Net-IOB & Exercise Toolkit Pilot Trial: Randomized, Crossover Evaluation of a Behavioral Decision Support Advisor to Improve Glycemic Safety During and After Exercise in Adults With Type 1 Diabetes (NEXT)
Stanford University
Summary
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.
Description
People with type 1 diabetes frequently experience variable glucose responses before, during, and after physical activity, including exercise-associated hypoglycemia and the need for unplanned carbohydrate intake. Although consensus-based recommendations exist to guide exercise preparation, many individuals continue to rely on trial-and-error strategies that can be burdensome or difficult to generalize across activities. This study evaluates the netIOB \& Exercise Toolkit (NEXT), a software-based, clinician-facing decision-support system intended to contextualize exercise preparation using rec…
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria Inclusion Criteria: All Participants (Type 1 Diabetes and Healthy Control Groups) * 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 Inclusion Criteria: Type 1 Diabetes Group Only * Clinical diagnosis of type 1 diabetes for \>1 year, based on the investigator's clinical judgement * Current use of continuous subcutaneous insulin i…
Interventions
- BehavioralStandard-of-Care Guidance (SoC)
Study staff provide insulin and carbohydrate adjustment advice based on consensus exercise management guidelines (Moer et al., 2024), tailored to the planned activity.
- BehavioralUsual Care (UC)
Participants independently manage their insulin and carbohydrate decisions around exercise, using their routine practices without study-provided guidance.
- DevicenetIOB & Exercise Toolkit (NEXT)
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.
- DeviceContinuous Glucose Monitoring
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.
- DeviceContinuous Ketone Monitoring
Investigational dual-analyte continuous glucose-ketone monitoring device used for continuous ketone data collection only during and after exercise. Glucose data generated by the device are not used for analysis or clinical decision-making. Ketone data are collected for exploratory research purposes only and are not used to assess device performance or accuracy.
Location
- Stanford UniversityPalo Alto, California