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Accuracy Comparison of Two CGMs in Hospitalized Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05081817
Recruitment Status : Enrolling by invitation
First Posted : October 18, 2021
Last Update Posted : November 5, 2021
Sponsor:
Collaborator:
DexCom, Inc.
Information provided by (Responsible Party):
Schafer Boeder, University of California, San Diego

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.

Condition or disease
Type 1 Diabetes Type 2 Diabetes

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Comparative Accuracy of Two Subcutaneous Continuous Glucose Monitoring Devices in Hospitalized Patients Requiring Continuous Intravenous Insulin Infusion
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : August 10, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
ICU
ICU patients on insulin drip



Primary Outcome Measures :
  1. Difference in glucose measurement [ Time Frame: 5 Days ]
    Difference between glucose as measured by continuous glucose monitor versus laboratory



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ICU patients requiring an insulin drip.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05081817


Locations
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United States, California
UC San Diego Medical Center
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
DexCom, Inc.
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Responsible Party: Schafer Boeder, Assistant Clinical Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT05081817    
Other Study ID Numbers: 190045
First Posted: October 18, 2021    Key Record Dates
Last Update Posted: November 5, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases