Closed Loop Glucose Control in Patients With Type 2 Diabetes (NCT05386849) | Clinical Trial Compass
CompletedNot Applicable
Closed Loop Glucose Control in Patients With Type 2 Diabetes
United States3 participantsStarted 2022-05-09
Plain-language 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 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion 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 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Percent of All Glucose Values Within Glucose Range < 70 mg/dL
Timeframe: From beginning of use of the FUSION system to end of use of the FUSION system, which will be a period of time of up to 24 hours
2
Percent of All Glucose Values Within Glucose Range 70-180 mg/dL
Timeframe: From beginning of use of the FUSION system to end of use of the FUSION system, which will be a period of time of up to 24 hours