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New data from a study performed by investigators at UVA Health details the accuracy of blood glucose measurements with factory-calibrated CGMs in patients undergoing dialysis.
New research provides evidence in support of off-shelf glucose monitors use for measuring blood sugar levels in patients on dialysis.
A study of 20 patients on dialysis, results indicate factory-calibrated continuous glucose monitors (CGM) provided reasonable accuracy for measuring blood glucose levels and investigators concluded, based on these results, that these devices were clinically relevant for use by individuals on hemodialysis.
“Patients with end-stage renal disease are often excluded from clinical research trials, as they are medically complex. Therefore, these CGM devices – often considered ‘game changers’ for patients with diabetes to monitor their sugars - are not yet FDA approved for patients with end-stage renal disease on dialysis,” said lead investigator Meaghan M. Stumpf, MD, assistant professor in the Division of Endocrinology and Metabolism at University of Virginia (UVA) Health, in a statement. “However, end-stage renal disease patients and their physicians may still benefit from their use. Our research team conducted this pilot study so that we could begin to understand the accuracy of these devices for patients with end-stage renal disease on hemodialysis. This study is not large enough to lead to FDA approval, but it is important to take the first step.”
As technology has advanced, the role of CGM in diabetes management has grown in stride. However, despite the advances in CGM technology and its growing role in diabetes care, Stumpf and colleagues cite a lack of data related to its reliability in individuals on hemodialysis as the onus behind the current study. With this in mind, investigators designed their study to include individuals with diabetes on thrice-weekly outpatient hemodialysis who would receive a Dexcom G6-Pro CGM on day 1 of the study. Investigators hoped to assess the accuracy of this system using venous blood glucose measurements (vBGM) recorded during hemodialysis sessions and self-monitoring blood glucose (SMBG) recorded at home over a 10-day study period.
As part of the study protocol, vBGM was recorded during hemodialysis sessions on days 4, 6, and 8 and SMBG values were measured at home using the ContourNext Glucometer. The primary outcome of interest for the trial was the mean absolute relative difference (MARD).
Overall, 20 participants were identified for inclusion in the study. Of these, 4 had type 1 diabetes, 15 had type 2 diabetes, and 1 had posttransplantation diabetes. This cohort has a mean age of 61.2±11.6 years, a mean BMI of 35.1±4.2 kg/m2, 70% were male, and 85% were treated with insulin. During the 10-day study period, the total number of SMBG measurements was lower than expected, with a median of 37.5 (IQR, 16-66) SMBG measurements per subject.
Upon analysis, investigators found the mean absolute relative difference of the CGM was 13.8% and 14.4%, when calculated on SMBG and on vBGM, and 98.7% and 100% of values in the Parkes error grid A/B zones, respectively. Throughout a total of 181 days of CGM monitoring, results demonstrated the median time in range was 38.5% (IQR, 29.3-57.9), with 28.7% (IQR, 7.8-40.6) of the time spent at a range above 250 mg/dL.
“Although we certainly need larger studies, I am encouraged that these factory- calibrated continuous glucose monitors may be reasonably accurate for patients on hemodialysis therapy,” Stumpf said. “CGM use for these patients could lead to improved glucose control, improved safety from life-threatening hypoglycemia and, very importantly, improved quality of life.”
This study, “Accuracy of a Factory-Calibrated Continuous Glucose Monitor in Individuals With Diabetes on Hemodialysis,” was published in Diabetes Care.