Closed Loop Glucose Control in a Simulated ICU Setting

Sponsor
Ideal Medical Technologies
Study ID
NCT07646067
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • FUSION closed loop glucose control system — DEVICE
    The 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 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 Dates

First listed
Jun 12, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: FUSION closed loop glucose control system safety study
    All subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours

Primary Outcome Measure

Primary Safety Measure [ 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 ]

Central Contacts

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