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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT07226583
Status
Not Yet Recruiting

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Conditions

  • Exercise Physiology
  • Type 1 Diabetes (T1D)
  • Type 1 Diabetes Mellitis
  • Type 1 Diabetes Mellitus (T1DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Standard-of-Care Guidance (SoC) — BEHAVIORAL
    Study staff provide insulin and carbohydrate adjustment advice based on consensus exercise management guidelines (Moer et al., 2024), tailored to the planned activity.
  • Usual Care (UC) — BEHAVIORAL
    Participants independently manage their insulin and carbohydrate decisions around exercise, using their routine practices without study-provided guidance.
  • netIOB & Exercise Toolkit (NEXT) — DEVICE
    An investigational software tool generates individualized insulin and carbohydrate adjustment recommendations before and after exercise using CGM data and recent insulin delivery. Study physicians review and relay these recommendations to participants.
  • Continuous Glucose Monitoring — DEVICE
    Continuous glucose monitoring using an FDA-cleared system (Dexcom G7) for research data collection during and after exercise. CGM data are used to assess glycemic responses and are not used to evaluate device performance or accuracy.
  • Continuous Ketone Monitoring — DEVICE
    A commercially available continuous ketone monitoring (CKM) device will be used for exploratory data collection during and after exercise. Ketone data are collected for research purposes only and are not used for clinical decision-making or to evaluate device performance.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Feb 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Other: Standard-of-Care (SoC)
    Participants follow consensus-based guidance for insulin and carbohydrate adjustments around exercise, as outlined in current international standards. These recommendations are applied by study staff in advance of the exercise session.
  • Other: Usual Care (UC)
    Participants use their own strategies for managing insulin and carbohydrate around exercise.
  • Experimental: netIOB & Exercise Toolkit (NEXT)
    Physicians receive personalized, algorithm-informed recommendations for exercise-related insulin and carbohydrate adjustments. Recommendations are generated using the investigational netIOB \& Exercise Toolkit based on CGM data, insulin history, and real-time inputs.
  • Other: Healthy Control
    Adults without diabetes complete one supervised moderate-intensity exercise session for physiologic comparison.

Primary Outcome Measure

Composite Score of Glycemic Safety and Carbohydrate Burden [ Time Frame: 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). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Ryan Kingman, BS
[email protected]
650-736-4417
Dessi Zaharieva, PhD
[email protected]
628-238-9420
Rayhan Lal, MD (PRINCIPAL_INVESTIGATOR)
Dessi Zaharieva, PhD (SUB_INVESTIGATOR)

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