Validation of the Artificial Pancreas Diabeloop Algorithm in the Hospital

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète; Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
• Treatments: Insulin; Insulin, Globin Zinc; Pancreatin; Pancrelipase

Criteria

Inclusion Criteria:

• Patient type 1 diabetic for at least one year

• Patient treated by external insulin pump for at least 6 months

• Patients with HbA1c <9%

• Patient affiliated with Social Security.

• Patient able to perform two tests of physical activity of 30 minutes (one event in each treatment period);

• aged at least 18 years Patient;

• Patient who signed consent

Exclusion Criteria:

• All serious disease that could interfere with the study

• BMI > 30 kg/m2

• insulin requirement > 2 U/kg/day

• Patient benefiting from a measure of legal protection;

• Pregnant or likely to be women.