NCT02101229

Validation of the Artificial Pancreas Diabeloop Algorithm in the Hospital

Diabeloop WP6-1 : Validation of the Artificial Pancreas Diabeloop Algorithm in the Hospital

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 17 (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

To assess whether the DIABELOOP algorithm provides better glycemic control than the usual algorithm of T1D patients on pump therapy: * at meals, with CHO roughly assessed by the patient. * during and after physical activity sessions qualified as moderate by the patient. Primary endpoint : time within the glycemic reference range. The study will be conduct with 15 patients at the following investigation centers : Corbeil Hospital, CHU of Grenoble, and CHU of Montpellier.

Detailed description

The 15 patients will have 2 visits during 24 hours (day and night), once with their usual algorithm and once with the Diabeloop system.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	Insulin, Asp(B28)-	the insulin dose is calculated by the "Diabeloop" algorithm and then administered to the patient

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2014-04-02
• Last updated: 2015-07-30

Locations

3 sites across 1 country: France