NCT03739099

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

November 5, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2023

Completed
Last Updated

December 16, 2021

Status Verified

December 1, 2021

Enrollment Period

3.8 years

First QC Date

November 5, 2018

Last Update Submit

December 15, 2021

Conditions

Type 1 Diabetes Mellitus in Prepubertal Children

Keywords

Type 1 diabetesPrepubertal childrenClosed-loop insulin infusion

Outcome Measures

Primary Outcomes (1)

  • Percent of time spent in the 70-180 mg/dl glucose range assessed on daily CGM data

    % time blood glucose in 70-180 mg/dl range

    18 weeks

Secondary Outcomes (8)

  • Percent of time spent with glucose level < 70, 60 and 50 mg/dl, assessed on daily CGM data

    18 and 36 weeks

  • Percent of time spent with glucose level > 180 and 300 mg/dl, assessed on daily CGM data

    18 and 36 weeks

  • Percent of time spent in the 70-140 mg/dl glucose range assessed on daily CGM data

    18 and 36 weeks

  • Mean glucose level assessed on daily CGM data

    18 and 36 weeks

  • HbA1c level measured at week 12, 18, 27 and 36

    12,18, 27 and 36 weeks

  • +3 more secondary outcomes

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

OTHER

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

Interventions

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

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

Also known as: Artificial pancreas
Closed-loop insulin delivery 24/7, day and nightClosed-loop insulin delivery 7/7, dinner and night

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Treatment of diabetes by insulin pump since \> 6 months
  • HbA1c level \< 10%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

Location

Related Publications (1)

  • 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.

    PMID: 36927054DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Pancreas, Artificial

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Artificial OrgansSurgical EquipmentEquipment and Supplies

Study Officials

  • Eric M RENARD, MD, PhD

    Montpellier University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2018

First Posted

November 13, 2018

Study Start

November 5, 2018

Primary Completion

September 5, 2022

Study Completion

May 5, 2023

Last Updated

December 16, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)