Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CONTROL-IQ (Tandem™) | Device | interaction with the CONTROL-IQ (Tandem™) hybrid closed-loop (HCL) system in individuals with type 1 diabetes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| time spent in closed-loop mode | Measurement of the quarterly evolution, over 24 months, of the percentage of time spent in closed-loop mode (CONTROL-IQ ON) | repeated measurement over 24 months (8 quarters) |
| insulin dose (UI) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
The population will be selected from the diabetes department of a French public hospital. All eligible patients will be included in the study.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Coralie AMADOU, MD | Centre Hospitalier Sud Francilien | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Sud Francilien | Corbeil-Essonnes | 91106 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Measurement of the quarterly evolution, over 24 months, of the average of total daily insulin dose (UI)
| repeated measurement over 24 months (8 quarters) |
| carbohydrates | Measurement of the quarterly evolution, over 24 months, of the average amount of carbohydrates reported daily in closed-loop mode (CONTROL-IQ). | repeated measurement over 24 months (8 quarters) |
| glucose | Measurement of the quarterly evolution, over 24 months, of continuous glucose monitoring parameters, including average glucose in closed-loop mode (CONTROL-IQ). | Repeated measurement over 24 months (8 quarters) |
| glucose management indicator | Measurement of the quarterly evolution, over 24 months, of continuous glucose monitoring parameters, including average glucose management indicator in closed-loop mode (CONTROL-IQ). | Repeated measurement over 24 months (8 quarters) |
| glucose coefficient of variation | Measurement of the quarterly evolution, over 24 months, of continuous glucose monitoring parameters, including glucose coefficient of variation in closed-loop mode (CONTROL-IQ). | Repeated measurement over 24 months (8 quarters) |
| percentage of time in target range (70-180 mg/dL) | 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). | Repeated measurement over 24 months (8 quarters) |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |