Demonstration of an Artificial Intelligence Based Closed Loop Glucose Control System as a Therapeutic Modality in Type 1 and Type 2 Diabetic Patients
Trial ID: NCT05644730
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2022-11-08
Completion date: 2024-06-21
Sponsor: Ideal Medical Technologies
Collaborators: Emory University
Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
Interventions: Fusion closed loop glucose control system
Locations: Emory University
Countries: United States
Enrollment: 7
Age range: 18 Years - 70 Years
Sex: ALL

Summary:
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.

Eligibility criteria:
Inclusion Criteria:

1. Are 18-70 years of age, inclusive.
2. Can understand and sign an informed consent, communicate with the investigator, and understand and comply with the protocol requirements.
3. Have had a diagnosis of type 1 or type 2 diabetes for a period of at least 1 year.
4. 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).
5. Have a hemoglobin A1c (HbA1c) in the range of 7.0 - 10.0%.
6. Have a hemoglobin in the normal range for sex:

   1. Females: 12-15.5 grams/dL.
   2. Males: 13.5-17.5 grams/dl.
7. Have adequate venous access sites in upper extremities.
8. Body weight between 40 - 150 kg.

Exclusion Criteria:

1. Have participated in an interventional medical, surgical, or pharmaceutical study within 30 days of screening.
2. Have a known hypersensitivity to any of the components of study treatment.
3. Have skin disease/injury at Dexcom G6 CGM insertion site(s) that would prevent insertion of the CGM.
4. Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be noncompliant.
5. Have a medical condition that in the opinion of the investigator could affect study participation and/or personal well-being.
6. Have a clinically significant history or presence of any of the following conditions:

   1. Hepatic failure or has alanine aminotransferase (ALT) greater than 3 times the upper limit of normal.
   2. Has an estimated glomerular filtration rate (GFR) \<60 ml/min/1.73 m2 or End Stage Kidney Disease on renal replacement therapy.
   3. 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).
   4. Have congestive heart failure of class 1 or greater on the New York Heart Association (NYHA) classification system.
   5. Have a history of seizures.
   6. Have a history of cerebrovascular accident.
   7. Have a history of ischemic heart disease.
7. For female subjects of potential childbearing age (age 18 to 55) they will be excluded if:

   1. Pregnant.
   2. Refuse to agree to a pregnancy test at the time of enrollment.
   3. Have a positive urine pregnancy test at the time of enrollment.
8. Have a positive COVID-19 test within 14 days of visit 3.
9. Have any COVID-19 related symptoms in the 14-day period prior to visit 3.
10. Have a known unprotected COVID-19 exposure in the 14-day period prior to visit 3.

Outcomes:
Primary Safety Outcome; Primary Efficacy Outcome