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N/A N=20 Health Services Research

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

Diabetes · Diabetes Mellitus, Type 1 · Diabetes Mellitus, Type 2

Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Mean Absolute Relative Difference Between CGM Value and Capillary Blood Glucose (Self-monitoring Blood Glucose [SMBG]) — 13.8 percent difference

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Continuous Glucose Monitor (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Virginia
Primary completion
Sep 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Absolute Relative Difference Between CGM Value and Capillary Blood Glucose (Self-monitoring Blood Glucose [SMBG])
13.8
PRIMARY
Mean Absolute Relative Difference (MARD) Between Continuous Glucose Monitor (CGM) Value and Venous Blood Glucose (vBGM)
14.3

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 the interstitial fluid and intravascular space during dialysis treatments.These fluid shifts, uremia, acidosis, and volume overload (increase in interstitial fluid volume due to ESRD) have the potential to impact the performance of the most advanced and commercially available CGMs; however, use of CGM in these patients has not yet been studied.Use of CGM, and potentially hybrid closed loop insulin delivery systems that are dependent on accurate continuous glucose monitoring, has the potential to improve glucose control and quality of life in these patients (7). This study team feels that this study will be valuable in collecting preliminary data needed with the goal of validating the use of CGM in this patient population. The specific aim is to conduct a pilot study to evaluate the accuracy of continuous glucose monitors (CGM) in End Stage Renal Disease (ESRD) patients on intermittent hemodialysis (iHD).

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Inability to comply with finger stick blood glucoses at least four times daily
  • Noncompliant with HD therapies
  • Pregnant women
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04094064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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