Diabeloop WP6.2 : Crossover Evaluation of Glycemic Control
NCT ID: NCT02627911
Last Updated: 2016-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
36 participants
INTERVENTIONAL
2015-11-30
2016-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Usual System (open-loop)
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.
Continuous Glucose Monitoring
Accelerometer and heart rate monitor
Monitoring and measurement of physical activity
Meals
Calibrated meals for all patients and outstanding dinners for patients being in outstanding meals situation (Centers : Grenoble, Toulouse, Montpellier)
DIABELOOP System (closed-loop)
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.
Diabeloop System
Insulin delivery
Continuous Glucose Monitoring
Accelerometer and heart rate monitor
Monitoring and measurement of physical activity
Meals
Calibrated meals for all patients and outstanding dinners for patients being in outstanding meals situation (Centers : Grenoble, Toulouse, Montpellier)
Interventions
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Diabeloop System
Insulin delivery
Continuous Glucose Monitoring
Accelerometer and heart rate monitor
Monitoring and measurement of physical activity
Meals
Calibrated meals for all patients and outstanding dinners for patients being in outstanding meals situation (Centers : Grenoble, Toulouse, Montpellier)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
OTHER
Responsible Party
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Locations
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Hôpital Jean Minjoz
Besançon, , France
Centre Hospitalier Universitaire
Caen, , France
Centre Hospitalier Sud-Francilien
Corbeil-Essonnes, , France
Centre Hospitalier Universitaire
Grenoble, , France
Centre Hospitalier Universitaire
Marseille, , France
Centre Hospitalier Universitaire
Montpellier, , France
Centre Hospitalier Universitaire
Nancy, , France
Centre Hospitalier Universitaire
Strasbourg, , France
Centre Hospitalier Universitaire
Toulouse, , France
Countries
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Other Identifiers
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2015-A01294-45
Identifier Type: -
Identifier Source: org_study_id