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Dexcom G6 Continuous Glucose Monitoring in Hemodialysis (DEXCOM-HD)

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: NCT04217161
Recruitment Status : Unknown
Verified June 2021 by University of California, Irvine.
Recruitment status was:  Recruiting
First Posted : January 3, 2020
Last Update Posted : June 15, 2021
Sponsor:
Collaborator:
DexCom, Inc.
Information provided by (Responsible Party):
University of California, Irvine

Study Description
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Brief Summary:
This is a pilot study enrolling adult hemodialysis patients with diabetes recruited from the University of California Irvine Medical Center (UCIMC) who will undergo simultaneous measurement of glucose levels using 1) continuous glucose monitor (CGM) measured by a Dexcom G6 device vs. 2) "gold-standard" blood glucose levels using capillary fingerstick or venous blood glucose measurements obtained on a point of care (POC) blood glucose meter. The study will assess Dexcom G6 accuracy by comparing glucose levels on the CGM device vs. blood glucose measurements in the study population.

Condition or disease Intervention/treatment Phase
Diabetes Hemodialysis Glucose Measurement Device: Dexcom G6 Continuous Glucose Monitor Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Dexcom G6 Continuous Glucose Monitoring System and Blood Glucose Levels in Adult Hemodialysis Patients With Diabetes
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : January 21, 2022
Estimated Study Completion Date : January 21, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dexcom G6 Continuous Glucose Monitor Device: Dexcom G6 Continuous Glucose Monitor
Eligible patients will undergo DDexcom G6 Continuous Glucose Monitor device placement


Outcome Measures
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Primary Outcome Measures :
  1. Blood glucose measurement [ Time Frame: 3 to 5 days ]
    Proportion of CGM values within 20% of blood glucose levels >100 mg/dl or within 20 mg/dl of blood glucose level for levels <=100 mg/dl. (Will examine different thresholds of CGM values within a certain range of blood glucose levels, i.e., 10%, 15%, 25%.)


Secondary Outcome Measures :
  1. Hypoglycemia events [ Time Frame: 3 to 5 days ]
    Comparison in number of hypoglycemia events (glucose <70 mg/dl) determined by CGM or by blood glucose measurements


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • Adult hemodialysis patients age 18 years or older
  • Have a comorbidity of diabetes
  • Receipt of care from the inpatient University of California Irvine Medical Center nephrology consult service
  • Expected hospital stay ≥48 hours
  • Have the ability to directly provide informed consent for participation in the study

Exclusion Criteria:

  • Critically-ill patients receiving care in the intensive care unit (ICU) or cardiac care unit (CCU)
  • Moribund patients expected to die within 48 hours
  • Presence of any condition deemed by PI's judgment that would seriously limit life expectancy (i.e., poor survival)
  • Pregnant
  • Unwilling or unable to provide informed consent
Contacts and Locations
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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): NCT04217161


Contacts
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Contact: Connie Rhee, MD, MSc 714-456-5142 crhee1@uci.edu
Contact: Kamyar Kalantar-Zadeh, MD, MPH, PhD 714-456-5142 kkz@uci.edu

Locations
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United States, California
University of California Irvine Recruiting
Orange, California, United States, 92868
Contact: Connie Rhee, MD, MSc    714-456-5142    crhee1@hs.uci.edu   
Contact: Kamyar Kalantar-Zadeh, MD, MPH, PhD    7144565142    kkz@hs.uci.edu   
Sponsors and Collaborators
University of California, Irvine
DexCom, Inc.
Investigators
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Principal Investigator: Connie Rhee, MD, MSc Faculty
More Information
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Publications:

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Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT04217161    
Other Study ID Numbers: HS# 2019-5585
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: June 15, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No