Accuracy Comparison of Two CGMs in Hospitalized Patients

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05081817
• Other study ID #: 190045
• Status: Completed
• Start date: August 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. All genders, admitted to UC San Diego Hillcrest Medical Center with an anticipated remaining length of stay of =24 hours

2. Age =18 years at the time of consent

3. Requiring standard of care intravenous insulin infusion therapy at the time of consent with an anticipated duration of intravenous insulin infusion =12 hours

4. Willingness to provide informed consent and follow all study procedures

Exclusion Criteria:

1. Current bleeding disorder, treatment with anticoagulants, or platelet count below 50,000/mL at enrollment

2. Lack of appropriate sites for sensor placement (sites must be free of scars, skin irritation, surgical wounds, dressings, etc.)

3. Planned magnetic resonance imaging (MRI) study within 24 hours of enrollment

4. Any other condition that, based on Investigator's judgment, would jeopardize patient safety during trial participation or would affect the study outcome

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes
• Type 2 Diabetes

Locations

Country	Name	City	State
United States	UC San Diego Medical Center	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in glucose measurement	Difference between glucose as measured by continuous glucose monitor versus laboratory	5 Days