Evaluation of Accuracy of Continuous Glucose Monitoring (CGM) in Patients With End Stage Renal Disease (ESRD) on Intermittent Hemodialysis (iHD).
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|ClinicalTrials.gov Identifier: NCT04094064|
Recruitment Status : Completed
First Posted : September 18, 2019
Last Update Posted : November 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2||Device: Continuous Glucose Monitor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Evaluation of Accuracy of Continuous Glucose Monitoring (CGM) in Patients With End Stage Renal Disease (ESRD) on Intermittent Hemodialysis (iHD).|
|Actual Study Start Date :||February 19, 2020|
|Actual Primary Completion Date :||September 29, 2021|
|Actual Study Completion Date :||September 29, 2021|
Experimental: CGM Use while on Hemodialysis Therapy
All subjects will use a CGM for 10 days. Subjects will continue their standard of care hemodialysis treatments during the study period.
Device: Continuous Glucose Monitor
Use of a continuous glucose monitor during study period.
- Mean Absolute Relative Difference between CGM value and capillary blood glucose [ Time Frame: 10 Days ]Mean Absolute Relative Difference between CGM value and capillary blood glucose
- Duration of Hemodialysis [ Time Frame: 10 Days ]Hemodialysis
- Volume removed during hemodialysis therapy [ Time Frame: 10 Days ]Volume removed during hemodialysis therapy
- Basic Metabolic Panel prior to hemodialysis session [ Time Frame: 10 days ]Basic Metabolic Panel prior to hemodialysis session
- Medications [ Time Frame: 10 Days ]Medications
- Daily Weights [ Time Frame: 10 Days ]Daily Weights
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04094064
|United States, Virginia|
|Meaghan Stumpf, MD|
|Charlottesville, Virginia, United States, 22903|
|Principal Investigator:||Meaghan Stumpf, MD||University of Virginia|