need some more data to make any definitive assumptions about what the overall care of diabetes has been as we are coming out of the pandemic.

Have you seen any particular characteristics or disparities in those patients who have been impacted by T2D and COVID-19?

Dr. Jain: With the mask mandate, physical distancing requirements, and differing vaccination rates across parts of the world, we have seen disparities in the impact of COVID-19, especially for those that are the most vulnerable. This includes people with multiple comorbidities.

We also know that, even at baseline, patients with T2D are often prone to multiple cardiovascular issues and dialysis requirements. These individuals still have to be extremely cautious. I have seen that those patients who actually need the most attention are still not able to go out and get the care. It is important that we are inclusive in our understanding of the requirements of people at high risk for T2D and other comorbidities. Necessary requirements to reduce infection risk include following physical distancing and masking requirements as appropriate and ensuring timely screening for retinopathy, nephropathy, and coronary artery disease as well as getting foot exams.

We have to give them all the care and access to healthcare that they need. Expert consensus suggests that we ensure optimization of vaccination status, glycemic control, cardiovascular risk, and weight control. We also need to ensure that these high-risk individuals have not slipped through the cracks and have appropriate appointment follow-ups, labs, etc. booked in a timely manner.

What guidelines and standards do you rely upon to ensure that patients are getting the most out of their treatment?

Dr. Jain: COVID-19 aside, we still want to make sure that the management of T2D is not glucose-centric. We now understand that diabetes requires 360-degree care, and that involves not only controlling the blood sugars but also making sure that we are mitigating risk factors for vascular complications. That includes ensuring blood pressure is well controlled and that cholesterol levels are in target range for patients who either have history of heart attacks, strokes, heart failure, kidney disease, or who are at future risk for these events.

We are using medications that can help protect the heart and the kidneys. Considering that T2D and obesity are so closely interlinked, we are using medications that help with overcoming the weight aspect as well. I think that a patient-centric, multidisciplinary approach is the most crucial and the most reliable way of getting that 360-degree comprehensive care for patients with diabetes.

Is there anything else you would like to share with your colleagues or peers?

Dr. Jain: As we are coming out of the pandemic, we still we need to realize that the repercussions of COVID-19 will still stay with us for a long, long time. We do know that COVID-19 infection leads to a tsunami of inflammation in the body. This can have long-lasting effects, including chronic conditions.

It is important that we continue to screen for diabetes given that there is a higher incidence of T2D in those with even mild COVID-19, and especially those at highest risk, such as people with obesity. We need to make sure that we are not missing any pieces of the puzzle there, especially because diabetes is a silent disease. We should not rely on symptoms to determine when we should screen; instead, we must be proactive about screening and management.

This transcript has been edited for clarity.

Today, I’m going to discuss the results of a new automated insulin delivery system that I think can really help many people with type 1 diabetes.

Dr. Steven Russell presented the results at the Advanced Technologies & Treatments for Diabetes meeting. The study focused on the iLet system, which is made by Beta Bionics and has been under development for a while. This was the single-hormone study, so it just looked at their algorithm using insulin alone. Eventually they’re going to study this, looking at the use of insulin plus glucagon together to see if that further improves outcomes.

One of the main reasons I think this study was so cool is because it included over 25% minority individuals who aren’t routinely studied in these insulin device trials. The study also included people who had a wide range of hemoglobin A1c levels; there was no high cut-point here. Over 30% of participants had an A1c greater than 8%. They also studied both children and adults and combined the results together.

Before I talk about the results, let me tell you about the pump. This is a tubed pump that has a sensor that it communicates with – it’s the Dexcom sensor – and it has an algorithm so it does automated insulin delivery. Instead of having to enter all sorts of information into the system, this thing requires that you put in only the patient’s weight. That’s it. From there, the system begins to figure out what the patient needs in terms of automated insulin delivery.

There are several different target settings that can be entered, and they can differ by time of day. There’s basically the time of day that one is eating a meal, so breakfast, lunch, or dinner, and there is the meal size, basically small, medium, and large. The individual enters this in real time so the system knows they’re eating, but other than that, the system just works.

It does this in a way that doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.

They compared this system with people on any other system, including other automated insulin delivery systems, and put them into this trial. People were randomized to this system vs. whatever they’d been on (that was the control group) and they followed them for 13 weeks, which is not all that long.

There was a 0.5% reduction in A1c between the two groups. There was also an increase in the time in range, and this improvement in time in range happened almost immediately – within the first day or two of people being on the system. In terms of actual numbers, the adult patients started out with a time in range of 56% and this increased to 69% by the end of the study. The biggest improvement was time in range overnight, as is seen with other automated insulin delivery systems.

There was no reduction in time below a glucose level of 54 and there was an increase in the number of episodes of severe hypoglycemia in the group treated with the iLet system, but this was not statistically significant between the two groups.

I think these results are hard to compare with other pivotal trials investigating automated insulin delivery systems. The Tandem pivotal trial was a randomized controlled trial similar to this one, but the Medtronic and Omnipod studies were single-arm trials where patients were compared before and after they used the device.

More than anything, I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.

I couldn’t be happier. I love what they’re doing at Beta Bionics, and I look forward to more results, and in particular, to see if these results improve further when they do a study of insulin and glucagon in their dual-hormone pump system.

Thank you very much. This has been Dr Anne Peters for Medscape.
 

Dr. Peters is professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes programs. She has published more than 200 articles, reviews, and abstracts, and three books, on diabetes, and has been an investigator for more than 40 research studies. She has spoken internationally at over 400 programs and serves on many committees of several professional organizations. She disclosed ties with Abbott Diabetes Care, AstraZeneca, Becton Dickinson, Boehringer Ingelheim Pharmaceuticals, Dexcom, Eli Lilly, Lexicon Pharmaceuticals, Livongo, MannKind Corporation, Medscape, Merck, Novo Nordisk, Omada Health, OptumHealth, Sanofi, and Zafgen.

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

This transcript has been edited for clarity.

Today, I’m going to discuss the results of a new automated insulin delivery system that I think can really help many people with type 1 diabetes.

Dr. Steven Russell presented the results at the Advanced Technologies & Treatments for Diabetes meeting. The study focused on the iLet system, which is made by Beta Bionics and has been under development for a while. This was the single-hormone study, so it just looked at their algorithm using insulin alone. Eventually they’re going to study this, looking at the use of insulin plus glucagon together to see if that further improves outcomes.

One of the main reasons I think this study was so cool is because it included over 25% minority individuals who aren’t routinely studied in these insulin device trials. The study also included people who had a wide range of hemoglobin A1c levels; there was no high cut-point here. Over 30% of participants had an A1c greater than 8%. They also studied both children and adults and combined the results together.

Before I talk about the results, let me tell you about the pump. This is a tubed pump that has a sensor that it communicates with – it’s the Dexcom sensor – and it has an algorithm so it does automated insulin delivery. Instead of having to enter all sorts of information into the system, this thing requires that you put in only the patient’s weight. That’s it. From there, the system begins to figure out what the patient needs in terms of automated insulin delivery.

There are several different target settings that can be entered, and they can differ by time of day. There’s basically the time of day that one is eating a meal, so breakfast, lunch, or dinner, and there is the meal size, basically small, medium, and large. The individual enters this in real time so the system knows they’re eating, but other than that, the system just works.

It does this in a way that doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.

They compared this system with people on any other system, including other automated insulin delivery systems, and put them into this trial. People were randomized to this system vs. whatever they’d been on (that was the control group) and they followed them for 13 weeks, which is not all that long.

There was a 0.5% reduction in A1c between the two groups. There was also an increase in the time in range, and this improvement in time in range happened almost immediately – within the first day or two of people being on the system. In terms of actual numbers, the adult patients started out with a time in range of 56% and this increased to 69% by the end of the study. The biggest improvement was time in range overnight, as is seen with other automated insulin delivery systems.

There was no reduction in time below a glucose level of 54 and there was an increase in the number of episodes of severe hypoglycemia in the group treated with the iLet system, but this was not statistically significant between the two groups.

I think these results are hard to compare with other pivotal trials investigating automated insulin delivery systems. The Tandem pivotal trial was a randomized controlled trial similar to this one, but the Medtronic and Omnipod studies were single-arm trials where patients were compared before and after they used the device.

More than anything, I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.

I couldn’t be happier. I love what they’re doing at Beta Bionics, and I look forward to more results, and in particular, to see if these results improve further when they do a study of insulin and glucagon in their dual-hormone pump system.

Thank you very much. This has been Dr Anne Peters for Medscape.
 

Dr. Peters is professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes programs. She has published more than 200 articles, reviews, and abstracts, and three books, on diabetes, and has been an investigator for more than 40 research studies. She has spoken internationally at over 400 programs and serves on many committees of several professional organizations. She disclosed ties with Abbott Diabetes Care, AstraZeneca, Becton Dickinson, Boehringer Ingelheim Pharmaceuticals, Dexcom, Eli Lilly, Lexicon Pharmaceuticals, Livongo, MannKind Corporation, Medscape, Merck, Novo Nordisk, Omada Health, OptumHealth, Sanofi, and Zafgen.

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

This transcript has been edited for clarity.

Today, I’m going to discuss the results of a new automated insulin delivery system that I think can really help many people with type 1 diabetes.

Dr. Steven Russell presented the results at the Advanced Technologies & Treatments for Diabetes meeting. The study focused on the iLet system, which is made by Beta Bionics and has been under development for a while. This was the single-hormone study, so it just looked at their algorithm using insulin alone. Eventually they’re going to study this, looking at the use of insulin plus glucagon together to see if that further improves outcomes.

One of the main reasons I think this study was so cool is because it included over 25% minority individuals who aren’t routinely studied in these insulin device trials. The study also included people who had a wide range of hemoglobin A1c levels; there was no high cut-point here. Over 30% of participants had an A1c greater than 8%. They also studied both children and adults and combined the results together.

Before I talk about the results, let me tell you about the pump. This is a tubed pump that has a sensor that it communicates with – it’s the Dexcom sensor – and it has an algorithm so it does automated insulin delivery. Instead of having to enter all sorts of information into the system, this thing requires that you put in only the patient’s weight. That’s it. From there, the system begins to figure out what the patient needs in terms of automated insulin delivery.

There are several different target settings that can be entered, and they can differ by time of day. There’s basically the time of day that one is eating a meal, so breakfast, lunch, or dinner, and there is the meal size, basically small, medium, and large. The individual enters this in real time so the system knows they’re eating, but other than that, the system just works.

It does this in a way that doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.

They compared this system with people on any other system, including other automated insulin delivery systems, and put them into this trial. People were randomized to this system vs. whatever they’d been on (that was the control group) and they followed them for 13 weeks, which is not all that long.

There was a 0.5% reduction in A1c between the two groups. There was also an increase in the time in range, and this improvement in time in range happened almost immediately – within the first day or two of people being on the system. In terms of actual numbers, the adult patients started out with a time in range of 56% and this increased to 69% by the end of the study. The biggest improvement was time in range overnight, as is seen with other automated insulin delivery systems.

There was no reduction in time below a glucose level of 54 and there was an increase in the number of episodes of severe hypoglycemia in the group treated with the iLet system, but this was not statistically significant between the two groups.

I think these results are hard to compare with other pivotal trials investigating automated insulin delivery systems. The Tandem pivotal trial was a randomized controlled trial similar to this one, but the Medtronic and Omnipod studies were single-arm trials where patients were compared before and after they used the device.

More than anything, I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.

I couldn’t be happier. I love what they’re doing at Beta Bionics, and I look forward to more results, and in particular, to see if these results improve further when they do a study of insulin and glucagon in their dual-hormone pump system.

Thank you very much. This has been Dr Anne Peters for Medscape.
 

Dr. Peters is professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes programs. She has published more than 200 articles, reviews, and abstracts, and three books, on diabetes, and has been an investigator for more than 40 research studies. She has spoken internationally at over 400 programs and serves on many committees of several professional organizations. She disclosed ties with Abbott Diabetes Care, AstraZeneca, Becton Dickinson, Boehringer Ingelheim Pharmaceuticals, Dexcom, Eli Lilly, Lexicon Pharmaceuticals, Livongo, MannKind Corporation, Medscape, Merck, Novo Nordisk, Omada Health, OptumHealth, Sanofi, and Zafgen.

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

Key clinical point: Greater glycemic variability measured as the coefficient of variation for glucose (%CV) level was associated with a higher risk for all-cause mortality in patients with type 2 diabetes (T2D) and a well-controlled glucose status.

Major finding: Compared with patients with a %CV level of ≤20%, those with a %CV level of 20%-25% (adjusted HR [aHR] 1.16; 95% CI 0.78-1.73), 25%-30% (aHR 1.38; 95% CI 0.89-2.15), 30%-35% (aHR 1.33; 95% CI 0.77-2.29), and >35% (aHR 2.26; 95% CI 1.13-4.52) had a higher risk for all-cause mortality.

Study details: This study was a part of the INDIGO study including 1839 patients with T2D who reached continuous glucose monitoring glycemic targets and were classified into five groups by %CV level.

Disclosures: This study was supported by the National Key R&D Program of China, the National Natural Science Foundation of China, and others. The authors declared no conflicts of interest.

Source: Mo Y et al. Impact of short-term glycemic variability on risk of all-cause mortality in type 2 diabetes patients with well-controlled glucose profile by continuous glucose monitoring: A prospective cohort study. Diabetes Res Clin Pract. 2022;189:109940 (Jun 1). Doi: 10.1016/j.diabres.2022.109940

Key clinical point: Greater glycemic variability measured as the coefficient of variation for glucose (%CV) level was associated with a higher risk for all-cause mortality in patients with type 2 diabetes (T2D) and a well-controlled glucose status.

Major finding: Compared with patients with a %CV level of ≤20%, those with a %CV level of 20%-25% (adjusted HR [aHR] 1.16; 95% CI 0.78-1.73), 25%-30% (aHR 1.38; 95% CI 0.89-2.15), 30%-35% (aHR 1.33; 95% CI 0.77-2.29), and >35% (aHR 2.26; 95% CI 1.13-4.52) had a higher risk for all-cause mortality.

Study details: This study was a part of the INDIGO study including 1839 patients with T2D who reached continuous glucose monitoring glycemic targets and were classified into five groups by %CV level.

Disclosures: This study was supported by the National Key R&D Program of China, the National Natural Science Foundation of China, and others. The authors declared no conflicts of interest.

Source: Mo Y et al. Impact of short-term glycemic variability on risk of all-cause mortality in type 2 diabetes patients with well-controlled glucose profile by continuous glucose monitoring: A prospective cohort study. Diabetes Res Clin Pract. 2022;189:109940 (Jun 1). Doi: 10.1016/j.diabres.2022.109940

Key clinical point: Greater glycemic variability measured as the coefficient of variation for glucose (%CV) level was associated with a higher risk for all-cause mortality in patients with type 2 diabetes (T2D) and a well-controlled glucose status.

Major finding: Compared with patients with a %CV level of ≤20%, those with a %CV level of 20%-25% (adjusted HR [aHR] 1.16; 95% CI 0.78-1.73), 25%-30% (aHR 1.38; 95% CI 0.89-2.15), 30%-35% (aHR 1.33; 95% CI 0.77-2.29), and >35% (aHR 2.26; 95% CI 1.13-4.52) had a higher risk for all-cause mortality.

Study details: This study was a part of the INDIGO study including 1839 patients with T2D who reached continuous glucose monitoring glycemic targets and were classified into five groups by %CV level.

Disclosures: This study was supported by the National Key R&D Program of China, the National Natural Science Foundation of China, and others. The authors declared no conflicts of interest.

Source: Mo Y et al. Impact of short-term glycemic variability on risk of all-cause mortality in type 2 diabetes patients with well-controlled glucose profile by continuous glucose monitoring: A prospective cohort study. Diabetes Res Clin Pract. 2022;189:109940 (Jun 1). Doi: 10.1016/j.diabres.2022.109940

Key clinical point: Monocyte-lymphocyte ratio (MLR) was significantly associated with proliferative diabetic retinopathy (PDR) in patients with type 2 diabetes (T2D).

Major finding: Each 0.1 unit increase in MLR increased the risk for PDR by 46% (adjusted odds ratio 1.46; P = .014), with the effects being stable across different subgroups stratified by age, sex, hemoglobin, and glycated hemoglobin categories.

Study details: Findings are from a cross-sectional study of 367 patients with T2D and diabetic retinopathy, of which 27% were diagnosed with PDR.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Wang H et al. Association of monocyte-lymphocyte ratio and proliferative diabetic retinopathy in the U.S. population with type 2 diabetes. J Transl Med. 2022;20:219 (May 13). Doi: 10.1186/s12967-022-03425-4

Key clinical point: Monocyte-lymphocyte ratio (MLR) was significantly associated with proliferative diabetic retinopathy (PDR) in patients with type 2 diabetes (T2D).

Major finding: Each 0.1 unit increase in MLR increased the risk for PDR by 46% (adjusted odds ratio 1.46; P = .014), with the effects being stable across different subgroups stratified by age, sex, hemoglobin, and glycated hemoglobin categories.

Study details: Findings are from a cross-sectional study of 367 patients with T2D and diabetic retinopathy, of which 27% were diagnosed with PDR.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Wang H et al. Association of monocyte-lymphocyte ratio and proliferative diabetic retinopathy in the U.S. population with type 2 diabetes. J Transl Med. 2022;20:219 (May 13). Doi: 10.1186/s12967-022-03425-4

Key clinical point: Monocyte-lymphocyte ratio (MLR) was significantly associated with proliferative diabetic retinopathy (PDR) in patients with type 2 diabetes (T2D).

Major finding: Each 0.1 unit increase in MLR increased the risk for PDR by 46% (adjusted odds ratio 1.46; P = .014), with the effects being stable across different subgroups stratified by age, sex, hemoglobin, and glycated hemoglobin categories.

Study details: Findings are from a cross-sectional study of 367 patients with T2D and diabetic retinopathy, of which 27% were diagnosed with PDR.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Wang H et al. Association of monocyte-lymphocyte ratio and proliferative diabetic retinopathy in the U.S. population with type 2 diabetes. J Transl Med. 2022;20:219 (May 13). Doi: 10.1186/s12967-022-03425-4