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

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Insulin, Asp(B28)-

About this trial

This is an interventional health services research trial for Type 1 Diabetes focused on measuring Glycemic control algorithm, closed loop, artificial pancreas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Centre Hospitalier du Sud Francillien
University Hospital of Grenoble
University Hospital of Montpellier

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

unsual treatment

The Diabeloop algorithm

Arm Description

The patient will have his usual treatment in this arm

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT02101229

First Posted

March 21, 2014

Last Updated

July 29, 2015

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT02101229

Brief Title

Validation of the Artificial Pancreas Diabeloop Algorithm in the Hospital

Acronym

WP6-1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

Keywords

Glycemic control algorithm, closed loop, artificial pancreas

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

unsual treatment

Arm Type

No Intervention

Arm Description

The patient will have his usual treatment in this arm

Arm Title

The Diabeloop algorithm

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Insulin, Asp(B28)-

Other Intervention Name(s)

NovoRapid insulin

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

up to 24 hours after each treatment period

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

24 hours after each treatment period

Title

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

Time Frame

up to 24 hours after each treatment period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: