NCT06858475

Brief Summary

The purpose of this study is to assess the long-term evolution of patient interaction with the CONTROL-IQ (Tandem™) hybrid closed-loop (HCL) system in individuals with type 1 diabetes over 24 months. Specifically, the study examines user-initiated boluses and carbohydrate announcements to determine whether initially low-engagement users increase their involvement over time or, conversely, whether highly engaged users gradually rely more on automation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
453

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2025

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 21, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

March 20, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

June 20, 2025

Status Verified

June 1, 2025

Enrollment Period

1 month

First QC Date

February 21, 2025

Last Update Submit

June 17, 2025

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 diabetes mellitusAutomated insulin deliveryContinuous glucose monitoringCarbohydrate countingMeal announcement

Outcome Measures

Primary Outcomes (1)

  • number of automatic boluses

    To assess the 24-month evolution of the automatic-to-user-initiated bolus ratio

    repeated measurement over 24 months (8 quarters)

Secondary Outcomes (7)

  • time spent in closed-loop mode

    repeated measurement over 24 months (8 quarters)

  • insulin dose (UI)

    repeated measurement over 24 months (8 quarters)

  • carbohydrates

    repeated measurement over 24 months (8 quarters)

  • glucose

    Repeated measurement over 24 months (8 quarters)

  • glucose management indicator

    Repeated measurement over 24 months (8 quarters)

  • +2 more secondary outcomes

Study Arms (1)

With device

Device: CONTROL-IQ (Tandem™)

Interventions

CONTROL-IQ (Tandem™)DEVICE

interaction with the CONTROL-IQ (Tandem™) hybrid closed-loop (HCL) system in individuals with type 1 diabetes

With device

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population will be selected from the diabetes department of a French public hospital. All eligible patients will be included in the study.

You may qualify if:

  • Patients using the CONTROL-IQ hybrid closed-loop system with data uploaded to the myDiabby platform at least once between October 2021 and October 2024, affiliated with the diabetology department of CHSF.

You may not qualify if:

  • Patients with a type of diabetes other than type 1 diabetes.
  • Patients who have objected to the use of their data.

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

  • Coralie AMADOU, 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 21, 2025

First Posted

March 5, 2025

Study Start

March 20, 2025

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

June 20, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)