Efficacy of Closed-loop Insulin Therapy in Prepubertal Child in Free-life

NCT ID: NCT03739099

Last Updated: 2021-12-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-05
• Study Completion Date: 2023-05-05

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).

Conditions

Type 1 Diabetes Mellitus in Prepubertal Children

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Closed-loop insulin delivery 24/7, day and night

Closed-loop subcutaneous insulin infusion driven by continuous glucose monitoring through an algorithm

Group Type: ACTIVE_COMPARATOR

Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions

Intervention Type: DEVICE

Continuous subcutaneous insulin infusion according to an automated algorithm from continuous glucose monitoring data

Closed-loop insulin delivery 7/7, dinner and night

Closed-loop subcutaneous insulin infusion driven by continuous glucose monitoring through an algorithm

Group Type: OTHER

Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions

Intervention Type: DEVICE

Continuous subcutaneous insulin infusion according to an automated algorithm from continuous glucose monitoring data

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Artificial pancreas

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric M RENARD, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Montpellier University Hospital

Locations

Montpellier University Hospital

Montpellier, , France

Countries

France

References

Coutant R, Bismuth E, Bonnemaison E, Dalla-Vale F, Morinais P, Perrard M, Trely J, Faure N, Bouhours-Nouet N, Levaillant L, Farret A, Storey C, Donzeau A, Poidvin A, Amsellem-Jager J, Place J, Quemener E, Hamel JF, Breton MD, Tubiana-Rufi N, Renard E. Hybrid Closed Loop Overcomes the Impact of Missed or Suboptimal Meal Boluses on Glucose Control in Children with Type 1 Diabetes Compared to Sensor-Augmented Pump Therapy. Diabetes Technol Ther. 2023 Jun;25(6):395-403. doi: 10.1089/dia.2022.0518. Epub 2023 Apr 6.

Reference Type: DERIVED

PMID: 36927054 (View on PubMed)

Other Identifiers

UF 7580

Identifier Type: -

Identifier Source: org_study_id