Résumé
The objective of DCLP2 trial is to assess the efficacy and safety of home use of a Control-to-Range (CTR) closed-loop (CL) system in patients with type 1 diabetes (T1D) prone to hypoglycemia. The study design is a Randomized Clinical Trial with 2:1 randomization to intervention with a CL system vs. sensor and pump for 3 months followed by a 3-month extension phase in which the original control group switches to the CL system and the original intervention group continues to use the system. The hybrid CL system includes a Tandem t:slim X2 insulin pump with embedded CTR algorithm and the Dexcom G6 CGM. The control system is patient’s personal insulin pump and Dexcom G6 CGM in an open-loop mode. The primary outcome is baseline-treatment difference in time below 70 mg/dL measured by CGM after 3-month use of CL control versus CGM and pump. Secondary outcomes include no increase of time above target range in CL group vs. control group over 3 months, other metrics of glycemic control, and patient reported outcomes. From 117 screened adult T1D patients (>1 year), treated by insulin pump >6 months, with a Clarke score >3 and/or severe hypoglycemia during the previous 6 months and a third party support in case of severe hypoglycemic episode, in two French sites, 72 have been randomized after they showed during a 2-week run-in phase a time spent with Dexcom G6 CGM below 70 mg/dl of 5% or above. Available study data will be presented.