Clinical trial NCT06876207: Real-world Study on the Effectiveness and Safety of Control-IQ Technology in Teenagers with Type 1 Diabetes Engaging in Regular Physical Activity
Official title: Real-world Study on the Effectiveness and Safety of Control-IQ Technology in Teenagers with Type 1 Diabetes Engaging in Regular Physical Activity
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type 1 Diabetes Mellitus
Keywords: type 1 diabetes
pediatric diabetes
sport
physical activity
automated insulin delivery
Lead sponsor: University of Messina
Sponsor class: OTHER
Collaborators: name: University of Messina
name: University of Verona, Italy
First posted: 2025-03-14
Enrollment: 50
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents with type 1 diabetes, using Control-IQ technology, and engaging in regular physical activity

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

Primary outcomes:
measure: Time in range (%)
timeFrame: 14 days
measure: Time in tight range (%)
timeFrame: 14 days
measure: Time above range level 1 (%)
timeFrame: 14 days
measure: Time above range level 2 (%)
timeFrame: 14 days
measure: Time below range level 1 (%)
timeFrame: 14 days
measure: Time below range level 2 (%)
timeFrame: 14 days
measure: Mean sensor glucose (mg/dl or mmol/L)
timeFrame: 14 days
measure: Coefficient of variation (%)
timeFrame: 14 days
Secondary outcomes:
measure: Daytime (h 07.00-23.00) Time in Range (%)
timeFrame: 14 days
measure: Nighttime (h 23.00 - 07.00) Time in Range (%)
timeFrame: 14 days
Other outcomes:
measure: Diabetic ketoacidosis episodes
timeFrame: 14 days
measure: Severe hypoglycemia episodes
timeFrame: 14 days
Locations:
Study officials:
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