Fact CheckerSign in

NCT07226583Not yet recruiting

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

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)

Source: ClinicalTrials.gov · Last updated 12 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
20 (estimated)
First submitted
7 Oct 2025
Start date
1 Oct 2026
Primary completion date
28 Feb 2027
Lead sponsor
Stanford University
NCT number
NCT07226583

What you commit to

  • Study type: Interventional
  • Planned participants: 20
  • From 1 Oct 2026 to the primary completion date, 28 Feb 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Lab values

  • Renal insufficiency with estimated GFR \<45 mL/min/1.73 m², dialysis dependence, or adrenal insufficiency

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Stanford University
Coordinator of this site? Confirm its status
Palo AltoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.