Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
NCT ID:
NCT07228195
Eligibility Criteria:
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 condition will be exclusionary.
* Expected to need systemic corticosteroids at \>25 mg/day hydrocortisone equivalent over the 6-month study interval;
* Known allergy to empagliflozin;
* Currently pregnant or plan to become pregnant in the next 6 months (for females), or currently breastfeeding;
* Unwillingness to consent or return for study visits;
* Non-English speaking.
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07228195
Study Brief:
Protocol Section:
NCT07228195