Bionic Pancreas More Effective at Managing T1D Compared With Standard Insulin Delivery

A bionic pancreas that automatically delivers insulin was more effective at maintaining normal blood glucose levels in people with type 1 diabetes (T1D) compared with standard of care, according to a multicenter clinical trial published in the New England Journal of Medicine.

Automated insulin delivery (AID) systems measure sugar levels using a continuous glucose monitor (CGM) and use an insulin pump to automatically deliver insulin when glucose levels get too high in people with T1D. AID systems replace other glucose moderating methods such as fingerstick, CGM with separate insulin delivery via daily injections, or insulin pump without automation.

According to the National Institutes of Health (NIH), the bionic pancreas uses a closed loop system and has more automation and requires less user input compared with other existing artificial pancreas technologies due to the bionic device’s algorithms that continually adjust insulin doses based on the user’s needs.

As the first step for these algorithms to begin collecting the necessary data, users enter their body weight at first use of the bionic pancreas.

Notably, users do not need to count carbohydrates or initiate insulin doses, and health care providers do not need to make periodic adjustments to device settings.

“Currently available semiautomated insulin-delivery systems require individualized insulin regimens for the initialization of therapy and meal doses based on carbohydrate counting for routine operation,” the study authors wrote. “In contrast, the bionic pancreas is initialized only on the basis of body weight, makes all dose decisions and delivers insulin autonomously, and uses meal announcements without carbohydrate counting.”

To assess how the bionic pancreas maintained glucose levels compared with standard of care, as well as its safety, the authors conducted a 13-week multicenter randomized trial including 326 participants with T1D from 16 clinical sites in the United States. Participants were randomly assigned 2:1 to either receive bionic pancreas treatment with insulin aspart or insulin lispro, or receive standard care, defined as any insulin-delivery method with unblinded, real-time CGM.

The primary outcome was glycated hemoglobin level at 13 weeks. The main secondary outcome was the percentage of time glucose level was below 54 mg per deciliter, with a noninferiority limit of 1%.

Patient ages ranged between 6 and 79 years. Of the 326 total participants, 219 were assigned to the bionic pancreas group and 107 were assigned to the standard of care group.

Over 13 weeks, the glycated hemoglobin level decreased from 7.9% to 7.3% in the bionic pancreas group, but stayed 7.7% at both times points for the standard of care group (mean adjusted difference at 13 weeks, −0.5 percentage points; 95% CI, −0.6 to −0.3; P <.001).

Additionally, participants who used the bionic pancreas spent approximately 2.5 more hours per day within the targeted blood glucose range compared with those who received standard of care, reflecting an 11% time difference.

“These results were similar in youth and adult participants, and improvements in blood glucose control were greatest among participants who had higher blood glucose levels at the beginning of the study,” the news release noted.

The percentage of time a patient’s glucose level was below 54 mg per deciliter did not differ significantly between the groups (13-week adjusted difference, 0.0 percentage points; 95% CI, −0.1 to 0.04; P<0.001 for noninferiority).

Among those who used the bionic pancreas, hyperglycemia or high blood glucose caused by problems with insulin pump equipment was the most frequently reported adverse event.

However, the number of hypoglycemia or low blood glucose events was low and did not differ between groups, and the frequency of such events was not statistically different between groups.

The rate of severe hypoglycemia among 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 of care group (P = .39).

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

“While we continue to search for a cure for type 1 diabetes, devices like the bionic pancreas can allow people to worry less about their blood-glucose levels and focus more on living their fullest, healthiest lives,” said Griffin P. Rodgers, MD, director of the National Institute of Diabetes and Digestive and Kidney Diseases, a part of the NIH that primarily funded the study.

The bionic pancreas used in the study, the iLet bionic pancreas, made by Beta Bionics, is under review by the FDA.

Reference

Bionic Pancreas Research Group, Russell SJ, Beck RW, et al. Multicenter, randomized trial of a bionic pancreas in type 1 diabetes. N Engl J Med. 2022;387(13):1161-1172. doi:10.1056/NEJMoa2205225