Evaluation of an Automated Priming Bolus for Improving Prandial Glucose Control in Full Closed Loop Delivery

Background: Automated insulin delivery (AID) is widely available to people with type 1 diabetes (T1D), providing superior glycemic control versus traditional methods. The next generation of AID devices focus on minimizing user/device interactions, especially around meals ("full closed loop," [FCL]). Our goal was to assess the postprandial glycemic impact of the bolus priming system (BPS), an algorithm delivering fixed insulin doses based on the likelihood of a meal having occurred, in conjunction with UVA's latest AID. Method: Eleven adults with T1D participated in a supervised randomized-crossover trial assessing glycemic control during two 24-h sessions with identical meals and activity-with and without BPS. On the day in-between study sessions, participants underwent food and activity challenges to test BPS safety and robustness. Continuous glucose monitor (CGM) outcomes and total insulin doses were assessed overall and following meals with potential for BPS to dose additional insulin (CGM >90 mg/dL for 1 h prior). Results: Daytime CGM outcomes were similar with and without BPS: time-in-range (TIR) 70-180 mg/dL 70.6% [62.2-76.5] versus 65.7% [58.6%-80.6%]; time-below-range <70 mg/dL 0% [0-2.1] versus 0% [0-1.3]; respectively. Insulin delivery during 3 h postprandial was indistinguishable 33.5 U [26.4-47.0] versus 35.7 U [28.7-44.9]. Among 43 out of 66 meals with potential to trigger BPS (24/19 BPS/no-BPS), postprandial incremental area-under-the-curve (iAUC) was lower for BPS versus no-BPS (2530 ± 1934 versus 3228 ± 2029, P = 0.047), but CGM outcomes were inconclusive: 4-h-TIR 51.2% [19.8-83.3] versus 40.2% [20.8-56.3] (P = 0.24). There were no severe adverse events. Conclusion: While there was no difference in TIR, when BPS was active an improved postprandial AUC in FCL was obtained via earlier insulin injection.