A Prospective Multicenter Evaluation of the Accuracy and Safety of an Implanted Continuous Glucose Sensor: The PRECISION Study
| العنوان: | A Prospective Multicenter Evaluation of the Accuracy and Safety of an Implanted Continuous Glucose Sensor: The PRECISION Study |
|---|---|
| المؤلفون: | Timothy S. Bailey, Leslie J. Klaff, Katherine S. Tweden, Ronald L. Brazg, Mark P. Christiansen, Grace Carlson |
| المصدر: | Diabetes Technology & Therapeutics |
| بيانات النشر: | Mary Ann Liebert Inc, 2019. |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | Adult, Blood Glucose, Male, medicine.medical_specialty, endocrine system diseases, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Type 2 diabetes, 03 medical and health sciences, Insulin Infusion Systems, 0302 clinical medicine, Endocrinology, Diabetes mellitus, medicine, Humans, Prospective Studies, 030212 general & internal medicine, Continuous glucose monitoring, Aged, Type 1 diabetes, accuracy, business.industry, Blood Glucose Self-Monitoring, Reproducibility of Results, nutritional and metabolic diseases, Original Articles, Middle Aged, medicine.disease, Medical Laboratory Technology, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Emergency medicine, Female, Implantable, business |
| الوصف: | Background: A prior study (PRECISE II) demonstrated that an implantable continuous glucose monitoring (CGM) system (Eversense® CGM System) provided accurate glucose readings through the 90-day sensor life with a favorable safety profile in participants with type 1 or type 2 diabetes (T1D, T2D). This study was performed to further characterize the accuracy of the system. Methods: PRECISION was a prospective multicenter study that evaluated the accuracy and safety of Eversense among adults with T1D or T2D through 90 days (NCT02647905). Accuracy measures included percentage system agreement and mean absolute relative difference (MARD) between Eversense and Yellow Springs Instrument reference measurements from 40 to 400 mg/dL. The primary safety endpoint was incidence of device-related or sensor insertion/removal procedure-related serious adverse events (SAEs) through 90 days. An updated glucose calculation algorithm was also applied to the sensor data from the PRECISE II study to evaluate consistency of accuracy results. Results: Thirty-five participants received the CGM system. Eighty-five percent of CGM values were within 15/15% of reference and the MARD value against reference was 9.6% (95% confidence interval [CI]: 8.9–10.4). All sensors were functional through day 90. No device- or procedure-related SAEs occurred. Application of the updated algorithm to PRECISE II sensor data resulted in 87% of readings within 15/15% of reference and an MARD value against reference of 8.5% (95% CI: 8.0%–9.1%). Conclusions: PRECISION corroborated prior accuracy and safety findings of the Eversense CGM System through the 90-day sensor life. The updated algorithm improved accuracy of measurements in PRECISE II. |
| تدمد: | 1557-8593 1520-9156 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::aa8190da4a33644a550d97d7aaf476caTest https://doi.org/10.1089/dia.2019.0020Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....aa8190da4a33644a550d97d7aaf476ca |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15578593 15209156 |
|---|