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Validation of the Artificial Pancreas Diabeloop Algorithm in the Hospital

NCT02101229 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2015-07-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Insulin, Asp(B28)-

the insulin dose is calculated by the "Diabeloop" algorithm and then administered to the patient

Sponsors & Collaborators

  • Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

    lead OTHER

Principal Investigators

  • Sylvia FRANC, MD · Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

  • Ahmed DAOUDI, MD · Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

  • Pierre-Yves BENHAMOU, Pr · CHU of Grenoble

  • Sandrine LABLANCHE, MD · CHU of Grenoble

  • Eric RENARD, Pr · CHU of Montpellier

  • Anne FARRET, MD · CHU of Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02101229 on ClinicalTrials.gov