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

November 18, 2016 updated by: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

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 .

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25030
        • Hôpital Jean Minjoz
      • Caen, France, 14033
        • Centre Hospitalier Universitaire
      • Corbeil-Essonnes, France, 91100
        • Centre Hospitalier Sud-Francilien
      • Grenoble, France, 38700
        • Centre Hospitalier Universitaire
      • Marseille, France, 13000
        • Centre Hospitalier Universitaire
      • Montpellier, France, 34295
        • Centre Hospitalier Universitaire
      • Nancy, France, 54000
        • Centre Hospitalier Universitaire
      • Strasbourg, France, 67000
        • Centre Hospitalier Universitaire
      • Toulouse, France, 31400
        • Centre Hospitalier Universitaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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.
Device: Continuous Glucose Monitoring
Device: Accelerometer and heart rate monitor
Monitoring and measurement of physical activity
Dietary supplement: Meals
Calibrated meals for all patients and outstanding dinners for patients being in outstanding meals situation (Centers : Grenoble, Toulouse, Montpellier)
Experimental: 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.
Device: Continuous Glucose Monitoring
Device: Accelerometer and heart rate monitor
Monitoring and measurement of physical activity
Dietary supplement: Meals
Calibrated meals for all patients and outstanding dinners for patients being in outstanding meals situation (Centers : Grenoble, Toulouse, Montpellier)
Device: Diabeloop System
Insulin delivery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
during the night for 3 days for each period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
Time Frame: during 3 days for each period
during 3 days for each period
Measurement of time spent in blood glucose <70 mg / dl and blood glucose > 180 mg / dl
Time Frame: during 3 days for each period
during 3 days for each period
Average blood glucose levels throughout the period and sub- periods: sedentarity, prandial and physical activity.
Time Frame: during 3 days for each period
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
Time Frame: during 3 days for each period
during 3 days for each period
Measuring the oral carbohydrates intake
Time Frame: during 3 days for each period
during 3 days for each period
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
during 3 days for each period
Total supplies of insulin during tests (total unit of insulin)
Time Frame: during 3 days for each period
during 3 days for each period
Average peak postprandial glycemic according meals and delays occurred
Time Frame: during 3 days for each period
during 3 days for each period
Number of technical problems causing interruptions of the closed loop
Time Frame: during 3 days for the closed loop period
during 3 days for the closed loop period
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
during 3 days for each period
Nadir glycemic means after physical activity and time of occurrence.
Time Frame: during 3 days for each period
during 3 days for each period
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
during 3 days for each period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015-A01294-45

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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