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Personalized Decision Support for Exercise in Type 1 Diabetes

This study is testing a new software tool called netIOB & Exercise Toolkit (NEXT) to help adults with type 1 diabetes manage their blood sugar during exercise. The NEXT tool uses your continuous glucose monitor (CGM) data and recent insulin history to give personalized advice on insulin and carbohydrate adjustments before and after exercise. Researchers want to see if using this tool leads to better blood sugar control and fewer problems compared to standard guidelines or your usual care. You might be able to join if you are an adult between 18 and 60 years old with type 1 diabetes and can do moderate exercise. The study aims to enroll 20 participants.

Study design
This interventional study involves adults with type 1 diabetes completing three supervised exercise sessions, each with a different guidance approach. A healthy adult control group will complete one exercise session for comparison.
What's involved
You would participate in three supervised exercise visits, each lasting about 50.5 hours, where you'll wear a continuous glucose monitor and a continuous ketone monitor. You'll also need to be able to perform moderate intensity walking for 60 minutes.
Compensation
Not stated in the trial record.
Follow-up
Your blood sugar and other data will be collected for up to 48 hours after each exercise session.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07226583

Using a Personalized Decision Support Tool to Help People With Type 1 Diabetes Manage Exercise

Not Yet Recruiting
NAAges 18–60InterventionalSupportive care
Stanford University
~20 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Standard-of-Care Guidance (SoC)Usual Care (UC)netIOB & Exercise Toolkit (NEXT)Continuous Glucose MonitoringContinuous Ketone Monitoring

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite Score of Glycemic Safety and Carbohydrate Burden
Measured over 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).

Conditions

Type 1 Diabetes Mellitus
Exercise Physiology

Explore related trials

Type 1 Diabetes Mellitus

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Rayhan Lal, MD · PRINCIPAL_INVESTIGATOR · Stanford University
  • Dessi [email protected], PhD · STUDY_DIRECTOR · Stanford University

Who to contact

Dessi Zaharieva, PhD
[email protected]
628-238-9420
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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)
No diagnosis of diabetes or other disorders of glucose metabolism
Not using insulin or glucose-lowering medications

Exclusion

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 physical activity, or history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the past 12 months
Pregnancy, lactation, or plans to become pregnant during the study period
Renal insufficiency with estimated GFR \<45 mL/min/1.73 m², dialysis dependence, or adrenal insufficiency
Concurrent participation in another interventional drug or device study within 30 days prior to enrollment
Inability to comply with study procedures or safety requirements (e.g., inability to achieve target heart-rate zone, attend scheduled visits, or enable required device data access), or otherwise deemed unsuitable by the investigator
Use of non-CSII insulin delivery, including long-acting injectable or inhaled insulin, during the study period
Use of medications with potential to substantially affect glycemia (e.g., SGLT-2 inhibitors, GLP-1 receptor agonists, or GIP agonists), unless on a stable regimen with no planned changes during the study
Use of systemic corticosteroids within 4 weeks prior to participation
History of severe hypoglycemia (requiring third-party assistance) or diabetic ketoacidosis within the prior 6 months

What this trial measures

  • Composite Score of Glycemic Safety and Carbohydrate BurdenBaseline (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).

    This composite outcome reflects glycemic risk during exercise and the subsequent post-exercise monitoring period. The score is based on a Magni risk-derived metric computed from continuous glucose monitoring (CGM) data, with the glycemic effects of rescue carbohydrate treatments removed to isolate underlying glycemic risk. Each evaluated timepoint is given a score ranging from 0 to 100, where lower scores indicate lower glycemic risk and higher scores indicate higher glycemic risk. Scores across the defined observation windows are summarized across intervention conditions.