An innovative implanted continuous glucose monitor (CGM) is both accurate and safe for as many as six months of use, according to data presented at the recent virtual American Diabetes Association (ADA) 81st Scientific Sessions.
The device, which is called the Eversense CGM System, is a product of Ascensia Diabetes Care, a global diabetes company founded in 2016 with American headquarters in Parsippany, New Jersey. When the Eversense system made its debut several years ago, it was manufactured by Maryland-based Senseonics. That company’s finances suffered during the COVID-19 pandemic, but a collaboration agreement with Ascensia supplied an infusion of funds and rescued the Eversense system, to which Ascencia now has exclusive global distribution rights.
The U.S. Food and Drug Administration (FDA) approved the first Eversense in June 2018, and it became the first and only long-term CGM available in the United States and Europe. That first monitor, however, was designed for 90 days use. In 2019, it was followed by an Eversense CGM that was meant to be used for 180 days. That older version is now being succeeded by the new Eversense CGM that was presented at the recent ADA sessions.
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Eversense CGM System data
The new Eversense has three main components: a fluorescence-based sensor, a transmitter, and a smartphone app. A health care provider inserts the sensor under the skin of the upper arm and the transmitter rests on top of it. Vibrations signal episodes of high or low blood sugar, which are also displayed on the smartphone app. The app also displays trends and alerts. The transmitter can be removed, recharged, and reattached without discarding the sensor.
The research was presented at the ADA sessions by Satish K. Garg, MD, of the University of Colorado in Aurora. The study consisted of 181 subjects at eight research sites. Two-thirds of the participants had type 1 diabetes; the rest had type 2. The male-female ratio was about 50/50, the average age was 49, the subjects were mostly white (90%), and on average they’d had diabetes for 22 years. Their average baseline HbA1c (a measure of long-term glucose control) was 7.6%. Ninety-six of the participants wore two sensors — one on each arm. In 53 of the subjects, the two sensors were identical, while the remaining 43 wore a second sensor that was modified with sacrificial boronic acid (SBA), an oxidation-reducing agent. During the 180 days of the trial, the subjects were examined at ten medical visits, with each visit lasting as many as ten hours.
To determine the accuracy of the Eversense CGM, the researchers used a metric called MARD, which stands for mean absolute relative difference. MARD is the most common method of evaluating CGM systems. It’s expressed as a percentage, and the lower the percentage, the more accurate the sensor. A percentage under 10% is considered excellent. When measuring all blood sugar ranges, the new Eversense system demonstrated a MARD of 6.7%.
During the trial, the average HbA1c improved throughout the group, dropping from 7.6% to 7.3%, a small but meaningful amount. The sensor with the SBA modification performed better than the other sensor, and Dr. Garg commented, “Clearly, this biochemical change in the SBA sensor will be the future way to go.” He then summed up his team’s findings: “The next-generation Eversense CGM system is safe and accurate for up to 180 days, particularly in hypoglycemia ranges … With many unique features, this system should be considered a welcome addition to options available for real-time CGM.”
Three weeks after the ADA presentation, Ascensia announced the launch of a Patient Assistance Program in the United States to help reduce the out-of-pocket costs of the Eversense CGM system. Under the program, users will need to pay the first $100 of their out-of-pocket costs. After that, Ascensia will cover up to $300 of the remaining balance for each 90-day sensor. The company estimates that Eversense users will potentially save $1,200 a year, and according to Mary Puncochar, head of Ascensia’s Region U.S., “We believe that over half the people using insulin in the U.S. could be eligible for our Patient Assistance Program.”
Want to learn more about CGM? Read “CGM for Diabetes.”