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

ConditionsType 1 Diabetes MellitusExercise Physiology
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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 4 treatment groups
Group A: Standard-of-Care (SoC)Other 3 interventions
Group B: Usual Care (UC)Other 3 interventions
Group C: netIOB & Exercise Toolkit (NEXT)Experimental treatment 3 interventions
Group D: Healthy ControlOther 2 interventions

Trial outcomes

Primary outcomes

1

Composite Score of Glycemic Safety and Carbohydrate Burden

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.

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).

Secondary outcomes

1

Percent-Based Continuous Glucose Monitor Metrics

Assess standard continuous glucose monitoring (CGM) metrics during defined time windows relative to exercise (0-90 minutes, 0-6 hours, 6-24 hours, and 24-48 hours post-exercise). These include: * Percent Time in Range (TIR): 70-180 mg/dL * Percent Time Below Range (TBR): \<70 mg/dL and \<54 mg/dL * Percent Time Above Range (TAR): \>180 mg/dL and \>250 mg/dL

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).
2

Glucose Concentration and Variability Metrics from Continuous Glucose Monitor

Mean glucose level, glucose standard deviation (SD), and coefficient of variation (CV) will be calculated using CGM data collected over defined time periods relative to exercise. These metrics describe overall glycemic variability and will be used to assess the stability of glucose control following each intervention. Units of Measure: Mean glucose: mg/dL SD: mg/dL CV: %

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).
3

Frequency of Hypoglycemic Events

Number of hypoglycemic episodes per participant at thresholds of \<70 mg/dL and \<54 mg/dL, stratified by treatment arm. Events will be classified as treated or untreated.

Time frame
Exercise (0 to 90 minutes), Early Post-Exercise (0 to 6 hours after exercise); total of 7.5 hours per visit (3 visits).
4

Glucose Nadir Value

Lowest glucose value (nadir mg/dl) recorded per participant during exercise period and 0-6 hours post-exercise, as measured by CGM.

Time frame
Exercise (0 to 90 minutes), Early Post-Exercise (0 to 6 hours after exercise); total of 7.5 hours per visit (3 visits).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

University College Dublin

Collaborator

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Source ClinicalTrials.gov

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