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

This is a proof of concept safety study of an artificial intelligence based closed loop glucose control system designed for use in the intensive care unit setting.The type 1 and type 2 diabetic subjects in this study will have their glucose controlled to a range of 100-140 mg/dL by a novel artificial intelligence based closed loop glucose control system for a period of 24 hours. The subjects will consume three standardized meals during the 24 hour study period.

Inclusion 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 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.Exclusion Criteria:Have participated in an interventional medical, surgical, or pharmaceutical study within 30 days of screening.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 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.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.Have a positive COVID-19 test within 14 days of visit 3.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.