CKM For Safe Use of SGLT2i in Type 1 Diabetes

Korábbi kezelés

• 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;

Más betegség

• 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.

Laborértékek

• 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;

Egyéb

• 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).