Closed Loop Glucose Control in a Simulated ICU Setting

Prior treatment

• Have participated in an interventional medical, surgical, or pharmaceutical study within 30 days of screening.
• Have any viral lower respiratory related symptoms (e.g., cough, chest tightness, respiratory distress) in the 14-day period prior to visit 3.
• Have a known unprotected Influenza or COVID 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 Influenza or COVID 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 GFR \<30 ml/min/1.73 m2 or End Stage Kidney Disease on renal replacement therapy.
  • Have congestive heart failure greater than class 1 on the NYHA classification system.
  • Have a history of seizures.
  • Have a history of cerebrovascular accident.
  • Have a history of ischemic heart disease.
• Are currently being treated with Hydroxyurea, a medication which may cause the Dexcom G6 CGM to produce glucose readings that are higher than the actual glucose value.

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.

• Participants with type 1 and type 2 diabetes are eligible to be included in the study only if they meet all the following criteria:
  • 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 3 months.
  • Use insulin injections at home for glucose control.
  • Have a hemoglobin A1c (HbA1c) in the range of 7.0 - 10.0%.
  • Have a hemoglobin in the range for sex:
  • Females: 7-15.5 grams/dL.
  • Males: 7-17.5 grams/dl.
  • Have adequate venous access sites in upper extremities.
  • Body weight between 40 - 150 kg.