Blue Sparrow Medical

This is National Diabetes Awareness Month.  You can see what events are in your area at the ADA website. The goal is to raise awareness of effects of diabetes.  That said, you can’t move forward until you know were you’ve been.  I may’ve made that up but, as the year winds down, let’s look at some promising technology from 1999.

 From the National Diabetes Clearing House - Diabetes Dateline 1999

 
Amira Medical’s New Blood Glucose Testing Device Now Available

 The Food and Drug Administration has approved Amira Medical’s new AtLast Blood Glucose System, now available for consumer use. The AtLast system allows patients to accurately monitor their blood glucose levels without the pain of sticking their fingers to get blood samples.

 The system is the first to contain both a lancing device and a blood glucose meter all in one. It uses a unique, disposable test strip to obtain blood samples from the forearm, thigh, or upper arm, areas that have fewer nerve endings and are therefore less sensitive than fingertips.

 A clinical study among patients with diabetes found that they preferred arm/thigh testing to fingersticks and that 90 percent experienced less pain or no pain with the AtLast system.

 That was great in 1999 but, most newer glucose meters including the WaveSense, Prodigy and TrueTrack (available from Blue Sparrow Medical under $20 for a box of 50 strips) all feature alternate site testing.

 Inhaled Insulin

 Pfizer Inc and Hoechst Marion Roussel AG have announced that they have entered into agreements to manufacture insulin and jointly develop and promote inhaled insulin worldwide.

 The first major, multicenter clinical trials successfully using the new inhaled form of insulin to treat the two most common types of diabetes were reported on last summer at the American Diabetes Association’s 58th Annual Scientific Sessions.

 Under the agreement, Pfizer and Hoechst said they would construct a jointly owned manufacturing plant in Frankfurt, Germany.

 Anything that could reduce or eliminate the need for multiple daily insulin shots would be welcome news for people with diabetes. Insulin normally cannot be taken by mouth because the pills are digested in the stomach, which renders them useless as a hormone.

 By minimizing the need for injections, the user-friendly option of inhaled insulin can broaden the use of insulin in patients with type 1 and type 2 diabetes. Phase II studies have demonstrated that inhaled insulin is as effective as regular injectable insulin and that inhaled insulin results in better control for patients who are not well controlled through oral agents.

 We all know how well inhaled insulin went,  see our article on exubera.

 FDA Approves Home Use of Laser for Diabetes

 The Food and Drug Administration (FDA) has approved a laser device that people with diabetes can use in place of the traditional lancet to draw blood for monitoring blood sugar.

 The device, which is manufactured by Cell Robotics Inc. of Albuquerque, New Mexico, is called the Lasette. It is a portable, battery-operated device that uses a YAG laser to pierce the skin, a nearly painless means of drawing blood for glucose testing. The device can be used in the home after patients have received a prescription and instruction from their health care provider.

 Currently, many people with diabetes must prick their fingers with a lancet once or twice a day to monitor blood sugar levels. This can be especially difficult for children.

 According to the FDA, “Clinical testing has shown that adequately trained patients can perform finger pinpricks with the laser device as easily and accurately as with lancets.”

 Wow! I know you are wondering if Blue Sparrow Medical has this device for sale.  A laser device that provides a nearly pain free way to draw blood.  So, let’s look at Cell Robotics, Inc the company that made it. Their lancing device cost was about $1094.00 when it was released. So, you have $1094 dollar device that basically does what a $12 lancing device does.   Now, lancing needles are much smaller. The wavesense lancets are 33g and the smallest on the market.  Most users report that they hardly notice the prick and they usually get the lancet for about $3 from Blue Sparrow Medical.  I guess that would explain why Cell Robotics went out of business in ’04.

Aside, from the numerous complications and risks of diabetes one of biggest pains (no pun intended) is the daily blood testing.  So, the promise of not having to prick your fingers to test your blood sugar is the “holy grail” of diabetics everywhere.  A non-invasive method for checking for blood sugar means less pain for users because blood will no longer have to be drawn.  This results in less pain and increased safety amongst users.  Non-invasive also helps users save money.  Since test strips will no longer have to be purchased, it will save users hundreds of dollars a year. (By using Blue Sparrow’s WaveSense meter and strips you can save money right now on the cost of glucose testing strips.) Health Insurance companies will also be able to reduce premiums for diabetics because there will be less financial coverage that they must provide. 

In a world of nanobots and satellites that can read a license plate, it is very fair to ask “why isn’t there a better way to do this?”  Since the 1990s, technology has allowed researchers to consider a non-invasive method to test for blood sugar.  Non-invasive means that no puncture of the skin necessary.  There are a few ways that researchers have tried to achieve this.  One method is using near IR detection.  This method works by analyzing very small molecular vibrations that glucose gives off.  As a result, the amount of vibrations could be analyzed by a sensor to give you a reading of your blood sugar.  Researchers are also considering using ultrasound, which are sound waves with very high frequencies that we cannot hear.  Ultrasounds cause small amounts of glucose to begin to come towards the outside layer of skin.  Although this amount is harmless, it can be read by a sensor that is placed just below the top of the skin.  A third method that could be considered is dielectric spectroscopy.  This technique could potentially find your blood sugar by using a sensor which analyzes how the glucose in your blood reacts when it is exposed to electric fields.

Currently, there is one FDA approved non-invasive glucose meter is the GlucoWatch G2 Biographer.  This device was intended to track trends and patterns of blood sugar over the course of the day for adults only.  By fitting around wrist like a watch, small electric currents result in specific body fluids to come towards the surface of the skin.  These fluids can be analyzed to give a ballpark figure of your blood sugar.  That’s the catch, it provides a ballpark range not an actual test that could be used to for insulin dosage.  The FDA also requires conventional blood samples to still be taken.  In other words, this new device is not a replacement for reliable blood sample testing and much work is still needed to be done to fix its accuracy and precision.  The other drawback of the glucowatch is the high price tag (about $5,000 per year). This product has not achieved widespread market exposure because it still requires blood samples. 

So, what’s on the horizon? There are countless projects being undertaken worldwide to design the most effective non-invasive meter.  A team in Hong-Kong recently used near IR detection to design a device to measure blood sugar.  Their device won a gold medal at the Geneva Invention Expo in April, 2007.  Their device has proven, in some cases, to be 85% accurate.  Another non-invasive meter, developed by Biosign Technologies in

Theirs still a long ways to go to increase the functionality of non-invasive meters.  One problem is caused by electrical interference by other processes in the body. Another problem is that the measurements are often not reproducible.  Thirdly, the position of a sensor has a big impact on its accuracy.  All three of these problems are still being tackled by researchers.  Scientists are currently trying to produce accurate readings that are able to be reproduced each time.  With constant technological advances, the time for reliable and convenient non-invasive blood sugar readings is at hand.  It could be only a few years until finding your blood sugar is as easy as taking your temperature.