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Efficacy of Automated Insulin Therapy Early Initiated After Diagnosis on Blood Glucose Control in Children and Adolescents With Type 1 Diabetes

NCT06283797 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2025-04-06

No results posted yet for this study

Summary

The main objective is to assess whether hybrid closed-loop (HCL) insulin delivery initiated early after diagnosis of Type 1 diabetes (T1D) allows a better efficacy on glucose control than conventional standard insulin therapy with multiple daily insulin injections (MDI) or insulin pumps after one year of use.

The secondary objectives are to assess whether HCL initiated early after diagnosis of T1D allows: (1) Higher time spent with glucose level in the near-normal range, (2) Lower time spent in hypoglycemia and hyperglycemia, (3) Lower glucose variability, (4) Lower perceived burden of diabetes management, (5) Better preserved endogenous insulin secretion, all the above after one year of use, (6) Lower occurrence of interventions for hypoglycemia, versus conventional standard insulin therapy with MDI or insulin pump.

An optional 1-year extension aims at assessing: (1) Sustainability of above mentioned parameters over a second year of HCL use in the group who started HCL early after diagnosis, (2) Efficacy on glucose control according to the above mentioned parameters when HCL is initiated early after diagnosis vs. after 1 year in the control group of the randomized phase.

Conditions

Interventions

DEVICE

OmniPod 5

Participants will be trained to use OmniPod 5 to treat type 1 diabetes for 1 year

DEVICE

Dexcom G6

Participants will use Dexcom G6 for continuous glucose monitoring

OTHER

PAID questionnaires

At visits 3, 7 and 11, parents/guardians and patients aged between 8 and 17 will complete diabetes-related problem questionnaires (PAID-PR, PAID-Peds)

Sponsors & Collaborators

  • Hopital Universitaire Robert-Debre

    collaborator OTHER

  • University Hospital, Tours

    collaborator OTHER

  • University Hospital, Angers

    collaborator OTHER_GOV

  • University of Virginia

    collaborator OTHER

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Eric RENARD, MD · University Hospital, Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-29
Primary Completion
2026-06-29
Completion
2027-06-29
FDA Device
Yes

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT06283797 on ClinicalTrials.gov