New bionic pancreas for T1DM: What gastros need to know

By Batya Swift Yasgur, LSW | Medically reviewed by Scott Cunningham, MD, PhD
Published March 18, 2024

Key Takeaways

  • A wearable bionic pancreas is more effective than standard care in maintaining glycated hemoglobin levels in patients with type 1 diabetes (T1D).

  • The device was recently cleared by the US FDA for use in patients with T1D who are aged 6 years and above.

  • The superior blood glucose control may have beneficial effects on GI function, but concerns of both hyperglycemia and hypoglycemia need to be addressed and monitored.

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.[]

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

The favorable results with the bionic pancreas are especially relevant to patients with gastrointestinal (GI) problems because GI manifestations of T1D are “common and represent a substantial cause of mortality and healthcare costs, as well as a diagnostic and therapeutic challenge.”[]

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.

It doesn’t use information about the patient’s previous insulin regimen, and it is initialized only on the basis of body weight. Importantly, it automates both the determination and the delivery of all insulin doses immediately after collecting body weight data, without requiring a warm-up period. It also “announces” meals on the basis of a qualitative estimate of carbohydrate content rather than a typical meal of the day. 

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

In the bionic-pancreas group, the glycated hemoglobin level decreased from 7.9% at baseline to 7.3% at 13 weeks, while there was no change in the standard-care group, with the level remaining at 7.7% at both time points (P<0.001).

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

Ibrahim Hanouneh, MD, a gastroenterologist at MNGI Digestive Health in Minnesota, and coauthor of the book Regenerative Health, tells MDLinx that although diabetes is typically treated and managed by endocrinologists rather than gastroenterologists, the complications of T1D and the potential role of the bionic pancreas in mitigating these complications are relevant to gastroenterologists as well.

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.

What this means for you

For your patients with T1D who require better blood glucose control or have a need for easier monitoring, consider having them discuss a bionic pancreas with their endocrinologist. It's important to remain aware of potential concerns regarding both hyperglycemia and hypoglycemia during treatment with the bionic pancreas, and to collaborate closely with the patient’s endocrinologist or other provider responsible for their T1D management.

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