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Diabeloop WP6.2 : Crossover Evaluation of Glycemic Control (WP6-2)

Primary Purpose

Closed Loop, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Diabeloop System
Continuous Glucose Monitoring
Accelerometer and heart rate monitor
Meals
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 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

Sites / Locations

  • Hôpital 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Usual System (open-loop)

DIABELOOP System (closed-loop)

Arm Description

In open loop, the patient will be provided with its usual pump and a CGM. To estimate rest and physical activity in patients being sedentary situation ( Centers : Caen, Nancy & Strasbourg) or in situations of physical activity ( Centers : CHSF Marseille and Besancon ) , the usual system will be complemented by an accelerometer " ActiGraph " and a " ActiHeart " heart rate monitor.

In the closed loop, the patient's pump will be replaced by the Diabeloop system consisting of insulin pump Cellnovo driven by remote control augmented by Diabeloop software and connected to the CGM.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of time spent in the area glycemic reference 70-180 mg / dl during the night measured continuously for 3 days with CGM
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
Measurement of time spent in blood glucose <70 mg / dl and blood glucose > 180 mg / dl
Average blood glucose levels throughout the period and sub- periods: sedentarity, prandial and physical activity.
Calculated risks of hypo- and hyperglycemia ( LBGI , HBGI ) throughout the period and sub- periods: physical inactivity, prandial and physical activity
Measuring the oral carbohydrates intake
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
Total supplies of insulin during tests (total unit of insulin)
Average peak postprandial glycemic according meals and delays occurred
Number of technical problems causing interruptions of the closed loop
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 )
Nadir glycemic means after physical activity and time of occurrence.
Measurement of AUC during physical activity , the two hours, then to lunch time , during dinner and throughout the night

Full Information

First Posted
December 7, 2015
Last Updated
November 18, 2016
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
NCT02627911
Brief Title
Diabeloop WP6.2 : Crossover Evaluation of Glycemic Control
Acronym
WP6-2
Official 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 .
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
November 2016 (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

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

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
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual System (open-loop)
Arm Type
Other
Arm Description
In open loop, the patient will be provided with its usual pump and a CGM. To estimate rest and physical activity in patients being sedentary situation ( Centers : Caen, Nancy & Strasbourg) or in situations of physical activity ( Centers : CHSF Marseille and Besancon ) , the usual system will be complemented by an accelerometer " ActiGraph " and a " ActiHeart " heart rate monitor.
Arm Title
DIABELOOP System (closed-loop)
Arm Type
Experimental
Arm Description
In the closed loop, the patient's pump will be replaced by the Diabeloop system consisting of insulin pump Cellnovo driven by remote control augmented by Diabeloop software and connected to the CGM.
Intervention Type
Device
Intervention Name(s)
Diabeloop System
Intervention Description
Insulin delivery
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitoring
Intervention Type
Device
Intervention Name(s)
Accelerometer and heart rate monitor
Intervention Description
Monitoring and measurement of physical activity
Intervention Type
Dietary Supplement
Intervention Name(s)
Meals
Intervention Description
Calibrated meals for all patients and outstanding dinners for patients being in outstanding meals situation (Centers : Grenoble, Toulouse, Montpellier)
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
Measurement of time spent in blood glucose <70 mg / dl and blood glucose > 180 mg / dl
Time Frame
during 3 days for each period
Title
Average blood glucose levels throughout the period and sub- periods: sedentarity, prandial and physical activity.
Time Frame
during 3 days for each period
Title
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
Title
Measuring the oral carbohydrates intake
Time Frame
during 3 days for each period
Title
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
Title
Total supplies of insulin during tests (total unit of insulin)
Time Frame
during 3 days for each period
Title
Average peak postprandial glycemic according meals and delays occurred
Time Frame
during 3 days for each period
Title
Number of technical problems causing interruptions of the closed loop
Time Frame
during 3 days for the closed loop period
Title
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
Title
Nadir glycemic means after physical activity and time of occurrence.
Time Frame
during 3 days for each period
Title
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

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 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
Facility Information:
Facility Name
Hôpital Jean Minjoz
City
Besançon
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
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
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Toulouse
ZIP/Postal Code
31400
Country
France

12. IPD Sharing Statement

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Diabeloop WP6.2 : Crossover Evaluation of Glycemic Control

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