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Evaluation of Accuracy of Continuous Glucose Monitoring (CGM) in Patients With End Stage Renal Disease (ESRD) on Intermittent Hemodialysis (iHD). 20 Hybrid Study

Completed
Clinical Trial NCT04094064 was an interventional study for Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2 that is now completed. The study started on February 19, 2020, with plans to enroll 20 participants. Led by University of Virginia, the expected completion date was September 29, 2021. The latest data from ClinicalTrials.gov was last updated on December 21, 2022.
Brief Summary
Recent advances in continuous glucose monitors (CGMs) and availability of commercial CGM products to patients with type 1 and type 2 diabetes has made the use of CGM more widespread. CGMs work by placing a probe underneath the skin of a patient, into the interstitial space. Patients with end stage renal disease (ESRD) who are on intermittent hemodialysis (iHD) or peritoneal dialysis (PD) undergo fluid shifts between ...Show More
Detailed Description
Recent advances in continuous glucose monitors (CGMs) and availability of commercial CGM products to patients with type 1 and type 2 diabetes has made the use of CGM more widespread (1). CGMs work by placing a probe underneath the skin of a patient, into the interstitial space. The probe is an electroenzymatic sensor which uses glucose oxidase to break down glucose to create hydrogen peroxidase and other elements. Hy...Show More
Official Title

Evaluation of Accuracy of Continuous Glucose Monitoring (CGM) in Patients With End Stage Renal Disease (ESRD) on Intermittent Hemodialysis (iHD).

Conditions
DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • 190012
NCT ID Number
NCT04094064
Start Date (Actual)
2020-02-19
Last Update Posted
2022-12-21
Completion Date (Estimated)
2021-09-29
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
N/A
Status
Completed
Keywords
Dialysis
Hemodialysis
Diabetes
Continuous Glucose Monitor (CGM)
Primary Purpose
Health Services Research
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalCGM 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.
Continuous Glucose Monitor
Use of a continuous glucose monitor during study period.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Mean Absolute Relative Difference Between CGM Value and Capillary Blood Glucose (Self-monitoring Blood Glucose [SMBG])
Mean Absolute Relative Difference (MARD) between CGM value and capillary blood glucose (SMBG) performed at home 4 to 7 times per day by the participant for 684 matched pairs.
From CGM placement to CGM removal (10 days)
Mean Absolute Relative Difference (MARD) Between Continuous Glucose Monitor (CGM) Value and Venous Blood Glucose (vBGM)
Venous blood glucose samples were collected approximately 12 blood samples from the existing hemodialysis (HD) intravenous (IV) line during each (three) HD session the CGM sensor was worn. These blood samples were immediately processed using the i-STAT System. While the goal was to have the subject participate in three hemodialysis sessions, two sessions were acceptable. 624 matched data pairs were analyzed.
From CGM placement to CGM removal (10 days)
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Ages 18+
  • Type 1 diabetes mellitus on intermittent HD thrice weekly OR Type 2 diabetes mellitus on intermittent HD thrice weekly
  • Willingness and ability to comply with scheduled visits and study procedures

  • Inability to comply with finger stick blood glucoses at least four times daily
  • Noncompliant with HD therapies
  • Pregnant women
University of Virginia logoUniversity of Virginia294 active studies to explore
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Study Responsible Party
Meaghan Stumpf, MD, Principal Investigator, Assistant Professor, University of Virginia
No contact data.
1 Study Locations in 1 Countries

Virginia

Meaghan Stumpf, MD, Charlottesville, Virginia, 22903, United States