Objective: Previous trials demonstrated an improvement of glycemic control with the single hormone closed-loop system Diabeloop DBLG1. Therefore, efficacy assessment of this system in real life situation is eagerly awaited. A preliminary analysis of glucose TIR (time-in-range) after a mean of 20 weeks of follow-up was previously communicated. The aim of this report is to present results of TIR and HbA1c after 6-month of follow-up.

Methods: After a run-in period with G6 sensor and usual pump, 25 patients with T1D in Corbeil-Essonne and Grenoble diabetes centers (France) were provided with the commercial setting of DBLG1 System (G6 sensor and Kaleido pump). They were taught to manage it during a one to five days hospitalization. Data on system parameters and glycemic control were collected from a cloud platform. We present here the results of TIR and HbA1c after 6 months of follow-up.

Results: Mean age of patients was 43 years (25-72) with a mean duration of diabetes of 19 years (2-43). All patients were already insulin pump users and 76% of patients were women. The run-in period lasted an average of 7 days (4-15). The mean HbA1c and TIR 70-180 mg/dL before DBLG1 System initiation were respectively 7.9% (5.6 to 8.5 %) [63mmol/mol, 38 to 69 mmol/mol] and 53% (21 to 85%). One patient decided to stop using the system after 2 months due to repeated system disconnections and was therefore excluded from the 6-months analysis. After a mean follow-up of 6 months, mean HbA1c decreased from 7.9% to 7.1% [63 to 54 mmol/mol] (p< 0.001*) and TIR 70-180 mg/dL increased from a mean of 53 to 67% (p<0.0001*). Moreover, TIR < 70 mg/dL decreased from a mean of 2.4 to 1.3% (p = 0.03*). No adverse event was reported. Closed loop was in functional mode for 85% of time. Conclusions: The DBLG1 System confirms its ability to significantly improve glycemic control in real life situation without serious adverse events.

Disclosure

C. Amadou: None. S. Franc: Consultant; Self; Diabeloop SA. P.Y. Benhamou: Consultant; Self; Abbott, Diabeloop SA, Eli Lilly and Company, Insulet Corporation, Novo Nordisk Inc., Sanofi. S. Lablanche: None. E. Huneker: Stock/Shareholder; Self; Diabeloop SA. G. Charpentier: Board Member; Self; Diabeloop SA. A. Penfornis: None.

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