Real-world Study on the Effectiveness and Safety of Control-IQ Technology in Teenagers with Type 1 Diabetes Engaging in Regular Physical Activity
Launched by BRUNO BOMBACI · Mar 11, 2025
Trial Information
Current as of April 29, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how well the Control-IQ technology helps manage blood sugar levels in teenagers with type 1 diabetes while they are physically active. Researchers believe that this system may improve blood sugar control during exercise. Over a 14-day period, participants will track their physical activities, like the types of exercises they do and how long they last, and compare their blood sugar levels on days when they are active versus days when they are not.
To participate, teenagers must be under 20 years old, have been diagnosed with type 1 diabetes for more than a year, and have been using Control-IQ technology and continuous glucose monitoring (CGM) regularly. They also need to engage in physical activities at least twice a week. Participants will keep a diary of their activities and meals, and researchers will look at how different factors, like the type of exercise and meal timing, influence blood sugar levels. The study will also monitor for any serious complications, such as dangerously low blood sugar or diabetic ketoacidosis, to ensure safety throughout the trial.
Gender
ALL
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
About Bruno Bombaci
Bruno Bombaci is a dedicated clinical trial sponsor renowned for its commitment to advancing medical research and innovation. With a focus on developing novel therapies, the organization collaborates with leading research institutions and healthcare professionals to ensure rigorous study design and execution. Bruno Bombaci prioritizes patient safety and ethical standards, striving to improve health outcomes through well-structured clinical trials. The sponsor's expertise encompasses a range of therapeutic areas, reflecting a deep understanding of the complexities of drug development and a steadfast commitment to bringing effective treatments to market.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported