Clinical trial NCT02101229: Validation of the Artificial Pancreas Diabeloop Algorithm in the Hospital
Official title: Diabeloop WP6-1 : Validation of the Artificial Pancreas Diabeloop Algorithm in the Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type 1 Diabetes
Keywords: Glycemic control algorithm
closed loop
artificial pancreas
Lead sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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.

Primary outcomes:
measure: Time spent in blood glucose range [70-180 mg/dl]
timeFrame: up to 24 hours after each treatment period
Secondary outcomes:
measure: Time spent Blood Glucose range [80-140 mg/dl]
timeFrame: 24 hours after each treatment period
measure: time spent below 70 mg/dl and above 180 mg/dl
timeFrame: up to 24 hours after each treatment period
Other outcomes:
Locations:
city: Evry
country: France
facility: Centre Hospitalier du Sud Francillien
city: Grenoble
country: France
facility: University Hospital of Grenoble
city: Montpellier
country: France
facility: University Hospital of Montpellier
Study officials:
affiliation: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
name: Sylvia FRANC, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
name: Ahmed DAOUDI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU of Grenoble
name: Pierre-Yves BENHAMOU, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU of Grenoble
name: Sandrine LABLANCHE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU of Montpellier
name: Eric RENARD, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU of Montpellier
name: Anne FARRET, MD
role: PRINCIPAL_INVESTIGATOR
References: