medwireNews: Researchers have reported good accuracy, durability, and acceptability of the Eversense continuous glucose monitoring (CGM) system in a group of primarily pediatric patients.
The Eversense glucose monitor is available in Europe and was very recently approved by the US FDA. It differs from other monitors currently on the market in that the sensor is implanted subcutaneously; the transmitter is placed on the skin over the sensor and can be taken on and off as desired by the patient, and vibrates to alert the user to impending high or low glucose levels.
In this study, reported by Ronnie Aronson (LMC Diabetes and Endocrinology, Toronto, Ontario, Canada) at the ADA’s 78th Scientific Sessions in Orlando, Florida, patients reacted favorably to these aspects of this CMG system, as well as to the long life of the sensor, and wore it on average for more than 23 hours per day.
The 30 children (average age 14 years) and six adults (average age 32 years) in the study wore the Eversense for 180 days; 78% of the sensors lasted for the full period. There were no serious adverse events related to the insertion or removal of the sensor. There were a few mild skin reactions to the sensor, which resolved within a few weeks of its removal, and one patient had a “limited” skin reaction to the transmitter adhesive.
Every 30 days, the patients attended a clinic for 7 hours, during which their blood glucose levels were monitored every 5–15 minutes and compared with the Eversense readings, revealing a mean absolute relative difference (MARD) of 9.4%, similar to those of other currently marketed CGM systems. Aronson noted that a MARD of less than 10% is considered highly accurate.
In the same session, Rabab Jafri (Massachusetts General Hospital, Boston, USA) presented a head-to-head comparison of the CGM sensors that were available at the time of the study: the Eversense; Dexcom G5; and the Libre Pro. When 23 participants wore all three devices concurrently for 6 weeks, the MARDs relative to directly measured blood glucose were 14.8%, 16.3%, 18.0%, respectively.
Jafri noted several reasons why these MARDs were higher than those measured in clinic studies, including patient behavior factors and the selected comparison measuring system. However, she stressed that conditions were the same for all three sensors, allowing direct comparisons of accuracy.
As expected, all three devices were less accurate for glucose levels below 70 mg/dL, with MARDs of 24.9%, 23.6%, and 36.1%. The Eversense was significantly more accurate than the Libre Pro for all glucose ranges except for 70–120 mg/dL. It was not significantly more accurate than the Dexcom G5 in this three-way comparison, but was so in a two-way comparison, for which more measurements were available.
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