Validation of the Artificial Pancreas Diabeloop Algorithm in the Hospital

Type 1 Diabetes Clinical Trial

— WP6-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101229
• Other study ID #: 2013-A01657-38
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 21, 2014
• Last updated: July 29, 2015
• Start date: May 2014
• Est. completion date: February 2015

Study information

• Verified date: July 2015
• Source: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

Drug:
• Insulin, Asp(B28)-
the insulin dose is calculated by the "Diabeloop" algorithm and then administered to the patient

Locations

Country	Name	City	State
France	Centre Hospitalier du Sud Francillien	Evry
France	University Hospital of Grenoble	Grenoble
France	University Hospital of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time spent in blood glucose range [70-180 mg/dl]	comparing the time spent in [70-180 mg/dl] with usual algorithm vs Diabeloop algorithm.	up to 24 hours after each treatment period	Yes
Secondary	Time spent Blood Glucose range [80-140 mg/dl]	Comparing the time spent in range [80-140 mg/dl] with usual algorithm vs Diabeloop algorithm	24 hours after each treatment period	Yes
Secondary	time spent below 70 mg/dl and above 180 mg/dl		up to 24 hours after each treatment period	Yes