Type 1 Diabetes MellitusPED-CIQAcT1veNCT06876207
Real-world Study on the Effectiveness and Safety of Control-IQ Technology in Teenagers With Type 1 Diabetes Engaging in Regular Physical Activity
An observational study of Type 1 Diabetes Mellitus, run by Bruno Bombaci at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2025to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents with type 1 diabetes, using Control-IQ technology, and engaging in regular physical activity
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Giuseppina Salzano, PhD MD contact
Italy1 site, 1 recruiting
- Recruiting
University Hospital of Messina
Messina, Italy, 98125
Bruno Bombaci, MD, +390902213023, brunobombaci@gmail.com
About this study
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.
Read more
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
- Being tested
- Tandem t:slim X2 with Control-IQ technology
- Keywords
- type 1 diabetes, pediatric diabetes, sport, physical activity, automated insulin delivery
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tandem t:slim X2 with Control-IQ technologyDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range (%)
Time spent with sensor glucose between 70 and 180 mg/dl (3.9 and 10 mmol/L)
Measured: 14 days
Time in tight range (%)
Time spent with sensor glucose between 70 and 140 mg/dl (3.9 and 7.8 mmol/L)
Measured: 14 days
Time above range level 1 (%)
Time spent with sensor glucose between 180 and 250 mg/dl (10.1 and 13.9 mmol/L)
Measured: 14 days
Time above range level 2 (%)
Time spent with sensor glucose > 250 mg/dl (13.9 mmol/L)
Measured: 14 days
Time below range level 1 (%)
Time spent with sensor glucose between 54 and 70 mg/dl (3.0 and 3.8 mmol/L)
Measured: 14 days
Time below range level 2 (%)
Time spent with sensor glucose < 54 mg/dl (3.0 mmol/L)
Measured: 14 days
Mean sensor glucose (mg/dl or mmol/L)
Measured: 14 days
Coefficient of variation (%)
Measured: 14 days
Secondary outcomes (2)
Daytime (h 07.00-23.00) Time in Range (%)
Measured: 14 days
Nighttime (h 23.00 - 07.00) Time in Range (%)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Jun 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bruno Bombaci
- Sponsor type
- University, hospital or other
- Collaborators
- University of Messina, Universita di Verona
- Responsible party
- Sponsor-investigator, Bruno Bombaci, University of Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876207
- Sponsor's protocol ID
- PED#CIQACT1VE
- Acronym
- PED-CIQAcT1ve
- Status last verified
- Jun 2025
- First submitted
- 6 Mar 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06876207
- Acronym / sponsor ID
- PED-CIQAcT1ve / PED#CIQACT1VE
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- type 1 diabetes, pediatric diabetes, sport, physical activity, automated insulin delivery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bruno BombaciUniversity, hospital or other
- Collaborators
- University of Messina, Universita di Verona
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents with type 1 diabetes, using Control-IQ technology, and engaging in regular physical activity
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tandem t:slim X2 with Control-IQ technologyControl-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. | Device | – |
Primary outcome
Time in range (%)
Time frame: 14 days
Time spent with sensor glucose between 70 and 180 mg/dl (3.9 and 10 mmol/L)
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)
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)
Time above range level 2 (%)
Time frame: 14 days
Time spent with sensor glucose > 250 mg/dl (13.9 mmol/L)
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)
Time below range level 2 (%)
Time frame: 14 days
Time spent with sensor glucose < 54 mg/dl (3.0 mmol/L)
Mean sensor glucose (mg/dl or mmol/L)
Time frame: 14 days
Coefficient of variation (%)
Time frame: 14 days
2 secondary outcomes
Daytime (h 07.00-23.00) Time in Range (%)
Time frame: 14 days
Nighttime (h 23.00 - 07.00) Time in Range (%)
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giuseppina Salzano, PhD MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by Bruno Bombaci at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruno Bombaci, MD (+393473931038, brunobombaci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (%) (time frame: 14 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.