Validation of the Artificial Pancreas Diabeloop Algorithm in the Hospital

Phase 2

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: Insulin, Asp(B28)-

• Registration Number: NCT02101229
• Lead Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Brief 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.

Study Timeline

• Study First Submitted: 2014-03-21
• Study First Submitted QC: 2014-03-28
• Study First Posted: 2014-04-02
• Study Start: 2014-05
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-29
• Last Update Posted: 2015-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
The Diabeloop algorithm	Insulin, Asp(B28)-	In this arm, the insulin Asp(B28) dose is calculated by the algorithm based on the usual treatment of the patient, the ratio I / C, the intensity of physical activity and blood glucose sensor.

Primary Outcome Measures

Name	Time	Method
Time spent in blood glucose range [70-180 mg/dl]	up to 24 hours after each treatment period	comparing the time spent in \[70-180 mg/dl\] with usual algorithm vs Diabeloop algorithm.

Secondary Outcome Measures

Name	Time	Method
Time spent Blood Glucose range [80-140 mg/dl]	24 hours after each treatment period	Comparing the time spent in range \[80-140 mg/dl\] with usual algorithm vs Diabeloop algorithm
time spent below 70 mg/dl and above 180 mg/dl	up to 24 hours after each treatment period

Trial Locations

Locations (3)

University Hospital of Montpellier; 🇫🇷 Montpellier, France

Centre Hospitalier du Sud Francillien; 🇫🇷 Evry, France

University Hospital of Grenoble; 🇫🇷 Grenoble, France