Previous trials demonstrated a 8.6% per protocol (PP) improvement with the single hormone closed-loop system Diabeloop’s DBLG1 (2017, with Cellnovo pump), then a 14.0% PP improvement (2018 with the Kaleido pump). The objective of the present study was to evaluate the efficacy and safety of the closed-loop system DBLG1 with an improved algorithm and the Kaleido pump, in patients with type 1 diabetes (T1D) in real life situation.
25 non selected T1D patients in Corbeil and Grenoble diabetes centers, after a 2-week run-in period with G6 sensor and usual pump, were provided with the commercial setting of DBLG1 System with an improved algorithm. They were taught to manage it , during a day-hospitalization, and were checked during a visit, the day after. There was no structured remote monitoring.
After 20 weeks follow-up, compared to run-in period, time in range (TIR) 70-180 mg/dl, improved by 17.1% (53.7% v 70.8%), TIR 50 – 70 mg/dl was halved (2.38% v 1.20%). TIR<50 mg/dl was very low (0.15% v 0.15%), TIR> 250 mg/dl decreased by 2/3 (17.7% v 7.3%). Mean blood glucose decreased from 179.4 mg/dl to 157.5 mg/dl. Satisfaction of patients was great, there was no adverse events due to the algorithm, and the only complaint was about frequent system disconnection. Nevertheless, closed loop was in functional mode for 88% of time during the 20 average weeks of the survey.
The DBLG1 System is able to largely improve glycemic control in real life situation, without serious adverse events.