Evaluation of Accuracy of Continuous Glucose Monitoring (CGM) in Patients With End Stage Renal Disease (ESRD) on Intermittent Hemodialysis (iHD).
Completed · Not applicable
Conditions studied: Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
In brief
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).
Key facts
- Study ID
- NCT04094064
- Run by
- University of Virginia
- People needed
- 20
- Starts
- 2020-02-19
- Expected to finish
- 2021-09-29
- Last updated by the study team
- 2022-12-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Inability to comply with finger stick blood glucoses at least four times daily
- Noncompliant with HD therapies
- Pregnant women
Where it is running
- Meaghan Stumpf, MD — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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