Dexcom G6 Continuous Glucose Monitoring in Hemodialysis

Not Applicable

Active, not recruiting

• Conditions: Diabetes; Hemodialysis; Glucose Measurement
• Interventions: Device: Dexcom G6 Continuous Glucose Monitor

• Registration Number: NCT04217161
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-02
• Study First Submitted QC: 2020-01-02
• Study First Posted: 2020-01-03
• Study Start: 2020-03-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-09
• Last Update Posted: 2023-06-12
• Primary Completion: 2023-12-21
• Study Completion: 2023-12-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dexcom G6 Continuous Glucose Monitor	Dexcom G6 Continuous Glucose Monitor	-

Primary Outcome Measures

Name	Time	Method
Blood glucose measurement	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

Name	Time	Method
Hypoglycemia events	3 to 5 days	Comparison in number of hypoglycemia events (glucose \<70 mg/dl) determined by CGM or by blood glucose measurements

Trial Locations

Locations (1)

University of California Irvine; 🇺🇸 Orange, California, United States