Real-life Follow-up of the Physical Activity in Type 1 Diabetes Participants Equipped With an Insulin Pump With Hybrid Closed Loop

This is a non-interventional, prospective, multi-site study conducted in France among adults with type 1 diabetes mellitus using automated insulin delivery (AID) systems and engaging in at least two exercise sessions per week, each lasting at least 30 minutes. The main objective of this study is to describe the glycemic control of athletic participants with type 1 diabetes mellitus who use an insulin pump with AID and engage in physical exercise under real-life conditions. Two physician data collection time points are planned: the first occurs at baseline and includes demographic and clinical data, glycemic control during the month preceding inclusion, diabetes management, and information on usual physical exercise (duration, type, sport practiced, competition participation, and adherence to a specific diet). The second occurs at 1-month follow-up and involves downloading insulin pump and glucose sensor data, covering the period from 15 days before the first reported exercise session to 15 days after the last session. During the 1-month study period, participants will complete a paper logbook after each exercise session to document information such as the type of exercise, self-reported intensity using the modified Borg scale and the WHO physical activity intensity scale, duration, system adjustments, dietary intake, occurrence of hypoglycemia and associated symptoms, snacks consumed, and treatments administered for hypoglycemia.

NCT Number	NCT07015970
Lead Sponsor	ISIS Diabete Service
Conditions	Diabetes Mellitus Type 1, Glucose Metabolism Disorder, Glycemic Control for Diabetes Mellitus, Fear of Hypoglycemia, Treatment Satisfaction, Quality of Life, Hypoglycaemia
Enrollment	87 participants
Start Date	2024-03-05
Primary Completion	2024-12-15 (estimated)
Study Completion	2024-12-15 (estimated)
Updated on ClinicalTrials.gov	2026-01-26