About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Standard-of-Care Guidance (SoC)
- Usual Care (UC)
- netIOB & Exercise Toolkit (NEXT)
- Continuous Glucose Monitoring
- Continuous Ketone Monitoring
Treatment groups
Sponsors and collaborators
Stanford University
Lead sponsor
University College Dublin
Collaborator
The Leona M. and Harry B. Helmsley Charitable Trust
Collaborator