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Diabetes and Visual Impairment: An Update on the Blood Glucose Monitor

Market - AccessWorld® - January 2008

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Technology and People Who Are Blind or Visually Impaired

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January 2008 Issue Volume 9 Number 1

Product Evaluation

Diabetes and Visual Impairment: An Update on the Blood Glucose

Monitor Market

Darren Burton

The latest demographic research shows that 3.2 million Americans

with diabetes are blind or have low vision. Because of the close

relationship between diabetes and vision loss, the researchers

at

the AFB TECH product evaluation lab have kept track of the

devices

that are used to manage this disease, which is affecting more

and

more people. In the March 2007 issue of AccessWorld, we

introduced

the Prodigy and the Advocate, two small, inexpensive blood

glucose

monitors that are produced in Taiwan by Taidoc Technology. These

monitors have some speech output to accommodate people who

cannot

read the screen, but the speech output is limited and does not

communicate all the information on the screen. This article

examines

the SensoCard Plus and the new Prodigy Voice, both of which

feature

much more accessibility and usability for people who are blind

or

have low vision. It also briefly discusses the new Advocate

Redi-Code and Prodigy Auto Code, both of which are similar to

the

originals but eliminate the need to calibrate the monitor to

each

new container of test strips. The sidebar accompanying this

article,

" Blind Entrepreneur Takes Action, " describes efforts by Bay Area

Digital to develop an accessible blood glucose meter. That

company

is headed by Gray, a blind man who is the former president

of

the American Council of the Blind.

Readers who are interested in the accessibility of blood glucose

monitors should be aware that the Accu-Chek Voicemate talking

blood

glucose monitor that we evaluated in the September 2002 issue of

AccessWorld was discontinued by its manufacturer, Roche

Diagnostics.

Although the price of the Voicemate was high ($500), and the

monitor

was heavy and bulky compared to other monitors, it was at one

time

the most fully accessible monitor on the market. It is

disturbing to

see it disappear from the market without a replacement being

introduced, and although a replacement unit may still come on

the

market, we have heard no news from Roche to support this hope.

For readers who are not familiar with the issue, here is some

brief

information from a previous AccessWorld article explaining the

use

of a blood glucose monitor to manage diabetes:

Because with diabetes, the body is unable to use and store

glucose, or sugar, properly, it is necessary for people with

this

disease to monitor their blood glucose levels. You measure

your

blood glucose level by placing a small sample of blood on a

test

strip inserted into the monitor, and the monitor analyzes the

blood and determines a blood sugar level. Using a blood

glucose

monitor to measure their blood glucose levels enables people

to

keep these levels within a normal range by taking a dose of

insulin or eating a certain food. When not managed properly,

diabetes can be a deadly disease, attacking several internal

organs, including the heart and pancreas, as well as the eyes.

Blood glucose meters have revolutionized diabetes care by

allowing

individuals with diabetes to control their condition more

actively. If you are not able to operate the meter and read

the

results, the meter is not usable, and you have a much lower

chance

of keeping the ravages of diabetes at bay.

The SensoCard Plus

The SensoCard Plus is distributed by BBI Healthcare in the

United

Kingdom and is manufactured by a Hungarian company called

Electronica 77. It is priced in Europe at £49.99. BBI is in the

middle of the cumbersome process of gaining approval from the

U.S.

Food and Drug Administration (FDA), so the SensoCard Plus is not

yet

available in the United States. However, BBI hopes to have FDA

approval soon, and AccessWorld will inform you when it does.

Caption: The SensoCard Plus.

The SensoCard is a thin, credit card-sized monitor with built-in

speech output that supports all its functions. It weighs 2.5

ounces

and measures 3.5 by 2.2 by 0.3 inches, with a small speaker

protruding an additional 0.25 inches from the back of the bottom

panel of the monitor. It has a 1.3-inch-square black-and-white

LCD

(liquid crystal display) screen and only three control buttons.

The

round main control button is below the display screen on the

right,

and there are two arrow-shaped Up and Down buttons on the right

side

panel. There is a small slot in the front panel of the monitor

for

inserting a test strip and another slot on the bottom of the

left

side panel for a code card strip that calibrates the meter with

each

new container of test strips. There is an infrared data port on

the

back panel for transferring data to a PC, but there is no

headphone

jack.

The Prodigy Voice

Priced at $79.99, the Prodigy Voice is distributed by Diagnostic

Devices and is manufactured in Taiwan by Taidoc Technology. It

came

on the U.S. market on November 19, 2007, and its speech output

supports every function of the meter, far surpassing the

accessibility of the original Prodigy, which we reviewed in the

March 2007 issue of AccessWorld. The Prodigy Voice weighs 2.7

ounces

and measures 2.0 by 3.5 by 0.8 inches. The front panel has a

1.34-inch by 1.75-inch monochrome black-on-gray display, with

three

control buttons just below. The round Power button is on the

right

and is larger than the other two buttons. It turns the meter on

and

off and is also used to enter Memory Recall mode. The Settings

button is in the middle and has a smaller, triangular shape. The

Repeat button is on the left and replays the last spoken message

or

test result. The speaker is just below the buttons. On the right

side panel are two triangular buttons pointing up and down that

are

used to adjust the various settings and to scroll through the

various readings in memory. The Eject button, on the top of the

left

panel, allows you to eject a used test strip easily and safely

without touching it. The standard 3.5 millimeter ear phone jack,

near the bottom of the right side panel, allows you to use a

headphone for privacy or to connect a speaker to amplify the

speech.

The data port, just below the ear phone jack, allows you to

download

the meter's test results to a computer using Prodigy's download

software.

Caption: The Prodigy Voice.

How Did We Evaluate the Monitors?

As with our previous evaluations of blood glucose monitors, we

first

examined the tasks involved in performing the basic function of

obtaining a blood glucose measurement and evaluated how easily a

person who is blind or has low vision could perform each task.

We

looked at each task and determined if it could be performed by

touch

alone or if vision would be required. We then did the same with

other tasks related to several other features and functions of

the

monitors. We also looked at how easily a person with low vision

could read the display information and perform the other tasks

that

require vision. In addition, we evaluated the accessibility of

the

print and electronic manuals.

Results

Obtaining a Blood Glucose Measurement

The process of obtaining a blood glucose measurement is fully

accessible on both the Prodigy Voice and the SensoCard, with

speech

output supporting the process the entire way and speaking your

test

results. Both feature high-quality recorded human speech, rather

than synthesized speech, and both speak test results in only 5

seconds. Both also alert you if your reading is out of the

normal

healthy range. Both have control buttons that are easy to

identify

tactilely, and both require a small sample of blood, with the

SensoCard requiring 0.5 microliters and the Prodigy Voice

requiring

0.6 microliters. Both use strips with capillary action, which

pulls

your blood sample into the strip, eliminating the need to place

a

large hanging drop of blood onto the strip. The strips also

stick

out away from the meter, which greatly reduces the chance that

you

will need to clean blood from the meter. The Prodigy has a handy

Eject button, so you can safely dispose of used strips without

having to touch them.

Both meters use strips with a tactile notch for orientation

purposes. The blood application end of the SensoCard strips is

pointed, which helps to ensure that you do not put the strip in

backward. The SensoCard alerts you if you accidentally inserted

a

used test strip, but it does not alert you if you inserted a

strip

upside down. It speaks the same message prompting you to apply

blood, so you may inadvertently waste the test strip. The

Prodigy

Voice does not alert you of either of these errors, but if you

use

or incorrectly inserted a test strip, it will not prompt you to

apply blood, so you will know something is wrong.

The Prodigy has a Repeat button to announce your reading again

if

you did not hear it the first time, and the SensoCard will

repeat

your reading if you press the Up button before you remove the

test

strip. Both meters can provide results in both milligrams per

deciliter (mg/dL) and millimoles per liter (mmol/L), and

changing

from one type of measurement result to the other is accessible

on

both meters. Both meters play a shutdown tune and turn

themselves

off automatically if they are not used for a short time.

Accessing Past Readings in Memory

The memory function of both meters is fully accessible and is

supported entirely by speech output. The SensoCard can store up

to

500 readings and provides 7-, 14-, and 28-day averages. The

Prodigy

Voice can store up to 450 readings and provides 7-, 14-, 21-,

30-,

60-, and 90-day averages. It is easy with each meter to scroll

through the averages and the individual readings, voicing the

glucose level, date, and time of each reading. You can also

clear

the memory data independently on each meter, but the meter

clears

all the readings from memory, and you cannot delete one reading

at a

time.

The SensoCard allows you to mark an abnormal reading, such as

one

taken after heavy exercise or a large meal, that may throw off

your

averages. Marked readings are not included in your averages, but

you

must mark them immediately after taking them. These readings

still

appear when you scroll through memory, but the speech output

tells

you that they are marked results.

Coding the Test Strips

Most blood glucose monitors require that you set a code number

to

calibrate them to the test strips every time you open a new

container of strips, and doing so is usually inaccessible for

people

who are blind or have low vision. However, the Prodigy Voice

eliminates this step. It has an auto code feature that

automatically

codes the meter when a strip is inserted and eliminates any

human

error involved in coding strips.

The SensoCard still requires coding for each new bottle of test

strips, but it uses a code card, eliminating the need to code

the

meter manually. You simply turn the monitor on and press the

Down

arrow after the welcome greeting. The voice says, " Code set

menu.

Insert the code card. " You then insert and remove the code card

in

one fluid movement in the slot in the bottom of the left side

panel.

The card sets the code and reads aloud the code setting. The

code

card comes with each new bottle of test strips; it is a small

plastic strip of paper about 1.5 inches long by half an inch

wide

and has a squared end that is inserted and a rounded end that

you

hold to insert it. You can code manually with speech support if

you

lose the strip, but you may need to get sighted assistance to

read

the code from the strip bottle.

Settings

The settings functions of both meters are fully accessible, with

speech supporting the entire process. The function is called the

Function menu on the SensoCard, and you are able to perform a

system

check, set the calibration code manually, upload your test data

to a

PC, set the time and date, delete your test memory, choose

between

mg/dL and mmol/L as the measurement unit, and set the voice to

speak

English or German or to be silent. The Prodigy settings include

time

and date, measurement unit, speech volume, and the delete memory

function. The fact that the Prodigy's Settings button is no

longer

hidden in the battery compartment is another improvement over

the

original Prodigy.

Performing a System Check

An occasional system check is recommended when using most blood

glucose meters to ensure proper performance. You may want to do

this

test after you have dropped your meter or left it in an

extremely

hot or cold environment, such as a parked car.

With the SensoCard, you use the talking menus and insert the

check

strip that comes with the meter. The meter performs a

measurement

and displays the result of the test. If the value spoken is

within

the range indicated on the label affixed to the pocket in the

carrying case, then the meter is performing properly. The test

is

accessible, but you need to learn how to orient the check strip

properly and to make a note of the range indicated on the pocket

in

the carrying case. If you lose the check strip, the test can

also be

performed with a regular test strip and the control solution

available from the manufacturer.

The Prodigy Voice has what they call an Auto System Function

Check,

so you do not use a check strip. Instead, you use a regular test

strip and the control solution from the manufacturer. The

control

solution bottle shows the range in which the test result should

fall

if your meter is performing properly.

Download Software

Both meters have free software available, so you can download

your

results to a PC. The Prodigy Voice requires a cable accessory to

connect the monitor to a PC, and the cable is available from the

manufacturer's web site. The SensoCard requires its " Light Link "

adapter, which creates an infrared link to the meter. The

software

creates charts and graphs for monitoring your test history and

prepares reports that you can send to your health care provider,

so

he or she can track your blood sugar levels over time. We used

both

Window-Eyes and JAWS to test the accessibility of the SensoCard

software, but the Prodigy Voice software was not yet available

at

the time of our testing. Although Diagnostic Devices, Inc. told

us

that the Prodigy voice's download software was designed

specifically

to work with screen readers, we cannot yet confirm that.

Caption: An AFB TECH intern connecting the SensoCard to a PC via

infrared.

The SensoCard software, called DiaTransfer, uses a nonstandard

installation procedure that is inaccessible to screen readers

because of unlabeled graphical buttons. After we got sighted

assistance to install the software, we took a look at the

software

manual. Although the manual is an untagged PDF document, it was

mainly accessible, except for some mouse-based instructions. The

software itself, though, was not accessible using a screen

reader. A

highly skilled user of screen readers may be able to glom some

usable information from the software, but there are far too many

accessibility problems, such as unlabeled buttons and edit

fields,

to consider this software accessible or usable for people who

use

screen readers.

Our testers with low vision had success using ZoomText to use

the

software. The ZoomText tools to change magnification and screen

colors worked fine. Although the speech functionality of

ZoomText

did not work perfectly, the ZoomText Speak It tool spoke the

onscreen text much better than the screen readers did.

Warnings and Error Messages

The Prodigy Voice speaks all warnings and error messages that

appear

on the meter's display screen, such as a warning that your blood

glucose measurement is too high or too low. The SensoCard also

speaks warnings and error messages. With some of the messages,

it

just speaks the letter or number of the error, such as " Error

C, "

and you have to look in the manual to determine what that code

represents. At other times, it also speaks what the warning

message

means, saying, " Error 7: insufficient blood. " Thus, it may be a

good

idea to keep a handy cheat sheet in braille or large print in

the

SensoCard's carrying case.

Battery Replacement

Both the Prodigy Voice and the SensoCard speak to warn you that

the

batteries are low and that it is time to change them. You can

change

the batteries independently on both meters, but it is a bit

easier

to do so with the Prodigy, which uses two AAA batteries, which

are

easier to orient tactilely than are the two small round, silver

watch-style batteries that the SensoCard uses.

Documentation

Each meter comes with a print manual in standard 12-point font,

which is too small for most people with low vision to read. Each

also has an electronic version of the manual available in PDF

format. Although both are untagged PDF documents, only the

SensoCard

manual works well when you use a screen reader. The SensoCard

also

provides instructions that have been written with the blind

reader

in mind, providing good descriptions of the meter and how to

perform

tasks nonvisually. The Prodigy Voice PDF manual has some

structural

problems and does not work well with screen readers. Although

most

of the text can be read with a screen reader, the manual was not

written with the blind reader in mind and does not provide good

descriptions of the meter or how to perform tasks nonvisually.

We

also had to experiment with the reading order in Adobe Acrobat

when

we read the Prodigy Voice manual.

Low Vision Accessibility

Both monitors have a monochrome display screen with black text

and

icons against a gray background. These low-contrast displays are

similar to the old calculator display screens and would not be

preferred by most people with low vision. On the Prodigy Voice,

the

icons, such as the low-battery icon and the frowny face

indicating

an out-of-range test result, are too small to be seen by most

people

with low vision, but some of the text is displayed in large

print

and could be read by our testers with low vision. The results of

the

blood glucose measurement are in a 60-point font, and the time

and

date are in a 26-point font. However, the text indicating the

type

of measurement, such as milligrams per deciliter, is in a 6- to

8-point font. The SensoCard consistently uses large fonts, with

font

sizes ranging from 18 points to 60 points, which can be easily

read

by most people with low vision.

As far as the visual nature of the other physical

characteristics of

the monitors, our testers with low vision said that the labels

on

the buttons are too small for most people with low vision to

read.

Also, the button labels on both monitors are nearly the same

color

as the buttons themselves, providing no contrast to accommodate

the

reader with low vision. However, because the buttons are easy to

identify tactilely, it is not as important an issue as the

visual

nature of the display screen. Of course, the speech output on

these

meters will accommodate a person whose vision is such that he or

she

cannot read the display screen.

The Prodigy Auto Code and Advocate Redi-Code

The Prodigy Auto Code and Advocate Redi-Code are two other blood

glucose meters that came on the U.S. market in 2007. They are

virtually the same as the Prodigy and Advocate evaluated in the

March 2007 issue of AccessWorld. The main difference is that

they

both have added the convenience of an audomatic coding system,

eliminating the need to calibrate the monitor to each new bottle

of

test strips. Although that convenience is also an accessibility

advancement, nothing else has been done with these two monitors

to

increase overall accessibility. Although they speak to guide you

through testing your blood and read out your measurement levels,

they do not have near the overall accessibility as the SensoCard

and

the Prodigy Voice.

The Prodigy and Advocate Duo, which also came on the market in

2007,

are basically the original Prodigy and Advocate meters combined

with

talking blood pressure monitors. However, we did not evaluate

them

for this article because the parts of the blood glucose meters

are

exactly like the ones we evaluated in the March 2007 issue of

AccessWorld. Also, they are wrist-type blood pressure monitors,

which are not considered to be as accurate as the over-the-arm

cuff-type monitors that we evaluated in the September 2004 issue

of

AccessWorld.

The Bottom Line

The Prodigy Voice and the SensoCard are both highly accessible

and

are much-needed additions to the blood glucose meter market.

They

are smaller; cheaper; faster; and, in general, much better than

anything we have had in the past as far as accessible blood

glucose

monitors. Although we are impressed with both meters, each has

an

advantage over the other here and there. We consider the Prodigy

Voice to be a slightly more accessible and usable meter. The

most

obvious advantage of the Prodigy Voice is that it is available

in

the United States now, while the SensoCard is still awaiting FDA

approval. The Prodigy Voice's earphone jack is a major advantage

over the SensoCard, allowing you to use a headset for privacy or

for

connecting a speaker for amplification of the speech output. You

can

also adjust the volume on the Prodigy Voice, but not on the

SensoCard. Although the SensoCard's volume is easy to hear in

normal

settings, it may be too loud in a setting where privacy is

desired

or too low in a noisy setting. The Prodigy Voice's Auto Code

feature

is another advantage of the Prodigy Voice, eliminating one step

in

the process and any human error that may occur when coding a new

bottle of test strips. When you use the Prodigy Voice, you know

if

you have inserted a test strip improperly, which is not the case

when you use the SensoCard. The Prodigy Voice's accessible

download

software is another advantage for those who are interested in

tracking their measurement data on their PCs or e-mailing their

data

to their health care providers. Finally, the Eject button is a

nice

convenience found only on the Prodigy.

We want to stress, however, that we like both these new meters,

and

the SensoCard has some advantages of its own. The major

advantage of

the SensoCard is its accessible and well-written electronic

manual,

which many people may consider the most important factor. The

SensoCard is also slightly smaller and more portable and uses

large

fonts more consistently on its display screen. Finally, it

allows

you to mark abnormal readings, so they are not included in your

weekly and monthly averages.

Both BBI and Diagnostic Devices should be applauded for their

efforts in making accessible blood glucose meters and for

seeking

input from many people who are blind or have low vision who will

use

the meters. In addition to contact with the American Foundation

for

the Blind, Diagnostic Devices worked with the National

Federation of

the Blind in developing the Prodigy Voice, and BBI is involved

with

the Royal National Institute of Blind People in the United

Kingdom.

We are happy that these small companies have brought

accessibility

to the market of blood glucose meters, but we would also like to

see

the large pharmaceutical companies that have dominated this

market

for the past several decades do something to serve people who

are

blind or have low vision. We also would like to see some

movement

toward accessibility with the other devices that people with

diabetes use, such as insulin pumps, insulin pens, and home

blood

pressure monitors. Certainly, the 3.2 million Americans with

diabetes who have some degree of vision loss are a large enough

market to attract some interest from the manufacturers. What do

you

say, Roche? and ? Abbott Labs?

Product Information

Products: Prodigy Auto Code, Prodigy Voice, and Advocate

Redi-Code

Blood Glucose Monitors..

Manufacturer: Taidoc Technology, Dot 4F, No. 88, Section 1,

Kwang-Fu

Road, San-Chung, Taipei County, Taiwan; phone: +886-2-6635-8080,

Ext. 368; e-mail: anthony@..., technical service:

tony.cc1128@..., customer service: service@...;

web

site: www.taidoc.com.

U.S. Distributor of the Advocate: Pharma Supply, 3381 Fairlane

Farms

Road, West Palm Beach, FL 33414; phone: Customer Care Center,

; e-mail: info@...; web site:

www.pharmasupply.com.

Price: $46.99.

U.S. Distributor of the Prodigy: Diagnostic Devices, 5900-A

Northwoods Business Park, Charlotte, NC 28269; phone: customer

service, , or technical support, ;

e-mail:

customer service, customerservice@..., or technical

support, techsupport@...; web site:

www.prodigymeter.com.

Price: Prodigy Auto Code $39.99, Prodigy Voice: $79.99.

Product: SensoCard Plus Blood Glucose Monitor.

Distributor: BBI Healthcare, Unit A, Kestrel Way, Garngoch

Industrial Estate, Gorseinon, Swansea, SA4 9WN, Wales; phone:

01792-229-333; e-mail: info@...; web site:

www.bbihealthcare.com.

U.K. Distributor of the SensoCard Plus: Royal National Institute

of

Blind People, 105 Judd Street, London, WC1H 9NE, England; phone:

020-7388-1266; e-mail: helpline@...; web site:

onlineshop.rnib.org.uk.

Price: No U.S. price currently available.

This product evaluation was funded by the Teubert Foundation,

Huntington, West Virginia. We also acknowledge the valuable

assistance provided by Marshall University intern Wesley

Clements.

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Blind Entrepreneur Takes Action

Growing tired of the ongoing lack of attention paid to the

accessibility of diabetes devices by the big pharmaceutical

companies, blind entrepreneur Gray decided to do something

about it. Gray is the former president of the American

Council

of the Blind, and his company, Bay Area Digital, is working on

solutions for making blood glucose testing more accessible for

the

millions of people with diabetes who are blind or have low

vision.

Gray visited AFB TECH in summer 2007 to discuss the work of Bay

Area

Digital. He showed us his prototype for an accessible blood

glucose

meter and another prototype for a little gadget that makes it

easier

to place your blood sample properly on the glucose meter test

strip.

Gray told us that when he approached the big manufacturers of

blood

glucose meters about accessibility, he learned that the profit

potential of the market of consumers who are blind or have low

vision does not interest them. He said that they build a minimum

of

7,500 to 10,000 meters per day, and our market is just too small

to

make a difference. With this point in mind, Gray's business plan

is

for Bay Area Digital to work on the accessibility and the

manufacturers to worry about the accuracy and other competitive

factors of the meters. He brought this idea to the Diabetes Care

Division of Abbott Labs, makers of the Freestyle Freedom blood

glucose meter. Bay Area Digital, along with the American Council

of

the Blind's Diabetes in Action division, is now collaborating

with

Abbott Labs to bring accessibility to the Freestyle Freedom.

Gray

has also asked for AFB TECH input on his prototype, which we are

more than happy to provide, and AFB also fully supports his

efforts

to bring more accessibility to the diabetes market.

Gray said that he likes the Freestyle Freedom for a couple of

important reasons. First, the meter does not have to be

calibrated

for each new bottle of test strips, which is similar to the auto

code feature of the Prodigy Voice. Second, and more important

according to Gray, is the auto-fill feature of the Freestyle

Freedom's test strips. With auto-fill strips, the meter does not

take a reading until the strip has the right amount of blood,

greatly increasing the accuracy of the test and minimizing the

need

for multiple testing.

Gray first showed us his prototype for the gadget that makes it

easier to place a blood sample properly on the glucose meter

test

strip. It is a simple plastic ring that attaches to your finger

with

a small band. It guides your lancet device to a spot on your

finger

and then guides the test strip to the same spot.

Gray's prototype blood glucose meter consists of the Freestyle

Freedom connected via a serial cable to a laptop computer. The

laptop runs Bay Area Digital's prototype software, which

controls

all the meter's functionality and speaks all the information

that is

displayed on the meter. It has other voice prompts guiding you

along

the way, and it is controlled entirely by keystroke commands.

Examining the prototype in the AFB TECH lab, we found that it

provides access to nearly all the features and functions of the

meter. It also adds an alarm feature to prompt you to check your

blood sugar level throughout the day. Of course, Gray asked us

to

provide feedback and to let him know of any suggestions we may

have.

The only thing we really think he should add, as far as how the

interface functions, would be a voice prompt telling you when

the

battery is low and needs to be replaced. Another minor issue

involves entering digits when setting the alarm, the time, and

the

date. The software does not echo the digits as you enter them or

delete the digits if you make a mistake. However, it does repeat

the

settings when you finish, and because it is a simple task, it is

no

problem to reenter the settings if you hear that you made a

mistake.

Our biggest concern, which Gray agrees with, is portability.

Being

tethered to a computer is fine for testing at home, but because

aggressive diabetes management requires several tests throughout

the

day, it is not always practical to carry a laptop with you

everywhere. Of course, this is just a prototype, and Bay Area

Digital's ultimate goal is to build this functionality into the

meter itself or perhaps into a small unit that attaches to the

meter. On November 13, Gray received notification that this

integration will be funded for six months by the National

Science

Foundation. So, there should be a lot more to this story before

long.

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