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 — 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 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 study
    All 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)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322-

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