Clinical trial NCT04217161: Dexcom G6 Continuous Glucose Monitoring in Hemodialysis
Official title: Comparison of Dexcom G6 Continuous Glucose Monitoring System and Blood Glucose Levels in Adult Hemodialysis Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Hemodialysis
Glucose Measurement
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2020-01-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Blood glucose measurement
timeFrame: 3 to 5 days
Secondary outcomes:
measure: Hypoglycemia events
timeFrame: 3 to 5 days
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California Irvine
state: California
Study officials:
affiliation: Faculty
name: Connie Rhee, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.