Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes

Sue Brown (1) , Boris Kovatchev (2) , Dan Raghinaru (3) , John Lum (4) , Bruce Buckingham (5) , Yogish Kudva , Lori Laffel , Carol Levy , Jordan Pinsker , R. Paul Wadwa , Eyal Dassau , Francis Doyle , Stacey Anderson , Mei Mei Church , Vikash Dadlani , Laya Ekhlaspour , Gregory Forlenza , Elvira Isganaitis , David Lam (6) , Craig Kollman , Roy Beck

1 University of Virginia
2 Department of Molecular Medicine [Tampa]
3 Stanford School of Medicine [Stanford]
4 Mayo Clinic [Rochester]
5 HMS - Harvard Medical School [Boston]
6 UL - Université de Lorraine

BACKGROUND: Closed-loop systems that automate insulin delivery may improve glycemic outcomes in patients with type 1 diabetes. METHODS: In this 6-month randomized, multicenter trial, patients with type 1 diabetes were assigned in a 2:1 ratio to receive treatment with a closed-loop system (closed-loop group) or a sensor-augmented pump (control group). The primary outcome was the percentage of time that the blood glucose level was within the target range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter), as measured by continuous glucose monitoring. CONCLUSIONS: In this 6-month trial involving patients with type 1 diabetes, the use of a closed-loop system was associated with a greater percentage of time spent in a target glycemic range than the use of a sensor-augmented insulin pump. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases; iDCL ClinicalTrials.gov number, NCT03563313.).

Domaines: Médecine humaine et pathologie; Sciences pharmaceutiques

Sue Brown, Boris Kovatchev, Dan Raghinaru, John Lum, Bruce Buckingham, et al.. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. New England Journal of Medicine, 2019, 381 (18), pp.1707-1717. ⟨10.1056/NEJMoa1907863⟩. ⟨hal-02555438⟩