In what is believed to be the first study of its kind, new UVA Health research reveals that a factory-calibrated continuous blood glucose monitor (CGM) may be accurate enough for use by people on dialysis, a group often plagued by dangerous blood fluctuations. sugar levels.
Findings suggest factory-calibrated blood glucose monitors may offer an important diabetes management tool for patients on dialysis and those with end-stage renal disease [ESRD]conclude the researchers.
Patients with end-stage renal disease are often excluded from clinical research trials because they are medically complex. Therefore, these CGM devices – often considered “game changers” for diabetic patients to monitor their blood sugar – are not yet FDA-approved for ESRD patients on dialysis. However, ESRD patients and their physicians can 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 ESRD on hemodialysis. This study is not large enough to lead to FDA approval, but it is important to take the first step.”
Meaghan M. Stumpf, MD, researcher, expert in diabetes and diabetes management technology at UVA Health
Continuous blood glucose monitors are increasingly used by diabetic patients. These devices allow patients to automatically track their blood sugar (glucose) levels, helping them prevent their blood sugar levels from getting dangerously high or low.
Blood sugar management is a particular challenge for patients on dialysis, which is a blood-filtering procedure for patients whose kidneys can no longer do so properly. Dialysis patients often suffer from “hypoglycemia”, or low blood sugar, which is life-threatening. This means that these patients need very reliable and accurate ways to track their blood sugar. Until now, doctors and researchers didn’t have accuracy data for factory-calibrated continuous glucometers, so it wasn’t clear if these devices would measure up.
To find out, Stumpf and his colleagues recruited 20 volunteers on UVA hemodialysis to test such a device, the Dexcom G6-Pro. Most participants were male, African American, and on insulin, with an average age of 61. Participants were asked to wear the CGM for 10 days and to take four to seven finger glucose readings daily with a home glucometer. . Venous blood samples were also taken during their hemodialysis sessions. The researchers compared the CGM glucose results with the blood glucose results collected by the patients and during the patients’ three times weekly dialysis sessions.
The researchers determined that the continuous blood glucose monitor, overall, showed “clinical reliability”, meaning that it was sufficiently accurate for estimating blood sugar levels. Nearly 99% of the readings were accurate enough to use without confirmatory fingertip blood glucose readings.
When the devices were wrong, they tended to overestimate, rather than underestimate, blood sugar levels, prompting the researchers to note that further research is warranted, especially since people on dialysis tend to be at high risk for hypoglycemia.
“While we certainly need larger studies, I’m encouraged that these factory-calibrated continuous blood glucose monitors can be reasonably accurate for patients on hemodialysis,” Stumpf said. “Using CGM for these patients could lead to better glycemic control, better safety against life-threatening hypoglycemia and, very importantly, better quality of life.”
The researchers published their findings in the scientific journal Diabetes Care. The research team consisted of Orianne Villard, Marc D. Breton, Swati Rao, Mary K. Voelmle, Morgan R. Fuller, Helen E. Myers, Ryan K. McFadden, Zander S. Luke, Christian A. Wakeman, Mary Clancy-Oliveri, Ananda Basu and Stumpf. Breton receives research support from Tandem Diabetes, Dexcom and Novo Nordisk and is a consultant for Dexcom, Adocia and Air Liquide; he has also received speaker fees from Tandem Diabetes and Arecor. Voelmle is an employee of LifeScan Inc. and has received research support from Medtronic and Insulet Corp. ; she has been on a panel of speakers for Abbott and Dexcom. Basu was a lecturer for Zealand Pharmaceuticals.
Dexcom provided the devices used in the study, but had no role in the data collection, analysis, or results. Additional support was provided by UVA and a grant from the Société Francophone du Diabète.
University of Virginia Health System