NCT02627911

Diabeloop WP6.2 : Crossover Evaluation of Glycemic Control

DIABELOOP WP6.2 : Crossover Evaluation of Glycemic Control Provided for Three Days by the Artificial Pancreas Diabeloop Compared to Conventional Treatment by External Insulin Pump in Patients With Type 1 Diabetes in Sedentary Position, Outstanding Meals and Physical Activity .

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will be conducted in crossover trial, with two 72-hour hospitalization separated by a period Wash-out of at least one week. Each hospitalization is a period of treatment. According to randomization, patients will be provided with either Diabeloop system or the usual system. In both treatment periods: * patients in a situation of sedentarity or physical activity, will be equipped with ActiGraph (measuring motricity) and a ActiHeart ( measuring heart rate) * meals and physical activities will be similar in both periods * the same blood glucose meter will be used throughout the duration of the study. * the capillary blood glucose will be performed : before bolus and 2 hours after a meal, before exercise, in case of hypo or hyper-glycemic episodes and when the patient and / or investigator deem it necessary.

Conditions

• Closed Loop
• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	Diabeloop System	Insulin delivery
DEVICE	Continuous Glucose Monitoring
DEVICE	Accelerometer and heart rate monitor	Monitoring and measurement of physical activity
DIETARY_SUPPLEMENT	Meals	Calibrated meals for all patients and outstanding dinners for patients being in outstanding meals situation (Centers : Grenoble, Toulouse, Montpellier)

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-08-01
• Completion: 2016-11-01
• First posted: 2015-12-11
• Last updated: 2016-11-21

Locations

9 sites across 1 country: France