Closed Loop Glucose Control in Patients With Type 1 and Type 2 Diabetes
Part of paid clinical trials in Atlanta, Georgia.
- Sponsor
- Ideal Medical Technologies
- Study ID
- NCT05644730
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Fusion closed loop glucose control system — DEVICEThe 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.
Study Details
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 1 and 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 Dates
- Start date
- Nov 8, 2022
- Status verified
- Jun 2025
- Primary completion
- Apr 21, 2023
- Completion
- Jun 21, 2024
Study Design
- Enrollment
- 7 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: FUSION closed loop glucose control system safety studyAll subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours
Primary Outcome Measure
Primary Safety Outcome [ Time Frame: From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time up to 24 hours ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | - |
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