Factory-calibrated continuous blood glucose monitors may be accurate enough to be used by dialysis patients

Believed to be the first study of its kind, the new UVA Health study is a factory-calibrated continuous blood glucose monitor (CGM) that often suffers from dangerous fluctuations in blood glucose. It reveals that it may be accurate enough for people inside to use. Blood glucose level.

The findings suggest that factory-adjusted glycemic monitors may provide important diabetes management tools for patients on dialysis and those suffering from end-stage renal disease. [ESRD]The researchers conclude.

Patients with end-stage renal disease are often excluded from clinical research trials due to their medical complexity. Therefore, these CGM devices (often considered “game changers” for diabetics to monitor sugar) have not yet been approved by the FDA for ESRD patients on dialysis. However, ESRD patients and their physicians may still benefit from their use. Our research team conducted this pilot study to help us begin to understand the accuracy of these devices for patients with ESRD during hemodialysis. This study isn’t big enough to lead to FDA approval, but it’s important to take the first step. “

Meaghan M. Stumpf, MD, Researcher, UVA Health Diabetes and Diabetes Management Technology Expert

Continuous blood glucose monitoring is becoming widely used by diabetics. With these devices, patients can automatically track their blood sugar (glucose) levels, preventing them from dangerously high or low.

Managing blood glucose is a particularly difficult task for patients on dialysis. This is a procedure to filter the blood of a patient whose kidneys are unable to sufficiently filter the blood. Patients on dialysis often suffer from “hypoglycemia” or hypoglycemia, which is potentially fatal. This means that these patients need a reliable and accurate way to track their blood glucose levels. Previously, doctors and researchers did not have accuracy data for factory-calibrated continuous blood glucose monitors, so it was unclear whether these devices would work.

To determine this, Stumpf and her colleagues asked 20 volunteers undergoing hemodialysis with UVA to test such a device, the Dexcom G6-Pro. Most of the participants were male, African-American, and used insulin, with an average age of 61 years. Participants were asked to wear CGM for 10 days and take 4-7 fingertip blood glucose readings per day on a home glucose meter. .. Venous blood samples were also collected during the hemodialysis session. The researchers compared the results of CGM glucose with the results of blood glucose levels collected by the patient during the patient’s three-week dialysis session.

The researchers determined that the continuous glucose monitor showed “clinical reliability” as a whole. This means that it is accurate enough to estimate blood glucose levels. Almost 99% of the readings were accurate enough to be used without a confirmatory fingertip blood glucose reading.

When a device fails, it tends to overestimate blood glucose rather than underestimate it, and additional research is needed, especially given that people on dialysis tend to be at increased risk of hypoglycemia. I urged researchers to note that there is.

“It certainly requires extensive research, but continuous blood glucose monitors calibrated at these factories can be fairly accurate for patients undergoing hemodialysis therapy,” Stumpf said. .. “The use of CGM in these patients can lead to improved glycemic control, improved safety from life-threatening hypoglycemia, and, most importantly, improved quality of life.”

Researchers have published their findings in the scientific journal Diabetes Care. The research team consists 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 and Mary Clancy-Oliveri. it was done. , Ananda Basu and Stumpf. Breton is research-backed by Tandem Diabetes, Dexcom and Novo Nordisk, and is a consultant to Dexcom, Adsia and Air Liquide. He also receives lecture fees from Tandem Diabetes and Areko-ru. Voelmle is an employee of LifeScan Inc. and receives research support from Medtronic and Insulet Corp. She participates in Abbott and Dexcom speaker panels. The bus was a speaker from Geeland Pharmaceuticals.

Dexcom provided the device used in the study, but played no role in data collection, analysis, or survey results. Additional support was provided by grants from UVA and Societe Francophone du Diabetes.