Using a Personalized Decision Support Tool to Help People With Type 1 Diabetes Manage Exercise
NCT ID: NCT07226583
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
10 participants
INTERVENTIONAL
2025-12-31
2026-06-30
Brief Summary
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Participants will complete three structured aerobic or mixed-exercise sessions using different guidance approaches:
(A) published consensus-based standard-of-care guidelines (B) usual personal care routines (C) the NEXT tool
The study compares glucose outcomes, safety, and carbohydrate use across these conditions to inform better exercise preparation and support tools for people with diabetes.
Detailed Description
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This study evaluates a software-based tool, netIOB \& Exercise Toolkit (NEXT), that provides real-time, individualized guidance for exercise preparation. The tool uses data from continuous glucose monitors (CGMs), insulin delivery history, and exercise timing to suggest adjustments such as carbohydrate intake, temporary targets, or delayed start times. Its goal is to reduce hypoglycemia and carbohydrate burden while preserving exercise safety and feasibility.
The trial uses a randomized, crossover design in which participants complete three supervised moderate-intensity exercise sessions, each under a different preparation strategy. The guidance methods include consensus standard-of-care, usual personal care, and the investigational NEXT tool. Each session is followed for 48 hours to assess glycemic and behavioral outcomes.
Exploratory analyses will stratify glycemic and treatment outcomes based on pre-exercise net insulin-on-board (netIOB) levels, categorized into predefined strata (e.g., 0.0-1.0u, 1.0-2.0u, 2.0-3.0u, 3.0u+), to assess potential effect modification across intervention arms.
The NEXT tool is investigational and classified as IDE-exempt. Findings from this study may inform the design of future clinical trials and support the development of open-source methods for exercise preparation in diabetes.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
Usual Care (UC)
Participants use their own strategies for managing insulin and carbohydrate around exercise.
Usual Care (UC)
Participants independently manage their insulin and carbohydrate decisions around exercise, using their routine practices without study-provided guidance.
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.
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.
Interventions
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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.
Usual Care (UC)
Participants independently manage their insulin and carbohydrate decisions around exercise, using their routine practices without study-provided guidance.
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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of type 1 diabetes for \>1 year (based on investigator's clinical judgement)
* Using Tandem Control-IQ and Dexcom G7 for ≥1 month
* Able to sustain moderate intensity walking for 60 minutes (target 50-60% age-predicted HR max) without limitation.
* Use of a stable insulin delivery regimen, with no planned changes in settings or dosing strategy during the study period, and consistent continuous glucose monitor (CGM) use in the prior 1 month (\>80% data)
Exclusion Criteria
* Use of other medications with the potential to confound glycemia (including SGLT-2 inhibitors, GIP or GLP-1 receptor agonists) unless on a stable regimen with no planned changes during the study.
* Use of systemic steroids within 4 weeks of planned study participation.
* Severe hypoglycemia (requiring assistance) or DKA within the prior 6 months.
* Intercurrent illness or medical conditions that preclude safe participation in moderate-intensity exercise (e.g. unstable cardiopulmonary disease, uncontrolled arrhythmia, or uncontrolled hypertension), as previously assessed by the individual's primary care physician.
* Pregnancy, lactation, or planned pregnancy during participation.
* Renal insufficiency with eGR \<45 mL/min/1.73 m2, dialysis, or adrenal insufficiency.
* Known coronary disease or angina that limits moderate activity, or myocardial infarction/PCI/CABG within 12 months.
* Concurrent participation in another interventional drug/device study within 30 days
* Inability to comply with study procedures or safety requirements (e.g., cannot achieve target HR zone, cannot attend visits, or cannot enable device data access), or otherwise deemed unsuitable by the investigator.
18 Years
60 Years
ALL
No
Sponsors
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University College Dublin
OTHER
The Leona M. and Harry B. Helmsley Charitable Trust
OTHER
Stanford University
OTHER
Responsible Party
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Rayhan A. Lal
Assistant Professor of Medicine & Pediatrics
Principal Investigators
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Rayhan Lal, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University
Palo Alto, California, United States
Countries
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Central Contacts
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Facility Contacts
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Ryan Kingman, BS
Role: primary
Dessi Zaharieva, PhD
Role: backup
Other Identifiers
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2407-07175
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
82224
Identifier Type: -
Identifier Source: org_study_id