NCT02627911|CompletedPhase 2

Diabeloop WP6.2 : Crossover Evaluation of Glycemic Control

WP6-2

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 .

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète ClinicalTrials.gov

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1 other identifier

2015-A01294-45

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredDec 2015

StartedNov 2015

CompletionNov 2016

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Nov 2015

Shorter than P25 for phase_2

Geographic Reach

1 country

9 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1 year study duration

Study Start

First participant enrolled

November 1, 2015

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed

4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed

Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

9 months

First QC Date

December 7, 2015

Last Update Submit

November 18, 2016

Conditions

Closed Loop Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (13)

Percentage of time spent in the area glycemic reference 70-180 mg / dl during the night measured continuously for 3 days with CGM
during the night for 3 days for each period
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
during 3 days for each period
Measurement of time spent in blood glucose <70 mg / dl and blood glucose > 180 mg / dl
during 3 days for each period
Average blood glucose levels throughout the period and sub- periods: sedentarity, prandial and physical activity.
during 3 days for each period
Calculated risks of hypo- and hyperglycemia ( LBGI , HBGI ) throughout the period and sub- periods: physical inactivity, prandial and physical activity
during 3 days for each period
+8 more secondary outcomes

Study Arms (2)

Usual System (open-loop)

OTHER

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.

Device: Continuous Glucose MonitoringDevice: Accelerometer and heart rate monitorDietary Supplement: Meals

DIABELOOP System (closed-loop)

EXPERIMENTAL

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.

Device: Diabeloop SystemDevice: Continuous Glucose MonitoringDevice: Accelerometer and heart rate monitorDietary Supplement: Meals

Interventions

Diabeloop SystemDEVICE

Insulin delivery

DIABELOOP System (closed-loop)

Continuous Glucose MonitoringDEVICE

DIABELOOP System (closed-loop)Usual System (open-loop)

Accelerometer and heart rate monitorDEVICE

Monitoring and measurement of physical activity

DIABELOOP System (closed-loop)Usual System (open-loop)

MealsDIETARY_SUPPLEMENT

Calibrated meals for all patients and outstanding dinners for patients being in outstanding meals situation (Centers : Grenoble, Toulouse, Montpellier)

DIABELOOP System (closed-loop)Usual System (open-loop)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabètelead