The iLet Bionic Pancreas was associated with improved glycemic control and time in target glucose range compared to standard care in a cohort of people with type 1 diabetes aged 6-79 years of age.
Full data from the 13-week trial of the iLet insulin-only bionic pancreas details the improvements in glycemic control achieved with use of the bionic pancreas in adults and children with type 1 diabetes aged from as young as 6 years old and up to 79 years of age.
With funding from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDKD), results of the 13-week, randomized trial suggest use of BetaBionic’s iLet bionic pancreas was associated with greater reductions in HbA1c than standard care, with those using a bionic pancreas experience a greater percentage of time in range as well.
“In this multicenter, randomized trial involving adults and children with type 1 diabetes, the use of the insulin-only configuration of a bionic pancreas was associated with a lower glycated hemoglobin level, a lower mean glucose level, an increase of 2.6 hours per day in the target glucose range, and less time in a hyperglycemic state without an increase in the incidence of hypoglycemia as assessed by continuous glucose monitoring,” wrote investigators.
Since initial data demonstrated feasibility of the system, the prospect of the iLet bionic pancreas has been looked upon by many as the next great advance in diabetes technology. The current trial was conducted with an interest in exploring the technology against usual care for improving glycemic control among patients with type 1 diabetes.
A 13-week, multicenter, parallel-group, unblinded, randomized trial, the trial people aged 6-79 years of age with type 1 diabetes to receive the bionic pancreas with insulin aspart or insulin lispro or to standard care, which was defined as any insulin-delivery method with unblinded, real-time continuous glucose monitoring. Conducted at 16 centers in the US, the trial had a primary outcome of interest of HbA1c at 13 weeks and a secondary outcome of interest of percentage of time in a target glucose range below 54 mg/dL.
A total of 326 individuals were identified for inclusion in the trial between January 4, 2021, and July 7, 2021, with 219 randomized to the bionic pancreas group and 107 randomized to standard care. This cohort had an observed range of HbA1c from 5.5-13.1% at baseline.
Upon analysis, results indicated the mean HbA1c decreased from 7.9% at baseline to 7.2% at week 13 in the bionic pancreas group and did not change in the standard-care group, which remained at 7.7% at both time points (adjusted between-group difference: -0.5 percentage points [95% CI, -0.6 to -0.3]; P <.001 for noninferiority). When assessing the secondary outcome of interest, results indicated the percentage of time in target glucose range below 54 mg/dL did not differ significantly between either group (adjusted difference, 0.0 percentage points [95% CI, −0.1 to 0.04]; P <.001 for noninferiority).
In safety analyses, results indicated the rate of severe hypoglycemia was 17.7 events per 100 participant-years in the bionic pancreas group compared to 10.8 events per 100 participant-years (P=.39). Investigators highlighted there were also no episodes of diabetic ketoacidosis occurred in either arm of the trial.
“In this 13-week, multicenter, randomized trial, adults and children with type 1 diabetes who had been randomly assigned to automated glycemic control with a bionic pancreas had lower glycated hemoglobin levels than participants in the standard-care group, who were using insulin therapy augmented by continuous glucose monitoring,” investigators added.
1. Bionic Pancreas Research Group. Multicenter, randomized trial of a bionic pancreas in type 1 diabetes. N Engl J Med. 2022 Sep 29;387(13):1161-1172. doi: 10.1056/NEJMoa2205225.