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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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria Inclusion Criteria: All Participants (Type 1 Diabetes and Healthy Control Groups) * 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 Inclusion Criteria: Type 1 Diabetes Group Only * 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) Inclusion Criteria: Health Control Group Only * No diagnosis of diabetes or other disorders of glucose metabolism * Not using insulin or glucose-lowering medications Exclusion Criteria Exclusion Criteria: All Participants * 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 * 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 * Pregnancy, lactation, or plans to become pregnant during the study period * Renal insufficiency with estimated GFR \<45 mL/min/1.73 m², dialysis dependence, or adrenal insufficiency * Concurrent participation in another interventional drug or device study within 30 days prior to enrollment * 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 Exclusion Criteria: Type 1 Diabetes Group Only * Use of non-CSII insulin delivery, including long-acting injectable or inhaled insulin, during the study period * 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

Study sites (1)

CA