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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM Use while on Hemodialysis Therapy | Experimental | All subjects will use a CGM for 10 days. Subjects will continue their standard of care hemodialysis treatments during the study period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitor | Device | Use of a continuous glucose monitor during study period. |
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| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meaghan Stumpf, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meaghan Stumpf, MD | Charlottesville | Virginia | 22903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35485908 | Result | Villard O, Breton MD, Rao S, Voelmle MK, Fuller MR, Myers HE, McFadden RK, Luke ZS, Wakeman CA, Clancy-Oliveri M, Basu A, Stumpf MM. Accuracy of a Factory-Calibrated Continuous Glucose Monitor in Individuals With Diabetes on Hemodialysis. Diabetes Care. 2022 Jul 7;45(7):1666-1669. doi: 10.2337/dc22-0073. |
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There are no current plans to share IPD for this study.
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Participants were approached during their regularly scheduled dialysis session. Upon consent, inclusion/exclusion criteria, medical history and medications were assessed. A serum pregnancy test was performed for women who were of child-bearing potential (negative result required). Eligible participants continued with the continuous glucose monitor (CGM) Pro training visit on the same day or at a later date.
Participants for this feasibility pilot study were recruited from three University of Virginia Hemodialysis Clinics - Charlottesville, Lynchburg, and Zion's Crossroads between February 2020 through September 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | CGM Use While on Hemodialysis Therapy | Participants enrolled in the study wore a blinded Dexcom G6 Pro CGM placed for 10 days which measured the interstitial glucose and recorded interstitial blood glucose every 5 minutes. The participants also checked venous blood glucose values (SMBGs) using a provided study blood glucometer seven times daily on non-hemodialysis (HD) days. During HD sessions, a study team member measured blood glucose with the use of an i-STAT System point of care machine approximately 10-12 times at the following intervals: q15 minutes x 90 minutes, q30 minutes x 60 minutes, then q60 minutes until HD finished. The results from the i-STAT System glucose measurements were recorded in a study flowsheet. The study glucometers recorded and stored the results of SMBG values that were collected each day (10 days) after placement of the sensor. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2021 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CGM Use While on Hemodialysis Therapy | Participants enrolled in the study wore a blinded CGM placed for 10 days which measured the interstitial glucose and recorded interstitial blood glucose every 5 minutes. The participants also checked venous blood glucose values (SMBGs) using a provided study blood glucometer seven times daily on non-hemodialysis (HD) days. During HD sessions, a study team member measured blood glucose with the use of an i-STAT System point of care machine approximately 10-12 times at the following intervals: q15 minutes x 90 minutes, q30 minutes x 60 minutes, then q60 minutes until HD finished. The results from the i-STAT System glucose measurements were recorded in a study flowsheet. The study glucometers recorded and stored the results of SMBG values that were collected each day (10 days) after placement of the sensor. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Diabetes Diagnosis | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Inter-Quartile Range | percent difference | From CGM placement to CGM removal (10 days) | Overall Matched Pairs | Overall Matched Pairs |
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| Primary | 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. | Posted | Mean | Inter-Quartile Range | percent difference | From CGM placement to CGM removal (10 days) | Overall Matched Pairs | Overall Matched Pairs |
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Data was recorded once continuous glucose monitor was placed on study participant and until the removal of the continuous glucose monitor (10 days).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CGM Use While on Hemodialysis Therapy | Participants enrolled in the study wore a blinded CGM placed for 10 days which measured the interstitial glucose and recorded interstitial blood glucose every 5 minutes. The participants also checked venous blood glucose values (SMBGs) using a provided study blood glucometer seven times daily on non-hemodialysis (HD) days. During HD sessions, a study team member measured blood glucose with the use of an i-STAT System point of care machine approximately 10-12 times at the following intervals: q15 minutes x 90 minutes, q30 minutes x 60 minutes, then q60 minutes until HD finished. The results from the i-STAT System glucose measurements were recorded in a study flowsheet. The study glucometers recorded and stored the results of SMBG values that were collected each day (10 days) after placement of the sensor. | 0 | 20 | 0 | 20 | 0 | 20 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Meaghan Stumpf | University of Virginia Center for Diabetes Technology | (434) 982-4351 | MMS5CF@hscmail.mcc.virginia.edu |
| Aug 17, 2022 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 13, 2021 | Aug 17, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Post-Transplantation Diabetes |
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