[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610361":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":52,"centralContacts":59,"locations":69,"responsibleParty":88,"collaborators":91,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":36,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":120,"overallStatus":131,"whyStopped":36,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Stanford University","OTHER",[8,15,20,26],{"label":9,"type":6,"description":10,"interventionNames":11},"Standard-of-Care (SoC)","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.",[12,13,14],"Behavioral: Standard-of-Care Guidance (SoC)","Device: Continuous Glucose Monitoring","Device: Continuous Ketone Monitoring",{"label":16,"type":6,"description":17,"interventionNames":18},"Usual Care (UC)","Participants use their own strategies for managing insulin and carbohydrate around exercise.",[19,13,14],"Behavioral: Usual Care (UC)",{"label":21,"type":22,"description":23,"interventionNames":24},"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.",[25,13,14],"Device: netIOB & Exercise Toolkit (NEXT)",{"label":27,"type":6,"description":28,"interventionNames":29},"Healthy Control","Adults without diabetes complete one supervised moderate-intensity exercise session for physiologic comparison.",[13,14],[31,37,40,44,48],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"BEHAVIORAL","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.",[9],null,{"type":32,"name":16,"description":38,"armGroupLabels":39,"otherNames":36},"Participants independently manage their insulin and carbohydrate decisions around exercise, using their routine practices without study-provided guidance.",[16],{"type":41,"name":21,"description":42,"armGroupLabels":43,"otherNames":36},"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.",[21],{"type":41,"name":45,"description":46,"armGroupLabels":47,"otherNames":36},"Continuous Glucose Monitoring","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.",[27,9,16,21],{"type":41,"name":49,"description":50,"armGroupLabels":51,"otherNames":36},"Continuous Ketone Monitoring","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.",[27,9,16,21],[53,56],{"name":54,"affiliation":5,"role":55},"Rayhan Lal, MD","PRINCIPAL_INVESTIGATOR",{"name":57,"affiliation":5,"role":58},"Dessi dessi@stanford.edu, PhD","STUDY_DIRECTOR",[60,65],{"name":61,"role":62,"phone":63,"phoneExt":36,"email":64},"Dessi Zaharieva, PhD","CONTACT","628-238-9420","dessi@stanford.edu",{"name":66,"role":62,"phone":67,"phoneExt":36,"email":68},"Ryan Kingman, BS","650-736-4417","rkingman@stanford.edu",[70],{"facility":5,"status":36,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Palo Alto","California","94304","United States","US",{"type":77,"coordinates":78},"Point",[79,80],-122.14302,37.44188,{"lat":80,"lon":79},[83,84,85,86],{"name":66,"role":62,"phone":67,"phoneExt":36,"email":68},{"name":61,"role":62,"phone":63,"phoneExt":36,"email":64},{"name":54,"role":55,"phone":36,"phoneExt":36,"email":36},{"name":61,"role":87,"phone":36,"phoneExt":36,"email":36},"SUB_INVESTIGATOR",{"type":55,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Rayhan A. Lal","Assistant Professor of Medicine & Pediatrics",[92,94],{"name":93,"class":6},"University College Dublin",{"name":95,"class":6},"The Leona M. and Harry B. Helmsley Charitable Trust","100610361","using-a-personalized-decision-support-tool-to-help-people-with-type-1-diabetes-manage-exercise-100610361",false,"NCT07226583","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)","NEXT","Inclusion Criteria Inclusion Criteria: All Participants (Type 1 Diabetes and Healthy Control Groups)\n\n* Adults between the age of 18-60 years\n* Able to perform moderate intensity walking for 60 minutes (target 40-60% age-predicted maximal heart rate).\n* Willing and able to comply with study procedures, including supervised exercise visits and device wear\n* Able to provide written informed consent\n\nInclusion Criteria: Type 1 Diabetes Group Only\n\n* Clinical diagnosis of type 1 diabetes for \\>1 year, based on the investigator's clinical judgement\n* Current use of continuous subcutaneous insulin infusion with Tandem Control-IQ and a compatible continuous glucose monitor (CGM) for \\>1 month prior to enrollment\n* Stable insulin delivery regimen, with no planned changes to insulin pump settings or insulin dosing strategy during the study period\n* Consistent CGM use during the month prior to enrollment (\\>80% data availability)\n\nInclusion Criteria: Health Control Group Only\n\n* No diagnosis of diabetes or other disorders of glucose metabolism\n* Not using insulin or glucose-lowering medications\n\nExclusion Criteria Exclusion Criteria: All Participants\n\n* 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\n* 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\n* Pregnancy, lactation, or plans to become pregnant during the study period\n* Renal insufficiency with estimated GFR \\\u003C45 mL\u002Fmin\u002F1.73 m², dialysis dependence, or adrenal insufficiency\n* Concurrent participation in another interventional drug or device study within 30 days prior to enrollment\n* 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\n\nExclusion Criteria: Type 1 Diabetes Group Only\n\n* Use of non-CSII insulin delivery, including long-acting injectable or inhaled insulin, during the study period\n* 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\n* Use of systemic corticosteroids within 4 weeks prior to participation\n* History of severe hypoglycemia (requiring third-party assistance) or diabetic ketoacidosis within the prior 6 months",true,"ALL","18 Years","60 Years",{"count":109,"type":110},20,"ESTIMATED","INTERVENTIONAL",[113],"NA","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.\n\nAdults with type 1 diabetes will complete three supervised exercise sessions under different pre-exercise guidance approaches:\n\n(A) published consensus-based standard-of-care guidance, (B) usual personal care routines, and (C) guidance informed by the NEXT Toolkit.\n\nA healthy adult control group will complete a single supervised exercise session to provide comparative physiologic data.",[116,117,118,119],"Type 1 Diabetes Mellitis","Type 1 Diabetes (T1D)","Type 1 Diabetes Mellitus (T1DM)","Exercise Physiology",[121,122,123,45,124,125,126,127,128,129,130],"Type 1 Diabetes","T1D","T1DM","Insulin Dosing","CGM","Insulin Pump","Exercise","carbohydrate Intake","closed-loop system","hybrid closed-loop","NOT_YET_RECRUITING","2026-05-11",{"date":134,"type":135},"2026-05-14","ACTUAL",{"date":137,"type":110},"2026-04",{"date":139,"type":110},"2026-08",{"name":5,"class":6},1]