Dexcom G6 Continuous Glucose Monitoring in Hemodialysis

NCT ID: NCT04217161

Last Updated: 2023-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2023-12-21

Brief Summary

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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

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Conditions

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Diabetes Hemodialysis Glucose Measurement

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Dexcom G6 Continuous Glucose Monitor

Group Type EXPERIMENTAL

Dexcom G6 Continuous Glucose Monitor

Intervention Type DEVICE

Eligible patients will undergo DDexcom G6 Continuous Glucose Monitor device placement

Interventions

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Dexcom G6 Continuous Glucose Monitor

Eligible patients will undergo DDexcom G6 Continuous Glucose Monitor device placement

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DexCom, Inc.

INDUSTRY

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Connie Rhee

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Connie Rhee, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Faculty

Locations

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University of California Irvine

Orange, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 28592525 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30448393 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30037725 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24588802 (View on PubMed)

Other Identifiers

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HS# 2019-5585

Identifier Type: -

Identifier Source: org_study_id

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