Using a Personalized Decision Support Tool to Help People With Type 1 Diabetes Manage Exercise (NCT07226583) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Using a Personalized Decision Support Tool to Help People With Type 1 Diabetes Manage Exercise
United States20 participantsStarted 2026-04
Plain-language summary
This study evaluates a clinician-facing decision-support toolkit designed to assist adults with type 1 diabetes in preparing for moderate-intensity exercise. The netIOB \& Exercise Toolkit (NEXT) integrates recent glucose data and insulin delivery history to provide individualized suggestions regarding exercise timing, insulin adjustments, and carbohydrate intake.
Adults with type 1 diabetes will complete three supervised exercise sessions under different pre-exercise guidance approaches:
(A) published consensus-based standard-of-care guidance, (B) usual personal care routines, and (C) guidance informed by the NEXT Toolkit.
A healthy adult control group will complete a single supervised exercise session to provide comparative physiologic data.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria Inclusion Criteria: All Participants (Type 1 Diabetes and Healthy Control Groups)
* Adults between the age of 18-60 years
* Able to perform moderate intensity walking for 60 minutes (target 40-60% age-predicted maximal heart rate).
* Willing and able to comply with study procedures, including supervised exercise visits and device wear
* Able to provide written informed consent
Inclusion Criteria: Type 1 Diabetes Group Only
* Clinical diagnosis of type 1 diabetes for \>1 year, based on the investigator's clinical judgement
* Current use of continuous subcutaneous insulin infusion with Tandem Control-IQ and a compatible continuous glucose monitor (CGM) for \>1 month prior to enrollment
* Stable insulin delivery regimen, with no planned changes to insulin pump settings or insulin dosing strategy during the study period
* Consistent CGM use during the month prior to enrollment (\>80% data availability)
Inclusion Criteria: Health Control Group Only
* No diagnosis of diabetes or other disorders of glucose metabolism
* Not using insulin or glucose-lowering medications
Exclusion Criteria Exclusion Criteria: All Participants
* Intercurrent illness or medical condition that precludes safe participation in moderate-intensity exercise (e.g., unstable cardiopulmonary disease, uncontrolled arrhythmia, or uncontrolled hypertension), as previously assessed by the participant's primary care physician
* Known coronary artery disease with symptoms limiting moderate phy…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite Score of Glycemic Safety and Carbohydrate Burden
Timeframe: Baseline (1 hour pre-exercise), Exercise (0 to 90 minutes), Early Post-Exercise (0 to 6 hours after exercise), Mid Post-Exercise (6 to 24 hours after exercise), Late Post-Exercise (24 to 48 hours after exercise); total of 50.5 hours per visit (3 visits).