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Completed

NCT Number: NCT02627911

Diabeloop WP6.2 : Crossover Evaluation of Glycemic Control

The study will be conducted in crossover trial, with two 72-hour hospitalization separated by a period Wash-out of at least one week. Each hospitalization is a period of treatment. According to randomization, patients will be provided with either Diabeloop system or the usual system.

In both treatment periods:

* patients in a situation of sedentarity or physical activity, will be equipped with ActiGraph (measuring motricity) and a ActiHeart ( measuring heart rate) * meals and physical activities will be similar in both periods * the same blood glucose meter will be used throughout the duration of the study. * the capillary blood glucose will be performed : before bolus and 2 hours after a meal, before exercise, in case of hypo or hyper-glycemic episodes and when the patient and / or investigator deem it necessary.

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Key information

Conditions

Closed Loop 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

Primary location

Hôpital Jean Minjoz, Besançon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 1 diabetic patient for at least one year, treated by external insulin pump for at least 6 months
  • Patient with 7.5 % < HbA1c < 9.5 %
  • Patient practicing functional insulin therapy
  • In the situation of physical activity , the patient must be able to perform one or more daily physical activities for 3 days in each treatment session
  • Patient aged over 18 years
  • Patient affiliated to Social Security
  • Patient who agreed to participate in the study and who signed an informed consent

Exclusion criteria

  • Type 2 diabetic patients
  • Any serious illness that may impair study participation*
  • Patient with insulin resistance defined in insulin requirements > 1.5 U / kg / day
  • Patient no longer sensing his hypoglycemia
  • Patient enjoying a measure of legal protection
  • Pregnant woman or likely to be

Treatment and study plan

Diabeloop System

Device

Insulin delivery

Continuous glucose monitoring

Device

Accelerometer and heart rate monitor

Device

Monitoring and measurement of physical activity

Meals

Dietary Supplement

Calibrated meals for all patients and outstanding dinners for patients being in outstanding meals situation (Centers : Grenoble, Toulouse, Montpellier)

Primary outcomes

  1. Percentage of time spent in the tight glycemic control area 80-140 mg / dl during the night, continuously measured for 3 days with CGM

    Time frame: during the night for 3 days for each period

Secondary outcomes

  1. Percentage of time spent in the area glycemic reference 70-180 mg / dl during the night measured continuously for 3 days with CGM

    Time frame: during the night for 3 days for each period

  2. Percentage of time spent in the glycemic range 70-180 mg / dl at d3 versus d1 during closed-loop period comparing with d3 versus d1 during open-loop period

    Time frame: during 3 days for each period

  3. Measurement of time spent in blood glucose <70 mg / dl and blood glucose > 180 mg / dl

    Time frame: during 3 days for each period

  4. Average blood glucose levels throughout the period and sub- periods: sedentarity, prandial and physical activity.

    Time frame: during 3 days for each period

  5. Calculated risks of hypo- and hyperglycemia ( LBGI , HBGI ) throughout the period and sub- periods: physical inactivity, prandial and physical activity

    Time frame: during 3 days for each period

  6. Measuring the oral carbohydrates intake

    Time frame: during 3 days for each period

  7. Number of hypoglycemic events , defined by any threshold crossing 70 mg / dL ( 3.9 mml / L) , and < 54 mg / dL ( 3 mmol / l ) measured by the CGM

    Time frame: during 3 days for each period

  8. Total supplies of insulin during tests (total unit of insulin)

    Time frame: during 3 days for each period

  9. Average peak postprandial glycemic according meals and delays occurred

    Time frame: during 3 days for each period

  10. Number of technical problems causing interruptions of the closed loop

    Time frame: during 3 days for the closed loop period

  11. Comparison of postprandial blood glucose sensor 2h , 3h and 4h and AUC in identical conditions of meals, to evaluate the efficacy and safety ( time spent in hypoglycemia, hyperglycemia and euglycemia )

    Time frame: during 3 days for each period

  12. Nadir glycemic means after physical activity and time of occurrence.

    Time frame: during 3 days for each period

  13. Measurement of AUC during physical activity , the two hours, then to lunch time , during dinner and throughout the night

    Time frame: during 3 days for each 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 WP6.2 : Crossover Evaluation of Glycemic Control Provided for Three Days by the Artificial Pancreas Diabeloop Compared to Conventional Treatment by External Insulin Pump in Patients With Type 1 Diabetes in Sedentary Position, Outstanding Meals and Physical Activity .

Acronym: WP6-2

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 11, 2015
Registry last updated
Nov 21, 2016

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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