Clinical Experience with the Hybrid Closed-Loop Insulin Delivery System (MinimedTM 670G) compared to Sensor Augmented Therapy (MiniMedTM 640G) and standard care

Abstract

Background: This real-world clinical study compared the efficacy of a hybrid closed-loop system (HCL) to a sensor integrated pump (SIP) system and usual care. Methods: Twenty-four subjects aged 8 to 65 years were randomly selected from 6 clinical centers to take part in this prospective study. Subjects were on a variety of standard care programs at base-line (Phase 1) and then used SIP for two months (Phase 2) followed by two months on HCL (Phase 3). Results: Compared with baseline, the mean HbA1c for the cohort reduced by 0.37% after 2 months of SIP therapy and by 0.7% after 2 months of HCL therapy. At study end, the mean HbA1c for the cohort was 7.2%. Time in severe hypoglycemia reduced to 0.4% (0.7% at baseline) for both SIP and HCL therapies. Time below 70 mg/dl reduced progressively between Phase 1 (baseline therapy), Phase 2 (SIP) and Phase 3 (HCL) (6%, 2.5% and 1.5% respectively) of the study. In the study intervention arms, less time was spent above 180 mg/dl (32.1% with SIP and 25.5% with HCL) versus 37% at baseline. The mean time-in-range (TIR) achieved was 72.5% with HCL, versus 65.2% with SIP (58.3% at baseline). Similarly, 50% of the subjects achieved a TIR of over 70% on HCL versus 33% on SIP (8% at baseline). Conclusions: This small, prospective, real-world study demonstrated that irrespective of the starting parameters, SIP therapy reduced mean HbA1c levels, TIR and hypoglycemic events. Implementation of an HCL system enhanced these outcomes further.