Treatment with a bionic pancreas reduced glycated hemoglobin levels more than standard treatment in patients with type 1 diabetes, according to study findings published in the New England Journal of Medicine.
Bionic pancreas devices use algorithms to determine and deliver all insulin doses based on body weight data and qualitative input regarding carbohydrate intake at each meal. This allows dose adaptability only by the device and not the user. Researchers sought to determine the safety and efficacy of an insulin-only bionic pancreas for adults and children with type 1 diabetes.
For the analysis, researchers conducted a 13-week, multicenter, randomized trial (ClinicalTrials.gov Identifier: NCT04200313) in adults and children with type 1 diabetes. Study participants were randomly assigned to receive treatment with an insulin-only configuration of the bionic pancreas (n=219; mean age (SD), 28 years) or standard care (n=107; mean age, 28 years). The primary outcome was the level of glycated hemoglobin at 13 weeks.
Glycated hemoglobin levels dropped from 7.9% at baseline to 7.3% after 13 weeks of treatment in the bionic pancreas group compared with the standard care group, which remained unchanged after 13 weeks (7.7% at baseline and 13 weeks) (-0.5 percentage point difference; 95% CI, -0.6 to -0.3; P <.001).
Additionally, patients in the bionic pancreas group maintained lower mean glucose levels, spent more time (2.6 hours/day) in the target glucose range, and spent less time in a hyperglycemic state per glucose monitoring than patients in the standard care group.
Severe hypoglycemia occurred at a rate of 17.7 events per 100 participant-years in the bionic pancreas group compared with a rate of 10.8 events per 100 participant-years in the standard care group (P =.39). No participants in either group experienced diabetic ketoacidosis.
“Since all insulin doses, including for meals, were autonomously determined by the bionic pancreas, the results of this trial suggest that good glycemic control can be achieved by the bionic pancreas with only qualitative meal announcements and without a prespecified insulin regimen, carbohydrate counting, user-initiated correction doses, or any adjustment of the insulin dose by the user or health care provider,” the study authors wrote.
Study limitations include the inability to assess whether the bionic pancreas treatment reduced severity and risk of hypoglycemia because of the low frequency of baseline hypoglycemia in this group, the variety of methods used for reporting and managing hyperglycemia and ketosis throughout the trial, the use of a single type of infusion set in the bionic pancreas group, and the increased number of unscheduled contacts in the bionic pancreas group compared with the standard care group.
This article originally appeared on Gastroenterology Advisor
Russell SJ, Beck RW, Damiano ER, et al; Bionic Pancreas Research Group. Multicenter, randomized trial of a bionic pancreas in type 1 diabetes. N Engl J Med. 2022;387(13):1161-1172. doi:10.1056/NEJMoa2205225