Efficacy of Closed-loop Insulin Therapy in Prepubertal Child in Free-life (FREELIFE-KID)

• ClinicalTrials.gov Identifier: NCT03739099
• Recruitment Status: Active, not recruiting
• First Posted: November 13, 2018
• Last Update Posted: December 16, 2021
• Sponsor: University Hospital, Montpellier
• Information provided by (Responsible Party): University Hospital, Montpellier

Study Description

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).

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

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 Design

• 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

Arms and Interventions

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	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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. 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
3. 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
4. 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.
5. 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.
6. 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.
7. 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
8. 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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

France

Montpellier University Hospital

Montpellier, France, 34295

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

• Principal Investigator: Eric M RENARD, MD, PhD; Montpellier University Hospital

More Information

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT03739099
• Other Study ID Numbers: UF 7580
• First Posted: November 13, 2018
• 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

Keywords provided by University Hospital, Montpellier:

Type 1 diabetes; Prepubertal children; Closed-loop insulin infusion

Additional relevant MeSH terms:

Diabetes Mellitus, Type 1; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pancrelipase; Gastrointestinal Agents