ORLANDO – The Eversense continuous glucose monitoring (CGM) system, recently approved for use in adults with diabetes, also provides safe, durable, and accurate monitoring in the pediatric population, according to findings from a prospective single-arm study of 30 children and 6 adults.
Study subjects, who were all over age 11 years, with an average of 14 years, had the fully implantable sensor inserted at day 0 and removed at day 180, and the mean absolute relative difference (MARD) between sensor and true laboratory glucose values showed high device accuracy, Ronnie Aronson, MD, reported at the annual scientific sessions of the American Diabetes Association.
“Anything under 10% is considered good, and ours was 9.4% – and it didn’t deteriorate throughout the duration, so at 180 days it was still at 9.4%; every accuracy measure we looked at showed similar high levels of accuracy,” Dr. Aronson, founder and chief medical officer of LMC Diabetes & Endocrinology in Ontario, Canada said in a video interview.
The sensor, which is roughly 1.5 cm long, is coated with a material that fluoresces when exposed to glucose; the sensor uses the amount of light emitted to calculate blood glucose levels. Patients use an adhesive patch, changed daily, to attach a “smart” transmitter that overlies the area where the sensor is implanted. This rechargeable transmitter sends blood glucose levels to the mobile app every 5 minutes, and also powers the sensor. The Food and Drug Administration approved it for use in adults on June 21.
The system was highly rated by study participants, he said. “What makes it stand out is that it’s implanted, it’s there for at least 180 days, it’s accurate for 180 days,” the transmitter can be taken on and off, and the results can be seen very easily on a smart phone or Apple Watch.
Dr. Aronson said he also hopes to study the device in younger patients and for longer durations.
Dr. Aronson is an advisor for Novo Nordisk and Sanofi. He also receives research support from AstraZeneca, Eli Lilly, Valeant, Janssen, and Senseonics.
SOURCE: Aronson R et al. ADA 2018 Abstract 13-OR.