NCT02101229

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

9 months

First QC Date

March 21, 2014

Last Update Submit

July 29, 2015

Conditions

Type 1 Diabetes

Keywords

Glycemic control algorithmclosed loopartificial pancreas

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    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

Study Arms (2)

unsual treatment

NO INTERVENTION

The patient will have his usual treatment in this arm

The Diabeloop algorithm

EXPERIMENTAL

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)-

Interventions

Insulin, Asp(B28)-DRUG

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

Also known as: NovoRapid insulin
The Diabeloop algorithm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre Hospitalier du Sud Francillien

Évry, 91058, France

Location

University Hospital of Grenoble

Grenoble, 38043, France

Location

University Hospital of Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2014

First Posted

April 2, 2014

Study Start

May 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

July 30, 2015

Record last verified: 2015-07

Locations

FR(3)