title: Performance characterization of an abiotic and fluorescent-based continuous glucose monitoring system in patients with type 1 diabetes.
abstract: A continuous glucose monitoring (CGM) system consisting of a wireless, subcutaneously implantable glucose sensor and a body-worn transmitter is described and clinical performance over a 28 day implant period in 12 type 1 diabetic patients is reported. The implantable sensor is constructed of a fluorescent, boronic-acid based glucose indicating polymer coated onto a miniaturized, polymer-encased optical detection system. The external transmitter wirelessly communicates with and powers the sensor and contains Bluetooth capability for interfacing with a Smartphone application. The accuracy of 19 implanted sensors were evaluated over 28 days during 6 in-clinic sessions by comparing the CGM glucose values to venous blood glucose measurements taken every 15 min. Mean absolute relative difference (MARD) for all sensors was 11.6 ± 0.7%, and Clarke error grid analysis showed that 99% of paired data points were in the combined A and B zones.
authors.affiliation: Senseonics, Incorporated, 20451 Seneca Meadows Parkway, Germantown, MD 20876, United States. Electronic address: mark.mortellaro@senseonics.com.
authors.forename: Mark
authors.initials: M
authors.lastname: Mortellaro
authors.affiliation: Senseonics, Incorporated, 20451 Seneca Meadows Parkway, Germantown, MD 20876, United States.
authors.forename: Andrew
authors.initials: A
authors.lastname: DeHennis
mesh_terms: D000328:Adult; D015374:Biosensing Techniques / Q000295:instrumentation; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation*; D001897:Boronic Acids / Q000737:chemistry*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood*; D004867:Equipment Design; D005260:Female; D005453:Fluorescence; D005456:Fluorescent Dyes / Q000737:chemistry*; D005947:Glucose; D006801:Humans; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged; D011108:Polymers / Q000737:chemistry; D019736:Prostheses and Implants; D015203:Reproducibility of Results; D059015:Wireless Technology / Q000295:instrumentation; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D001897:Boronic Acids; D005456:Fluorescent Dyes; D011108:Polymers; D005947:Glucose
keywords: Boronic acid; Continuous glucose monitoring; Fluorescent sensor; Implantable