Closed Loop Glucose Control in Patients With Type 2 Diabetes

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2

In brief

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 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.

Key facts

Study ID

NCT05386849

Run by

Ideal Medical Technologies

People needed

3

Starts

2022-05-09

Expected to finish

2022-07-19

Last updated by the study team

2026-03-27

Who can join

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

You may qualify if…

• 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 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 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.

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 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.

Where it is running

• Emory University — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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