Status:
RECRUITING
Real-world Study on the Effectiveness and Safety of Control-IQ Technology in Teenagers With Type 1 Diabetes Engaging in Regular Physical Activity
Lead Sponsor:
Bruno Bombaci
Collaborating Sponsors:
University of Messina
University of Verona, Italy
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
Up to 20 years
Brief Summary
We hypothesize that the use of the Control-IQ system positively influences glycemic control in teenagers with type 1 diabetes during physical activity. To test this hypothesis, we will evaluate the gl...
Eligibility Criteria
Inclusion
- Diagnosis of type 1 diabetes according to International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines
- Duration of diabetes \> 12 months
- Age \< 20 years
- Pubertal development completed according to the Tanner stage
- Use of Control-IQ technology for at least 3 months
- Automatic mode use for at least 70% of the time during the 2 weeks preceding enrollment
- CGM use for at least 70% of the time during the 2 weeks preceding enrollment
- Regular physical activity (at least 2 sessions per week, each lasting at least 45 minutes)
Exclusion
- Uncontrolled celiac disease or thyroid disease
- Presence of other chronic illnesses
- Psychiatric or neurological conditions, including eating disorders, that may interfere with the study
- Chronic use of medications (other than insulin) that may affect glucose control
- Chronic use of substances or drugs that could impact CGM accuracy
Key Trial Info
Start Date :
June 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06876207
Start Date
June 1 2025
End Date
June 1 2026
Last Update
June 25 2025
Active Locations (1)
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1
University Hospital of Messina
Messina, Italy, Italy, 98125