NCT02987556|Completed

Diabeloop WP7 : Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop (WP7)

WP7

Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop for Three Months at Home in Comparison With Conventional Treatment by External Insulin Pump in Patients With Type 1 Diabetes.

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

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1 other identifier

2016-A01198-43

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredDec 2016

StartedMar 2017

CompletionAug 2018

Brief Summary

The study will be conducted in crossover trial, with two 12-weeks periods separated by a Wash-out period of at least one month. According to randomization ,patients will be provided with either Diabeloop system or the usual system. Patients will be trained for the use of blood glucose meter, of external Insulin Pump and Diabeloop system. In both treatment periods, the same blood glucose meter will be used throughout the duration of the study. In two centers (Centre Hospitalier Sud-Francilien and Grenoble), a pre-study will be performed during four weeks to improve the efficacy of Diabeloop system with data collection, to test the manual settings by health care providers and patients and to check the good-working of the follow-up platform.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Mar 2017

Geographic Reach

1 country

12 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

1.4 years study duration

First Submitted

Initial submission to the registry

November 28, 2016

Completed

11 days until next milestone

First Posted

Study publicly available on registry

December 9, 2016

Completed

4 months until next milestone

Study Start

First participant enrolled

March 30, 2017

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2018

Completed

Last Updated

February 1, 2019

Status Verified

May 1, 2018

Enrollment Period

1.4 years

First QC Date

November 28, 2016

Last Update Submit

January 30, 2019

Conditions

Closed Loop Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

Percentage of time spent in the tight glycemic control area 70-180 mg/dl continuously measured for 12 weeks
measurement of glucose by CGM
For 12 weeks

Secondary Outcomes (12)

Percentage of time spent in the glycemic range 70-180 mg/dl, 80-140 mg/dl and in blood glucose >180 mg/dL during nights and during 24 hours for 12 weeks
During 24 hours for 12 weeks
Measurement of HbA1c at the onset and at the end of each period of treatment
During 12 weeks for each period of treatment
Average blood glucose levels throughout the full period
During 12 weeks for each period of treatment
Calculated risks of hypo- and hyperglycemia (LBGI, HBGI) throughout the full period during 12 weeks
Throughout the full period during 12 weeks
Total supplies of insulin during tests
During 12 weeks for each period
+7 more secondary outcomes

Study Arms (2)

Usual System (open-loop)

ACTIVE COMPARATOR

In open loop, patients will be provided with an Continuous Glucose Monitoring (CGM) and an external insulin pump programmed with its usual treatment previously prescribed by its physician.

Device: Continuous Glucose MonitoringDevice: External Insulin Pump

DIABELOOP System (closed-loop)

EXPERIMENTAL

In the closed-loop, patients will be provided with the Diabeloop system consisting of insulin pump Cellnovo or Kaleido driven by remote control augmented by Diabeloop software and connected to the CGM Prescription of insulin doses proposed by a predictive algorithm.

Device: Continuous Glucose MonitoringDevice: External Insulin PumpOther: telemdecineDevice: The Diabeloop Software (Model predictive control)

Interventions

Continuous Glucose MonitoringDEVICE

Collection of glucose data

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

External Insulin PumpDEVICE

insulin delivery

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

telemdecineOTHER

Remote follow up by care health providers team

DIABELOOP System (closed-loop)

The Diabeloop Software (Model predictive control)DEVICE

Diabeloop is a Closed-loop (CL) system with a Model Predictive Control (MPC) algorithm reinforced by a decisional matrix, uploaded on a dedicated android smartphone linked to Dexcom CGM and a Cellnovo or Kaleido insulin patch-pump. The Diabeloop software calculates the insulin dose according to the patient's needs.

DIABELOOP System (closed-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 two years
Patient treated by external insulin pump for at least 6 months
Patient with HbA1c ≤ 10%; dosage of less than 4 months done in analysis laboratory medical or equivalent.
Patient requiring a daily dose of insulin ≤ 50 units
Patient domiciled in an area with Global System for Mobile Communication (GSM)
Not isolated patient, not living alone, or having a person "resource" living nearby and having a phone and the key of its place of residence
Patient not envisaging a journey outside France during the "closed-loop" period
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:

Patient with any serious illness that may impair study participation
Patient having a treatment known to have a significant interference on the glycemia.
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