RecruitingNCT06876207

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

Sponsor

Bruno Bombaci

Enrollment

50 participants

Start Date

Jun 1, 2025

Study Type

OBSERVATIONAL

Conditions

Type 1 Diabetes Mellitus

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

Max Age: 20 Years

Inclusion Criteria8

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 Criteria5

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

Interventions

DEVICETandem t:slim X2 with Control-IQ technology

Control-IQ is one of the second-generation AID technologies currently available worldwide and is approved for people \> 6 years. Control-IQ can predict glucose levels 30 minutes in advance and automatically adjust basal insulin delivery, providing corrective boluses if needed. The system can prevent hypoglycemia by suspending insulin delivery if glucose is predicted to drop below 70 mg/dl (8). Additionally, the device offers specific settings for circumstances such as sleep or exercise. When the exercise mode is activated, the system temporarily raises the minimum glucose target from 112.5 to 140 mg/dl to minimize the risk of hypoglycemia, a common effect of physical activity.