Status:
COMPLETED
Closed Loop Glucose Control in Patients With Type 2 Diabetes
Lead Sponsor:
Ideal Medical Technologies
Collaborating Sponsors:
Emory University
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 2 diabetic subjects in thi...
Detailed Description
Tight glucose control in the intensive care unit (ICU) setting is difficult to achieve. The investigators hypothesize that a closed loop glucose control system based on artificial intelligence (AI) wi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2022
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT05386849
Start Date
May 9 2022
End Date
July 19 2022
Last Update
July 20 2022
Active Locations (1)
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1
Emory University
Atlanta, Georgia, United States, 30322