Accuracy Comparison of Two CGMs in Hospitalized Patients

NCT05081817 | Completed

• 1 other identifier: 190045
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Difference in glucose measurement

  Difference between glucose as measured by continuous glucose monitor versus laboratory

  5 Days

Study Arms (1)

ICU

ICU patients on insulin drip

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU patients requiring an insulin drip.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• DexCom, Inc.: collaborator

Study Sites (1)

UC San Diego Medical Center

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 18, 2021
• Study Start: August 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)