STABILOOP, a cohort trial to assess automated insulin delivery in the management of patients living with type 1 diabetes who are eligible for islet transplantation

Abstract

A limited subset of people living with type 1 diabetes (T1D) is affected by extreme glycemic lability and frequent unpredictable severe hypoglycemia, significantly impairing quality of life and associated with higher morbidity, mortality, and healthcare costs. Islet transplantation (IT) has demonstrated efficacy in stabilizing glucose control and preventing severe hypoglycemia in these people, but it carries risks related to the procedure and chronic immunosuppression. Automated insulin delivery (AID) has emerged as a new standard of care for T1D, offering significant improvements in glycemic control. However, the efficacy of AID in patients with high glucose variability, who are eligible for IT, remains poorly evaluated. This study aims to assess the suitability of AID as a therapeutic option for these people. This prospective, multicenter cohort study involves six clinical centers experienced in both IT and AID systems. All patients referred for unstable T1D management will be considered for enrollment. According to patient’s preference, registration for IT will be processed after inclusion, or AID will be initiated and IT could be later processed according to AID outcomes. Data will include clinical, glucose control, and quality of life assessments over a follow-up period of up to 4 years. For study analysis, participants will be categorized into three groups: (1) patients immediately registered for IT, (2) patients achieving improved glycemic stability under AID, and (3) patients in whom AID fails to achieve adequate glycemic control. The primary endpoint is the proportion of patients experiencing severe hypoglycemia under AID therapy. Secondary endpoints include changes in glucose metrics based upon continuous glucose monitoring (CGM), quality of life measurements, clinical evolution, and the medico-economic impact of IT versus AID. This first study of AID in patients eligible for islet transplantation includes clinical, psychosocial, and economic outcomes. Its strengths are the comprehensive evaluation and real-world design. Findings will support evidence-based guidance for treating severe glycemic instability in T1D. n°38RC24.0169, NCT07006272, name: Cohort Study to Refine the Positioning of Closed-loop Therapy Versus Islet Transplantation in the Management of Patients With Unstable Type 1 Diabetes, Version 1.0_10.12.24. Registered on June 5, 2025.