[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tpiat\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tpiat":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100610485","phase-4-sglt2i-therapy-in-islet-transplantation-sit-100610485",false,"NCT07228195","SGLT2i Therapy in Islet Transplantation (SIT)","Inclusion Criteria:\n\n* Age 18-70 years old;\n* \\>1 year after TPIAT date at enrollment;\n* Partial islet function defined as stimulated C-peptide ≥0.6 ng\u002FmL at screening\u002Fbaseline visit, AND either (1) on insulin at ≤0.25 unit\u002Fkg\u002Fday OR (2) not on insulin but HbA1c \\>6.5%;\n* Stable diabetes management defined by stable on pump or multiple daily injections (MDI) for at least 8 weeks and \\\u003C25% change in insulin dosing over prior 8 weeks.\n* Willing to manage diabetes medication management\u002Fdose adjustments for the duration of the study with study team MD\n* Willing to wear continuous glucose monitor for diabetes management (currently standard of care for TPIAT diabetes)\n* Willing to record insulin doses for 14 day intervals x 3 study visits.\n* Willing and able to come to the UMN Clinical Research Unit for 3 study visits, approximately 3 months apart\n* No prescribed medications other than insulin to treat diabetes in the past 4 weeks.\n\nExclusion Criteria:\n\n* HbA1c \\>9%; on any non-insulin antihyperglycemic medication;\n* History of diabetic ketoacidosis (DKA) in the past 1 year;\n* Unable to drink Boost HP due to true milk protein allergy;\n* Underweight (BMI \\\u003C18.5 kg\u002Fm2) \\[contraindicated by possible weight loss with SGLT2 inhibitors\\];\n* Renal failure defined by glomerular filtration rate \\\u003C30 mL\u002Fmin\u002Fm2;\n* Recurrent dehydration necessitating ED\u002Fhospital visits; one time\u002F rare hospital visits due to intercurrent illness are not exclusionary but repeated dehydration from a chronic condition will be exclusionary.\n* Expected to need systemic corticosteroids at \\>25 mg\u002Fday hydrocortisone equivalent over the 6-month study interval;\n* Known allergy to empagliflozin;\n* Currently pregnant or plan to become pregnant in the next 6 months (for females), or currently breastfeeding;\n* Unwillingness to consent or return for study visits;\n* Non-English speaking.\n* Any other medical contraindication to treatment or study participation in the opinion of the investigator that would impact either patient's safety or their ability to complete the study.","ALL","18 Years","70 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","This pilot clinical trial is designed to gather preliminary data on the efficacy and safety of empagliflozin, a diabetes drug in the sodium-glucose cotransporter 2 inhibitor (SGLT2i) class, in islet autotransplant recipients who have partial islet function.",[26,27,28],"Partial Islet Function","TPIAT","Diabetes","RECRUITING","2026-07-21",{"date":32,"type":33},"2026-07-22","ACTUAL",{"date":30,"type":33},{"date":36,"type":20},"2028-12-01",{"name":38,"class":39},"University of Minnesota","OTHER"]