Trial Outcomes & Findings for Evaluation of Accuracy of Continuous Glucose Monitoring (CGM) in Patients With End Stage Renal Disease (ESRD) on Intermittent Hemodialysis (iHD). (NCT NCT04094064)
NCT ID: NCT04094064
Last Updated: 2022-12-21
Results Overview
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.
COMPLETED
NA
20 participants
From CGM placement to CGM removal (10 days)
2022-12-21
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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20
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Overall Study
COMPLETED
|
20
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Accuracy of Continuous Glucose Monitoring (CGM) in Patients With End Stage Renal Disease (ESRD) on Intermittent Hemodialysis (iHD).
Baseline characteristics by cohort
| Measure |
CGM Use While on Hemodialysis Therapy
n=20 Participants
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.
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|---|---|
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Age, Customized
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60.2 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
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Sex: Female, Male
Female
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6 Participants
n=5 Participants
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Sex: Female, Male
Male
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14 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Diabetes Diagnosis
Type 1 Diabetes
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4 Participants
n=5 Participants
|
|
Diabetes Diagnosis
Type 2 Diabetes
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15 Participants
n=5 Participants
|
|
Diabetes Diagnosis
Post-Transplantation Diabetes
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1 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
MARD (%): Self-Monitoring Blood Glucose (SMBG)
n=684 Overall Matched Pairs
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.
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|---|---|
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Mean Absolute Relative Difference Between CGM Value and Capillary Blood Glucose (Self-monitoring Blood Glucose [SMBG])
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13.8 percent difference
Interval 4.9 to 18.2
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
MARD (%): Self-Monitoring Blood Glucose (SMBG)
n=624 Overall Matched Pairs
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.
|
|---|---|
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Mean Absolute Relative Difference (MARD) Between Continuous Glucose Monitor (CGM) Value and Venous Blood Glucose (vBGM)
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14.3 percent difference
Interval 5.0 to 19.7
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Adverse Events
CGM Use While on Hemodialysis Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Meaghan Stumpf
University of Virginia Center for Diabetes Technology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place