Interference Assessment of Various Endogenous and Exogenous Substances on the Performance of the Eversense Long-Term Implantable Continuous Glucose Monitoring System

Abstract

Background: A variety of prescriptions and over-the-counter medications interfere with transcutaneous continuous glucose monitoring (CGM) sensors. This study characterized the interference profile of the Eversense® CGM System (Senseonics, Inc., Germantown, MD), which has a different mechanism of glucose detection than other CGM systems.Materials and Methods: Sensor bias (sensor glucose concentration measurement – plasma glucose concentration measured by a reference test) was measured in vitro against 41 different substances at supratherapeutic/supraphysiologic plasma concentrations. Testing was performed using a paired-sample method adapted from the Clinical and Laboratory Standards Institute guidance document EP7-A2. Any substance producing sensor bias that exceeded the International Organization for Standardization (ISO) document 15197:2013 limits was then tested using an in vitro dose–response method to determine whether the concentration producing a significant sensor bias was within physiologic/therapeutic concentration ranges.Results: Eight of 41 substances produced a sensor bias that exceeded ISO 15197:2013 limits when tested in vitro at supratherapeutic/supraphysiologic plasma concentrations. Only two of these substances (tetracycline and mannitol) exceeded bias limits within therapeutic concentration ranges. Notably, neither acetaminophen nor ascorbic acid, which are substances reported to interfere with other CGM systems, produced sensor bias that exceeded ISO limits when used at physiologic concentrations.Conclusions: Although tetracycline and mannitol interfered with the Eversense sensor, substances frequently reported to interfere with enzymatic, electrochemical-based transcutaneous CGM systems, such as acetaminophen and ascorbic acid, did not affect Eversense readings.

Improving patient self-care using diabetes technologies

“…The main benefit of this system is the sensor’s duration, which can potentially increase adherence to CGM use with all the previously mentioned advantages. 49 Other potential benefits for users are: avoiding frequent sensor insertions, no interferences with common use substances like acetaminophen or ascorbic acid, 62 silent vibration alarms offer safety while not sacrificing discretion, and compatibility with all types of physical activities given that the transmitter unit may be detached as needed.…”

Molecular Design of a New Diboronic Acid for the Electrohydrodynamic Monitoring of Glucose

“…The addition of fructose caused a 3 % increase in resistance under low glucose (5 m m ) conditions and only a transient increase under high glucose (20 m m ) conditions. Maltose and lactose, which have been shown to influence other DBA‐based assays, were also tested . Under our conditions, 10 m m maltose and 1 m m lactose show no significant change to R .…”

“…Importantly, the maximum physiological or therapeutic plasma concentrations of fructose (0.13 m m ) and galactose (0.28 m m ) are well below those for glucose (normal range=4–8 m m , diabetic range=0–30 m m ). Owing to the marked difference in absolute concentrations, any effect from the presence of fructose and/or galactose on the DBA2+ ‐based system is predicted to be negligible …”

Monitoring of Pediatric Type 1 Diabetes

“…In contrast to systems using glucose oxidase based measurements, the implantable Eversense sensor is coated in a fluorescent glucose-indicating polymer that emits light in a magnitude proportional to the amount of glucose present. Tetracycline causes falsely low sensor glucose values at therapeutic levels with the Eversense system; mannitol results in falsely elevated sensor glucose values when given intravenously, used for peritoneal dialysis, or for local irrigation at the sensor site (64).…”