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Closed Loop Glucose Control in Patients With Type 1 and Type 2 Diabetes

NCT05644730 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-07-17

Study results available
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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 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.

Conditions

  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2

Interventions

DEVICE

Fusion closed loop glucose control system

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.

Sponsors & Collaborators

  • Emory University

    collaborator OTHER

  • Ideal Medical Technologies

    lead INDUSTRY

Principal Investigators

  • Leon DeJournett, MD · Ideal Medical Technologies

  • Francisco Pasquel, MD · Emory University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-08
Primary Completion
2023-04-21
Completion
2024-06-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05644730 on ClinicalTrials.gov