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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-70 years old;
* \>1 year after TPIAT date at enrollment;
* Partial islet function defined as stimulated C-peptide ≥0.6 ng/mL at screening/baseline visit, AND either (1) on insulin at ≤0.25 unit/kg/day OR (2) not on insulin but HbA1c \>6.5%;
* Stable diabetes management defined by stable on pump or multiple daily injections (MDI) for at least 8 weeks and \<25% change in insulin dosing over prior 8 weeks.
* Willing to manage diabetes medication management/dose adjustments for the duration of the study with study team MD
* Willing to wear continuous glucose monitor for diabetes management (currently standard of care for TPIAT diabetes)
* Willing to record insulin doses for 14 day intervals x 3 study visits.
* Willing and able to come to the UMN Clinical Research Unit for 3 study visits, approximately 3 months apart
* No prescribed medications other than insulin to treat diabetes in the past 4 weeks.
Exclusion Criteria:
* HbA1c \>9%; on any non-insulin antihyperglycemic medication;
* History of diabetic ketoacidosis (DKA) in the past 1 year;
* Unable to drink Boost HP due to true milk protein allergy;
* Underweight (BMI \<18.5 kg/m2) \[contraindicated by possible weight loss with SGLT2 inhibitors\];
* Renal failure defined by glomerular filtration rate \<30 mL/min/m2;
* Recurrent dehydration necessitating ED/hospital visits; one time/ rare hospital visits due to intercurrent illness are not exclusionary but repeated dehydration from a chronic condi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.