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Testing a Decision Tool to Guide Exercise in Adults With Type 1 Diabetes

Tests a decision-support tool for exercise planning in adults with type 1 diabetes.

Plain-language title generated from the registry record
Registry title: Using a Personalized Decision Support Tool to Help People With Type 1 Diabetes Manage Exercise

Key facts

Where
Palo Alto, United StatesSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 60 years old?

Source: NCT07226583, who can take part

Where in United States

  • Stanford UniversityPalo Alto, United StatesNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Stanford University
Trial code
NCT07226583
Record updated
12 August 2026
Original description
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.Read full original descriptionShow less

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)

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.

Inclusion: 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; Clinical diagnosis of type 1 diabetes for >1 year, based on the investigator's clinical judgement; Current use of continuous subcutaneous insulin infusion with Tandem Control-IQ and a compatible continuous glucose monitor (CGM) for >1 month prior to enrollment; Stable insulin delivery regimen, with no planned changes to insulin pump settings or insulin dosing strategy during the study period; Consistent CGM use during the month prior to enrollment (>80% data availability); No diagnosis of diabetes or other disorders of glucose metabolism; Not using insulin or glucose-lowering medications.

Exclusion: 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; Concurrent participation in another interventional drug or device study within 30 days prior to enrollment; Use of medications with potential to substantially affect glycemia (e.g., SGLT-2 inhibitors, GLP-1 receptor agonists, or GIP agonists), unless on a stable regimen with no planned changes during the study; Use of systemic corticosteroids within 4 weeks prior to participation; History of severe hypoglycemia (requiring third-party assistance) or diabetic ketoacidosis within the prior 6 months; 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; Inability to comply with study procedures or safety requirements (e.g., inability to achieve target heart-rate zone, attend scheduled visits, or enable required device data access), or otherwise deemed unsuitable by the investigator; Renal insufficiency with estimated GFR <45 mL/min/1.73 m², dialysis dependence, or adrenal insufficiency; Pregnancy, lactation, or plans to become pregnant during the study period; Use of non-CSII insulin delivery, including long-acting injectable or inhaled insulin, during the study period.

ClinicalTrials.gov NCT07226583