Closed Loop Glucose Control in Patients With Type 1 and Type 2 Diabetes
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Closed Loop Glucose Control, Artificial Pancreas, Artificial Intelligence, Glucose, Intensive Care Unit
Eligibility Criteria
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.
Sites / Locations
- Emory UniversityRecruiting
Arms of the Study
Arm 1
Experimental
FUSION closed loop glucose control system
All subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours