Performance characterization of an abiotic and fluorescent-based continuous glucose monitoring system in patients with type 1 diabetes

Biosens Bioelectron. 2014 Nov 15;61:227-31. doi: 10.1016/j.bios.2014.05.022. Epub 2014 May 17.

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.

Keywords: Boronic acid; Continuous glucose monitoring; Fluorescent sensor; Implantable.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Biosensing Techniques / instrumentation
  • Blood Glucose / analysis*
  • Blood Glucose Self-Monitoring / instrumentation*
  • Boronic Acids / chemistry*
  • Diabetes Mellitus, Type 1 / blood*
  • Equipment Design
  • Female
  • Fluorescence
  • Fluorescent Dyes / chemistry*
  • Glucose
  • Humans
  • Insulin Infusion Systems
  • Male
  • Middle Aged
  • Polymers / chemistry
  • Prostheses and Implants
  • Reproducibility of Results
  • Wireless Technology / instrumentation
  • Young Adult

Substances

  • Blood Glucose
  • Boronic Acids
  • Fluorescent Dyes
  • Polymers
  • Glucose