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NOT YET RECRUITING
NCT07226583
NA

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

Sponsor: Stanford University

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-04

Completion Date

2026-08

Last Updated

2026-02-19

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Standard-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.

BEHAVIORAL

Usual Care (UC)

Participants independently manage their insulin and carbohydrate decisions around exercise, using their routine practices without study-provided guidance.

DEVICE

netIOB & 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.

DEVICE

Continuous 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.

DEVICE

Continuous 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.

Locations (1)

Stanford University

Palo Alto, California, United States