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

Study Overview
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Brief Summary
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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).

Detailed Description
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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. Hydrogen peroxidase then interacts with a base metal layer of the sensor and is oxidized, which results in release of electrons which creates a current. The current is proportional to the glucose concentration. The current is measured by the probe and transmits a calculated glucose concentration to a receiving device (2). Substances that are widely distributed in body water, and thereby present in the interstitial space, potentially affect this technology. Acetaminophen and aspirin are substances that are have been known to affect the accuracy of these devices (3); however, more recently developed CGMs such as the Dexcom G6, were able to demonstrate no interference by acetaminophen (4). 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. They are also often uremic and have metabolic acidosis (5). 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 (3). Moderate to severe CKD is associated with both increase in insulin resistance and decrease in insulin clearance, which results in often unpredictable and labile glucose concentrations and increased risk of hypoglycemia in these patients (6). 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.OBJECTIVE: 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). Accuracy will be assessed by calculating the mean absolute relative difference (MARD) between CGM values and concurrent finger stick or capillary blood glucose (CBG) in these patients during hemodialysis, and on non-dialysis days.

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

Conditions
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Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: Continuous Glucose Monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGM Use while on Hemodialysis Therapy<br>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<br>* Use of a continuous glucose monitor during study period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis, Hemodialysis, Diabetes, Continuous Glucose Monitor (CGM)