NCT06253351

Brief Summary

The purpose of this study is to determine the effect of hybrid closed loop on glycemic outcomes in young patients aged between 15 and 25 years old with type 1 diabetes, whatever is their initial metabolic control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 2, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 13, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2024

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

February 2, 2024

Last Update Submit

November 22, 2024

Conditions

Type1 DiabetesAdolescentsYoung Adults

Keywords

type 1 diabeteshybrid closed-loopadolescentsyoung adultsHbA1cTIR

Outcome Measures

Primary Outcomes (1)

  • HbA1c after HCL

    Comparison of HbA1c (%) before and after HCL (at least 3 months of use)

    at 3 months

Secondary Outcomes (11)

  • HbA1c after HCL

    at 6 months

  • HbA1c after HCL

    at 12 months

  • HbA1c after HCL

    at 24 months

  • Use of HCL

    at 3 months

  • HCL stop

    at 3 months

  • +6 more secondary outcomes

Study Arms (1)

Group1

Patients between 15 and 25 years old with type 1 diabetes and treated by hybrid closed loop

Device: Hybrid closed loop (HCL)

Interventions

Hybrid closed loop (HCL)DEVICE

* Control IQ : T-Slim pump with Dexcom G6 * Smartguard : Medtronic 780G pump with Guardian G4S * Diabeloop : Kaliedo pump with Dexcom G6

Group1

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Tertiary care center from Centre Hospitalier Sud Francilien

You may qualify if:

  • Patient aged between 15 and 25 years old
  • Type 1 diabetes since at least 1 year at the moment of instauring HCL
  • At least 3 months of HCL use

You may not qualify if:

  • Informed patient that have been opposed for their data collect

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

  • Juliette EROUKHMANOFF, MD

    Centre Hospitalier Sud Francilien

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2024

First Posted

February 12, 2024

Study Start

March 13, 2024

Primary Completion

May 6, 2024

Study Completion

May 6, 2024

Last Updated

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)