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Completed

NCT Number: NCT02101229

Validation of the Artificial Pancreas Diabeloop Algorithm in the Hospital

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Hospital of Grenoble, Grenoble, France

Loading trial locations.

About this study

The 15 patients will have 2 visits during 24 hours (day and night), once with their usual algorithm and once with the Diabeloop system.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin, Asp(B28)-

Drug

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

Other names: NovoRapid insulin

Primary outcomes

  1. Time spent in blood glucose range [70-180 mg/dl]

    Time frame: up to 24 hours after each treatment period

    comparing the time spent in [70-180 mg/dl] with usual algorithm vs Diabeloop algorithm.

Secondary outcomes

  1. Time spent Blood Glucose range [80-140 mg/dl]

    Time frame: 24 hours after each treatment period

    Comparing the time spent in range [80-140 mg/dl] with usual algorithm vs Diabeloop algorithm

  2. time spent below 70 mg/dl and above 180 mg/dl

    Time frame: up to 24 hours after each treatment period

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: WP6-1

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 2, 2014
Registry last updated
Jul 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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