Search

This study aims to assess the interoperability of Diabeloop’s DBLG1 Closed Loop System on glycemic control for T1D patients, based on data from clinical trials NCT02987556[1] (SP7) and NCT04190277 (SP8). SP7 study was conducted on 63 out of 68 patients randomly assigned to two arms equipped with DBLG1 system using Cellnovo pump for arm 1 and Kaleido pump for arm 2. All patients attended a 12-week open loop (OL) phase (receiving their usual treatment) and a 12-week closed loop (CL) phase (using DBLG1 system). In SP8 study, 178 out of 184 patients, randomly assigned to two arms, started with a 2-week baseline phase in OL. The next 12 weeks, patients in arm 2 remained in OL while patients in arm 1 switched to CL equipped with DBLG1 System using DANA Diabecare-i insulin pump. The study was shortened due to COVID-19 epidemic. To assess the improvement reached by DBLG1 System, we compared the average time in range 70-180 mg/dL (TIR) between OL and active CL phases. For SP7 study, we analysed data from both arms. For SP8 study, to assess the TIRs for the same patients, we compared baseline and CL phases for arm 1. As shown in Figure 1, for SP7 the average TIRs increased by 8.6% for arm 1 (32 patients) and by 14.0% for arm 2 (31 patients in CL, 30 in OL). For SP8 arm 1 the average TIR increased by 12.8% (142 patients). DBLG1 System improved the TIR despite the use of 3 different pumps. Therefore, improvement linked with DBLG1 System on the average TIR is independent of the pump used. Disclosure A. Adenis: Employee; Self; Diabeloop SA. L. Pou: Employee; Self; Diabeloop SA. H. M. Romero-ugalde: Employee; Self; Diabeloop SA. Y. Tourki: Employee; Self; Diabeloop SA. S. Franc: Advisory Panel; Self; Diabeloop SA, Board Member; Self; Novo Nordisk, Other Relationship; Self; Abbott Diabetes, Research Support; Self; Merck Sharp & Dohme Corp., Stock/Shareholder; Self; Diabeloop SA. G. Charpentier: Other Relationship; Self; Diabeloop. P. Y. Benhamou: Consultant; Self; Diabeloop SA, Eli Lilly and Company, Insulet Corporation, Other Relationship; Self; Abbott Diabetes. M. Doron: Research Support; Self; Diabeloop SA. E. Huneker: Employee; Self; Diabeloop SA.