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

• ClinicalTrials.gov Identifier: NCT02987556
• Recruitment Status: Completed
• First Posted: December 9, 2016
• Last Update Posted: February 1, 2019
• Sponsor: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
• Information provided by (Responsible Party): Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Closed Loop; Diabetes Mellitus, Type 1	Device: Continuous Glucose Monitoring; Device: External Insulin Pump; Other: telemdecine; Device: The Diabeloop Software (Model predictive control)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Closed loop vs. Open loop,
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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.
• Actual Study Start Date: March 30, 2017
• Actual Primary Completion Date: August 28, 2018
• Actual Study Completion Date: August 28, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Usual System (open-loop); In open loop, patients will be provided with an Continuous Glucose Monitoring (CGM) and an external insulin pump programmed with its usual treatment previously prescribed by its physician.	Device: Continuous Glucose Monitoring; Collection of glucose data; Device: External Insulin Pump; insulin delivery
Experimental: DIABELOOP System (closed-loop); In the closed-loop, patients will be provided with the Diabeloop system consisting of insulin pump Cellnovo or Kaleido driven by remote control augmented by Diabeloop software and connected to the CGM Prescription of insulin doses proposed by a predictive algorithm.	Device: Continuous Glucose Monitoring; Collection of glucose data; Device: External Insulin Pump; insulin delivery; Other: telemdecine; Remote follow up by care health providers team; Device: The Diabeloop Software (Model predictive control); 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

France

Centre Hospitalier Universitaire Jean Minjoz

Besancon, France, 25030

Centre Hospitalier Universitaire

Caen, France, 14033

Centre Hospitalier Sud-Francilien

Corbeil-Essonnes, France, 91100

Centre Hospitalier Universitaire

Grenoble, France, 38700

Centre Hospitalier Universitaire

Lyon, France, 69000

Centre Hospitalier Universitaire

Marseille, France, 13000

Centre Hospitalier Universitaire

Montpellier, France, 34295

Centre Hospitalier Universitaire

Nancy, France, 54000

Centre Hospitalier Universitaire

Nantes, France, 44000

Centre Hospitalier Universitaire

Reims, France, 51100

Centre Hospitalier Universitaire

Strasbourg, France, 67000

Centre Hospitalier Universitaire

Toulouse, France, 31400

Sponsors and Collaborators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Benhamou PY, Huneker E, Franc S, Doron M, Charpentier G; Diabeloop Consortium. Customization of home closed-loop insulin delivery in adult patients with type 1 diabetes, assisted with structured remote monitoring: the pilot WP7 Diabeloop study. Acta Diabetol. 2018 Jun;55(6):549-556. doi: 10.1007/s00592-018-1123-1. Epub 2018 Mar 9.

• Responsible Party: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
• ClinicalTrials.gov Identifier: NCT02987556
• Other Study ID Numbers: 2016-A01198-43
• First Posted: December 9, 2016
• Last Update Posted: February 1, 2019
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

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