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In data published in the New England Journal of Medicine, 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 (NIDDK), 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.
“Keeping tight control over blood glucose is important in managing diabetes and is the best way to prevent complications like eye, nerve, kidney, and cardiovascular disease down the road," said Guillermo Arreaza-Rubín, MD director of NIDDK’s diabetes technology program, in a statement. “The bionic pancreas technology introduces a new level of ease to the day-to-day management of type 1 diabetes, which may contribute to improved quality of life.”
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.
“Our observation that this system can safely improve glucose control to the degree we found, and do so despite requiring much less input from users and their health care providers, has important implications for children and adults living with diabetes,” said Steven Russell, MD, study chair and associate professor of medicine at Harvard Medical School, in the aforementioned statement.
This study, “Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes,” was published in the New England Journal of Medicine.