Page 118 - Glucose Monitoring Devices
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                  have developed such glucose-responsive inks and demonstrated feasibility on an
                  ex vivo pig skin model; a change in ink color from brown to blue was visible as
                  the glucose concentration increased [30].
                     A noninvasive and removable glucose monitoring product that attaches to the ear
                  (GlucoTrack) is available from Integrity Applications (Ashdod, Israel) but has not
                  been approved by the FDA for use in the United States. This CGM technology is
                  reported to measure the physiological effects of glucose in tissue via ultrasonic, elec-
                  tromagnetic, and thermal measurements, but certain factors such as body mass,
                  gender, age, and ear piercings may affect measurement results [2].
                     Lakowicz and coworkers of the University of Maryland School of Medicine
                  (Baltimore, MD) have reported on development of a contact lens that optically
                  measures glucose in tear fluid [58]. Phenylboronic acid containing fluorescent
                  dyes whose intensity changes with glucose concentrations are polymerized into
                  hydrogels. One potential method for measuring the change in the fluorescent signal
                  would use a handheld device that flashes light into the eye and measures the fluores-
                  cence intensity emanating from the contact lens. Similarly, color or fluorescent life-
                  time changes could be measured in response to glucose binding at the boronic acid
                  sites using the appropriate dyes [8]. In one proposed type of contact lens, a change of
                  color is monitored by a user by looking at a mirror and comparing glucose levels by a
                  color strip [10]. Platform that utilize contact lenses with integrated, on-site
                  electronics and wireless telemetry have also been developed [59]. These platforms
                  could use either enzymatic or optical transduction, but the systems would need to
                  compensate for the differences in the physiological differences between blood and
                  tear glucose concentrations [60].




                  Sensor interface and system connectivity
                  A CGM System is composed of subcomponents and systems that span transduction,
                  embedded systems, Apps, and PC/Cloud-based systems. An overview of the
                  functional interaction of these components is shown in Fig. 6.4.
                     Stepping through this sequence begins with the acquisition of signal through the
                  glucose transducer; the measurement, either analog or digital at that point, is then
                  sent to a wearable transmitter using a short-range interface via wired or wireless
                  connections. The commercial transcutaneous CGM sensors are wired and the subcu-
                  taneous sensors utilize near-field communication (NFC) wireless communication
                  with a read range of <2 cm. This signal is then processed in the signal conversion
                  electronics that is within the wearable transmitter. This wearable transmitter also
                  enables the conversation of that signal into the glucose value. At this point, the signal
                  is sent via a mid-range wireless to a unit that is implemented either using a custom
                  RF protocol, or Bluetooth low energy, or using NFC direct to a hand-held device.
                  With the measurement information in the handheld device, which is either a custom
                  receiver or mobile phone, various informatics about the glycemic status and history
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