Clinical trial NCT06858475: Long-term Observation of Patient Engagement in Automated Insulin Delivery
Official title: Long-term Observation of Patient Engagement in Automated Insulin Delivery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 diabetes mellitus
Automated insulin delivery
Continuous glucose monitoring
Carbohydrate counting
Meal announcement
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 453
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_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.

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.

Detailed description: Automated insulin delivery (AID) systems have revolutionized type 1 diabetes (T1D) management, offering superior glycemic control and quality of life compared to sensor-augmented insulin pumps or multiple daily injections (MDI). However, current AID systems operate as hybrid closed-loop (HCL) systems, requiring user intervention for meal boluses, including carbohydrate counting and timely insulin administration.

Control-IQ (Tandem™) was the second AID system reimbursed by the French National Health Insurance and is now widely used in France. It combines the Tandem™ t:slim insulin pump with Dexcom™ G6 continuous glucose monitoring (CGM), adjusting basal insulin every five minutes based on glucose predictions and delivering automatic correction boluses once per hour. Despite these automation features, users must still manually initiate meal boluses, and additional correction boluses remain optional. While engagement in carbohydrate counting and timely meal announcements improves metabolic outcomes, real-world data suggest that AID benefits individuals across varying engagement levels.

Long-term data on patient behavior and engagement, particularly regarding carbohydrate announcements and the ratio of automatic to user-initiated boluses, remain limited. Understanding these patterns could reveal whether initially low-engagement users increase involvement over time or whether highly engaged users eventually rely more on automation.

This single-center, 24-month observational study will follow all T1D patients treated with Control-IQ at the Centre Hospitalier Sud-Francilien between October 2021 and October 2024.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: number of automatic boluses
timeFrame: repeated measurement over 24 months (8 quarters)
Secondary outcomes:
measure: time spent in closed-loop mode
timeFrame: repeated measurement over 24 months (8 quarters)
measure: insulin dose (UI)
timeFrame: repeated measurement over 24 months (8 quarters)
measure: carbohydrates
timeFrame: repeated measurement over 24 months (8 quarters)
measure: glucose
timeFrame: Repeated measurement over 24 months (8 quarters)
measure: glucose management indicator
timeFrame: Repeated measurement over 24 months (8 quarters)
measure: glucose coefficient of variation
timeFrame: Repeated measurement over 24 months (8 quarters)
measure: percentage of time in target range (70-180 mg/dL)
timeFrame: Repeated measurement over 24 months (8 quarters)
Other outcomes:
Locations:
city: Corbeil-essonnes Cedex
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
affiliation: Centre Hospitalier Sud Francilien
name: Coralie AMADOU, MD
role: PRINCIPAL_INVESTIGATOR
References: