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Trial record 2 of 28 for:    dexcom | Not yet recruiting Studies

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.
 
ClinicalTrials.gov Identifier: NCT04217161
Recruitment Status : Not yet recruiting
First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Sponsor:
Collaborator:
DexCom, Inc.
Information provided by (Responsible Party):
University of California, Irvine

Tracking Information
First Submitted Date  ICMJE January 2, 2020
First Posted Date  ICMJE January 3, 2020
Last Update Posted Date January 3, 2020
Estimated Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2020)
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%.)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2020)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexcom G6 Continuous Glucose Monitoring in Hemodialysis
Official Title  ICMJE Comparison of Dexcom G6 Continuous Glucose Monitoring System and Blood Glucose Levels in Adult Hemodialysis Patients With Diabetes
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Diabetes
  • Hemodialysis
  • Glucose Measurement
Intervention  ICMJE Device: Dexcom G6 Continuous Glucose Monitor
Eligible patients will undergo DDexcom G6 Continuous Glucose Monitor device placement
Study Arms  ICMJE Experimental: Dexcom G6 Continuous Glucose Monitor
Intervention: Device: Dexcom G6 Continuous Glucose Monitor
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 2, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Connie Rhee, MD, MSc 714-456-5142 crhee1@uci.edu
Contact: Kamyar Kalantar-Zadeh, MD, MPH, PhD 714-456-5142 kkz@uci.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04217161
Other Study ID Numbers  ICMJE HS# 2019-5585
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Irvine
Study Sponsor  ICMJE University of California, Irvine
Collaborators  ICMJE DexCom, Inc.
Investigators  ICMJE Not Provided
PRS Account University of California, Irvine
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP