Feasibility Study of a Hybrid Closed-Loop System with Automated Insulin Correction Boluses.

Background: The Medtronic MiniMed™ 670G system adjusts basal insulin delivery in response to continuous glucose monitoring levels and is already in use in clinical practice. We tested the home-based feasibility of the new MiniMed advanced hybrid closed-loop (AHCL) system, which includes several algorithm enhancements and an optional autocorrection bolus mode.

Methods: Twelve adolescents and young adults (eight females) with type 1 diabetes [median (interquartile range)] aged 16.6 (15.9, 18.2) years and diabetes duration of 7.1 (4.7, 8.8) years] participated in this single-arm study. The first stage was a 6-day open-loop run-in period, with the predictive low-glucose suspend feature on. This was followed by 6 days/5 nights in a supervised hotel setting, using the AHCL system, including closed-loop challenges (missed meal bolus, late meal bolus, and physical activity); and finally, 3 weeks with unrestricted home use. Glycemic parameters were compared between the open-loop and closed-loop periods.

Results: Participants spent 93.3% (4.7) of the time in SmartGuard™ Auto Mode. Hemoglobin A1C levels decreased from median (interquartile range) 7.1% (6.7, 7.9) at baseline to 6.8% (6.6, 7.4) at study end, after 4 weeks (P = 0.0027). Time in range (TIR) (70-180 mg/dL) was 68.4% (10.6) and time below 70 mg/dL was 4% (3.5) during open-loop; and 74% (6.1) and 2.6% (1.9), respectively, during the closed-loop at home phase (P = 0.06, P = 0.27). TIR increased during the nighttime, from 64.6% (17.4) to 80.7% (7.8), P = 0.007, without change in time below 70 mg/dL (P = 0.15). No serious adverse events occurred.

Conclusions: The new AHCL system demonstrated safety and effectiveness in controlling day and night glucose levels.