In a 13-week trial of 219 adults and children with type 1 diabetes, levels of glycated hemoglobin were significantly lower with the use of a bionic pancreas than with standard care, researchers report. The bionic pancreas delivers either insulin aspart or insulin lispro; standard care was defined as any insulin-delivery method with unblinded, real-time continuous glucose monitoring.
The iLet bionic pancreas (Beta Bionics) is initialized only on the basis of body weight (not previous basal of bolus settings). Insulin dosing begins immediately. At mealtime, patients can enter “usual for me,” “more, or “less” to estimate its carbohydrate content. Insulin doses are determined by an algorithm that adapts to the patient’s needs, and the patient cannot determine or modify insulin doses.
Based on a primary efficacy endpoint of glycated hemoglobin level at 13 weeks, the investigators determined: “The glycated hemoglobin level decreased from 7.9% to 7.3% in the bionic-pancreas group and did not change (was at 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 percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter 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). The rate of severe hypoglycemia was 17.7 events per 100 participant-years in the bionic-pancreas group and 10.8 events per 100 participant-years in the standard-care group (P = 0.39). No episodes of diabetic ketoacidosis occurred in either group.”
Editorial: “Academic societies have altered clinical practice guidelines and standards of medical care to highlight the recommendation that automated insulin delivery should be considered in all persons with diabetes who can safely use available technology,” writes an editorialist. “Now, the goal will be to ensure that access to such technologies is not limited because of insurance coverage or perceptions about who may be an ‘ideal’ candidate for such treatment. Recent registry data have highlighted the finding that the provision of subsidized continuous glucose monitors has led to an exponential growth in sensor use, with a concomitant reduction in glycated hemoglobin levels that were maintained over a 2-year period. These results are impressive, but there is no doubt that automated insulin delivery will be even more promising in the outcomes that it will achieve. In fact, although population-based studies show that rates of death and cardiovascular disease have decreased over time among persons with type 1 diabetes, a gap exists when comparisons are made with rates in the general population. The time is now to close this chasm, and simplified, automated insulin delivery, as with the bionic pancreas, may be the solution.”