Using Wearable Sensors To Understand Low Blood Sugar in Type 1 Diabetes

1. Men and women between the ages of 18 and 75 years old, inclusive, at the time of screening;
2. Females of non-childbearing potential must be ≥ 1 year post-menopausal or documented as being surgically sterile. Females of childbearing potential must agree to use two methods of contraception during the entire study;
3. Diagnosed with Type 1 diabetes >2-year duration based on clinical history or as defined by the current American Diabetes Association (ADA) criteria;
4. Using hybrid closed loop, standard pump, or multiple daily injections;
5. Able to use a Continuous Glucose Monitoring (CGM) device;
6. A1c > 7% and ≤ 10%:
7. eGFR ≥ 60 mL/min/1.73m²;
8. BMI 18.5-35.0 kg/m2 ;
9. Able to provide written informed consent approved by an Institutional Review Board (IRB).

Exclusion Criteria:

1. 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;
2. History of pancreatitis, medullary thyroid carcinoma or liver disease:
3. Clinically significant diagnosis of anemia (Hemoglobin \< 9 g/dl at screening);
4. Body Mass Index (BMI) \< 18.5 kg/m2 and/or weight \<50kg;
5. Body Mass Index (BMI) > 35 kg/m2;
6. Whole blood donation of 1 pint (500 mL) within 8 weeks prior to Screening. Donations of plasma, packed RBCs, platelets or quantities less than 500 mL are allowed at investigator discretion;
7. Current or recent (within 1 month of screening) use of diabetes medications other than insulin; (examples include GLP-1, RA, SGLT-2i, Pramlintide, Metformin);
8. Women who are pregnant or lactating/breastfeeding;
9. Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits;
10. 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;
11. Severe hypoglycemic events or DKA within 3 months;
12. Currently using beta-blockers;
13. Adrenal insufficiency diagnosis.