Closed Loop Glucose Control in a Simulated ICU Setting

Starting soon · Not applicable

Conditions studied: Type 1 Diabetes, Type 2 Diabetes, Stress Induced Hyperglycemia

In brief

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.

Key facts

Study ID

NCT07646067

Run by

Ideal Medical Technologies

People needed

6

Starts

2026-07-01

Expected to finish

2027-12-01

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 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.
• 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 Influenza or COVID test within 14 days of visit 3.
• 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.
• 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.

Full record on ClinicalTrials.gov

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