Clinical trial NCT03739099: Efficacy of Closed-loop Insulin Therapy in Prepubertal Child in Free-life
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes Mellitus in Prepubertal Children
Keywords: Type 1 diabetes
Prepubertal children
Closed-loop insulin infusion
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 122
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: Percent of time spent in the 70-180 mg/dl glucose range assessed on daily CGM data
timeFrame: 18 weeks
Secondary outcomes:
measure: Percent of time spent with glucose level < 70, 60 and 50 mg/dl, assessed on daily CGM data
timeFrame: 18 and 36 weeks
measure: Percent of time spent with glucose level > 180 and 300 mg/dl, assessed on daily CGM data
timeFrame: 18 and 36 weeks
measure: Percent of time spent in the 70-140 mg/dl glucose range assessed on daily CGM data
timeFrame: 18 and 36 weeks
measure: Mean glucose level assessed on daily CGM data
timeFrame: 18 and 36 weeks
measure: HbA1c level measured at week 12, 18, 27 and 36
timeFrame: 12,18, 27 and 36 weeks
measure: Number of needed interventions by the patients or care providers to treat hypoglycemia
timeFrame: 18 and 36 weeks
measure: Percent of time with AP functional, discriminating between each component failure modes
timeFrame: 18 and 36 weeks
measure: Score of the Artificial Pancreas Acceptance Questionnaire
timeFrame: 18 and 36 weeks
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
affiliation: Montpellier University Hospital
name: Eric M RENARD, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: