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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04217161
Recruitment Status : Not yet recruiting
First Posted : January 3, 2020
Last Update Posted : January 3, 2020
DexCom, Inc.
Information provided by (Responsible Party):
University of California, Irvine

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

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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
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

1) Adult hemodialysis patients age 18 years or older; 2) have a comorbidity of diabetes; 3) receipt of care from the inpatient University of California Irvine Medical Center nephrology consult service; 4) expected hospital stay ≥48 hours; and 5) have the ability to directly provide informed consent for participation in the study.

Exclusion Criteria:

1) Critically-ill patients receiving care in the intensive care unit (ICU) or cardiac care unit (CCU), 2) moribund patients expected to die within 48 hours, 3) presence of any condition deemed by PI's judgment that would seriously limit life expectancy (i.e., poor survival), 4) pregnant, and 5) unwilling or unable to provide informed consent.

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 identifier (NCT number): NCT04217161

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Contact: Connie Rhee, MD, MSc 714-456-5142
Contact: Kamyar Kalantar-Zadeh, MD, MPH, PhD 714-456-5142

Sponsors and Collaborators
University of California, Irvine
DexCom, Inc.
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Responsible Party: University of California, Irvine Identifier: NCT04217161    
Other Study ID Numbers: HS# 2019-5585
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: December 2019

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