- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03739099
Efficacy of Closed-loop Insulin Therapy in Prepubertal Child in Free-life (FREELIFE-KID)
December 15, 2021 updated by: University Hospital, Montpellier
Assessment of the Efficacy of Closed-loop Insulin Therapy (Artificial Pancreas) on the Control of Type 1 Diabetes in Prepubertal Child in Free-life: Comparison Between Nocturnal and 24-hour Use on 18 Weeks, Followed by an Extension on 18 Weeks
The study is a randomized trial preceded by a run-in period and followed by a non-randomized study extension.
After 3 weeks of outpatient use of study pump (1 week) and study pump+CGM (2weeks) as run-in period, patient and parents will be admitted for 4-hour training to closed-loop (AP) mode.
Following randomization (1:1), patient will be allocated to '24-hour' use of AP or 'dinner and overnight AP mode/day time pump and CGM use' for the next 18-week period.
At 18-week visit, a study extension for a further 18-week period will be initiated.
AP mode that will be prescribed to all patients will depend from an independent DSMB decision based upon study safety data collected after 6 and 12 weeks from the first 30 included patients.
Visits will occur at week 27 (safety follow-up) and 36 (final visit).
Study Overview
Status
Active, not recruiting
Detailed Description
The study is a randomized trial preceded by a run-in period and followed by a non-randomized study extension.
After 3 weeks of outpatient use of study pump (1 week) and study pump+CGM (2weeks) as run-in period, patient and parents will be admitted for 4-hour training to closed-loop (AP) mode.
Following randomization (1:1), patient will be allocated to '24-hour' use of AP or 'dinner and overnight AP mode/day time pump and CGM use' for the next 18-week period.
A hotline phone number will be given to the patient and parents so that they can contact the study staff as needed.
A logbook will be provided to collect details about hypoglycemic and hyperglycemic episodes, physical activity and noticeable events.
Phone calls will be scheduled between investigator and patient+parents 48 hours, 1 week and 2 weeks after AP mode initiation.
Potential misbehaviors will be corrected and all questions answered.
If needed, AP parameters may be revised and reconfigured.
Hospital visits will be scheduled 6, 12 and 18 weeks after AP mode initiation for the same purposes, plus HbA1c measurement at week 12 and 18.
At 18-week visit, a study extension for a further 18-week period will be initiated.
AP mode that will be prescribed to all patients will depend from an independent DSMB decision based upon study safety data collected after 6 and 12 weeks from the first 30 included patients.
Visits will occur at week 27 (safety follow-up) and 36 (final visit).
Study Type
Interventional
Enrollment (Actual)
122
Phase
- Not Applicable
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
-
-
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Montpellier, France, 34295
- Montpellier University Hospital
-
-
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
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Treatment of diabetes by insulin pump since > 6 months
- HbA1c level < 10%
Exclusion Criteria:
- Unwillingness of one parent or the legally responsible party to participate in insulin treatment
- Any associated chronic disease or therapy (except insulin) affecting glucose metabolism
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: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Closed-loop insulin delivery 24/7, day and night
Closed-loop subcutaneous insulin infusion driven by continuous glucose monitoring through an algorithm
|
Continuous subcutaneous insulin infusion according to an automated algorithm from continuous glucose monitoring data
Other Names:
|
Other: Closed-loop insulin delivery 7/7, dinner and night
Closed-loop subcutaneous insulin infusion driven by continuous glucose monitoring through an algorithm
|
Continuous subcutaneous insulin infusion according to an automated algorithm from continuous glucose monitoring data
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of time spent in the 70-180 mg/dl glucose range assessed on daily CGM data
Time Frame: 18 weeks
|
% time blood glucose in 70-180 mg/dl range
|
18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of time spent with glucose level < 70, 60 and 50 mg/dl, assessed on daily CGM data
Time Frame: 18 and 36 weeks
|
Percent time while blood glucose is kept in safe 70-180 mg/dl range
|
18 and 36 weeks
|
Percent of time spent with glucose level > 180 and 300 mg/dl, assessed on daily CGM data
Time Frame: 18 and 36 weeks
|
Percent time while blood glucose is kept in safe 70-180 mg/dl range
|
18 and 36 weeks
|
Percent of time spent in the 70-140 mg/dl glucose range assessed on daily CGM data
Time Frame: 18 and 36 weeks
|
Percent time while blood glucose is kept in safe 70-180 mg/dl range
|
18 and 36 weeks
|
Mean glucose level assessed on daily CGM data
Time Frame: 18 and 36 weeks
|
CGM data will be used to calculate daily glucose mean to assess the efficacy of the algorithm on glucose control.
|
18 and 36 weeks
|
HbA1c level measured at week 12, 18, 27 and 36
Time Frame: 12,18, 27 and 36 weeks
|
Levels of glycated hemoglobin will be measured at different time intervals to assess the clinical impact of the use of the algorithm on patient diabetes.
|
12,18, 27 and 36 weeks
|
Number of needed interventions by the patients or care providers to treat hypoglycemia
Time Frame: 18 and 36 weeks
|
A logbook will be used all along the study by patients to record carbs intake in case of hypoglycemia.
If patient required further assistance, care provider who will record third parties intervention.
|
18 and 36 weeks
|
Percent of time with AP functional, discriminating between each component failure modes
Time Frame: 18 and 36 weeks
|
Percent time while blood glucose is kept in safe 70-180 mg/dl range
|
18 and 36 weeks
|
Score of the Artificial Pancreas Acceptance Questionnaire
Time Frame: 18 and 36 weeks
|
This questionnaire consists of 15 affirmations about the use of AP and patient can answer in a scale from 0 (do not agree) to 6 (totally agree).
The global score is calculated by the sum of all answers.
A high score means a good acceptation of the system.
There is no subscale.
|
18 and 36 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eric M RENARD, MD, PhD, Montpellier University Hospital
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 (Actual)
November 5, 2018
Primary Completion (Anticipated)
September 5, 2022
Study Completion (Anticipated)
May 5, 2023
Study Registration Dates
First Submitted
November 5, 2018
First Submitted That Met QC Criteria
November 9, 2018
First Posted (Actual)
November 13, 2018
Study Record Updates
Last Update Posted (Actual)
December 16, 2021
Last Update Submitted That Met QC Criteria
December 15, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UF 7580
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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