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

Status: Recruiting
Location: See location...
Intervention Type: Device
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 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
Participation Requirements
Sex: All
Maximum Age: 20
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Italy
University Hospital of Messina
RECRUITING
Messina
Contact Information
Primary
Bruno Bombaci, MD
brunobombaci@gmail.com
+393473931038
Backup
Giuseppina Salzano, PhD MD
gsalzano@unime.it
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 50
Sponsors
Collaborators: University of Verona, Italy, University of Messina
Leads: Bruno Bombaci

This content was sourced from clinicaltrials.gov

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