NCT04217161

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 3, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2023

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

3.8 years

First QC Date

January 2, 2020

Last Update Submit

June 9, 2023

Conditions

DiabetesHemodialysisGlucose Measurement

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Hypoglycemia events

    3 to 5 days

Study Arms (1)

Dexcom G6 Continuous Glucose Monitor

EXPERIMENTAL
Device: Dexcom G6 Continuous Glucose Monitor

Interventions

Dexcom G6 Continuous Glucose MonitorDEVICE

Eligible patients will undergo DDexcom G6 Continuous Glucose Monitor device placement

Dexcom G6 Continuous Glucose Monitor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Irvine

Orange, California, 92868, United States

Location

Related 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.

    PMID: 28592525BACKGROUND

  • 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.

    PMID: 30448393BACKGROUND

  • 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.

    PMID: 30037725BACKGROUND

  • 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.

    PMID: 24588802BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Connie Rhee, MD, MSc

    Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

January 2, 2020

First Posted

January 3, 2020

Study Start

March 1, 2020

Primary Completion

December 21, 2023

Study Completion

December 21, 2023

Last Updated

June 12, 2023

Record last verified: 2023-06

Locations

US(1)