We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04094064
Recruitment Status : Completed
First Posted : September 18, 2019
Last Update Posted : November 3, 2021
Sponsor:
Collaborator:
DexCom, Inc.
Information provided by (Responsible Party):
Meaghan Stumpf, MD, University of Virginia

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 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).

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Device: Continuous Glucose Monitor Not Applicable

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. 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Duration of Hemodialysis [ Time Frame: 10 Days ]
    Hemodialysis

  2. Volume removed during hemodialysis therapy [ Time Frame: 10 Days ]
    Volume removed during hemodialysis therapy

  3. Basic Metabolic Panel prior to hemodialysis session [ Time Frame: 10 days ]
    Basic Metabolic Panel prior to hemodialysis session

  4. Medications [ Time Frame: 10 Days ]
    Medications

  5. Daily Weights [ Time Frame: 10 Days ]
    Daily Weights



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Virginia
Meaghan Stumpf, MD
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
University of Virginia
DexCom, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Meaghan Stumpf, MD University of Virginia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Meaghan Stumpf, MD, Assistant Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT04094064    
Other Study ID Numbers: HSR190012
First Posted: September 18, 2019    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are no current plans to share IPD for this study.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Meaghan Stumpf, MD, University of Virginia:
Dialysis
Hemodialysis
Diabetes
Continuous Glucose Monitor (CGM)
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Failure, Chronic
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Autoimmune Diseases
Immune System Diseases