Observing patient engagement with automated insulin delivery in type 1 diabetes
Long-term Observation of Patient Engagement in Automated Insulin Delivery
This study looks at how people with type 1 diabetes use an automated insulin delivery system over two years to see if their level of engagement changes over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 453 (estimated) |
| Sex | All |
| Sponsor | Centre Hospitalier Sud Francilien Academic / other |
| Locations | 1 site (Corbeil-essonnes Cedex) |
| Trial ID | NCT06858475 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess how patients interact with the CONTROL-IQ hybrid closed-loop insulin delivery system over a 24-month period. It focuses on user-initiated boluses and carbohydrate announcements to understand changes in patient engagement levels. The study will analyze whether users who initially engage less with the system increase their involvement over time, or if those who are highly engaged begin to rely more on automation. The research is conducted at a single center in France, utilizing real-world data from patients using the system.
Who should consider this trial
Good fit: Ideal candidates are individuals with type 1 diabetes using the CONTROL-IQ system and who have uploaded data to the myDiabby platform.
Not a fit: Patients with diabetes types other than type 1 or those who do not consent to data usage may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of patient engagement, leading to improved diabetes management strategies for individuals with type 1 diabetes.
How similar studies have performed: While there is limited long-term data on patient engagement with automated insulin delivery systems, similar studies have shown promising results in understanding user interaction with diabetes management technologies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Corbeil-essonnes Cedex
- Centre Hospitalier Sud Francilien — Corbeil-essonnes Cedex, France (Recruiting)
Study contacts
- Principal investigator: Coralie AMADOU, MD — Centre Hospitalier Sud Francilien
- Study coordinator: Coralie AMADOU, MD
- Email: coralie.amadou@chsf.fr
- Phone: 01 61 69 33 87
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.