Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:41 AM
Study NCT ID:
NCT07421518
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT-2 Inhibitors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077203', 'term': 'Sodium-Glucose Transporter 2 Inhibitors'}, {'id': 'C575681', 'term': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-09-04', 'size': 892415, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2026-01-30T11:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2030-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2026-01-30', 'studyFirstSubmitQcDate': '2026-02-17', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ketone events with Beta-hydroxybutyrate (BOHB) >1.5 mmol/L', 'timeFrame': '6 months', 'description': 'Number of ketone events with BOHB \\> 1.5 mmol/L for 15 consecutive minutes, as measured by the DGK. The event will end when BOHB is \\< 1.5 for 15 consecutive minutes. These events will be measured during the risk mitigation phase (Period 3 and Period 4) of the study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes', 'Type 2 Diabetes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.adventhealth.com/institute/adventhealth-research-institute/translational-research', 'label': 'AdventHealth Translational Research Institute'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to see how well a special education plan using continuous ketone monitoring (DGK) works to lower the risk of a condition called diabetic ketoacidosis (DKA) in people with type 1 diabetes (T1D) taking SGLT2 inhibitors (a type of medication commonly used to treat type 2 diabetes). This special education plan is compared to a general education plan and considers the higher risk of DKA when using medicines like SGLT2 inhibitors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Men and nonpregnant women ≥18 years and older\n2. Diagnosis of T1D according to American Diabetes Association (ADA) criteria\n3. HbA1c \\< 9 %\n4. Participants treated with multiple daily injections of insulin, insulin pump, or advanced insulin delivery systems\n5. Has provided written informed consent to participate in the study.\n6. Must be willing to wear the investigational device\n7. Use of adequate contraception for the duration of the study by women of childbearing potential\n\nExclusion Criteria:\n\n1. Pregnancy, lactation or planning to become pregnant\n2. Any form of diabetes other than T1D\n3. People with T1D using weekly insulin (when approved)\n4. Use of sodium-glucose cotransporter 2 inhibitors within 4 weeks prior to screening\n5. Chronic systematic corticosteroids (\\>4 consecutive weeks) within 6 months before screening\n6. History of diabetic ketoacidosis within 6 months of screening\n7. History of multiple (≥ 3 infections) genital mycotic infections within 6 months of screening\n8. Hypotension at screening is defined as systolic blood pressure \\< 90 and diastolic blood pressure \\< 60 with symptoms of low blood pressure (confusion, dizziness, lightheadedness, fainting, heart palpitations)\n9. History of a level 3 hypoglycemic event (as defined by ADA criteria) within 3 months of screening\n10. Recent myocardial infarction, stroke, hospitalization for unstable angina or heart failure within 3 months prior to screening\n11. New York Heart Association Class IV heart failure\n12. CKD-EPI estimated glomerular filtration rate (eGFR) \\<30 mL/min/1.73m²\n13. 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.\n14. 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\n15. Active Hepatitis B or C, acquired immunodeficiency syndrome (HIV infection controlled with suppressive medications is allowed) or tuberculosis\n16. 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\n17. Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites, or hepatic encephalopathy), and/or known diagnosis of cirrhosis\n18. 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\n19. Any condition or factor that would compromise the participant's safety or the scientific integrity of the study (cognitive impairment, bipolar disorder, or history of eating disorder)\n20. Inability to perform the study follow up/ unwilling to wear the investigational device\n21. People who are unwilling to consume at least 20% of calories from carbohydrates"}, 'identificationModule': {'nctId': 'NCT07421518', 'acronym': 'KARMA', 'briefTitle': 'Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT-2 Inhibitors', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth Translational Research Institute'}, 'officialTitle': 'Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT2 Inhibitors', 'orgStudyIdInfo': {'id': '2289759'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'People with Type 1 Diabetes', 'interventionNames': ['Drug: SGLT-2 inhibitor (Sotagliflozin)', 'Other: Insulin withdrawal test (IWT)']}], 'interventions': [{'name': 'SGLT-2 inhibitor (Sotagliflozin)', 'type': 'DRUG', 'otherNames': ['Inpefa'], 'description': 'Participants will be asked to take the SGLT-2 inhibitor.', 'armGroupLabels': ['People with Type 1 Diabetes']}, {'name': 'Insulin withdrawal test (IWT)', 'type': 'OTHER', 'description': 'An Insulin withdrawal test (IWT) will be given to participants on an SGLT-2 inhibitor. Participants will be monitored.', 'armGroupLabels': ['People with Type 1 Diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth Translational Research Institute', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'centralContacts': [{'name': 'JaWanda Thacker', 'role': 'CONTACT', 'email': 'CFD.TRI.Recruitment@AdventHealth.com', 'phone': '407-303-7100'}], 'overallOfficials': [{'name': 'Richard Pratley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AdventHealth'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth Translational Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}