NCT03739099: FREELIFE-KID

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

Status unknown NA Last updated 16 December 2021

What this trial tests

NA trial testing Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions in Type 1 Diabetes Mellitus in Prepubertal Children in 122 participants. Status unknown.

Timeline

5 November 2018

Primary endpoint
5 September 2022

5 May 2023

Quick facts

Lead sponsor	University Hospital, Montpellier
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	122
Start date	5 November 2018
Primary completion	5 September 2022
Estimated completion	5 May 2023
Sites	1 location across France

Drugs / interventions tested

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

Conditions studied

• Type 1 Diabetes Mellitus in Prepubertal Children — all drugs for Type 1 Diabetes Mellitus in Prepubertal Children →

Sponsor

University Hospital, Montpellier

Who can join

Adults 6 to 12, any sex, with Type 1 Diabetes Mellitus in Prepubertal Children. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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. 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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety and Performance of the Tandem t:slim X2 with Control-IQ Automated Insulin Delivery System in Toddlers and Preschoolers.
   Ekhlaspour L, Schoelwer MJ, Forlenza GP, DeBoer MD, et al · · 2021 · cited 36× · PMID 33226837 · DOI 10.1089/dia.2020.0507
2. 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.
   Coutant R, Bismuth E, Bonnemaison E, Dalla-Vale F, et al · · 2023 · cited 15× · PMID 36927054 · DOI 10.1089/dia.2022.0518
3. 56^th EASD Annual Meeting of the European Association for the Study of Diabetes : 21-25 September 2020.
   · 2020 · cited 9× · PMID 32840677 · DOI 10.1007/s00125-020-05221-5