[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ketones\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ketones":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,83],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100617944","phase-2-reducing-risk-of-diabetic-ketoacidosis-in-type-1-diabetes-and-kidney-disease-using-continuous-ketone-monitoring-100617944",false,"NCT07325201","Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring.","Mitigating Diabetic Ketoacidosis in People With T1D and Chronic Kidney Disease on an SGLT1&2 Inhibitor: Ketosis Risk Factor Determination and Incorporation Into an Enhanced Glucose Ketone Report","SCOUT-CKD","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Males and females; Ages 18-75.\n4. Diagnosis of type 1 diabetes, based on a clinical diagnosis with onset at least 3 months prior to screening.\n5. Using an automated insulin delivery system (AID) or multiple daily injections (MDI), (defined by use of rapid analogue with meals and approved long-acting analogue (e.g. detemir or glargine)).\n6. Most recent eGFR ≥25 (and within prior 12 months).\n7. HbA1c 7-\\\u003C-9%.\n8. Have never used SGLT2i medications.\n9. Must be willing and able to wear a DGK device and willing to follow the study protocol.\n10. Must be able to read and speak English.\n11. Use of adequate contraception for the duration of the study be the women of childbearing potential.\n12. Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access).\n\nExclusion Criteria:\n\n1. Pregnant, lactating, or planning to become pregnant or unwillingness to be on contraception during the trial.\n2. Any form of diabetes other than T1D.\n3. Any history of use of sodium-glucose cotransporter inhibitors and use of other non-insulin glucose lowering medication within the last 6 months.\n4. Chronic systemic corticosteroids (\\>4 consecutive weeks) within 6 months before screening or planned use during the study period.\n5. History of diabetic ketoacidosis within 3 months of screening or 2 or more episodes of DKA within the last year.\n6. History of multiple (≥ 3 infections) genital mycotic or bacterial infections within 6 months of screening or any history of necrotizing fasciitis.\n7. Hypotension at screening as defined as, systolic blood pressure \\\u003C 90 and diastolic blood pressure \\\u003C 60 with symptoms of low blood pressure (confusion, dizziness, lightheadedness, fainting, heart palpitations).\n8. History of a level 3 hypoglycemic event (as defined by ADA criteria) within 3 months of screening.\n9. Recent myocardial infarction, stroke, hospitalization for unstable angina or heart failure within 3 months prior to screening.\n10. New York Heart Association Class IV heart failure.\n11. CKD-EPI estimated glomerular filtration rate (eGFR) \\\u003C25 mL\u002Fmin\u002F1.73m2.\n12. Impairment of systems and organs that may increase their risk of participating in the intervention study or compromise the results (for example: end stage kidney disease, active liver dysfunction, gastroparesis, anemia, organ transplant).\n13. Active Hepatitis B or C, or tuberculosis.\n14. Abnormal liver function at screening defined as any of the following: aspartate aminotransferase (AST) \\>2X upper limit of the normal reference range (ULN), ALT \\>2X ULN, serum total bilirubin (TB) \\>1.5X ULN.\n15. History of severe acquired immune deficiency syndrome or human immunodeficiency virus (HIV) infection or severely immunocompromised status, in the opinion of the investigator, including, but not limited to patients who have undergone organ or bone marrow transplantation. HIV positive patients who are on stable immunosuppressive therapy and have undetectable viral load may be eligible for inclusion in the study, subject to the investigator's discretion.\n16. Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites or hepatic encephalopathy), and\u002For known diagnosis of cirrhosis.\n17. Cancer treatment (excluding non-melanoma skin cancer treated by excision, carcinoma in situ of the cervix or uterus, ductal breast cancer in situ, resected non-metastatic breast or prostate cancer) within one year of screening.\n18. History of kidney transplant.\n19. Chronic kidney disease (CKD) from a known cause other than T1D.\n20. Current or clinically significant history of an eating disorder.\n21. BMI \\\u003C22 at time of screening.\n22. Adherence to a very low carbohydrate or ketogenic diet (\\\u003C100g carbohydrate \u002Fday) and unwilling to change during study participation.\n23. History of foot amputation.\n24. Non-healing wounds of extremities.\n25. Documented medical adhesive allergy, as evaluated by investigator.\n26. Inability to perform the study follow up or unwilling to wear the DGK device.\n27. Heavy alcohol use (for men, ≥5 drinks on any day or ≥15 drinks per week; for women, ≥4 drinks on any day or ≥8 drinks per week) at screening, history of alcohol use disorder or binge drinking.\n28. Participation in another treatment or intervention study within the past six weeks.\n29. Any condition or factor that would compromise the participant's safety or conduct of the study (for example: cognitive impairment, bipolar disorder, or eating disorder) or any other reason the PI deems that the patient should not be included.","ALL","18 Years","75 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The goal of this clinical trial is to develop and evaluate a novel diabetes ketoacidosis risk mitigation strategy to support the safe use of sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy in participants with type 1 diabetes (T1D) and mild to moderate chronic kidney disease (CKD). The main objectives of this study are to:\n\n1. Evaluate how ketone metrics differ between participants no chronic kidney disease (CKD), moderate risk CKD and high or very high-risk CKD in three time periods.\n2. Identify potentially modifiable ketosis risk factors.\n3. Use continuous dual ketone and glucose monitoring (DGK) data prior to and following treatment to determine ketosis risk factors and gain knowledge to further refine reporting of risk factors and determine which factors in the Ketone Action Plan (KAP) were most valuable.\n4. Gather information on how participants and clinicians like and use the DGK reports.\n\nParticipants will be asked to:\n\n* Meet with study investigators to determine if they are eligible\n* Sign written informed consent\n* Take a pregnancy test, if applicable\n* Have blood taken to assess kidney function and hemoglobin A1c\n* Take the study medication, following the study team instructions\n* Wear the study provided sensor throughout participation.\n* Complete 5 in person visits, and 11 phone check ins over a nine-month period\n* Provide feedback on their experience, usefulness of CGM\u002FCKM reports, and the most valuable factors of the Ketone Action Plan (KAP).",[28,29,30,31,32],"Type 1 Diabetes Mellitus","Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM)","Chronic Kidney Disease","Diabetic Ketoacidosis","Ketones",[34,30,35,31,36],"Type 1 Diabetes","Continuous Glucose Monitoring","Continuous Ketone Monitoring","NOT_YET_RECRUITING","2026-08-18",{"date":40,"type":41},"2026-08-19","ACTUAL",{"date":43,"type":22},"2026-09",{"date":45,"type":22},"2028-08",{"name":47,"class":48},"HealthPartners Institute","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":68,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":49},"100633474","phase-4-prolonged-nasogastric-administration-of-ketones-in-decompensated-heart-failure-100633474","NCT07527156","Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure","Feasibility and Safety of Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure","KADHEF-2","Inclusion Criteria:\n\n* LVEF \\\u003C35%\n* Acute heart failure with low cardiac output syndrome or cardiogenic shock\n\nExclusion Criteria:\n\n* Severe liver failure\n* Severe acidosis\n* Inability to insert nasogastric tube\n* Gastric paralysis \u002F ileus\n* Repeated vomiting\n* Severe hypokalemia",{"count":59,"type":22},12,[61],"PHASE4","This study will evaluate the feasibility and safety of achieving therapeutic concentrations of beta-hydroxybutyrate using continuous infusion of D-beta-hydroxybutyrate monoester administered via a nasogastric tube in patients with acutely decompensated heart failure with reduced left ventricular ejection fraction.",[64,65,66,32,67],"Acute Heart Failure (AHF)","Cardiogenic Shock","Heart Failure","Ketone Body Metabolism",[69,70,71],"acute heart failure","ketones","ketone body","RECRUITING","2026-04-07",{"date":75,"type":41},"2026-04-14",{"date":77,"type":41},"2026-04-04",{"date":79,"type":22},"2027-03-31",{"name":81,"class":82},"Institute for Clinical and Experimental Medicine","OTHER_GOV",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":23,"phases":94,"briefSummary":95,"conditions":96,"keywords":101,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":49},"100607292","phase-2-evaluation-of-a-novel-insulin-sensitizer-in-people-with-type-1-diabetes-100607292","NCT07186660","Evaluation of a Novel Insulin Sensitizer in People With Type 1 Diabetes","Evaluation of a Novel Insulin Sensitizer on Glycemic Control, Insulin Usage, and Cardiovascular Biomarkers in People With Type 1 Diabetes Who Use Closed-loop Automated Insulin Delivery","WBH003","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. History of type 1 diabetes for at least one year\n4. Age 18-45 years\n5. HbA1c \\\u003C10%\n\n   * BMI 18-35 kg\u002Fm2. Within this criterion, participants must have either BMI ≥25 or total daily insulin dose of ≥0.5 units\u002Fkg\u002Fday.\n   * Currently utilizing closed-loop AID therapy that is compatible with Dexcom G7 CGM.\n   * On stable regimen of non-diabetic medications for the last 6 months.\n   * All screening labs within normal limits or not clinically significant.\n   * Ability to take oral medication and be willing to adhere to the study drug\u002Fplacebo for 12 weeks.\n   * For females and males of reproductive potential: agreement to use adequate contraception during study participation and for an additional 2 weeks after the end of CIR-0602K administration.\n   * For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study intervention.\n   * Agreement to adhere to Lifestyle Considerations throughout study duration.\n\nExclusion Criteria:\n\n* Current Pregnancy or currently breastfeeding.\n* History of smoking tobacco products within the last two years.\n* History of alcohol abuse or illicit drug abuse within 6 months of screening.\n* Known history of human immunodeficiency virus (HIV).\n* History of other significant disease (e.g., cardiac, cerebrovascular, gastrointestinal, liver, renal, or endocrine) that could, in the investigator's view, alter study outcomes\n* Any surgical or medical condition which may significantly alter the absorption of the study drug including but not limited to the following: history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling, or gastric banding, currently active inflammatory bowel syndrome.\n* Current use of any antihyperglycemic medication beyond insulin (i.e., GLP-1 receptor agonists, SGLT2 inhibitors, etc.).\n* Unstable doses (i.e., dose change within the last 4 months) of vasoactive medications (e.g., calcium-channel blockers, statins, angiotensin-converting enzyme inhibitors, diuretics, nitrates, alpha-blockers, beta-blockers, etc.).\n* Daily use of anti-inflammatory medications (e.g., ibuprofen, aspirin, prednisone, dexamethasone, etc.).\n* Diagnosis of peripheral neuropathy (assessed by screening monofilament exam).\n* Macroalbuminuria (i.e., urine albumin: creatinine \\>300 mg per g).\n* Retinopathy beyond mild, nonproliferative retinopathy.\n* History of Level 3 hypoglycemia within the last 12 months.\n* History of diabetic ketoacidosis (DKA) within the last 12 months.\n* Screening electrocardiogram (ECG) findings indicative of arrhythmia, sinus node disease, or ischemic heart disease.\n* Screening oxygen saturation \\\u003C90%\n* History of hypersensitivity or prior adverse reaction to the study drug, closely-related compounds, or any of the stated ingredients.\n* Use of concomitant medications with a known significant metabolism by CYP2C8 or CYP2C (including paclitaxel, phenytoin, warfarin, celecoxib, tolbutamide, or repaglinide) for the duration of the study.\n* Participation in an investigational study (other than a non-treatment registry study) or received an investigational drug withing 30 days or 5 half-lives (whichever is longer) prior to randomization.","45 Years",{"count":93,"type":22},40,[25],"The purpose of this study is to see if the study drug CIR-0602K will improve glucose time-in-range and\u002For lower total daily insulin dose in people with type 1 diabetes who are using closed-loop automated insulin delivery. Researchers will compare CIR-0602K to a placebo (a look-alike substance that contains no drug) to see if it achieves the investigational endpoints. If the study results show that the drug works to increase time-in-range and lower insulin doses, this will lead to further studies which may then make the drug available to the public.",[97,98,99,32,100],"Type 1 Diabetes (T1D)","Glycemic Control for Diabetes Mellitus","Insulin","Cardiovascular Health",[34,102,103,104,105],"closed loop technology","time-in-range","adjunct therapy","cardiovascular health","2026-02-23",{"date":108,"type":41},"2026-02-25",{"date":110,"type":41},"2026-02-22",{"date":112,"type":22},"2028-09",{"name":114,"class":48},"University of Virginia"]