Accuracy Comparison of Two CGMs in Hospitalized Patients

The purpose of the study is to determine the accuracy of two different continuous blood sugar monitoring systems in hospitalized patients by comparing them standard laboratory blood sugar testing in the hospital.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UC San Diego Medical Center

La Jolla, California, 92037, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All genders, admitted to UC San Diego Hillcrest Medical Center with an anticipated remaining length of stay of ≥24 hours
Age ≥18 years at the time of consent
Requiring standard of care intravenous insulin infusion therapy at the time of consent with an anticipated duration of intravenous insulin infusion ≥12 hours
Willingness to provide informed consent and follow all study procedures

Exclusion criteria

Current bleeding disorder, treatment with anticoagulants, or platelet count below 50,000/mL at enrollment
Lack of appropriate sites for sensor placement (sites must be free of scars, skin irritation, surgical wounds, dressings, etc.)
Planned magnetic resonance imaging (MRI) study within 24 hours of enrollment
Any other condition that, based on Investigator's judgment, would jeopardize patient safety during trial participation or would affect the study outcome

Treatment and study plan

Primary outcomes

Difference in glucose measurement

Time frame: 5 Days

Difference between glucose as measured by continuous glucose monitor versus laboratory

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

DexCom, Inc.

Registry information

Official study title

Comparative Accuracy of Two Subcutaneous Continuous Glucose Monitoring Devices in Hospitalized Patients Requiring Continuous Intravenous Insulin Infusion

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: Oct 18, 2021
Registry last updated: Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed