New UVA Health research shows that a factory calibrated continuous glucose monitor (CGM), is accurate enough to be used by dialysis patients. This group is often plagued with dangerous swings in blood sugar levels.
The results suggest that factory-calibrated, calibrated blood glucose monitors could be an effective tool for diabetes management in patients on dialysis as well as those with end-stage kidney disease. [ESRD]According to the researchers,
End-stage renal disease patients are often excluded from clinical trials because they are complex medically. Therefore, these CGM devices—often considered ‘game changers’ for patients with diabetes to monitor their sugars—are not yet FDA approved for patients with ESRD on dialysis,” said researcher Meaghan M. Stumpf, MD, an expert on diabetes and diabetes-management technology at UVA Health. However, ESRD patients and their doctors may still be able to benefit from their use. This pilot study was done by our research team to help us understand the accuracy and suitability of these devices for patients with ESRD who are on hemodialysis. While this pilot study isn’t large enough to be FDA approved, it is important to make the first step.
Patients with diabetes are increasingly turning to continuous glucose monitors. These devices allow patients with diabetes to monitor their blood sugar (glucose) levels and prevent them from becoming dangerously high/low.
Patients on dialysis have to manage their blood sugar levels. This is a procedure used to filter blood for patients who can no longer filter it properly. Patients on dialysis are often affected by hypoglycemia (low blood sugar), which can lead to serious complications. This means that patients on dialysis need reliable and accurate ways to monitor their blood sugar. Researchers and physicians did not have the accuracy data to calibrate continuous glucose monitors at factory, so it was difficult to know if these devices were up for the task.
To test this device, Stumpf along with her colleagues recruited 20 volunteers from UVA who were undergoing hemodialysis. The majority of participants were male, African-American and insulin-dependent, with an average age around 61. Participants were asked not to remove the CGM from their hands for 10 days. They were also asked to take 4-7 fingerstick blood-sugar readings daily with a home glucosemeter. During hemodialysis, blood samples from the venous system were also taken. Researchers compared the CGM glucose results to the blood-sugar samples collected by patients during their thrice-weekly dialysis sessions.
The continuous glucose monitor was found to have “clinical reliability” overall. This means they are accurate enough for estimating blood sugar levels. Nearly 99% of the readings could be used without additional fingerstick blood sugar readings.
The devices made errors and overestimated rather than underestimated blood-sugar levels. Researchers noted that further research was needed, especially since dialysis patients are at higher risk of low blood sugar.
“Although larger studies are needed, I am encouraged that these factory calibrated continuous glucose monitors may prove to be reasonably accurate for patients receiving hemodialysis therapy,” Stumpf explained. “CGM use in these patients could lead improved glucose control, safer from life-threatening hypoglycemia, and, most importantly, a better quality of life.”
The researchers published their findings in Diabetes Care.
Type 2 diabetes can be managed with continuous glucose monitors
Orianne Vanillard et. al. Accuracy of a Factory Calibrated Continuous Glucose Monitoring Device in Patients with Diabetes on Hemodialysis Diabetes Care (2022). DOI: 10.2337/figshare.19491329
For dialysis patients, glucose monitors off-the-shelf prove to be accurate (2022, June 29).
Retrieved 5 July 2022
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