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

June 9, 2023 updated by: Connie Rhee, University of California, Irvine

Comparison of Dexcom G6 Continuous Glucose Monitoring System and Blood Glucose Levels in Adult Hemodialysis Patients With Diabetes

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kamyar Kalantar-Zadeh, MD, MPH, PhD
  • Phone Number: 714-456-5142
  • Email: kkz@uci.edu

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • University of California Irvine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.)
3 to 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 to 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

DexCom, Inc.

Investigators

  • Principal Investigator: Connie Rhee, MD, MSc, Faculty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Estimated)

December 21, 2023

Study Completion (Estimated)

December 21, 2023

Study Registration Dates

First Submitted

January 2, 2020

First Submitted That Met QC Criteria

January 2, 2020

First Posted (Actual)

January 3, 2020

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 9, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • HS# 2019-5585

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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