Type 1 Diabetes MellitusNEXTNCT07226583
Using a Personalized Decision Support Tool to Help People With Type 1 Diabetes Manage Exercise
A study testing Standard-of-Care Guidance (SoC), netIOB & Exercise Toolkit (NEXT) and Continuous Glucose Monitoring in people with Type 1 Diabetes Mellitus and Exercise Physiology, run by Stanford University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus, Exercise Physiology
- What is being tested?
- Standard-of-Care Guidance (SoC), netIOB & Exercise Toolkit (NEXT) and Continuous Glucose Monitoring
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stanford University
Palo Alto, California, 94304
Ryan Kingman, BS, 650-736-4417, rkingman@stanford.edu
Dessi Zaharieva, PhD, 628-238-9420, dessi@stanford.edu
About this study
Official title: 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:
Read more
(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.
Read the detailed description
People with type 1 diabetes frequently experience variable glucose responses before, during, and after physical activity, including exercise-associated hypoglycemia and the need for unplanned carbohydrate intake. Although consensus-based recommendations exist to guide exercise preparation, many individuals continue to rely on trial-and-error strategies that can be burdensome or difficult to generalize across activities.
This study evaluates the netIOB \& Exercise Toolkit (NEXT), a software-based, clinician-facing decision-support system intended to contextualize exercise preparation using recent continuous glucose monitoring (CGM) data and insulin delivery history. The Toolkit estimates net insulin-on-board relative to an individual's programmed basal insulin profile and presents structured, non-automated suggestions related to exercise timing, insulin target adjustments, and carbohydrate intake. All decisions remain under clinician and participant control.
The primary study population consists of adults with type 1 diabetes who complete three supervised, moderate-intensity exercise sessions in a randomized, three-period crossover design. Each session is conducted under a different pre-exercise strategy: consensus standard-of-care guidance, usual personal care routines, or guidance informed by the NEXT Toolkit. Sessions are separated by washout periods to minimize physiologic carryover, and glycemic, insulin delivery, and behavioral outcomes are assessed during exercise and for up to 48 hours post-exercise.
In addition, a healthy adult control group completes a single supervised exercise session without pre-exercise glucose or insulin management interventions. This group is included to provide comparative physiologic context for exploratory analyses.
Exploratory analyses will examine relationships between pre-exercise net insulin-on-board (netIOB) strata and glycemic, insulin, and treatment outcomes across exercise sessions. These analyses are intended to characterize patterns of response rather than to test formal efficacy hypotheses.
Participants in both the type 1 diabetes and healthy control groups will wear a commercially available continuous ketone monitoring (CKM) sensor (SiBio KS1) for exploratory data collection during exercise and defined post-exercise monitoring periods. CKM data are collected solely for research purposes, are not used to guide clinical or study-related decisions, and are not intended to evaluate device performance.
The NEXT Toolkit is classified as a non-significant risk, IDE-exempt investigational tool. Results from this pilot study are intended to inform future research design and the development of transparent, open-access methods for studying exercise physiology and glucose management in diabetes.
- Conditions
- Type 1 Diabetes Mellitus, Exercise Physiology
- Being tested
- Standard-of-Care Guidance (SoC), Usual Care (UC), netIOB & Exercise Toolkit (NEXT), Continuous Glucose Monitoring, Continuous Ketone Monitoring
- Keywords
- Type 1 Diabetes, T1D, T1DM, Continuous Glucose Monitoring, Insulin Dosing, CGM, Insulin Pump, Exercise, carbohydrate Intake, closed-loop system, hybrid closed-loop, CKM, Continuous Ketone Monitoring, Glucose Metabolism, Ketone Metabolism, Exercise Metabolism
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard-of-Care Guidance (SoC)Behavioural
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)Behavioural
Participants independently manage their insulin and carbohydrate decisions around exercise, using their routine practices without study-provided guidance.
netIOB & Exercise Toolkit (NEXT)Device
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.
Continuous Glucose MonitoringDevice
Continuous glucose monitoring using an FDA-cleared system (Dexcom G7) for research data collection during and after exercise. CGM data are used to assess glycemic responses and are not used to evaluate device performance or accuracy.
Continuous Ketone MonitoringDevice
A commercially available continuous ketone monitoring (CKM) device will be used for exploratory data collection during and after exercise. Ketone data are collected for research purposes only and are not used for clinical decision-making or to evaluate device performance.
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-Care (SoC) | Other | 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. Receives: Behavioral: Standard-of-Care Guidance (SoC); Device: Continuous Glucose Monitoring; Device: Continuous Ketone Monitoring |
| Usual Care (UC) | Other | Participants use their own strategies for managing insulin and carbohydrate around exercise. Receives: Behavioral: Usual Care (UC); Device: Continuous Glucose Monitoring; Device: Continuous Ketone Monitoring |
| netIOB & Exercise Toolkit (NEXT) | Experimental | 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. Receives: Device: netIOB & Exercise Toolkit (NEXT); Device: Continuous Glucose Monitoring; Device: Continuous Ketone Monitoring |
| Healthy Control | Other | Adults without diabetes complete one supervised moderate-intensity exercise session for physiologic comparison. Receives: Device: Continuous Glucose Monitoring; Device: Continuous Ketone Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Score of Glycemic Safety and Carbohydrate Burden
This composite outcome reflects glycemic risk during exercise and the subsequent post-exercise monitoring period.
The score is based on a Magni risk-derived metric computed from continuous glucose monitoring (CGM) data, with the glycemic effects of rescue carbohydrate treatments removed to isolate underlying glycemic risk.
Each evaluated timepoint is given a score ranging from 0 to 100, where lower scores indicate lower glycemic risk and higher scores indicate higher glycemic risk. Scores across the defined observation windows are summarized across intervention conditions.
Measured: Baseline (1 hour pre-exercise), Exercise (0 to 90 minutes), Early Post-Exercise (0 to 6 hours after exercise), Mid Post-Exercise (6 to 24 hours after exercise), Late Post-Exercise (24 to 48 hours after exercise); total of 50.5 hours per visit (3 visits).
Secondary outcomes (11)
Percent-Based Continuous Glucose Monitor Metrics
Assess standard continuous glucose monitoring (CGM) metrics during defined time windows relative to exercise (0-90 minutes, 0-6 hours, 6-24 hours, and 24-48 hours post-exercise).
These include:
- Percent Time in Range (TIR): 70-180 mg/dL
- Percent Time Below Range (TBR): <70 mg/dL and <54 mg/dL
- Percent Time Above Range (TAR): >180 mg/dL and >250 mg/dL
Measured: Baseline (1 hour pre-exercise), Exercise (0 to 90 minutes), Early Post-Exercise (0 to 6 hours after exercise), Mid Post-Exercise (6 to 24 hours after exercise), Late Post-Exercise (24 to 48 hours after exercise); total of 50.5 hours per visit (3 visits).
Glucose Concentration and Variability Metrics from Continuous Glucose Monitor
Mean glucose level, glucose standard deviation (SD), and coefficient of variation (CV) will be calculated using CGM data collected over defined time periods relative to exercise. These metrics describe overall glycemic variability and will be used to assess the stability of glucose control following each intervention.
Units of Measure:
Mean glucose: mg/dL SD: mg/dL CV: %
Measured: Baseline (1 hour pre-exercise), Exercise (0 to 90 minutes), Early Post-Exercise (0 to 6 hours after exercise), Mid Post-Exercise (6 to 24 hours after exercise), Late Post-Exercise (24 to 48 hours after exercise); total of 50.5 hours per visit (3 visits).
Frequency of Hypoglycemic Events
Number of hypoglycemic episodes per participant at thresholds of <70 mg/dL and <54 mg/dL, stratified by treatment arm. Events will be classified as treated or untreated.
Measured: Exercise (0 to 90 minutes), Early Post-Exercise (0 to 6 hours after exercise); total of 7.5 hours per visit (3 visits).
Glucose Nadir Value
Lowest glucose value (nadir mg/dl) recorded per participant during exercise period and 0-6 hours post-exercise, as measured by CGM.
Measured: Exercise (0 to 90 minutes), Early Post-Exercise (0 to 6 hours after exercise); total of 7.5 hours per visit (3 visits).
Time to First Hypoglycemic Event
Time (in minutes) from exercise start to the first hypoglycemic episode (<70 mg/dL) for each participant.
Measured: Exercise (0 to 90 minutes), Early Post-Exercise (0 to 6 hours after exercise); total of 7.5 hours per visit (3 visits).
Carbohydrate Consumption for Hypoglycemia Prevention/Treatment
Quantify carbohydrate use related to exercise using:
- Total grams of carbohydrate consumed
- Number of carbohydrate treatment episodes
- Categorization as prophylactic or reactive
Measured: Exercise (0 to 90 minutes); total of 1.5 hours per visit (3 visits).
Total and Programmed Insulin Delivery
Compare the total insulin delivered (actual) to the amount that would have been delivered based on the participant's pre-programmed basal rates. This includes both basal and bolus insulin.
Measured: Baseline (1 hour pre-exercise), Exercise (0 to 90 minutes), Early Post-Exercise (0 to 6 hours after exercise), Mid Post-Exercise (6 to 24 hours after exercise), Late Post-Exercise (24 to 48 hours after exercise); total of 50.5 hours per visit (3 visits).
Frequency of User-Initiated Pump Adjustments
Number of times participants manually modified insulin delivery during the exercise period, including suspensions, temporary targets, exercise mode, or basal rate changes.
Measured: Baseline (1 hour pre-exercise), Exercise (0 to 90 minutes), Early Post-Exercise (0 to 6 hours after exercise), Mid Post-Exercise (6 to 24 hours after exercise), Late Post-Exercise (24 to 48 hours after exercise); total of 50.5 hours per visit (3 visits).
Duration of User-Initiated Pump Adjustments
Cumulative duration of user-initiated pump modifications, including time spent in temporary targets, pump suspensions, and exercise modes.
Measured: Baseline (1 hour pre-exercise), Exercise (0 to 90 minutes), Early Post-Exercise (0 to 6 hours after exercise), Mid Post-Exercise (6 to 24 hours after exercise), Late Post-Exercise (24 to 48 hours after exercise); total of 50.5 hours per visit (3 visits).
Baseline and Peak Ketone Levels
Baseline and peak ketone concentrations (mmol/L) measured using continuous ketone monitoring during the exercise period. Outcomes will be explored across pre-exercise strategies in participants with type 1 diabetes and relative to healthy control participants.
Measured: Baseline (immediately prior to exercise) and Exercise (0 to 90 minutes from exercise).
Ketone Exposure (AUC) During and After Exercise
Ketone exposure quantified as area under the curve (AUC) from continuous ketone monitoring during exercise (0-90 minutes from exercise start) and early post-exercise (0-6 hours after exercise). Outcomes will be explored across pre-exercise strategies in participants with type 1 diabetes and relative to healthy control participants.
Measured: Exercise (0 to 90 minutes), Early Post-Exercise (0 to 6 hours after exercise) per visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study startOct 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants with type 1 diabetes complete three supervised moderate-intensity exercise visits in a randomized, three-period crossover design, with each visit conducted under a different pre-exercise management strategy (standard-of-care guidance, usual care, or the NEXT decision-support toolkit). Visits are separated by a washout period to minimize physiologic carryover. In addition, a healthy adult control group completes a single supervised exercise visit without randomization to provide comparative physiologic data.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University College Dublin, The Leona M. and Harry B. Helmsley Charitable Trust
- Responsible party
- Principal investigator, Rayhan A. Lal, Stanford University
- Investigators
- Rayhan Lal, MD, Principal investigator, Stanford UniversityDessi dessi@stanford.edu, PhD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226583
- Sponsor's protocol ID
- 82224
- Other IDs
- 2407-07175
- Acronym
- NEXT
- Status last verified
- Aug 2026
- First submitted
- 7 Oct 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant-level data will be shared, including: * Continuous glucose monitoring (CGM) metrics from the Dexcom G7 (e.g., time in range, time below/above range, mean glucose, glucose variability) * Carbohydrate treatment data (timing, amount, type) * Insulin delivery data (e.g., pump settings, suspensions, automated adjustments) * Demographic information (e.g., age range, sex, diabetes duration) IPD that will not be shared includes: * Direct identifiers (e.g., names, exact dates of birth, addresses) * Free-text responses or notes containing potentially identifiable information * Any raw data not essential to the reported outcomes or secondary analyses
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07226583
- Acronym / sponsor ID
- NEXT / 82224
- Conditions
- Type 1 Diabetes Mellitus, Exercise Physiology
- Keywords
- Type 1 Diabetes, T1D, T1DM, Continuous Glucose Monitoring, Insulin Dosing, CGM, Insulin Pump, Exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University College Dublin, The Leona M. and Harry B. Helmsley Charitable Trust
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
People with type 1 diabetes frequently experience variable glucose responses before, during, and after physical activity, including exercise-associated hypoglycemia and the need for unplanned carbohydrate intake. Although consensus-based recommendations exist to guide exercise preparation, many individuals continue to rely on trial-and-error strategies that can be burdensome or difficult to generalize across activities.
This study evaluates the netIOB \& Exercise Toolkit (NEXT), a software-based, clinician-facing decision-support system intended to contextualize exercise preparation using recent continuous glucose monitoring (CGM) data and insulin delivery history. The Toolkit estimates net insulin-on-board relative to an individual's programmed basal insulin profile and presents structured, non-automated suggestions related to exercise timing, insulin target adjustments, and carbohydrate intake. All decisions remain under clinician and participant control.
The primary study population consists of adults with type 1 diabetes who complete three supervised, moderate-intensity exercise sessions in a randomized, three-period crossover design. Each session is conducted under a different pre-exercise strategy: consensus standard-of-care guidance, usual personal care routines, or guidance informed by the NEXT Toolkit. Sessions are separated by washout periods to minimize physiologic carryover, and glycemic, insulin delivery, and behavioral outcomes are assessed during exercise and for up to 48 hours post-exercise.
In addition, a healthy adult control group completes a single supervised exercise session without pre-exercise glucose or insulin management interventions. This group is included to provide comparative physiologic context for exploratory analyses.
Exploratory analyses will examine relationships between pre-exercise net insulin-on-board (netIOB) strata and glycemic, insulin, and treatment outcomes across exercise sessions. These analyses are intended to characterize patterns of response rather than to test formal efficacy hypotheses.
Participants in both the type 1 diabetes and healthy control groups will wear a commercially available continuous ketone monitoring (CKM) sensor (SiBio KS1) for exploratory data collection during exercise and defined post-exercise monitoring periods. CKM data are collected solely for research purposes, are not used to guide clinical or study-related decisions, and are not intended to evaluate device performance.
The NEXT Toolkit is classified as a non-significant risk, IDE-exempt investigational tool. Results from this pilot study are intended to inform future research design and the development of transparent, open-access methods for studying exercise physiology and glucose management in diabetes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants with type 1 diabetes complete three supervised moderate-intensity exercise visits in a randomized, three-period crossover design, with each visit conducted under a different pre-exercise management strategy (standard-of-care guidance, usual care, or the NEXT decision-support toolkit). Visits are separated by a washout period to minimize physiologic carryover. In addition, a healthy adult control group completes a single supervised exercise visit without randomization to provide comparative physiologic data.
| Arm | Type | Receives |
|---|---|---|
| Standard-of-Care (SoC) | Other | Behavioral: Standard-of-Care Guidance (SoC), Device: Continuous Glucose Monitoring, Device: Continuous Ketone MonitoringParticipants 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. |
| Usual Care (UC) | Other | Behavioral: Usual Care (UC), Device: Continuous Glucose Monitoring, Device: Continuous Ketone MonitoringParticipants use their own strategies for managing insulin and carbohydrate around exercise. |
| netIOB & Exercise Toolkit (NEXT) | Experimental | Device: netIOB & Exercise Toolkit (NEXT), Device: Continuous Glucose Monitoring, Device: Continuous Ketone MonitoringPhysicians 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. |
| Healthy Control | Other | Device: Continuous Glucose Monitoring, Device: Continuous Ketone MonitoringAdults without diabetes complete one supervised moderate-intensity exercise session for physiologic comparison. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Standard-of-Care (SoC) |
| Usual Care (UC)Participants independently manage their insulin and carbohydrate decisions around exercise, using their routine practices without study-provided guidance. | Behavioural | Usual Care (UC) |
| 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. | Device | netIOB & Exercise Toolkit (NEXT) |
| Continuous Glucose MonitoringContinuous glucose monitoring using an FDA-cleared system (Dexcom G7) for research data collection during and after exercise. CGM data are used to assess glycemic responses and are not used to evaluate device performance or accuracy. | Device | Healthy Control, Standard-of-Care (SoC), Usual Care (UC), netIOB & Exercise Toolkit (NEXT) |
| Continuous Ketone MonitoringA commercially available continuous ketone monitoring (CKM) device will be used for exploratory data collection during and after exercise. Ketone data are collected for research purposes only and are not used for clinical decision-making or to evaluate device performance. | Device | Healthy Control, Standard-of-Care (SoC), Usual Care (UC), netIOB & Exercise Toolkit (NEXT) |
Primary outcome
Composite Score of Glycemic Safety and Carbohydrate Burden
Time frame: Baseline (1 hour pre-exercise), Exercise (0 to 90 minutes), Early Post-Exercise (0 to 6 hours after exercise), Mid Post-Exercise (6 to 24 hours after exercise), Late Post-Exercise (24 to 48 hours after exercise); total of 50.5 hours per visit (3 visits).
This composite outcome reflects glycemic risk during exercise and the subsequent post-exercise monitoring period. The score is based on a Magni risk-derived metric computed from continuous glucose monitoring (CGM) data, with the glycemic effects of rescue carbohydrate treatments removed to isolate underlying glycemic risk. Each evaluated timepoint is given a score ranging from 0 to 100, where lower scores indicate lower glycemic risk and higher scores indicate higher glycemic risk. Scores across the defined observation windows are summarized across intervention conditions.
11 secondary outcomes
Percent-Based Continuous Glucose Monitor Metrics
Time frame: Baseline (1 hour pre-exercise), Exercise (0 to 90 minutes), Early Post-Exercise (0 to 6 hours after exercise), Mid Post-Exercise (6 to 24 hours after exercise), Late Post-Exercise (24 to 48 hours after exercise); total of 50.5 hours per visit (3 visits).
Glucose Concentration and Variability Metrics from Continuous Glucose Monitor
Time frame: Baseline (1 hour pre-exercise), Exercise (0 to 90 minutes), Early Post-Exercise (0 to 6 hours after exercise), Mid Post-Exercise (6 to 24 hours after exercise), Late Post-Exercise (24 to 48 hours after exercise); total of 50.5 hours per visit (3 visits).
Frequency of Hypoglycemic Events
Time frame: Exercise (0 to 90 minutes), Early Post-Exercise (0 to 6 hours after exercise); total of 7.5 hours per visit (3 visits).
Glucose Nadir Value
Time frame: Exercise (0 to 90 minutes), Early Post-Exercise (0 to 6 hours after exercise); total of 7.5 hours per visit (3 visits).
Time to First Hypoglycemic Event
Time frame: Exercise (0 to 90 minutes), Early Post-Exercise (0 to 6 hours after exercise); total of 7.5 hours per visit (3 visits).
Carbohydrate Consumption for Hypoglycemia Prevention/Treatment
Time frame: Exercise (0 to 90 minutes); total of 1.5 hours per visit (3 visits).
Total and Programmed Insulin Delivery
Time frame: Baseline (1 hour pre-exercise), Exercise (0 to 90 minutes), Early Post-Exercise (0 to 6 hours after exercise), Mid Post-Exercise (6 to 24 hours after exercise), Late Post-Exercise (24 to 48 hours after exercise); total of 50.5 hours per visit (3 visits).
Frequency of User-Initiated Pump Adjustments
Time frame: Baseline (1 hour pre-exercise), Exercise (0 to 90 minutes), Early Post-Exercise (0 to 6 hours after exercise), Mid Post-Exercise (6 to 24 hours after exercise), Late Post-Exercise (24 to 48 hours after exercise); total of 50.5 hours per visit (3 visits).
Duration of User-Initiated Pump Adjustments
Time frame: Baseline (1 hour pre-exercise), Exercise (0 to 90 minutes), Early Post-Exercise (0 to 6 hours after exercise), Mid Post-Exercise (6 to 24 hours after exercise), Late Post-Exercise (24 to 48 hours after exercise); total of 50.5 hours per visit (3 visits).
Baseline and Peak Ketone Levels
Time frame: Baseline (immediately prior to exercise) and Exercise (0 to 90 minutes from exercise).
Ketone Exposure (AUC) During and After Exercise
Time frame: Exercise (0 to 90 minutes), Early Post-Exercise (0 to 6 hours after exercise) per visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant-level data will be shared, including: * Continuous glucose monitoring (CGM) metrics from the Dexcom G7 (e.g., time in range, time below/above range, mean glucose, glucose variability) * Carbohydrate treatment data (timing, amount, type) * Insulin delivery data (e.g., pump settings, suspensions, automated adjustments) * Demographic information (e.g., age range, sex, diabetes duration) IPD that will not be shared includes: * Direct identifiers (e.g., names, exact dates of birth, addresses) * Free-text responses or notes containing potentially identifiable information * Any raw data not essential to the reported outcomes or secondary analyses
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rayhan Lal, MD principal investigator
Stanford University
Dessi dessi@stanford.edu, PhD study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard-of-Care Guidance (SoC), netIOB & Exercise Toolkit (NEXT) and Continuous Glucose Monitoring in people with Type 1 Diabetes Mellitus and Exercise Physiology, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dessi Zaharieva, PhD (628-238-9420, dessi@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Score of Glycemic Safety and Carbohydrate Burden (time frame: Baseline (1 hour pre-exercise), Exercise (0 to 90 minutes), Early Post-Exercise (0 to 6 hours after exercise), Mid Post-Exercise (6 to 24 hours after exercise), Late Post-Exercise (24 to 48 hours after exercise); total of 50.5 hours per visit (3 visits).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.