NCT06185348

Brief Summary

Overweigth and obesity are commonly diagnosed in children with type 1 diabetes, and frequently an increase of wiegth and BMI is observed after diagnoses. Hybrid cloosed loop system are new system where insulin is continually adapted to glycemia (using an algorythme). The weight and growth trajectory of children treated with this system is poorly described.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 29, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

10 months

First QC Date

October 12, 2023

Last Update Submit

December 14, 2023

Conditions

Diabetes Mellitus, Type 1ObesityOverweightChild Obesity

Outcome Measures

Primary Outcomes (1)

  • Body mass index (BMI) variation after 6 months of treatment with hybrid closed loop (HCL)

    variation of BMI expressed in standard deviations after 6 months with HCL

    6 months

Secondary Outcomes (8)

  • Body mass index (BMI) variation after 12 months of treatment with hybrid closed loop (HCL)

    12 months

  • Body mass index (BMI) variation after 24 months of treatment with hybrid closed loop (HCL)

    24 months

  • Growth velocity variation after 6 months of treatment with hybrid closed loop (HCL)

    6 months

  • Growth velocity variation after 12 months of treatment with hybrid closed loop (HCL)

    12 months

  • Growth velocity variation after 24 months of treatment with hybrid closed loop (HCL)

    24 months

  • +3 more secondary outcomes

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

children with type 1 diabetes follow up in Hospital of Nancy with HCL since 6 months minimum

You may qualify if:

  • children between 6 and 18 years at the beginning of treatment with HCL
  • type 1 diabetes
  • follow up in University Hospital of Nancy between 01/01/2021 - 31/12/2023
  • treatement with HCL since 6 months

You may not qualify if:

  • parental opposition for the study
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1ObesityOverweightPediatric Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

RENARD Emeline, PhD MD

CONTACT

0627647129e_renard@hotmail.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

October 12, 2023

First Posted

December 29, 2023

Study Start

January 1, 2024

Primary Completion

November 1, 2024

Study Completion

November 1, 2025

Last Updated

December 29, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share