NCT06876207 Real-world Study on the Effectiveness and Safety of Control-IQ Technology in Teenagers With Type 1 Diabetes Engaging in Regular Physical Activity
| NCT ID | NCT06876207 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bruno Bombaci |
| Condition | Type 1 Diabetes Mellitus |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-06-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 ketoacidosis (DKA). This is an observational, open-label, non-randomized, real-world study. Each participant will be provided with a diary to record detailed information about physical activity sessions over a 14-day period, including type, intensity, and duration of exercise, and timing and composition of pre-exercise meals. Clear instructions on how to complete the diary will be provided. CGM metrics will be analyzed throughout the 14-day observation period, including time in range, time in tight range, time above range, time below range, mean glucose level, and coefficient of variation. A daily comparison will be performed between metrics recorded on days of physical activity and sedentary days, assessing the entire day as well as daytime (07:00-23:00) and nighttime (23:00-07:00) periods. The influence of factors such as anthropometrics, type of physical activity, the use of the exercise mode and other specific management strategies, type and duration of exercise, and pre-exercise meals on CGM metrics will be evaluated. The frequency of severe hypoglycemia and DKA episodes, as defined by international guidelines, will be assessed.
Eligibility Criteria
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 of medications (other than insulin) that may affect glucose control * Chronic use of substances or drugs that could impact CGM accuracy
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06876207 clinical trial?
This trial is open to participants of all sexes, up to 20 Years, studying Type 1 Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06876207 currently recruiting?
Yes, NCT06876207 is actively recruiting participants. Contact the research team at brunobombaci@gmail.com for enrollment information.
Where is the NCT06876207 trial being conducted?
This trial is being conducted at Messina, Italy.
Who is sponsoring the NCT06876207 clinical trial?
NCT06876207 is sponsored by Bruno Bombaci. The trial plans to enroll 50 participants.
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