Efficacy of Closed-loop Insulin Therapy in Prepubertal Child in Free-life (FREELIFE-KID)
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ClinicalTrials.gov Identifier: NCT03739099 |
Recruitment Status :
Active, not recruiting
First Posted : November 13, 2018
Last Update Posted : December 16, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 1 Diabetes Mellitus in Prepubertal Children | Device: Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 122 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | November 5, 2018 |
Estimated Primary Completion Date : | September 5, 2022 |
Estimated Study Completion Date : | May 5, 2023 |

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
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Device: Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions
Continuous subcutaneous insulin infusion according to an automated algorithm from continuous glucose monitoring data
Other Name: Artificial pancreas |
Closed-loop insulin delivery 7/7, dinner and night
Closed-loop subcutaneous insulin infusion driven by continuous glucose monitoring through an algorithm
|
Device: Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions
Continuous subcutaneous insulin infusion according to an automated algorithm from continuous glucose monitoring data
Other Name: Artificial pancreas |
- 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
- 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
- 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
- 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
- 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.
- 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.
- 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.
- 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
- 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.

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Ages Eligible for Study: | 6 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739099
France | |
Montpellier University Hospital | |
Montpellier, France, 34295 |
Principal Investigator: | Eric M RENARD, MD, PhD | Montpellier University Hospital |
Responsible Party: | University Hospital, Montpellier |
ClinicalTrials.gov Identifier: | NCT03739099 |
Other Study ID Numbers: |
UF 7580 |
First Posted: | November 13, 2018 Key Record Dates |
Last Update Posted: | December 16, 2021 |
Last Verified: | December 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Type 1 diabetes Prepubertal children Closed-loop insulin infusion |
Diabetes Mellitus, Type 1 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Autoimmune Diseases Immune System Diseases Pancrelipase Gastrointestinal Agents |