GLUCOMETER-BIOMEDICAL DEVICE

December 1, 2009

GLUCOBAND The Glucoband is a compact electronic scanning device that utilizes a bio-electromagnetic resonance phenomenon to non-invasively measure blood glucose levels in the human body, and to continuously monitor the blood glucose level. The device is based on the technology called Bio-Electric Impedance Spectroscopy (BEIS). A wrist-watch-like Glucoband, with fully integrated LCD screen, electronic circuits, integrated electrodes, battery and adjustable wrist-band, is placed on the persons wrist. The initial measurement process takes only a few minutes, however, in the monitoring mode, measurements can be continuous and only the frequency of measurements must be determined. The Glucoband targets diabetics who are measuring their own blood glucose, and medical personnel who are using blood glucose measuring and monitoring devices in clinics, hospitals and other point-ofcare facilities. The measurements meet FDA requirements for accuracy and correlation. The design of the Glucoband is such that it may be used as a regular wrist-watch or be used as a blood glucose measurement device, at the discretion of the wearer.In the Continuous Monitoring mode, Glucoband can be set to alert upon surpassing a lowest and/or highest preset value. Glucoband worn on the wrist like regular wristwatch would allow people with diabetes to continuously and non-invasively monitor their blood glucose levels without the pain and inconvenience of multiple fingerstick blood tests or implanting a sensor. Prototypes of the device have shown the capability of providing readings once in 6 minutes. Continuous glucose monitoring has become an important component of diabetes management for both children and adults.Blood glucose levels are a measure of an individuals health status. Because people with diabetes cannot properly metabolize glucose, they typically monitor their glucose levels by frequently pricking their fingertips to draw the drop of blood necessary for conventional glucose monitoring. The estimated worldwide market for glucose testing is $5.5 billion with an annual growth rate of 15 to 18 percent. GLUCOWATCH

The Cygnus GLUCOWATCH wrist monitor uses a low electric current to pull glucose through the skin. The system, which employs a disposable sensor pad to collect and measure the glucose sample, provides automatic glucose readings up to three times an hour for as long as twelve hours at a time.

(CYGNUS GLUCOWATCH) Cygnus GLUCOWATCH G2 BIOGRAPHER, a special version of the GLUCOWATCH is designed for younger diabetic patients aged 7 to 17. It gained FDA approval in May 2005.

GLUCOPHONE

GLUCOMETER + CELL PHONE = GLUCOPHONE Glucophone is a new technology that integrates a blood glucose meter with a standard cellphone. It not only allows you to send results over the air, but specially equipped mobiles will actually be fitted with a GlucoPack that enables you to test Glucose level yourself as you would do with any other traditional glucometer.

(LG GLUCOPHONE) Glucophone is essentially a cellphone and glucometer. It will measure blood sugar levels, record and send results to yourself and others. GLUCOPHONE A company called Healthpia America has developed an integrated cell phone-glucometer system that uses custom software along with an LG UX5000, VX5200, or LX350 and a Glucopack. According to the companys website, they believe that their system is the worlds first, all-inone, glucometer cell phone and service for managing diabetes remotely. Whether youre a guardian, physician, or healthcare institution, you can provide 24/7 support and emergency intervention to Diabetes Phone subscribers anytime, anywhere. Its a full disease management system. WORKING OF GLUCOPHONES

HealthPia has developed a glucose meter (GlucoPack) that can be fitted onto regular cell phones. The customer uses the GlucoPack in the same manner as any standard glucose meter. Software has been developed that can be downloaded into your cell phone that can interface with the GlucoPack to test and read your glucose level. (When you go visit or talk to your doctor or a hospital, with the subscribers permission all the test results are accessible online.) The test reslults are stored in the cell phone and also sent to an online medical management database. The results can also be automatically sent to other sources such as your physician, guardian, family members in real-time at the subscribers direction. (When you go visit or talk to your doctor or a hospital, with the subscribers permission all the test results are accessible online.) The disease management center analyzes the test results and provides professional medical management for the subscriber.

advertisement

GlucoPhone Gets Real Sleek Models You Bleed On

By AmyT August 7, 2007

When I first reported on the GlucoPhone last summer, it was looking like a classic case of vaporware. But now it seems that New Jersey-based HealthPia has actually pulled it off: theyve obtained FDA approval for their patent-pending technology that integrates a blood glucose meter

with a standard-issue

cell phone.

The GlucoPhone is not just for SENDING blood glucose data over the net. Its actually a special glucose meter (GlucoPack) thats fitted onto the back of a cell phone. So yes, you stick your test strip into a little slot on the side of the phone and bleed on it, just like you would any meter. Then you can immediately text your results to a database available online with the subscribers permission, i.e. you set the access rights. Check out this Fox News link for a quick demonstration. After several years of what seemed like empty talk, HealthPia has quietly launched its first marketable model, the Verizon LG5200 phone (CDMA platform) for the US market at last weeks AADE Conference. The fact of the matter is that most people with diabetes are more concerned with the daily hassle of managing the disease than the long-term complications. But with something like this, we can help cut the hassle and focus on whats important, HealthPia President Kathi ONeill tells me. She is Type 1 herself for 27 years and insists that she wouldnt feel right promoting any diabetes product that didnt live up to its promise of improving on the usability aspect.

The original GlucoPhone technology was developed in Korea, and imported to the US by Dr. Stephen Kim in 2003.

The glucose meter component actually replaces the back of the cell phone, and software functions normally contained in traditional bulky glucose meters are handled by the cellular technology. The hardware is specially designed to fit in standard commercial cell phones. The company has ambitious plans to develop more models for popular, sleek consumer phones including the Motorola Razr and the Apple iPhone, if you can believe it (see prototypes pictured and yes, Kathi read my recent appeal to Steve Jobs for some help consumerizing D-devices). HealthPias iPhone prototype uses a small dongle device called the Gluco+, about the size of a quarter.

But it hasnt been and wont be easy, since a new mold must be developed for each individual phone design, and HealthPia must negotiate certification with each cellular carrier. The wireless people dont understand the glucose monitoring business, and the glucose monitoring people dont understand the wireless companies, ONeill laments. Meanwhile, the first models have hit the market at a humble introductory rate of $149 for the unit, plus $20 for each vial of 50 test strips. Yes, yes, I know, you have lots of questions for Ms. ONeill. So did I: So who actually makes the BG meter technology and test strips? We work with a major, established OEM (original equipment manufacturer). But you have to buy the test strips from HealthPia? What about insurance coverage?

Yes, we distribute them exclusively at the moment. Were selling the supplies at a loss for the introductory period, to make them affordable without insurance coverage. You have to get a foothold in the market. Later on, with reimbursement, we can move to more equitable market pricing. What about calibration and test strip coding? Yes, you have to enter a code (calibrate), and it comes with control solution, just like most regular meters on the market today. Is there any charge for the database service? No, thats part of the deal. By the way, if you already have a Verizon LG5200 phone in the US, you can purchase the meter pack and software only as an add-on. Otherwise, its a turnkey solution: you buy the whole product together. Theres no extra charge for transmitting your data, and you can text message anyone you want. You can either provide your login and password to individuals you want to allow access, or we can add other authorized users for you, but only with your express permission, and there are lots of security layers. The huge advantage is the ability set parameters to automatically send results to anyone you want, any time you want. So if a kids in school from 9 to 3, for example, you could set the GlucoPhone to send results to their parent during that time period. And the cellphone service? Of course, you still have to pay for that. Thats handled by the carrier, Verizon or AT&T, etc. Its totally separate from the glucose meter portion. So whos actually used this in the real world so far? We held clinical trials with adolescents at Indiana University. It was a relatively small sample size, but the results were amazing even in regard to lowering A1c levels. Ive worn an insulin pump since 1986. Now my doctor might actually be happy, because I refuse to write down my blood sugars. Im more visual, I need graphs. But its impossible for me to do my own trend charting. I just never download all the data. The ultimate goal here is to get the meter manufacturers and the wireless technology manufacturers to work together to get us something useful. I mean, I go out often and forget my meter. I forget other things, but I never forget my phone Well now, that SOUNDS pretty real. I cant wait to try one in my real, very wireless, no-datalogging, impatient, less-blood-and-fewer-gadgets-please world.

HealthPia GlucoPhone
With every new step in diabetes technology, there seems to be a new piece of equipment to carry around. Carrying an insulin pump, glucose meter, and a continuous monitor or logbook along with your cell phone, wallet, and other daily use items can be a little cumbersome. Thanks to HealthPia, you can combine two diabetes tools into one, the GlucoPhone, an all-in-one product that combines a cell phone with a blood glucose monitor. The convenience of this device makes it easier to monitor blood sugars.

Glucose results are recorded in an "electronic logbook" that eliminates the need for manual log books or synchronization with a computer. Your logs are placed online where the results are accessible to you and any authorized healthcare professional you choose. A text message of the results can also be transmitted to anyone you choose.

The Technology
The glucose meter component, called a GlucoPack, replaces the back of a cell phone and works with several standard commercial cell phones, including the VX-5200, VX-5300, VX-6100, VX7000, VX-8100, VX-8300, VX-9800 made by LG. The phone/GlucoPack combo handles all the functions of traditional blood glucose meters handled. The company has plans to develop more models for other popular phones, including the Motorola Razr and the Apple iPhone.

Just as you would with a standard blood glucose meter, you place a small drop of blood on a test strip. You place the strip in a small slot on the side of the GlucoPak and 9 seconds later your results are shown on the phone, uploaded to the HealthPia website, and securely stored there. You can view the information from any computer without having to download any extra software. The results can also be automatically sent to other sources such as your physician, guardian, family member(s) in real-time at the subscriber's direction.

The Cost
The GlucoPhone site offers various bundles for people interested in the GlucoPhone. The GlucoPak meter alone is $69.95. If you already own a compatible phone, you can just buy the meter, test strips, and service. The test strips are relatively expensive at a regular price of $44.95 for 50 strips. HealthPia currently provides these strips for $10.00, but there is no indication of how long this discount will be available. Even the regular price is offset by the value of instant communication of glucose values. Insurance coverage is unclear at this time. Visit www.logicmobile.com for rates for compatible phone plans. If you do not have any parts of the Glucophone, the promotional bundle may be best for you. The GlucoPhone Promotional Bundle includes:

FREE LG 5200 cell phone (a $149.99 value) GlucoPack starter kit (a $79.95 value)

Free activation on LOGIC Mobile (a $30 value).

The GlucoPhone can be a helpful tool. Parents of teens with diabetes no longer have to continuously check to make sure they are testing their blood sugar. Every time they check a result can be automatically sent to you or your physician. You or the physician also have the ability call or text back instructions on how to adjust doses. This device can make carrying a glucose meter and checking glucoses easier, while encouraging improvements in your overall diabetes maintenance. Accuracy of glucose readings from the GlucoPack meter compared to other meters is unknown.