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

Primary Purpose

Closed Loop, Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Continuous Glucose Monitoring
External Insulin Pump
telemdecine
The Diabeloop Software (Model predictive control)
Sponsored by
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Closed Loop

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire Jean Minjoz
  • Centre Hospitalier Universitaire
  • Centre Hospitalier Sud-Francilien
  • Centre Hospitalier Universitaire
  • Centre Hospitalier Universitaire
  • Centre Hospitalier Universitaire
  • Centre Hospitalier Universitaire
  • Centre Hospitalier Universitaire
  • Centre Hospitalier Universitaire
  • Centre Hospitalier Universitaire
  • Centre Hospitalier Universitaire
  • Centre Hospitalier Universitaire

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual System (open-loop)

DIABELOOP System (closed-loop)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Measurement of HbA1c at the onset and at the end of each period of treatment
Dosage of HbA1c every 3 months
Average blood glucose levels throughout the full period
measurement of glucose by CGM
Calculated risks of hypo- and hyperglycemia (LBGI, HBGI) throughout the full period during 12 weeks
measurement of glucose by CGM
Total supplies of insulin during tests
total basal and bolus by 24h
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
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
Measuring the oral carbohydrates intake during the last week of each period of treatment
data collected on a booklet
Number of technical problems causing interruptions of the closed loop
technical incidents data collected during the study
Percentage of time spent in good-working mode during the closed loop period
measurement of glucose by CGM
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.
Percentage of time spent in blood glucose <70 mg/dl continuously measured for 12 weeks
measurement of glucose by CGM

Full Information

First Posted
November 28, 2016
Last Updated
January 30, 2019
Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
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1. Study Identification

Unique Protocol Identification Number
NCT02987556
Brief Title
Diabeloop WP7 : Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop (WP7)
Acronym
WP7
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
August 28, 2018 (Actual)
Study Completion Date
August 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Closed Loop, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Closed loop vs. Open loop,
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual System (open-loop)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
DIABELOOP System (closed-loop)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitoring
Intervention Description
Collection of glucose data
Intervention Type
Device
Intervention Name(s)
External Insulin Pump
Intervention Description
insulin delivery
Intervention Type
Other
Intervention Name(s)
telemdecine
Intervention Description
Remote follow up by care health providers team
Intervention Type
Device
Intervention Name(s)
The Diabeloop Software (Model predictive control)
Intervention Description
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 Outcome Measure Information:
Title
Percentage of time spent in the tight glycemic control area 70-180 mg/dl continuously measured for 12 weeks
Description
measurement of glucose by CGM
Time Frame
For 12 weeks
Secondary Outcome Measure Information:
Title
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
Description
measurement of glucose by CGM
Time Frame
During 24 hours for 12 weeks
Title
Measurement of HbA1c at the onset and at the end of each period of treatment
Description
Dosage of HbA1c every 3 months
Time Frame
During 12 weeks for each period of treatment
Title
Average blood glucose levels throughout the full period
Description
measurement of glucose by CGM
Time Frame
During 12 weeks for each period of treatment
Title
Calculated risks of hypo- and hyperglycemia (LBGI, HBGI) throughout the full period during 12 weeks
Description
measurement of glucose by CGM
Time Frame
Throughout the full period during 12 weeks
Title
Total supplies of insulin during tests
Description
total basal and bolus by 24h
Time Frame
During 12 weeks for each period
Title
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)
Description
measurement of glucose by CGM
Time Frame
During 12 weeks for each period
Title
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
Description
measurement of glucose by CGM
Time Frame
During 12 weeks for each period
Title
Measuring the oral carbohydrates intake during the last week of each period of treatment
Description
data collected on a booklet
Time Frame
During 24 hours for one week before the end of each period of treatment
Title
Number of technical problems causing interruptions of the closed loop
Description
technical incidents data collected during the study
Time Frame
During 12 weeks for the closed loop period
Title
Percentage of time spent in good-working mode during the closed loop period
Description
measurement of glucose by CGM
Time Frame
During 12 weeks for the closed loop period
Title
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
Description
DTSQ satisfaction questionnaire, with scale from 6 to 0 where 0 is the worth and 6 the best outcome.
Time Frame
During 12 weeks at the end of each period of treatment
Title
Percentage of time spent in blood glucose <70 mg/dl continuously measured for 12 weeks
Description
measurement of glucose by CGM
Time Frame
For 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Centre Hospitalier Universitaire Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Centre Hospitalier Sud-Francilien
City
Corbeil-Essonnes
ZIP/Postal Code
91100
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Grenoble
ZIP/Postal Code
38700
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Toulouse
ZIP/Postal Code
31400
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32958628
Citation
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.
Results Reference
derived
PubMed Identifier
33323237
Citation
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.
Results Reference
derived
PubMed Identifier
29520615
Citation
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.
Results Reference
derived

Learn more about this trial

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

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