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6-month implantable CGM safe, accurate in teens, adults
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ORLANDO, Fla. — A continuous glucose monitoring system with a fully implantable sensor and compatible mobile app demonstrated more than 80% agreement with reference glucose values over 180 days of continuous wear in a group of mostly adolescent patients with type 1 diabetes, according to a speaker here.
The Eversense XL (Senseonics) CGM is approved in Europe for use in adults for up to 180 days, and Thursday, the FDA approved the Eversense CGM for use in adults for up to 90 days.
The study presented by Ronnie Aronson, MD, FRCPC, FACE, founder and chief medical officer of LMC Diabetes & Endocrinology in Toronto, is the first to assess the system in adolescents for longer than 14 days of continuous wear.
“The Eversense CGM system is different than traditional CGM systems in that it has a long-term sensor — up to 180 days — which is implantable,” Aronson told Endocrine Today. “The transmitter is worn on the body and can be removed and reapplied as desired and can provide vibratory alerts for high and low glucose readings.”
Aronson and colleagues enrolled 30 adolescents and six adults with type 1 diabetes (13 girls and women; mean age, 17 years; mean BMI, 22 kg/m2) in a 180-day prospective, single-arm study of the system. Two sensors were inserted in the upper arm of the adult participants, and one in the adolescents. The researchers assessed safety from insertion through 180 days of wear and system accuracy every 30 days, with effectiveness measured as mean absolute relative difference, agreement with Yellow Springs Instrument glucose values, and Clarke error grid analysis using paired CGM and reference glucose analyzer values.
The mean absolute relative difference was 9.4% (95% CI, 8.6-10.5) overall.
“That accuracy was maintained over the duration of the study, as the sensor was shown to provide accurate glucose readings at the end of the study as it did in the beginning,” Aronson said. “The lower the [mean absolute relative difference] value, the greater the accuracy, with a value below 10% considered excellent accuracy.”
After 7,163 glucose values, the sensor’s glucose readings agreed within 15 mg/dL, or 15%, for 82.9% accuracy (95% CI, 78.4-86.1) at 60 days, 83.6% accuracy (95% CI, 80.4-85.7) at 120 days and 83.4% accuracy (95% CI, 79.7-85.5) at 180 days. Paired values were within clinically acceptable error zones A and B 99% of the time in Clarke error grid analysis.
One participant dropped out before the beginning of the study due to problems with IV access. No other adverse events were reported.
“The efficacy and accuracy over 180 days is a dramatically new finding considering that other sensors have only shown durability of 7 to 14 days,” Aronson said.
There was “remarkable likeability for the new system,” he said. “The median wear time of the transmitter was 23 hours per day. In questionnaire responses, for example, 90% liked the ability to see their glucose values on their mobile device (smartphone or Apple Watch), 76% liked that it was implanted and 79% liked the long duration.” – by Jill Rollet
Reference:
Aronson R, et al. 13-OR. Presented at: American Diabetes Association 78th Scientific Sessions; June 22-26, 2018; Orlando, Fla.
Disclosures: Aronson reports he has financial relationships with AstraZeneca, Janssen Pharmaceuticals, Novo Nordisk and Sanofi, and research support from Becton, Dickinson and Co., Boehringer Ingelheim, Eli Lilly and Co., Merck and Senseonics. Please see the abstract for all other authors’ relevant financial disclosures.
Perspective
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Timothy S. Bailey, MD, FACE, CPI
The critical points are that Eversense is unique — the first fully-implantable sensor; the longest lasting approved sensor. Because it is only changed every few months patients don’t have to insert/remove every 7 to 10 days (i.e. fewer bothersome procedures), and there are fewer “day 1’s (sensor performance is typically worst on the first day).
Patients appreciate the advantages of this sensor, particularly in terms of no site reactions, it is easy to completely remove the replace the transmitter, and there on-body vibratory alarms on the transmitter so they get information even if they are not using their phone.
The availability of this device will lead to greater adoption of CGM by those currently not using it but could benefit it. This will lead to some users of other CGM devices switching to Eversense.
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