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Closed LoopPhase 2WP6-2NCT02627911

Diabeloop WP6.2 : Crossover Evaluation of Glycemic Control

A Phase 2 study testing Diabeloop System, Continuous Glucose Monitoring and Accelerometer and heart rate monitor in people with Closed Loop and Diabetes Mellitus, Type 1, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 9 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Closed Loop, Diabetes Mellitus, Type 1
What is being tested?
Diabeloop System, Continuous Glucose Monitoring and Accelerometer and heart rate monitor
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
9 sitesFrance
Study dates
Nov 2015to Nov 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

France9 sites

  • Hôpital Jean Minjoz

    Besançon, 25030

  • Centre Hospitalier Universitaire

    Caen, 14033

  • Centre Hospitalier Sud-Francilien

    Corbeil-Essonnes, 91100

  • Centre Hospitalier Universitaire

    Grenoble, 38700

  • Centre Hospitalier Universitaire

    Marseille, 13000

  • Centre Hospitalier Universitaire

    Montpellier, 34295

  • Centre Hospitalier Universitaire

    Nancy, 54000

  • Centre Hospitalier Universitaire

    Strasbourg, 67000

  • Centre Hospitalier Universitaire

    Toulouse, 31400

Other trials in France

About this study

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 .

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.
Being tested
Diabeloop System, Continuous Glucose Monitoring, Accelerometer and heart rate monitor, Meals
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diabeloop SystemDevice

    Insulin delivery

  • Continuous Glucose MonitoringDevice

  • Accelerometer and heart rate monitorDevice

    Monitoring and measurement of physical activity

  • MealsDietary supplement

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

Study groups in NCT02627911
Study groupRoleWhat they receive
Usual System (open-loop)OtherIn 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.
Receives: Device: Continuous Glucose Monitoring; Device: Accelerometer and heart rate monitor; Dietary Supplement: Meals
DIABELOOP System (closed-loop)ExperimentalIn 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.
Receives: Device: Diabeloop System; Device: Continuous Glucose Monitoring; Device: Accelerometer and heart rate monitor; Dietary Supplement: Meals

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: during the night for 3 days for each period

Secondary outcomes (13)

  1. Percentage of time spent in the area glycemic reference 70-180 mg / dl during the night measured continuously for 3 days with CGM

    Measured: during the night for 3 days for each period

  2. 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

    Measured: during 3 days for each period

  3. Measurement of time spent in blood glucose <70 mg / dl and blood glucose > 180 mg / dl

    Measured: during 3 days for each period

  4. Average blood glucose levels throughout the period and sub- periods: sedentarity, prandial and physical activity.

    Measured: during 3 days for each period

  5. Calculated risks of hypo- and hyperglycemia ( LBGI , HBGI ) throughout the period and sub- periods: physical inactivity, prandial and physical activity

    Measured: during 3 days for each period

  6. Measuring the oral carbohydrates intake

    Measured: during 3 days for each period

  7. 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

    Measured: during 3 days for each period

  8. Total supplies of insulin during tests (total unit of insulin)

    Measured: during 3 days for each period

  9. Average peak postprandial glycemic according meals and delays occurred

    Measured: during 3 days for each period

  10. Number of technical problems causing interruptions of the closed loop

    Measured: during 3 days for the closed loop period

  11. 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 )

    Measured: during 3 days for each period

  12. Nadir glycemic means after physical activity and time of occurrence.

    Measured: during 3 days for each period

  13. Measurement of AUC during physical activity , the two hours, then to lunch time , during dinner and throughout the night

    Measured: during 3 days for each period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionAug 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02627911
Sponsor's protocol ID
2015-A01294-45
Acronym
WP6-2
Status last verified
Nov 2016
First submitted
7 Dec 2015
Last updated
21 Nov 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Diabeloop System, Continuous Glucose Monitoring and Accelerometer and heart rate monitor in people with Closed Loop and Diabetes Mellitus, Type 1, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 9 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02627911.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2016.

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