[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610275":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":90,"collaborators":94,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":107,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":24,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":131,"whyStopped":24,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"St Vincent's Hospital Melbourne","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dual glucose and ketone (DGK) sensor threshold 1.0mmol\u002FL","ACTIVE_COMPARATOR","The DGK will be set with threshold alarms activated at 1.0mmol\u002FL for participant response to ketosis",[13],"Drug: FORXIGA",{"label":15,"type":10,"description":16,"interventionNames":17},"Dual glucose and ketone (DGK) sensor threshold 1.5mmol\u002FL","The DGK will be set with threshold alarms activated at 1.5mmol\u002FL for participant response to ketosis",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","FORXIGA","All participants will take FORXIGA (Dapagliflozin) orally at a dose of 10mg\u002Fday for 12 weeks",[9,15],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Prof. David O'Neal","CONTACT","+61 3 9231 2757","DTRG-t1research@unimelb.edu.au",[32,47,63,76],{"facility":5,"status":24,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Fitzroy","Victoria","3065","Australia","AU",{"type":39,"coordinates":40},"Point",[41,42],144.97833,-37.79839,{"lat":42,"lon":41},[45],{"name":46,"role":28,"phone":29,"phoneExt":24,"email":30},"Dr Yee Wen Kong",{"facility":48,"status":24,"city":49,"state":34,"zip":50,"country":36,"countryCode":37,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Austin Health","Heidelberg","3084",{"type":39,"coordinates":52},[53,54],145.06667,-37.75,{"lat":54,"lon":53},[57,61],{"name":58,"role":28,"phone":59,"phoneExt":24,"email":60},"Prof Elif Ekinci","+61 3 9496 2160","elif.ekinci@unimelb.edu.au",{"name":62,"role":28,"phone":59,"phoneExt":24,"email":24},"Adele Manzoney",{"facility":64,"status":24,"city":65,"state":34,"zip":66,"country":36,"countryCode":37,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Baker Heart and Diabetes Institute","Melbourne","3004",{"type":39,"coordinates":68},[69,70],144.96332,-37.814,{"lat":70,"lon":69},[73],{"name":74,"role":28,"phone":29,"phoneExt":24,"email":75},"Prof David O'Neal","dno@unimelb.edu.au",{"facility":77,"status":24,"city":78,"state":34,"zip":79,"country":36,"countryCode":37,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"The Royal Melbourne Hospital","Parkville","3050",{"type":39,"coordinates":81},[82,83],144.95,-37.78333,{"lat":83,"lon":82},[86],{"name":87,"role":28,"phone":88,"phoneExt":24,"email":89},"Prof Spiros Fourlanos","+61 3 9342 7365","diabetesendo@mh.org.au",{"type":91,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","David O'Neal","Coordinating Principal Investigator",[95,96,99,101,103],{"name":64,"class":6},{"name":97,"class":98},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",{"name":100,"class":6},"University of Melbourne",{"name":102,"class":6},"Melbourne Health",{"name":48,"class":104},"OTHER_GOV","100610275","phase-2-evaluating-safe-ketone-thresholds-to-minimise-ketosis-in-people-with-type-1-diabetes-using-dapagliflozin-100610275",false,"NCT07225465","Evaluating Safe Ketone Thresholds To Minimise Ketosis in People With Type 1 Diabetes Using Dapagliflozin","The Evaluation of Two Response Thresholds to Continuous Ketone Monitoring Information Minimising Ketosis in People With Type 1 Diabetes Treated With Dapagliflozin","KETO-TRACK","Inclusion Criteria:\n\n* Aged between 24 and 85 years of age inclusive (66% 24Y to 65Y; and 33% \\>65Y to 85Y)\n* Diagnosed with T1D (made on clinical criteria) for at least 1 year\n* Insulin regimen either on MDI or insulin pump with at least 40% in one mode\n* Minimum total daily insulin dose 0.4 Units per kg \u002F day (can be on insulin pump or MDI);\n* HbA1c \\\u003C10% (86mmol\u002F mol)\n* Minimum daily carbohydrate intake of 100g\n* Willing to adhere to the study protocol\n* Ability to perform high-intensity exercise (specific to the exercise sub-study)\n\nExclusion Criteria:\n\n* Pregnancy or planned pregnancy\n* eGFR \\\u003C30ml\u002Fmin\u002F1.73m2\n* History of DKA in the last 12 months\n* Use of low carbohydrate diet (\\\u003C100g\u002Fday)\n* Diabetic gastroparesis\n* Tape allergy\n* Heavy alcohol use (15 standard drinks per week or binge drinking)\n* Use of SGLT inhibitor in the last month\n* Medications increasing the risk of DKA e.g. steroids, anorectic agents (eg phentermine, naltrexone HCl\u002Fbupropion HCl, and GLP 1 agonists).\n* Major medical or psychiatric illness that in the opinion of the investigator would interfere with protocol adherence or impact participant safety.","ALL","24 Years","85 Years",{"count":117,"type":118},115,"ESTIMATED","INTERVENTIONAL",[121],"PHASE2","Sodium glucose cotransporter 2 (SGLT2) inhibitors are a type of medicine that help the kidneys get rid of extra sugar in the blood through urine. In people with type 2 diabetes (T2D), these medications help lower blood sugar levels, help people lose weight and improve heart and kidney health.\n\nSGLT2 inhibitors are mainly used in T2D, however some studies show they might also help people with type 1 diabetes (T1D). The same health benefits observed in people with T2D the investigators anticipate may help those with T1D. Currently, there is a safety concern that people with T1D using these medicines can raise the risk of diabetic ketoacidosis (DKA). DKA occurs when the body doesn't have enough insulin (a hormone made in the pancreas that helps your body use sugar (glucose) for energy), it starts to break down fats as a source of energy. This breakdown of fats produces ketones. Very high levels of ketones in the blood can make the blood acidic (toxic) and lead to DKA. If not treated in time, this can make the person living with T1D very ill and can be life-threatening. Because of this risk, health agencies like the FDA in the U.S., and the TGA in Australia have not approved use of SGLT2 inhibitors for people with T1D.\n\nStill, some experts believe SGLT2 inhibitors may safely be used alongside insulin in T1D if DKA risk is carefully managed. This might be possible with early detection and treatment of rising ketone levels. One approach is using continuous ketone monitors, which track ketone levels in real time and can alert users early. People would also need proper education on what to do if ketone levels start rising.\n\nTo date, there's no official agreement on the exact ketone level that should trigger action. Some suggest action when ketone levels reach 1.0 or 1.5 mmol\u002FL. A lower limit like 1.0 mmol\u002FL may be safer, but it could also lead to too many alarms and extra stress, or unnecessary eating to bring ketones down.\n\nTherefore, the aim of this study is to assess if initiating responses to elevated ketone levels at a threshold of 1.0 mmol\u002FL, compared to a threshold of 1.5 mmol\u002FL, will reduce the risk of DKA in people with T1D using Dapagliflozin.\n\nThe investigators will recruit 115 adults with T1D and provide Dapagliflozin (SGLT2 inhibitor) and continuous glucose and ketone monitoring (DGK) devices. Participants will be randomly assigned to two groups. Group 1 will wear a DGK with alarms set at ketone level of 1.0 mmol\u002FL and receive education about taking action when ketone levels are ≥1.0 mmol\u002FL. Group 2 will wear a DGK with alarms set at ketone level of 1.5 mmol\u002FL and receive education about taking action when ketone levels are ≥1.5 mmol\u002FL. Participants will be assessed for time spent with critically high ketone levels, incidence of DKA, glucose and person reported outcomes.\n\nFindings from this study will provide real life data and clinical evidence to help guide safe use of SGLT2 inhibitors in people with T1D by informing protocols for monitoring and managing associated DKA risks.",[124],"Type 1 Diabetes Mellitus",[126,127,128,129,130],"Ketosis","Dapagliflozin","Type 1 Diabetes","Dual Glucose and Ketone Monitor","SGLT2 inhibitor","NOT_YET_RECRUITING","2025-11-04",{"date":134,"type":135},"2025-11-06","ACTUAL",{"date":137,"type":118},"2026-02",{"date":139,"type":118},"2028-02",{"name":5,"class":6},4]