Bionic pancreas is more effective in managing T1D compared to standard insulin delivery

A bionic pancreas that automatically delivered insulin was more effective in maintaining normal blood sugar levels in patients type 1 diabetes compared to standard care (T1D) according to a multicenter clinical trial published in New England Journal of Medicine.

Automated insulin delivery (AID) systems use a continuous glucose monitor (CGM) to measure glucose levels and use insulin pumps to automatically deliver insulin when blood glucose levels in T1D patients become too high . AID systems replace other methods of glucose regulation such as fingersticks, CGM by individual insulin delivery by daily injections, or non-automated insulin pumps.

According to the National Institutes of Health According to the (NIH), the bionic pancreas uses a closed-loop system, which is more automated than other existing artificial pancreas technologies, and continuously adjusts insulin dosage based on the user’s needs. The bionic device’s algorithms require less user input.

As a first step for these algorithms to start collecting the necessary data, the user enters their weight the first time they use the Bionic Pancreas.

Best of all, users don’t have to count carbs or start insulin dosing, and providers don’t have to regularly adjust device settings.

“Currently available semi-automated insulin delivery systems require individualized insulin regimens for therapy initiation and carbohydrate-counted meal sizes for routine manipulation,” the study authors wrote. “In contrast, the bionic pancreas is initialized based on body weight only, makes all dose decisions, delivers insulin autonomously, and uses meal announcements without counting carbohydrates.” ”

To assess how the bionic pancreas maintains glucose levels compared to standard therapy and its safety, the authors enrolled 326 participants with T1D from 16 US clinical sites. A 13-week, multicenter, randomized trial was conducted. Participants were randomly assigned 2:1 to receive either bionic pancreatic therapy with insulin aspart or insulin lispro, or standard therapy defined as any insulin delivery method with open-label real-time CGM was given.

The primary endpoint was glycated hemoglobin level at week 13. The primary secondary endpoint was the percentage of time glucose levels were <54 mg/dl with a non-inferiority limit of 1%.

Patients’ ages ranged from 6 to 79 years. Of a total of 326 participants, 219 were assigned to the living pancreas group and 107 to the standard care group.

Over 13 weeks, glycated hemoglobin levels decreased from 7.9% to 7.3% in the bionic pancreas group, but remained at 7.7% at both time points in the standard care group (mean adjusted difference at 13 weeks, -0.5 percent points; 95% CI, -0.6 to -0.3. P. <.001).

Additionally, participants with the Bionic Pancreas spent approximately 2.5 more hours per day within their target blood glucose range compared to participants receiving standard care, reflecting a time difference of 11%.

“These results were similar in adolescent and adult participants, with improvements in glycemic control being greatest in participants who had high blood sugar levels at the start of the study,” said the news release.

The percentage of time patients had blood glucose levels <54 mg/dl did not differ significantly between groups (13-week adjusted difference, 0.0 percentage points, 95% CI, -0.1 to 0.04, P for non-inferiority < 0.001).

Among those who used Bionic Pancreas, hyperglycemia or hyperglycemia caused by problems with the insulin pump device was the most frequently reported adverse event.

However, the number of hypoglycemia or hypoglycemic events was small and did not differ between groups, and the frequency of such events did not differ statistically between groups.

The incidence of severe hypoglycemia in participants was 17.7 events per 100 participant-years in the bionic pancreas group and 10.8 events per 100 participant-years in the standard care group (P. = .39).

The authors state that there were no episodes of diabetic ketoacidosis in either group.

“As we continue to search for a cure for type 1 diabetes, devices like the Bionic Pancreas allow people to worry less about their blood sugar levels and focus more on living their most fulfilling and healthy lives. ,” said Griffin P. Rodgers, MD. , director of the National Institute of Diabetes and Digestive and Kidney Diseases, part of the NIH that primarily funded the research.

The bionic pancreas used in this study, the iLet Bionic Pancreas from Beta Bionics, is FDA-reviewed.

reference

Bionic Pancreas Research Group, Russell SJ, Beck RW, et al. A multicenter, randomized trial of bionic pancreas in type 1 diabetes. N Engl J Med2022;387(13):1161-1172. doi:10.1056/NEJ Moa2205225