Real-world Study on the Effectiveness and Safety of Control-IQ Technology in Teenagers Wit
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 glucose profiles (based on CGM metrics) of adolescents engaging in different types, intensities, and durations of physical
| Condition(s) | Type 1 Diabetes Mellitus |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 glucose profiles (based on CGM metrics) of adolescents engaging in different types, intensities, and durations of physical activity over a 14-day period, in real-life conditions. We will compare glucose control on exercise days with that on sedentary days. As a secondary objective, we will investigate the influence of factors such as anthropometric characteristics, type and duration of exercise, the use of the exercise mode and other management strategies used for physical activity, on glycemic outcomes. Regarding the safety, we will report any episodes of severe hypoglycemia or diabetic ketoaci |
| Who can participate | Inclusion Criteria: * 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 Criteria: * 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 |
| Ages | 20 Years |
| Sex | All |
| Lead sponsor | Bruno Bombaci |
| Locations | Messina, Italy, Italy |
| Start date | 2025-06-01 |
| NCT ID | NCT06876207 |
| Official listing | https://clinicaltrials.gov/study/NCT06876207 |