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NCT07646067

Closed Loop Glucose Control in a Simulated ICU Setting

Sponsor: Ideal Medical Technologies

View on ClinicalTrials.gov

Summary

This is a proof of concept safety study of a rule-based closed loop glucose control system designed for use in the intensive care unit setting. The persons with type 1 and type 2 diabetes in this study will have their glucose controlled to a range of 100-140 mg/dL by a fully autonomous novel rule-based closed loop glucose control system for a period of 24 hours. The subjects will consume three standardized meals and receive a continuous intravenous infusion of dextrose (D-glucose) during the 24 hour study period. Meals will not be announced to the glucose control system.

Official title: Demonstration of an Expert Rule-Based Automated Insulin Delivery (AID) System for People With Type 1 and Type 2 Diabetes

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-07

Completion Date

2027-12

Last Updated

2026-06-12

Healthy Volunteers

Conditions

Type 1 Diabetes Type 2 Diabetes Stress Induced Hyperglycemia

Interventions

DEVICE

FUSION closed loop glucose control system

The FUSION system will be used to control the subjects glucose to a range of 100-140 mg/dL. Data will be collected for up to 24 hours, or upon early termination of the study session.

Inclusion Criteria: * Participants with type 1 and type 2 diabetes are eligible to be included in the study only if they meet all the following 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 3 months. 4. Use insulin injections at home for glucose control. 5. Have a hemoglobin A1c (HbA1c) in the range of 7.0 - 10.0%. 6. Have a hemoglobin in the range for sex: 1. Females: 7-15.5 grams/dL. 2. Males: 7-17.5 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 GFR \<30 ml/min/1.73 m2 or End Stage Kidney Disease on renal replacement therapy. 3. Have congestive heart failure greater than class 1 on the NYHA classification system. 4. Have a history of seizures. 5. Have a history of cerebrovascular accident. 6. 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 Influenza or COVID test within 14 days of visit 3. 9. Have any viral lower respiratory related symptoms (e.g., cough, chest tightness, respiratory distress) in the 14-day period prior to visit 3. 10. Have a known unprotected Influenza or COVID exposure in the 14-day period prior to visit 3. 11. 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.