Diabeloop - Under Project 6.0 (UP 6.0)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
ClinicalTrials.gov Identifier:
NCT01754181
First received: December 18, 2012
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

The main objective is to assess if the Diabeloop algorithm provides better glycemic control than a "manual" usual algorithm of patients with type 1 diabetes treated by insulin pump during meals, and during activity qualified "moderate" to "severe" by the patients.

The study will be conducted in 18 patients. The investigation centers are: CHSF (for Diabeloop algorithm test during activity), CHU of Grenoble and CHU of Toulouse (for Diabeloop algorithm test during meals.


Condition Intervention Phase
Type 1 Diabetes
Drug: Insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Development of the Glycemic Control Algorithm, in Prandial and Physical Effort Situations.

Resource links provided by NLM:


Further study details as provided by Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète:

Primary Outcome Measures:
  • Time spent in glucose reference intervals [ Time Frame: After the end of the tests ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measuring glucose sensor 2h, 3h and 4h post-prandial and AUC, in every situation tested to evaluate the efficacy and safety (time spent in hypoglycemia) [ Time Frame: After the end of the tests ] [ Designated as safety issue: Yes ]
    To evaluate the efficacy and safety of prandial algorithm, informed carbohydrate intake by the patient either quantitatively or semi-quantitative, or not informed way.


Other Outcome Measures:
  • Comparison of glucose sensor 2h, 3h and 4h post-prandial and AUC in conditions identical meals for each trigger level (50 or 75%). Measuring AUC during and 2 hours after physical activity, then to lunch time, during dinner and throughout the night. [ Time Frame: After the end of the tests ] [ Designated as safety issue: Yes ]
    1. Comparison of glucose sensor 2h, 3h and 4h post-prandial and AUC, in conditions identical meals for each trigger level (50 or 75%).
    2. Comparison of blood glucose 2h, 3h and 4h post-prandial and AUC, in conditions identical meals for each trigger level, in three configurations: quantitative, semi-quantitative and bolus omitted.
    3. Measuring AUC, during and 2 hours after physical activity, then to lunch time, during dinner and throughout the night;
    4. Measure the time spent in hypoglycemia (<0.70 g / l)
    5. Measuring the number of carbohydrate ingested


Enrollment: 18
Study Start Date: March 2013
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proposed treatment by Diabeloop algorithm
the insulin 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
the intervention is applied only at the dose of insulin
No Intervention: usual treatment

Detailed Description:
  • Grenoble and Toulouse will test the prandial algorithm with several carbohydrate intake and a primer of 50% or 75% of the total bolus. Groups of patients are described as follows:

    • Group I: patients have a meal with the usual carbohydrate intake. The meal bolus is made according to the current treatment.
    • Group II: patients have a meal with a "low" carbohydrate intake (50% reduction of carbohydrate).
    • Group III: patients have a meal with a "strong" carbohydrate intake (increase 50% of carbohydrate).
    • Group IV: patients of group IV have each meal with carbohydrate intake but their usual bolus will be omitted.
    • Inclusion visit V1: The study will be proposed at the patients who meet the inclusion criteria. After signing the consent, the investigator shall designate one group for each patient.
    • Visit V2 (24 hours before the visit V3): Installation, calibration and education of two glucose sensors dexcom G4 ™ will be performed by a nurse. The patient will keep two sensors until the end of the study (end of V4).
    • Visit V3 (algorithm test): Patient will be fitted with its insulin pump and the two sensors dexcom G4 ™. These will be coupled by the engineer LETI to the computer on which is installed the control algorithm to be tested. Lunch will be taken at 1 pm. The algorithm will provide proposals insulin every 15 minutes until 6 pm.
    • Visit V4 (patient control): Patient will be fitted with two sensors dexcom G4 ™ and its insulin pump programmed according to the usual algorithm. The meal will be taken at 1h PM. Patient can leave the site at 6 pm after removal of sensors.
  • CHSF (Centre Hospitalier Sud Francilien) will test the algorithm glycemic control during physical activity of moderate (50% VO2max) or high intensity (75% VO2max) for 30 minutes on a bicycle ergometer. In different situations, three patient groups will be created:

    • Group A: Patients practice an "average" physical activity(50% VO2max) with usual temporary basal reduction (usually 50% of reduction during the test and 2h next).
    • Group B: Patients practice an "intense" physical activity (75% VO2max) with usual temporary basal reduction (usually 80% of reduction during the test and 2h after).
    • Group C: patients practice an "average" physical activity (50% VO2max) but without concomitant reduction of temporary basal.
    • Inclusion visit V1 : The study will be proposed at the patients who meet the inclusion criteria. After signing the consent, the investigator shall designate one group for each patient.
    • Visit V2 : Patient will be equipped with two sensors dexcom G4 ™ and a heart rate monitor. Calibrated meal is expected at 11h 30 pm. The patient will be administered his insulin dose according to his usual algorithm. The physical test will begin three hours after the meal. It will be carried on bicycle ergometer for 30 minutes at an medium or high intensity. (Average = 50% VO2max, or high level = 75% VO2max).
    • Visit V3: The same test is repeated for each patient during this visit. Its insulin pump will be controlled by the doses proposal of the algorithm after manual validation by the investigator. These will continue until the next morning, and the patient will spend overnight in the hospital.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with type 1 diabetes treated by external insulin pump;
  • Patients with HbA1c <8.5%.
  • Patients aged 18 years or less;
  • Patient who signed consent;
  • Patient affiliated with Social Security.

For Grenoble and Toulouse Centers (Prandial algorithm test : MEAL):

  • Patient is practicing functional insulin therapy is a fixed meal plan.

For CHSF center (test of algorithm during activity):

  • Patient able to perform moderate or intense activity during 30 minutes.

Exclusion Criteria:

  • Patients with type 2 diabetes
  • All serious diseases that could interfere with the study
  • Insulin resistance and obesity (BMI> 30 kg/m2 and / or insulin requirements> 2 U / kg / day)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754181

Locations
France
Centre Hospitalier Sud Francilien
Evry, France, 91058
University Hospital of Grenoble
Grenoble, France, 38043
University Hospital of Toulouse
Toulouse, France, 31403
Sponsors and Collaborators
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: Pierre-Yves BENHAMOU, Pr. CHU of Grenoble
Study Chair: Guillaume CHARPENTIER, MD Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
  More Information

No publications provided

Responsible Party: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
ClinicalTrials.gov Identifier: NCT01754181     History of Changes
Other Study ID Numbers: 2012-A01489-34
Study First Received: December 18, 2012
Last Updated: September 26, 2013
Health Authority: France : The National Security Agency of Medicines and Health Products (ANSM; old AFSSAPS)

Keywords provided by Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète:
Glycemic control algorithm
closed loop
artificial pancreas

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014