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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorStanford University

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

20 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Stanford University

Lead sponsor

University College Dublin

Collaborator

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator