CKM For Safe Use of SGLT2i in Type 1 Diabetes

Open to people ages 18 years and up

1. All individuals between the ages of >18 years old, inclusive, at the time of screening;
2. Individuals able to become pregnant must:
   1. be ≥1 year post-menopausal or documented as being surgically sterile, or
   2. agree to use two methods of contraception during the entire study and for an additional 2 weeks after the end of dosing with the investigational product;
3. Individuals able to cause a pregnancy must be willing to use clinically acceptable method of contraception during the entire study and for an additional 2 weeks after the end of the treatment period;
4. Diagnosed with Type 1 diabetes ≥ 1 year prior to screening, based on clinical history or as defined by the current American Diabetes Association (ADA) criteria;
5. Treatment with a stable insulin regimen for at least 8 weeks before screening with:
   1. a continuous subcutaneous insulin infusion (CSII) via a hybrid closed loop system, or
   2. multiple daily insulin injections;
6. Currently using a Continuous Glucose Monitoring (CGM) system;
7. Hemoglobin A1c ≤10% at the time of screening;
8. Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m2;
9. Agrees and is able to wear the investigational device;
10. Able to provide written informed consent approved by an Institutional Review Board (IRB).

1. Individuals who are currently pregnant or lactating/breastfeeding, or planning to become pregnant within 10 months after screening;
2. Any concurrent diagnosis of diabetes other than type 1 diabetes;
3. History or evidence of clinically significant disorder or condition that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;
4. Hypotension at screening as defined as, systolic blood pressure < 90 and diastolic blood pressure < 60 with symptoms of low blood pressure (confusion, dizziness, lightheadedness, fainting, heart palpitations);
5. Current or recent (within 1 month prior to screening) use of diabetes medications other than insulin; (examples include, Sodium-Glucose Cotransporter 2 (SGLT-2i), Pramlintide, Metformin);
6. Use of glucagon-like-peptide 1 (GLP-1) analogues if not on a stable dose for > 2 months at screening (participants can be rescreened after being on stable dose for > 2 months). Participants on a stable dose of GLP-1 receptor antagonist (RA) and not experiencing frequent vomiting may be included.
7. Chronic systemic corticosteroids use ( > 4 consecutive weeks) within 6 months prior to screening;
8. History of diabetic ketoacidosis within 3 months prior screening;
9. History of a level 3 hypoglycemic event (as defined by ADA criteria) within 3 months of screening.
   • ADA Level 3 Definition - A severe hypoglycemic event characterized by altered mental or physical status requiring the assistance for treatment of hypoglycemia, irrespective of glucose level;
10. History of multiple (≥3 infections) genital mycotic infections within 6 months of screening;
11. Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits;
12. Any other condition(s) that might reduce the chance of obtaining study data, or that might cause safety concerns, or that might compromise the ability to give truly informed consent.