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

NCT03739099 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2021-12-16

No results posted yet for this study

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).

Conditions

  • Type 1 Diabetes Mellitus in Prepubertal Children

Interventions

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

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Eric M RENARD, MD, PhD · Montpellier University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-05
Primary Completion
2022-09-05
Completion
2023-05-05

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03739099 on ClinicalTrials.gov