Implantable Continuous Glucose Monitoring Device Safe, Effective for Adolescents
The study population consisted of 30 adolescents and 6 adults, 13 women and 23 men, with a mean age of 17±9.2 years.
|The following article is part of conference coverage from the American Diabetes Association's 78th Scientific Sessions (ADA 2018) in Orlando,Florida. Endocrinology Advisor's staff will report on medical research and technological advances in diabetes and diabetes education, conducted by experts in the field. Check back for the latest news from ADA 2018.|
ORLANDO – An implantable continuous glucose monitoring (CGM) system is safe and accurate through 180 days of wear in adolescents with type 1 diabetes, according to results presented at the American Diabetes Association's 78th Scientific Sessions held in Orlando, Florida, June 22 to 26, 2018.
The device, called the Eversense XL (Senseonics), recently received the CE mark for 180-day duration in adults.
The study included 30 adolescents and 6 adults with type 1 diabetes. Adult participants had 2 sensors inserted, whereas adolescent participants had 1 sensor in the upper arm. The researchers measured effectiveness, including mean absolute relative difference, system agreement with Yellow Springs Instrument (YSI) glucose values, and Clarke Error Grid analysis, using paired CGM and reference YSI glucose analyzer values.
On day 1, 1 participant withdrew because of intravenous access issues.
After 180 days of follow-up, the CGM system was in agreement with YSI glucose within 15 mg/dL or 15% of YSI glucose values, it was 82.9% at day 60, (95% CI, 78.4%-86.1%), 83.6% at day 120 (95% CI, 80.4%-85.7%), and 83.4% at day 180(95% CI, 79.7%-85.5%). The overall mean absolute relative difference was 9.4% (95% CI, 8.6%-10.5%).
After using Clarke Error Grid analysis, the researchers found that 99% of paired values were in clinically acceptable error zones A and B.
In terms of the device's safety profile, no insertion/removal or device-related serious adverse events were reported.
For more coverage of ADA 2018, click here.
Aronson R, Rastogi R, Mdingi C, et al. First assessment of the performance of an implantable CGM system through 180 days in a primarily adolescent population with type 1 diabetes. Presented at: ADA 2018 78th Scientific Sessions; June 22-26, 2018; Orlando, FL. Poster 13.