Studies an automated insulin device in teens with type 1 diabetes during exercise
Observes glucose control in teens with type 1 diabetes using an automated insulin pump.
Plain-language title generated from the registry record
Registry title: Real-world Study on the Effectiveness and Safety of Control-IQ Technology in Teenagers With Type 1 Diabetes Engaging in Regular Physical Activity
Key facts
- Where
- Messina, ItalySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for teenagers with type 1 diabetes who use Control-IQ technology and exercise regularly.
- Age
- Younger than 20 years
- Sex
- All sexes can join.
- Disease stage
- Type 1 diabetes diagnosed according to ISPAD guidelines, for more than 12 months. Pubertal development completed (Tanner stage).
- Earlier treatment
- Must have used Control-IQ technology for at least 3 months. Automatic mode and CGM must each have been used at least 70% of the time in the 2 weeks before enrollment.
Main reasons for not taking part
- Uncontrolled celiac disease or thyroid disease
- 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 affect CGM accuracy
Read by machine on 12 November 2026.
Where in Italy
- University Hospital of MessinaMessina, ItalyContact: Bruno Bombaci, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Bruno Bombaci
- Trial code
- NCT06876207
- Record updated
- 25 June 2025
- Original description
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.Read full original descriptionShow less
Real-world Study on the Effectiveness and Safety of Control-IQ Technology in Teenagers With Type 1 Diabetes Engaging in Regular Physical Activity
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.
Inclusion: 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: Chronic use of substances or drugs that could impact CGM accuracy; 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.