Long-term Observation Of Patient Engagement in Automated Insulin Delivery (LOOPED)

Centre Hospitalier Sud Francilien

Status

Completed

Conditions

Type 1 Diabetes Mellitus

Treatments

Device: CONTROL-IQ (Tandem™)

Study type

Observational

Funder types

Other

Identifiers

NCT06858475

2025/0001

Details and patient eligibility

About

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.

Full 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.

Enrollment

453 patients

Sex

All

Volunteers

No Healthy Volunteers

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