Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Keywords
Dialysis, Hemodialysis, Diabetes, Continuous Glucose Monitor (CGM)
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).
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.
Interventions
DEVICEContinuous Glucose Monitor
Use of a continuous glucose monitor during study period.
Sponsors
DexCom, Inc.
University of Virginia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Absolute Relative Difference Between CGM Value and Capillary Blood Glucose (Self-monitoring Blood Glucose [SMBG]) | From CGM placement to CGM removal (10 days) | 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. |
| Mean Absolute Relative Difference (MARD) Between Continuous Glucose Monitor (CGM) Value and Venous Blood Glucose (vBGM) | From CGM placement to CGM removal (10 days) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | CGM Use While on Hemodialysis Therapy |
|---|---|
| Age, Customized | 60.2 years STANDARD_DEVIATION 11.6 |
| Diabetes Diagnosis Post-Transplantation Diabetes | 1 Participants |
| Diabetes Diagnosis Type 1 Diabetes | 4 Participants |
| Diabetes Diagnosis Type 2 Diabetes | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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.
Time frame: From CGM placement to CGM removal (10 days)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MARD (%): Self-Monitoring Blood Glucose (SMBG) | Mean Absolute Relative Difference Between CGM Value and Capillary Blood Glucose (Self-monitoring Blood Glucose [SMBG]) | 13.8 percent difference |
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.
Time frame: From CGM placement to CGM removal (10 days)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MARD (%): Self-Monitoring Blood Glucose (SMBG) | Mean Absolute Relative Difference (MARD) Between Continuous Glucose Monitor (CGM) Value and Venous Blood Glucose (vBGM) | 14.3 percent difference |