Brief Therapeutic Update from PES Drugs and Therapeutics Committee
iLet ® Bionic Pancreas
On May 19, 2023, the U.S. Food and Drug Administration approved the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people 6 years of age and older with type 1 diabetes (1). These two devices are used with an approved continuous glucose monitor, Dexcom G6, to form the iLet ® Bionic Pancreas.
The iLet ® Bionic Pancreas (BP; Beta Bionics, Inc). is an automated insulin delivery system is designed to use body weight to initialize insulin delivery without requiring the input of any information about previous insulin dosing. In addition, it does not require a run-in or warm-up period before automated insulin delivery is commenced. The iLet Dosing Decision Software adjusts basal insulin according to sensor glucose readings. The system replaces the need for conventional carbohydrate counting with a qualitative meal announcement feature, for example, “Usual For Me,” “More”, or “Less” . The glucose target can be set between 110 and 130 mg/dl and can be adjusted through the day as needed. However, all insulin titrations, including for meals, are determined autonomously by the BP insulin-dosing algorithm, and cannot be modified by the user or health care team (2).
The recently published multicenter, randomized trial of BP in type 1 diabetes evaluated efficacy and safety of the iLet system compared to standard care in a cohort of 326 participants aged 6 to 79 years with type 1 diabetes (3). Participants were randomly assigned to BP (with insulin aspart or insulin lispro) or to standard care (defined as any insulin-delivery method, including hybrid closed looped systems, with unblinded, real-time continuous glucose monitoring). The HbA1c level decreased from 7.9% to 7.3% at 13 weeks in the BP group and did not change (7.7% at both time points) in the standard-care group (mean adjusted difference at 13 weeks, −0.5 percentage points; 95% confidence interval [CI], −0.6 to −0.3; P<0.001). The mean adjusted difference in the HbA1c level at 13 weeks was similar between adult and pediatric cohorts.
The key secondary outcome, percentage of time below 54 mg/dL as assessed by CGM, did not differ significantly between the two groups (13-week adjusted difference, 0.0 percentage points; 95% CI, −0.1 to 0.04; P<0.001 for noninferiority). No episodes of diabetic ketoacidosis occurred in either group. The difference in the percentage of time that the glucose level was in the target range of 70 to 180 mg/dL was 11 percentage points (95% CI, 9 to 13; P<0.001), which equated to an increase of 2.6 hours per day in the BP group. The difference in the percentage of time that the glucose level was > 180 mg/dL was -10 (95% CI, -12 to -8; P<0.001), favoring use of the BP.
Analysis of the pediatric subgroup, consisting of 165 participants (6-17 years old; mean 12±3), showed a mean HbA1c decrease from 8.1 ± 1.2% at baseline to 7.5 ± 0.7% at 13 weeks with BP versus 7.8 ± 1.1% at both baseline and 13 weeks with standard care (P<0.001). Participants with baseline HbA1c ≥9.0% in the BP group had a decrease in mean HbA1c from 9.7 ± 0.8% to 7.9 ± 0.6% after 13 weeks compared to 9.7 ± 0.5% to 9.8 ± 0.8% in the standard care group (P < 0.001). Over 13 weeks, mean time in range increased by 10% (2.4 h per day) and mean CGM glucose was reduced by 15 mg/dL in the BP group compared to the standard care group (P < 0.001) (4).
In a sub-analysis, a similar treatment effect of BP on change in HbA1c from baseline to 13 weeks was observed in both Whites and Minorities (decrease from 7.7 ± 1.1% to 7.2 ± 0.7% in Whites; decrease from 8.3 ± 1.5% to 7.4 ± 0.6% in Minorities). Time in range increased similarly among the Minorities group (5).
Rates of hypoglycemia were overall low; therefore, it was not possible to determine if the iLet Bionic Pancreas system reduces the rate of severe hypoglycemia.
- Kruger D, Kass A, Lonier J, et al. A Multicenter Randomized Trial Evaluating the Insulin-Only Configuration of the Bionic Pancreas in Adults with Type 1 Diabetes. Diabetes Technology & Therapeutics 2022;24(10):697-711.
- Russell SJ, Beck RW, Damiano ER, et al. Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes. New England Journal of Medicine 2022 Sept 29; 387(13):1161-1172.
- Messer L, Buckingham B, Cogen F, et al. Positive impact of the bionic pancreas on diabetes control in youth 6-17 years old with type 1 diabetes: a multicenter randomized trial. Diabetes Technology & Therapeutics 2022;24:712-725.
- Castellanos LE, Russell SJ, Damiano ER, et al. The insulin-only bionic pancreas improves glycemic control in non-hispanic white and minority adults and children with type 1 diabetes. Diabetes Care 2023;46(6):1185-1190.
Prepared on behalf of PES Drugs and Therapeutics Committee by Dania Al-Hamad, MD and Elizabeth Rosolowsky, MD, MPH
Last updated on: July 7, 2023