CKM For Safe Use of SGLT2i in Type 1 Diabetes

Prior treatment

• Any concurrent diagnosis of diabetes other than type 1 diabetes;
• Chronic systemic corticosteroids use ( \> 4 consecutive weeks) within 6 months prior to screening;
• History of diabetic ketoacidosis within 3 months prior screening;

Other illness

• 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;
• 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);
• History of multiple (≥3 infections) genital mycotic infections within 6 months of screening;
• 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.

Lab values

• 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);
• 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;

Other

• Individuals who are currently pregnant or lactating/breastfeeding, or planning to become pregnant within 10 months after screening;
• 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.
• Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits;

• All individuals between the ages of \>18 years old, inclusive, at the time of screening;
• Individuals able to become pregnant must:
  • be ≥1 year post-menopausal or documented as being surgically sterile, or
  • 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;
• 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;
• 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;
• Treatment with a stable insulin regimen for at least 8 weeks before screening with:
  • a continuous subcutaneous insulin infusion (CSII) via a hybrid closed loop system, or
  • multiple daily insulin injections;
• Currently using a Continuous Glucose Monitoring (CGM) system;
• Hemoglobin A1c ≤10% at the time of screening;
• Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m2;
• Agrees and is able to wear the investigational device;
• Able to provide written informed consent approved by an Institutional Review Board (IRB).