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Completed

NCT Number: NCT02987556

Diabeloop WP7 : Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop (WP7)

The study will be conducted in crossover trial, with two 12-weeks periods separated by a Wash-out period of at least one month. According to randomization ,patients will be provided with either Diabeloop system or the usual system.

Patients will be trained for the use of blood glucose meter, of external Insulin Pump and Diabeloop system.

In both treatment periods, the same blood glucose meter will be used throughout the duration of the study.

In two centers (Centre Hospitalier Sud-Francilien and Grenoble), a pre-study will be performed during four weeks to improve the efficacy of Diabeloop system with data collection, to test the manual settings by health care providers and patients and to check the good-working of the follow-up platform.

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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

Not applicable

Primary location

Centre Hospitalier Universitaire 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 two years
  • Patient treated by external insulin pump for at least 6 months
  • Patient with HbA1c ≤ 10%; dosage of less than 4 months done in analysis laboratory medical or equivalent.
  • Patient requiring a daily dose of insulin ≤ 50 units
  • Patient domiciled in an area with Global System for Mobile Communication (GSM)
  • Not isolated patient, not living alone, or having a person "resource" living nearby and having a phone and the key of its place of residence
  • Patient not envisaging a journey outside France during the "closed-loop" period
  • 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

  • Patient with any serious illness that may impair study participation
  • Patient having a treatment known to have a significant interference on the glycemia.
  • Patient enjoying a measure of legal protection
  • Pregnant woman or likely to be

Treatment and study plan

Continuous glucose monitoring

Device

Collection of glucose data

External Insulin Pump

Device

insulin delivery

telemdecine

Other

Remote follow up by care health providers team

The Diabeloop Software (Model predictive control)

Device

Diabeloop is a Closed-loop (CL) system with a Model Predictive Control (MPC) algorithm reinforced by a decisional matrix, uploaded on a dedicated android smartphone linked to Dexcom CGM and a Cellnovo or Kaleido insulin patch-pump. The Diabeloop software calculates the insulin dose according to the patient's needs.

Primary outcomes

  1. Percentage of time spent in the tight glycemic control area 70-180 mg/dl continuously measured for 12 weeks

    Time frame: For 12 weeks

    measurement of glucose by CGM

Secondary outcomes

  1. Percentage of time spent in the glycemic range 70-180 mg/dl, 80-140 mg/dl and in blood glucose >180 mg/dL during nights and during 24 hours for 12 weeks

    Time frame: During 24 hours for 12 weeks

    measurement of glucose by CGM

  2. Measurement of HbA1c at the onset and at the end of each period of treatment

    Time frame: During 12 weeks for each period of treatment

    Dosage of HbA1c every 3 months

  3. Average blood glucose levels throughout the full period

    Time frame: During 12 weeks for each period of treatment

    measurement of glucose by CGM

  4. Calculated risks of hypo- and hyperglycemia (LBGI, HBGI) throughout the full period during 12 weeks

    Time frame: Throughout the full period during 12 weeks

    measurement of glucose by CGM

  5. Total supplies of insulin during tests

    Time frame: During 12 weeks for each period

    total basal and bolus by 24h

  6. Number of hyper-glycemic events defined by American Diabetes Association (ADA) : severe hyperglycemia > 360 mg/dl (20 mmol/l) measured by CGM or significant ketose (acetonemia > 3 mmol/l)

    Time frame: During 12 weeks for each period

    measurement of glucose by CGM

  7. Number of hypoglycemic events, defined by any threshold crossing 60 mg/dl ( 3,33 mmol/l); 70 mg/dl (3,9 mmol/l) and < 54 mg/dl (3 mmol/l) measured by the CGM

    Time frame: During 12 weeks for each period

    measurement of glucose by CGM

  8. Measuring the oral carbohydrates intake during the last week of each period of treatment

    Time frame: During 24 hours for one week before the end of each period of treatment

    data collected on a booklet

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

    Time frame: During 12 weeks for the closed loop period

    technical incidents data collected during the study

  10. Percentage of time spent in good-working mode during the closed loop period

    Time frame: During 12 weeks for the closed loop period

    measurement of glucose by CGM

  11. For the use and the acceptance, a satisfaction survey will be done on the daily management of diabetes, the modification of daily life with the system dan the fear of hypoglycemia

    Time frame: During 12 weeks at the end of each period of treatment

    DTSQ satisfaction questionnaire, with scale from 6 to 0 where 0 is the worth and 6 the best outcome.

  12. Percentage of time spent in blood glucose <70 mg/dl continuously measured for 12 weeks

    Time frame: For 12 weeks

    measurement of glucose by CGM

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop for Three Months at Home in Comparison With Conventional Treatment by External Insulin Pump in Patients With Type 1 Diabetes.

Acronym: WP7

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 9, 2016
Registry last updated
Feb 1, 2019

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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