Automated insulin delivery and exercise for type 1 diabetes management
"Impact of an Automated Closed-loop Insulin Infusion System on Adherence to Physical Activity in Patients With Type 1 Diabetes "
This study tests how regular exercise affects blood sugar control in people with type 1 diabetes who use automated insulin delivery systems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 65 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 1 site (Nice, Alpes Maritimes) |
| Trial ID | NCT06460558 on ClinicalTrials.gov |
What this trial studies
This observational study examines the impact of physical activity on patients with type 1 diabetes (T1DM) using automated insulin delivery systems. It aims to assess how regular physical activity can improve glycemic control and reduce diabetes-related complications in individuals who have been living with T1DM for over six months. Participants will be monitored for their physical activity levels and the corresponding effects on their blood sugar management. The study focuses on patients who are already using insulin pumps and meet specific criteria for glycemic control.
Who should consider this trial
Good fit: Ideal candidates are individuals with type 1 diabetes who have been using an insulin pump for at least six months and meet specific glycemic control criteria.
Not a fit: Patients who are pregnant, have contraindications to physical activity, or are involved in other experimental studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of type 1 diabetes through improved physical activity guidelines and automated insulin delivery.
How similar studies have performed: Previous studies have shown positive outcomes with similar approaches, indicating the potential for success in this observational study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Type 1 diabetes defined by clinical history and positive measurement of autoantibodies (anti-GAD or IA2), evolving for more than 6 months and treated by insulin pump for at least 6 months, for whom an indication for automated insulin delivery is retained, by criteria of glycemic control (HbA1c ≥ 8% and/or significant glycemic variability and/or severe hypoglycemia) or poor quality of life, in accordance with reimbursement criteria validated by the CNAM for available systems. * For women, existence of effective contraception (hormonal or mechanical) and no plans for pregnancy during the study period. * Having a Health Care insurance."" " Exclusion Criteria: * Patient already involved in another experimental study * Patient in a particular situation deemed incompatible with the study by the investigator * Patient living in a department other than Alpes-Maritimes or Var * Pregnant women * Presence of a contraindication to physical activity * Patient with linguistic or psychological incapacity to understand written information * Patient refusing to give consent * Patient deprived of liberty by administrative or judicial decision, under guardianship or trusteeship"" "
Where this trial is running
Nice, Alpes Maritimes
- CHU NiICE — Nice, Alpes Maritimes, France (Recruiting)
Study contacts
- Principal investigator: Nicolas CHEVALIER — Centre Hospitalier Universitaire de Nice
- Study coordinator: Nicolas CHEVALIER, MD
- Email: chevalier.n@chu-nice.fr
- Phone: 0492035519
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.