Real-world Study on the Effectiveness and Safety of Control-IQ Technology in Teenagers With Type 1 Diabetes Engaging in Regular Physical Activity (PED-CIQAcT1ve)

June 18, 2025 updated by: Bruno Bombaci

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Messina, Italy, 98125
        • Recruiting
        • University Hospital of Messina
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adolescents with type 1 diabetes, using Control-IQ technology, and engaging in regular physical activity

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in range (%)
Time Frame: 14 days
Time spent with sensor glucose between 70 and 180 mg/dl (3.9 and 10 mmol/L)
14 days
Time in tight range (%)
Time Frame: 14 days
Time spent with sensor glucose between 70 and 140 mg/dl (3.9 and 7.8 mmol/L)
14 days
Time above range level 1 (%)
Time Frame: 14 days
Time spent with sensor glucose between 180 and 250 mg/dl (10.1 and 13.9 mmol/L)
14 days
Time above range level 2 (%)
Time Frame: 14 days
Time spent with sensor glucose > 250 mg/dl (13.9 mmol/L)
14 days
Time below range level 1 (%)
Time Frame: 14 days
Time spent with sensor glucose between 54 and 70 mg/dl (3.0 and 3.8 mmol/L)
14 days
Time below range level 2 (%)
Time Frame: 14 days
Time spent with sensor glucose < 54 mg/dl (3.0 mmol/L)
14 days
Mean sensor glucose (mg/dl or mmol/L)
Time Frame: 14 days
14 days
Coefficient of variation (%)
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Daytime (h 07.00-23.00) Time in Range (%)
Time Frame: 14 days
14 days
Nighttime (h 23.00 - 07.00) Time in Range (%)
Time Frame: 14 days
14 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetic ketoacidosis episodes
Time Frame: 14 days
(safety)
14 days
Severe hypoglycemia episodes
Time Frame: 14 days
(safety)
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bruno Bombaci

Collaborators

University of Messina
University of Verona, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 14, 2025

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 18, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PED#CIQACT1VE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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