Closed Loop Glucose Control in Patients With Type 1 and Type 2 Diabetes

Prior treatment

• Have participated in an interventional medical, surgical, or pharmaceutical study within 30 days of screening.
• Have any COVID-19 related symptoms in the 14-day period prior to visit 3.
• Have a known unprotected COVID-19 exposure in the 14-day period prior to visit 3.

Other illness

• Have a known hypersensitivity to any of the components of study treatment.
• Have skin disease/injury at Dexcom G6 CGM insertion site(s) that would prevent insertion of the CGM.
• Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be noncompliant.
• Have a medical condition that in the opinion of the investigator could affect study participation and/or personal well-being.
• Have a positive COVID-19 test within 14 days of visit 3.

Lab values

• Have a clinically significant history or presence of any of the following conditions:
  • Hepatic failure or has alanine aminotransferase (ALT) greater than 3 times the upper limit of normal.
  • Has an estimated glomerular filtration rate (GFR) \<60 ml/min/1.73 m2 or End Stage Kidney Disease on renal replacement therapy.
  • Type 2 diabetic subjects who have a C-peptide level less than 0.2 nmol/L (these subjects will be referred to their primary care doctor or endocrinologist for further work up).
  • Have congestive heart failure of class 1 or greater on the New York Heart Association (NYHA) classification system.
  • Have a history of seizures.
  • Have a history of cerebrovascular accident.
  • Have a history of ischemic heart disease.

Age

• For female subjects of potential childbearing age (age 18 to 55) they will be excluded if:
  • Pregnant.
  • Refuse to agree to a pregnancy test at the time of enrollment.
  • Have a positive urine pregnancy test at the time of enrollment.

• Are 18-70 years of age, inclusive.
• Can understand and sign an informed consent, communicate with the investigator, and understand and comply with the protocol requirements.
• Have had a diagnosis of type 1 or type 2 diabetes for a period of at least 1 year.
• Use insulin injections at home for glucose control and are on a stable insulin regimen without more than a 20% change in their total daily insulin dose during the previous 3 months. Their total daily insulin dose during the previous 3 months will be confirmed through a review of the subject's electronic health record, insulin prescriptions, and insulin pump settings (if applicable).
• Have a hemoglobin A1c (HbA1c) in the range of 7.0 - 10.0%.
• Have a hemoglobin in the normal range for sex:
  • Females: 12-15.5 grams/dL.
  • Males: 13.5-17.5 grams/dl.
• Have adequate venous access sites in upper extremities.
• Body weight between 40 - 150 kg.