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

NCT ID: NCT06876207

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-06-01

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Tandem 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.

Intervention Type: DEVICE

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

• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Messina

OTHER

Sponsor Role: collaborator

University of Verona, Italy

UNKNOWN

Sponsor Role: collaborator

Bruno Bombaci

OTHER

Sponsor Role: lead

Responsible Party

Bruno Bombaci

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University Hospital of Messina

Messina, Italy, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Bruno Bombaci, MD

Role: CONTACT

brunobombaci@gmail.com

+393473931038

Giuseppina Salzano, PhD MD

Role: CONTACT

gsalzano@unime.it

Facility Contacts

Bruno Bombaci, MD

Role: primary

brunobombaci@gmail.com

+390902213023

Other Identifiers

PED#CIQACT1VE

Identifier Type: -

Identifier Source: org_study_id