Dexcom G6 Continuous Glucose Monitoring in Hemodialysis

Diabetes Clinical Trial

— DEXCOM-HD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04217161
• Other study ID #: HS# 2019-5585
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: December 21, 2023

Study information

• Verified date: June 2023
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 21, 2023
• Est. primary completion date: December 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Glucose Measurement
• Hemodialysis

Intervention

Device:
• Dexcom G6 Continuous Glucose Monitor
Eligible patients will undergo DDexcom G6 Continuous Glucose Monitor device placement

Locations

Country	Name	City	State
United States	University of California Irvine	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	DexCom, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

Rhee CM, Kovesdy CP, Ravel VA, Streja E, Brunelli SM, Soohoo M, Sumida K, Molnar MZ, Brent GA, Nguyen DV, Kalantar-Zadeh K. Association of Glycemic Status During Progression of Chronic Kidney Disease With Early Dialysis Mortality in Patients With Diabetes. Diabetes Care. 2017 Aug;40(8):1050-1057. doi: 10.2337/dc17-0110. Epub 2017 Jun 7. — View Citation

Rhee CM, Kovesdy CP, Ravel VA, Streja E, Sim JJ, You AS, Gatwood J, Amin AN, Molnar MZ, Nguyen DV, Kalantar-Zadeh K. Glycemic Status and Mortality in Chronic Kidney Disease According to Transition Versus Nontransition to Dialysis. J Ren Nutr. 2019 Mar;29(2):82-90. doi: 10.1053/j.jrn.2018.07.003. Epub 2018 Nov 15. — View Citation

Rhee CM, Kovesdy CP, You AS, Sim JJ, Soohoo M, Streja E, Molnar MZ, Amin AN, Abbott K, Nguyen DV, Kalantar-Zadeh K. Hypoglycemia-Related Hospitalizations and Mortality Among Patients With Diabetes Transitioning to Dialysis. Am J Kidney Dis. 2018 Nov;72(5):701-710. doi: 10.1053/j.ajkd.2018.04.022. Epub 2018 Jul 20. — View Citation

Rhee CM, Leung AM, Kovesdy CP, Lynch KE, Brent GA, Kalantar-Zadeh K. Updates on the management of diabetes in dialysis patients. Semin Dial. 2014 Mar;27(2):135-45. doi: 10.1111/sdi.12198. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose measurement	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	Hypoglycemia events	Comparison in number of hypoglycemia events (glucose <70 mg/dl) determined by CGM or by blood glucose measurements	3 to 5 days