An interventional study of Continuous Glucose Monitor in Diabetes, Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, sponsored by University of Virginia. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-21.
Sponsored by University of Virginia · Not applicable, Interventional, and Health services research
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.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's enrollment of 20 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
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Exclusion Criteria:
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.
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.
Time frame: 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.
Time frame: From CGM placement to CGM removal (10 days)
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.
| Milestone | CGM Use While on Hemodialysis Therapy |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
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.
| percent difference | MARD (%): Self-Monitoring Blood Glucose (SMBG) |
|---|---|
| Mean Absolute Relative Difference Between CGM Value and Capillary Blood Glucose (Self-monitoring Blood Glucose [SMBG]) | 13.8 (4.9 to 18.2) |
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.
| percent difference | CGM Use While on Hemodialysis Therapy |
|---|---|
| Mean Absolute Relative Difference (MARD) Between Continuous Glucose Monitor (CGM) Value and Venous Blood Glucose (vBGM) | 14.3 (5.0 to 19.7) |
Collected over Data was recorded once continuous glucose monitor was placed on study participant and until the removal of the continuous glucose monitor (10 days).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CGM Use While on Hemodialysis Therapy | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Customized(years) | CGM Use While on Hemodialysis Therapy |
|---|---|
| Mean | 60.2 ± 11.6 |
| Sex: Female, Male(Participants) | CGM Use While on Hemodialysis Therapy |
|---|---|
| Female | 6 |
| Male | 14 |
| Race (NIH/OMB)(Participants) | CGM Use While on Hemodialysis Therapy |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 11 |
| White | 8 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Diabetes Diagnosis(Participants) | CGM Use While on Hemodialysis Therapy |
|---|---|
| Type 1 Diabetes | 4 |
| Type 2 Diabetes | 15 |
| Post-Transplantation Diabetes | 1 |
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Plan to share: No — There are no current plans to share IPD for this study.
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