Hybrid Closed-Loop Control With Smart Prandial Insulin Dosing in Type 1 Diabetes

Exclusion Criteria

• •1. Hemoglobin A1c \<5% or \>10% if measured at screening or available from historical medical report performed within the last 6 months; in absence of a valid HbA1c measurement, average blood glucose estimated from CGM data to be approximately between 100 and 240 mg/dL
• •2. History of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment
• •3. Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment
• •4. Pregnancy or intent to become pregnant during the trial
• •5. Currently breastfeeding or planning to breastfeed
• •6. Currently being treated for a seizure disorder
• •7. Planned surgery during study duration
• •8. History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted)
• •9. Treatment with any non-insulin glucose-lowering agent (metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals)
• •10. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
• •11. Use of an insulin delivery mechanism that is not downloadable by the participant or study team
• •12. Known contact with COVID-positive individual within 14 days of any study admission without negative follow-up COVID-19 Polymerase Chain Reaction (PCR) test performed 3-5 days after the date of exposure
• •13. Symptoms of COVID-19 (e.g., fever, shortness of breath, unexpected loss of taste or smell) developed within 14 days of any study admission
• •14. A positive COVID-19 test within 14 days of any study admission or during study admission participation
• •15. Not being fully vaccinated at the time of the first camp admission (according to Center for Disease Control (CDC) guidelines a person is intended to be fully vaccinated after two weeks from either the second dose of the Pfizer or Moderna vaccine, or the single dose of the Johnson \& Johnson vaccine)