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

C

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

Status and phase

Completed
Phase 3
Phase 2

Conditions

Type 1 Diabetes

Treatments

Drug: Insulin, Asp(B28)-

Study type

Interventional

Funder types

Other

Identifiers

NCT02101229
2013-A01657-38

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

17 participants in 2 patient groups

unsual treatment
No Intervention group
Description:
The patient will have his usual treatment in this arm
The Diabeloop algorithm
Experimental group
Description:
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.
Treatment:
Drug: Insulin, Asp(B28)-

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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