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

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.

Conditions

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

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

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.

Sponsors & Collaborators

• University College Dublin

  collaborator OTHER

• The Leona M. and Harry B. Helmsley Charitable Trust

  collaborator OTHER

• Stanford University

  lead OTHER

Principal Investigators

• Rayhan Lal, MD · Stanford University

• Dessi [email protected], PhD · Stanford University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-04-30

Primary Completion

2026-08-31

Completion

2026-08-31

FDA Device

Yes

Countries

• United States

Study Locations