Bionic pancreatic system is safe and cuts HbA1c in type 1 diabetes

A fully automated bionic pancreas was shown to improve HbA1c in children and adults with type 1 diabetes in a multicenter randomized trial.

Use of this bionic pancreatic system reduced HbA1c from 7.9% to 7.3%, while in the standard care arm it remained stable at 7.7% over 13 weeks (mean adjusted difference -0.5%, 95% CI -0.6 ~ – 0.3, P.The Bionic Pancreas Research Group, led by Stephen Russell, M.D., Ph.D., of Massachusetts General Hospital in Boston, reported that the trial met its primary endpoint.

The same between-group differences in HbA1c reduction were found when bionic pancreas users were divided into pediatric (6 to <18 years) and adult (18 years and older) groups. New England Journal of Medicine.

Bionic Pancreas users also spent an average of 11% longer in the target glucose range (70-180 mg/dL), an increase of 2.6 hours per day, compared to the standard care group. It also significantly reduced the time spent in hyperglycemia (>180 mg/dL) and severe hyperglycemia (>250 mg/dL).

The fully automated system was considered non-inferior to standard care for the percentage of time that glucose levels fell into the severely hypoglycemic range. -weekly adjusted difference 0.0%, 95% CI -0.1 to 0.04, P.<0.001 non-inferiority).

Overall, users of the bionic pancreas had a severe hypoglycemia rate of 17.7 events per 100 participant-years compared to 10.8 events in the standard care group (P.=0.39). No participants in either group experienced diabetic ketoacidosis.

Beta Bionics’ iLet Bionic Pancreatic System dosed insulin aspart or insulin lispro based on weight and diet presentations, without counting carbohydrates. Standard of care included real-time CGM with the Dexcom system combined with any insulin delivery method.

“Inappropriate insulin regimens and errors in estimation and calculation can lead to suboptimal glycemic control,” explained Russell and team.

“Because all insulin doses, including meals, were determined autonomously by the living pancreas, the results of this study were based on qualitative meal notifications only, without pre-specified insulin regimens or carbohydrate calculations, and on living pancreases.” It suggests that good glycemic control can be achieved by either a user-initiated correction dose or adjustment of the insulin dose by the user or health care provider,” they added.

and Accompanying editorialsaid Jennifer Sher, M.D., Ph.D., Yale University School of Medicine, New Haven, Connecticut. What makes it important is that using this mode of insulin delivery really only constitutes one thing: type 1 diabetes.”

She said, “With a characterization that reflects the real-world experience of patients with type 1 diabetes, these findings will be readily generalizable to real-world applications of the technology once regulatory approval is obtained.” ” he pointed out.

The simplicity of the system is one of the most attractive features of the bionic pancreas, especially in regions where endocrinologists are sparse, because “the complexity of the systems available to date rarely prevents prescribing.” added Sherr.

In this study, Russell et al. recruited 326 participants aged 6 to 79 (mean age 28). Of those, he had 219 in the bionic pancreas group and 107 in the standard care group. His HbA1c at baseline ranged from 5.5% for him to 13.1% for him. About three-quarters were white, 10% black, and 10% Hispanic.

At screening, 31% used a hybrid closed-loop system, 31% used a non-automated insulin pump, 34% used multiple daily insulin injections, and 4% used a system with a predicted low-glucose suspension.

The most commonly reported adverse event with Bionic Pancreas was hyperglycemia (43%). Nearly all of the events in the Bionic Pancreas group were determined by medical monitors to be due to infusion set failure.