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Completed

NCT Number: NCT06858475

Long-term Observation Of Patient Engagement in Automated Insulin Delivery

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CONTROL-IQ (Tandem™)

Device

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

Primary outcomes

  1. number of automatic boluses

    Time frame: repeated measurement over 24 months (8 quarters)

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

Secondary outcomes

  1. time spent in closed-loop mode

    Time frame: repeated measurement over 24 months (8 quarters)

    Measurement of the quarterly evolution, over 24 months, of the percentage of time spent in closed-loop mode (CONTROL-IQ ON)

  2. insulin dose (UI)

    Time frame: repeated measurement over 24 months (8 quarters)

    Measurement of the quarterly evolution, over 24 months, of the average of total daily insulin dose (UI)

  3. carbohydrates

    Time frame: repeated measurement over 24 months (8 quarters)

    Measurement of the quarterly evolution, over 24 months, of the average amount of carbohydrates reported daily in closed-loop mode (CONTROL-IQ).

  4. glucose

    Time frame: Repeated measurement over 24 months (8 quarters)

    Measurement of the quarterly evolution, over 24 months, of continuous glucose monitoring parameters, including average glucose in closed-loop mode (CONTROL-IQ).

  5. glucose management indicator

    Time frame: Repeated measurement over 24 months (8 quarters)

    Measurement of the quarterly evolution, over 24 months, of continuous glucose monitoring parameters, including average glucose management indicator in closed-loop mode (CONTROL-IQ).

  6. glucose coefficient of variation

    Time frame: Repeated measurement over 24 months (8 quarters)

    Measurement of the quarterly evolution, over 24 months, of continuous glucose monitoring parameters, including glucose coefficient of variation in closed-loop mode (CONTROL-IQ).

  7. percentage of time in target range (70-180 mg/dL)

    Time frame: Repeated measurement over 24 months (8 quarters)

    Measurement of the quarterly evolution, over 24 months, of continuous glucose monitoring parameters, including percentage of time in target range (70-180 mg/dL) in closed-loop mode (CONTROL-IQ).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Acronym: LOOPED

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 5, 2025
Registry last updated
Jun 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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