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

Diabeloop WP6-1 : 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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Drug: Insulin, Asp(B28)-

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• France
  • Evry, France, 91058
    • Centre Hospitalier du Sud Francillien
  • Grenoble, France, 38043
    • University hospital of Grenoble
  • Montpellier, France, 34295
    • University Hospital of Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: unsual treatment; The patient will have his usual treatment in this arm
Experimental: The Diabeloop algorithm; 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.	Drug: Insulin, Asp(B28)-; the insulin dose is calculated by the "Diabeloop" algorithm and then administered to the patient; Other Names: NovoRapid insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
time spent below 70 mg/dl and above 180 mg/dl		up to 24 hours after each treatment period

Collaborators and Investigators

• Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
• Investigators: Principal Investigator: Sylvia Franc, MD, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète; Principal Investigator: Ahmed DAOUDI, MD, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète; Principal Investigator: Pierre-Yves BENHAMOU, Pr, CHU of Grenoble; Principal Investigator: Sandrine LABLANCHE, MD, CHU of Grenoble; Principal Investigator: Eric RENARD, Pr, CHU of MONTPELLIER; Principal Investigator: Anne FARRET, MD, CHU of MONTPELLIER

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: March 21, 2014
• First Submitted That Met QC Criteria: March 28, 2014
• First Posted (Estimate): April 2, 2014

Study Record Updates

• Last Update Posted (Estimate): July 30, 2015
• Last Update Submitted That Met QC Criteria: July 29, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: artificial pancreas; closed loop; Glycemic control algorithm
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: 2013-A01657-38