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The
AGRID device will be developed to be a simple, non-invasive, and accurate
method to help insulin-dependent diabetics responsibly maintain their
blood-glucose levels. The AGRID device is designed to require a
minimal amount of user input to maintain the optimum level of blood-glucose
in the wearer. The coupling of a continuous glucose-monitoring device
with a continuous insulin-dispensing device will ensure that the diabetic
will continuously maintain the optimum glucose levels; which will ensure
optimum health.
The
reason that the following devices have been chosen is that they are all
virtually non-invasive methods of attaining the necessary input while still
performing the same functionalities as their intrusive predecessors.
All of the devices that we propose to use have received government approval
by passing many stringent testing requirements. These input devices
are available off-the-shelf in today’s American market and will require
minimal alterations in order to be effective in our project.
Non-Invasive Glucose Monitoring System
Among
the various methods of glucose monitoring, we have chosen to use the
GlucoWatch Biographer developed by Cygnus. This device has the ability
to monitor the wearer’s glucose levels in non-invasive manner using FDA
approved software, which is called the GlucoWatch AutoSensor. The
GlucoWatch Biographer is able to read the glucose levels through the use of
an extremely low-level electrical current. This low-level current is
able to extract a small sample of the wearer’s glucose from the
interstitial fluid that surrounds the skin cells. The information that
is obtained from the sample is then passed from the GlucoWatch Biographer to
the GlucoWatch AutoSensor software.
The
GlucoWatch AutoSensor software then analyzes this sample of glucose.
The AutoSensor software then calculates the wearer’s glucose levels using
Cygnus’ proprietary biosensor technology. The AutoSensor is
calibrated with a standard blood glucose measurement. In order to
obtain the standard blood glucose level the AutoSensor must go through a
warm up period that takes approximately 3 hours. Following the warm up
period the AutoSensor will then measure the wearer’s glucose level every
20 minutes for up to a 12-hour period. As they are measured each input
reading will then be transmitted to the integration device while also being
stored within the monitoring device.
Non-Invasive Insulin Patch
In
the current configuration of the AGRID device, the one-use insulin patch
must back device the monitoring element. It is because of this set up
that the currently available insulin patch will need to be minimally
reconfigured. The insulin patch that is currently available has
no such device to regulate its dispensing properties. In order to
attain the required level of functionality, a chip will have to be placed
within the patch. The chip would serve simply as an extension of the
glucose-monitoring device. This extension’s input responsibilities
would simply be the transfer of the glucose sample information from the
user’s skin to the back to the GlucoWatch AutoSensor software.
User
In
order for the AGRID device to dispense the required amount of insulin the
user must input only a single parameter into the device. The parameter
that will need to be inputted is that of the carbohydrate level. In
order for this to occur the user will simply select carbohydrates option
listed on the LCD screen. Once that is selected, the grams of
carbohydrates will then be selected by using the up and down buttons that
are located on the monitor face. This information will then be passed
to the integration device.
Integration Configuration Requirements
Integration Device
To
create the prototype for the AGRID device, we will be required to create the
integration device that will be responsible for reading in the required
inputs. The first input that will need to be entered into the device
is that of the current glucose reading as well as the past two consecutive
readings. The user’s blood-glucose history is to be stored in the
glucose-monitoring component of the AGRID device similar to the way that the
GlucoWatch Biographer is able to store historical data. The glucose
reading element will then give these three inputs to the integration device.
The other input that will need to be entered into the integration device, is
that of the user’s carbohydrate intake. The carbohydrate intake will
be given to the integration device indirectly by the user through the user
interface.
Testing Characteristics
AGIRD (Automated Glucose Reading Insulin Dispenser)
The automated glucose-reading element of the device will need to be tested
to determine its overall accuracy. To test for the level of accuracy
of the GlucoWatch Biographer, the results calculated by the monitor were
compared to that of the standard finger-prick test. According to the
Cynus’ test reports, the glucose-monitoring element has a 71% acceptable
accuracy rate when compared to that of the standard finger-prick.
Based on these results, we estimate that our monitoring component will have
a comparable level of accuracy.
Also
approved by the FDA for medical use, the insulin patch has proven itself
effectual in it duties of dispensing insulin through the skin. However
due to our planned modifications, further testing will be required for our
modified insulin patches.
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