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Real-world Study on the Effectiveness and Safety of Control-IQ Technology in Teenagers With Type 1 Diabetes Engaging in Regular Physical Activity

Recruitingn/aAges any - 20 YearsAllBruno Bombaci
NCT06876207 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 partici

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📋 Eligibility rules (as published)
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
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What it tests

  • Tandem t:slim X2 with Control-IQ technology
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Where

1 site
University Hospital of Messina
Messina, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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