Overview
Initial Testing of the Diabeloop Algorithm in T1D Patients on Pump Therapy Over the Prandial Period and Physical Activity.
Status:
Completed
Completed
Trial end date:
2013-07-01
2013-07-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The main objective is to assess if the Diabeloop algorithm provides better glycemic control than a "manual" usual algorithm of patients with type 1 diabetes treated by insulin pump during meals, and during activity qualified "moderate" to "severe" by the patients. The study will be conducted in 18 patients. The investigation centers are: CHSF (for Diabeloop algorithm test during activity), CHU of Grenoble and CHU of Toulouse (for Diabeloop algorithm test during meals.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
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 DiabèteTreatments:
Insulin
Insulin, Globin Zinc
Criteria
Inclusion Criteria:- Patients with type 1 diabetes treated by external insulin pump;
- Patients with HbA1c <8.5%.
- Patients aged 18 years or less;
- Patient who signed consent;
- Patient affiliated with Social Security.
For Grenoble and Toulouse Centers (Prandial algorithm test : MEAL):
- Patient is practicing functional insulin therapy is a fixed meal plan.
For CHSF center (test of algorithm during activity):
- Patient able to perform moderate or intense activity during 30 minutes.
Exclusion Criteria:
- Patients with type 2 diabetes
- All serious diseases that could interfere with the study
- Insulin resistance and obesity (BMI> 30 kg/m2 and / or insulin requirements> 2 U / kg
/ day)