Control‑IQ use and glucose control during regular exercise in teenagers with type 1 diabetes
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
Run by University of Messina · NCT06876207 · Data updated 2026-11-12
This project will see if the Control‑IQ automated insulin system helps teenagers with type 1 diabetes keep glucose levels in range during regular physical activity.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 20 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University of Messina Academic / other |
| Locations | 1 site (Messina, Italy) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | December 31, 2025 |
| Study ends | June 1, 2026 |
| Registry record updated | June 25, 2025 |
| Trial ID | NCT06876207 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Teenagers under 20 with established type 1 diabetes (>12 months), completed pubertal development, who have been using Control‑IQ and CGM regularly (≥70% use) and who perform at least two 45‑minute exercise sessions per week are ideal candidates.
✕Probably not a fit
Patients who do not use the Control‑IQ system, are not regularly physically active, have uncontrolled comorbidities, or cannot meet the device‑use requirements are unlikely to benefit from this observational project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational, open‑label real‑world study will monitor adolescents with type 1 diabetes who already use the Tandem t:slim X2 with Control‑IQ for a 14‑day period. Participants will wear continuous glucose monitoring and keep a diary recording the type, intensity, and duration of physical activity so investigators can compare glucose profiles on exercise versus sedentary days. Secondary analyses will examine how factors such as anthropometry, exercise modality and duration, use of the pump's exercise mode, and other management strategies relate to glycemic outcomes. Safety reporting will document any episodes of severe hypoglycemia or diabetic ketoacidosis during the observation period.
Why it matters
Potential benefit: If successful, the findings could help teenagers using Control‑IQ manage glucose more safely around exercise and reduce hypoglycemia or large glucose excursions.
How similar studies have gone: Prior research shows automated insulin delivery systems including Control‑IQ improve overall time‑in‑range, but real‑world evidence specifically focused on adolescent exercise is limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University Hospital of Messina
Messina, Italy, Italy Recruiting
Study contacts
- Study coordinator: Bruno Bombaci, MD
- Email: brunobombaci@gmail.com
- Phone: +393473931038
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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VV-14300: a gene therapy approach for adults with type 1 diabetes not well controlled on an automated insulin system
This trial tests VV-14300 in adults with type 1 diabetes who aren’t reaching their blood sugar goals despite using an automated insulin delivery system.
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New gene therapies VV-14299 and VV-14300 for adults with Type 1 Diabetes failing automated insulin delivery
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.