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

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.

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1; Closed Loop
• Intervention / Treatment: Device: Continuous Glucose Monitoring; Device: External Insulin Pump; Other: telemdecine; Device: The Diabeloop Software (Model predictive control)

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besancon, France, 25030
    • Centre Hospitalier Universitaire Jean Minjoz
  • Caen, France, 14033
    • Centre Hospitalier Universitaire
  • Corbeil-Essonnes, France, 91100
    • Centre Hospitalier Sud-Francilien
  • 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
    • Centre Hospitalier Universitaire

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of time spent in the tight glycemic control area 70-180 mg/dl continuously measured for 12 weeks	measurement of glucose by CGM	For 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	measurement of glucose by CGM	During 24 hours for 12 weeks
Measurement of HbA1c at the onset and at the end of each period of treatment	Dosage of HbA1c every 3 months	During 12 weeks for each period of treatment
Average blood glucose levels throughout the full period	measurement of glucose by CGM	During 12 weeks for each period of treatment
Calculated risks of hypo- and hyperglycemia (LBGI, HBGI) throughout the full period during 12 weeks	measurement of glucose by CGM	Throughout the full period during 12 weeks
Total supplies of insulin during tests	total basal and bolus by 24h	During 12 weeks for each period
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)	measurement of glucose by CGM	During 12 weeks for each period
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	measurement of glucose by CGM	During 12 weeks for each period
Measuring the oral carbohydrates intake during the last week of each period of treatment	data collected on a booklet	During 24 hours for one week before the end of each period of treatment
Number of technical problems causing interruptions of the closed loop	technical incidents data collected during the study	During 12 weeks for the closed loop period
Percentage of time spent in good-working mode during the closed loop period	measurement of glucose by CGM	During 12 weeks for the closed loop period
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	DTSQ satisfaction questionnaire, with scale from 6 to 0 where 0 is the worth and 6 the best outcome.	During 12 weeks at the end of each period of treatment
Percentage of time spent in blood glucose <70 mg/dl continuously measured for 12 weeks	measurement of glucose by CGM	For 12 weeks

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Benhamou PY, Madrolle S, Lablanche S, Gallegos A, Tourki Y, Franc S, Doron M, Charpentier G. Comment on Leelarathna et al. Duration of Hybrid Closed-Loop Insulin Therapy to Achieve Representative Glycemic Outcomes in Adults With Type 1 Diabetes. Diabetes Care 2020;43:e38-e39. Diabetes Care. 2020 Oct;43(10):e167. doi: 10.2337/dc20-1291. No abstract available.
• Benhamou PY, Franc S, Reznik Y, Thivolet C, Schaepelynck P, Renard E, Guerci B, Chaillous L, Lukas-Croisier C, Jeandidier N, Hanaire H, Borot S, Doron M, Jallon P, Xhaard I, Melki V, Meyer L, Delemer B, Guillouche M, Schoumacker-Ley L, Farret A, Raccah D, Lablanche S, Joubert M, Penfornis A, Charpentier G; DIABELOOP WP7 Trial Investigators. Closed-loop insulin delivery in adults with type 1 diabetes in real-life conditions: a 12-week multicentre, open-label randomised controlled crossover trial. Lancet Digit Health. 2019 May;1(1):e17-e25. doi: 10.1016/S2589-7500(19)30003-2. Epub 2019 May 2.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2017
• Primary Completion (Actual): August 28, 2018
• Study Completion (Actual): August 28, 2018

Study Registration Dates

• First Submitted: November 28, 2016
• First Submitted That Met QC Criteria: December 6, 2016
• First Posted (Estimate): December 9, 2016

Study Record Updates

• Last Update Posted (Actual): February 1, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 2016-A01198-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No