New app aims to prevent dangerous blood sugar dips during workouts for type 1 diabetes
NCT ID NCT07226583
First seen Jun 24, 2026 · Last updated Aug 13, 2026 · Updated 3 times
Summary
This pilot study tests a software tool called NEXT that gives personalized advice on insulin and carbohydrate adjustments before and after exercise for adults with type 1 diabetes. Twenty participants will try three different approaches to managing their blood sugar around exercise: standard guidelines, their usual routine, and the NEXT toolkit. The goal is to see if the tool helps keep blood sugar in a safe range during and after physical activity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- netIOB & Exercise Toolkit (NEXT) – a software tool that gives personalized advice on insulin and carbs before and after exercise
- What this could lead to
- If it works, this could help people with type 1 diabetes exercise more safely by reducing dangerous blood sugar swings.
- What could go wrong
- This is a very small pilot study (20 participants) testing a software tool, not a treatment. It may not show clear benefits or work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Stanford University
Palo Alto, California, 94304, United States
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