Last reviewed · How we verify

Exercise-induced Glycemic Variations and Hybrid Closed-loop Systems (SAFE-T1D)

NCT05736263 NA UNKNOWN

Type 1 diabetes is characterized by high risk of hypoglycemia and associated fear of hypoglycemia. Hypoglycemia risk is higher during and after physical activity, especially aerobic activity of long duration. Fear of hypoglycemia can result in avoidance of exercise or overcompensatory eating, both related to worse metabolic control and increased cardiometabolic risk. Hybrid closed-loop (HCL)systems have significantly improved risk of hypoglycemia. They also offer the possibility to set a temporary target for physical activity, further reducing the risk of hypoglycemia during physical activity. Although temporary target seems to work rather well with moderate-intensity aerobic exercise, little data is available for other types of exercise, like resistance exercise, high-intensity interval exercise, combined modalities of exercise, in which the temporary target seems to perform less well. The present study aims to test the performance of current HCL systems under different exercise conditions and evaluate the relationship between different exercise variables (recorded during exercise), physical activity variables (measured by accelerometry) and glycemic variations in HCL system users.

Details

Lead sponsorUniversity of Roma La Sapienza
PhaseNA
StatusUNKNOWN
Enrolment50
Start dateFri Mar 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionSun Dec 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

Italy