A bionic pancreas—a pocket-size wearable device that uses new technology to automatically deliver insulin—was more effective at maintaining blood glucose levels within normal range when compared with standard care, according to a study that appeared in the New England Journal of Medicine.

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 Sep 29;387(13):1161–1172

 

Since the publication of that study, the bionic pancreas has been cleared by the FDA; it became commercially available in May 2023.

US FDA. FDA clears new insulin pump and algorithm-based software to support enhanced automatic insulin delivery [press release]. May 19, 2023.

 

 

Automated insulin delivery systems

 

Among patients with T1D, only about one-fifth meet the goal of a glycated hemoglobin value of <7.0%.  To the study authors, this suggested that a different approach—particularly automated and semi-automated insulin delivery systems—was warranted. 

 

Optimizing glycemic control is important, as hyperglycemia has an inhibitory effect on gastric emptying. Thus, advances in glucose control (including continuous infusion and monitoring) are particularly important to gastroenterologists. 

 

Technological advances

 

 In their research report, the study authors explained that most hybrid closed-loop systems partially automate insulin delivery: They track the patient’s blood glucose levels by using a continuous glucose monitor, and then automatically deliver insulin via pump as needed. They replace more traditional reliance on finger stick tests of glucose levels, glucose monitoring that requires multiple daily insulin injections, and non-automated pumps.

However, even these modern-day devices have limitations, requiring a complex set of steps, including inputting of basal rates, insulin-sensitivity factors, carbohydrate-to-insulin ratios, the total daily dose of insulin, and input entered by the user. A warm-up period, during which the system gathers information about insulin doses controlled by the user, must take place before automation can even begin.

The bionic pancreas used in the study (iLet, manufactured by Beta Bionics) has some key differentiating features.

“The pump uses more artificial intelligence than other pumps on the market,” said coauthor Irl Hirsch, MD, in a news release.

UW Medicine. Study: ‘Bionic pancreas’ improves type 1 diabetes control [news release]. September 27, 2022.

“It identifies trends of the continuous glucose monitor to give insulin that keeps blood glucose in the normal range—without patients having to count carbohydrates.”

 

 

Superior blood glucose control

 

The multicenter, randomized trial evaluated the efficacy and safety of the insulin-only configuration of the bionic pancreas in adults and children (aged ≥6 years) with T1D (n=219). The comparison group received standard care, defined as “any method of insulin delivery combined with unblinded, real-time continuous glucose monitoring” (n=107). 

The trial lasted 13 weeks. The primary outcome measure was the glycated hemoglobin level, and the secondary outcome was the percentage of time that the glucose level was <54 mg/dL.

 

There were no significant differences between the groups in the percentage of time that the glucose level was <54 mg/dL.

There were more cases of severe hypoglycemia in the bionic-pancreas group vs the standard-care group (17.7 events per 100 participant-years vs 10.8 events per 100 participant-years, respectively; P=0.39). There were also more episodes of hyperglycemia in the bionic-pancreas group vs the standard-care group (214 vs 2, respectively); these episodes were adjudicated as being due to infusion-set failure. However, the authors note, infusion-set failures were not reported as adverse events in the standard-care group.

In the news release, Dr. Hirsch put these results in perspective: “Many patients closely manage their T1D and do so extremely well,” he said. “But there’s another very large group of patients who don’t pay as much attention for a variety of reasons. Our findings could be informative for those patients, in terms of keeping their blood sugar under better control.”

 

Insights from gastroenterologists

 

 

In particular, patients with T1D are “at significantly increased risk of gastrointestinal complications, such as gastroparesis, decreased intestinal motility, and small intestinal bacterial overgrowth,” he emphasized.

Referencing the study, Dr. Hanouneh said the bionic pancreas is associated with "better control of blood sugar in patients with T1D, and strict management of blood sugar in these patients with new technology such as the bionic pancreas is essential to avoid these complications."

However, he offered a caveat, noting that the study was conducted over a “relatively short 13-week period.” Long-term effects, as well as “real-world application and user experience, may vary.” 

For this reason, “further research and evaluation are needed to assess the device’s effectiveness and safety over extended periods and in a broader population,” Dr. Hanouneh observed.