Kyrra Richards, who has type 1 diabetes, has transformed her desire for a stylish diabetes carrying case into a thriving business. Her sense of style has struck a chord with a large audience, including a company that is working with her to customize her line to its pump. It’s been several years since Diabetes Health interviewed Kyrra at an AADE conference (http://www.diabeteshealth.com/tv/play/182.html). I spoke to her recently to catch up and see how things were going.
A new study has proven that use of a blood glucose meter with advanced features, when paired with diabetes education, more effectively manages blood glucose than using a basic feature meter. This information was presented at the recent 46th European Association for the Study of Diabetes (EASD) Annual Meeting in Stockholm, Sweden.
My almost 20 years as a diabetes educator have been memorable in many ways, but certain moments stand out more than others. Because blood glucose testing is an important part of diabetes management for everyone I see, I try to assess each person’s skills and habits in this key area. I’ll never forget the time I asked a client how often he changed his lancet. He had been diagnosed with type 1 diabetes about four years earlier and was checking regularly, so it seemed like a reasonable question. He proceeded to look at me with a puzzled expression and say, “You mean you’re supposed to change those things?”
It doesn't matter if you're a computer geek or complete technophobe: If you've ever made the effort to download your blood glucose meter, you probably don't have a clue about what to do with the data once you've gotten it. That needs to change. Those of us who live with diabetes need to become more adept at analyzing our own data, to see what's working and what isn't both for our own sake and that of our time-strapped healthcare providers. .
Research firm Frost & Sullivan, a leading international healthcare consulting company, released a market study analyzing and estimating the demand for Pepex Biomedical Inc.'s new biosensor technology for blood glucose monitoring for diabetes sufferers worldwide. The researchers interviewed diagnosed diabetics, diabetes educators, endocrinologists, and manufacturers of biosensors, blood glucose meters, or other clinical diagnostic or patient monitoring equipment suppliers for the study. The Frost & Sullivan report concluded that the Pepex Trio technology has the "potential as a new standard for measuring blood glucose levels."
In July, I went to order a refill of my pump and was refused. My account was overdue, and my pump company wouldn't issue a refill until I could pay at least $400 of the $1200 I owed. I didn't have $400. I am a freelance writer and stay-at-home mom with a knack for stretching my husband's paycheck. I'd been making small monthly payments of about $50 because that was all we could afford, but now they wouldn't send me any more. So I went to the pharmacy and bought a box of syringes for $25. I didn't want to go back to multiple daily injections, but I didn't see that I had a choice.
Sanofi-aventis announced the upcoming launch of the blood glucose monitoring (BGM) devices BGStar® and iBGStarTM, developed by sanofi-aventis and its partner AgaMatrix. Due to their convenience, accuracy and ease-of-use, BGStar® and iBGStarTM will help the decision-making process for people with diabetes and their healthcare professionals, with the aim of improving patient self-management. iBGStarTM connects to the iPhone® or iPod touch®. This is an important step towards sanofi-aventis' vision of becoming the leader in global diabetes care by integrating innovative monitoring technology, therapeutic innovations, personalized services and support solutions. BGStar® and iBGStarTM are planned to be made commercially available in the first markets in early 2011.
In my office, there is a box. Nothing fancy, just a plain brown box filled with a collection of "old school" diabetes stuff: "boil and re-use" syringes, urine test tape, screw-driven insulin pumps, medieval injection aids and lancing devices, and so on. Of course, no such collection would be complete without an array of classic blood glucose meters. The oldest one I have is a plug-in-the-wall model called a "Dextrometer" that featured test strip rinsing solution and a red LED display that could burn the retina of anyone within six feet.
We can all come up with plenty of excuses not to test our blood sugar. For one, yeah, it stings a little (No pain, no gain, the angel on my shoulder whispers in my ear). For another, testing isn't convenient, no matter how quickly the meter works or how small it is. While seemingly everyone else is carelessly enjoying a meal or leaping into the swimming pool, you are on the sidelines trying to ignore your diabetes. And of course, sometimes, we just do not want to know what the number will be. It's easier to ignore the ugly truth than face it.
A massive study involving 485 people with type 1 diabetes at 30 locations across North America shows that the combination of an insulin pump and a continuous glucose monitor helps patients achieve significantly lower A1c levels than multiple daily insulin injections.
Bayer Diabetes Care today announced the introduction of the DIDGETTM blood glucose monitoring system in the United States. The DIDGET meter is unique because it isthe only blood glucose meter that connects directly to Nintendo DSTM and DS Lite gaming systems to help kids manage a lifelong disease by rewarding them for building consistent testing habits and meeting personalized blood glucose target ranges. Bayer's DIDGET meter is now available for purchase in the U.S. through CVS.com, Drugstore.com and Walgreens.com.
At a two-day meeting (March 16 and 17, 2010) to review blood glucose meters, Food and Drug Administration officials and staff pointed to a number of issues that can prevent people from getting proper treatment and sought input from medical experts and industry on ways to improve test results with the widely used devices.
Bayer's A1CNow SELFCHECK, cleared by the Food and Drug Administration last year, is the first and only system of its kind with at-home results in five minutes. It enables patients to more closely watch their A1C level in between doctor visits so they may have a more informed discussion with their healthcare provider to ensure their diabetes plan is working.
In our last issue, we published a letter from reader Sheila Payne, who wrote that we had been far too positive about continuous glucose monitoring (CGM) in our June/July article Get the Facts on Continuous Glucose Monitoring. But her opinion provoked a stack of letters from people who believe that the benefits of CGM substantially outweigh its negatives. To let you in on the debate, we are reprinting Ms. Payne's thought-provoking letter here, followed by two equally thoughtful responses from readers.
The U.S. Food and Drug Administration has issued a warning against the use of GDH-PQQ blood glucose test strips by people with diabetes who are taking medications that contain non-glucose sugars. [Note: GDH-PQQ is the abbreviation of "glucose dehydrogenase pyrroloquinoline quinone," a chemical that reacts with the non-glucose sugars maltose, galactose, and xylose, which are contained in some therapeutic products.]
People often ask me, "Why limit diabetes-related services to the iPhone when there are so many other cell phones out there?" I always answer them by asking, "How many applications have you downloaded onto your cell phone?"
Here’s a handy meter to have if reading your meter is a challenge. The Prodigy Autocode meter speaks your test results in seconds, and it’ll do so in English or Spanish. The audible function also promotes team work by allowing you to hear your child’s or spouse’s test result from across the room and work together as a team to manage diabetes.
For 2,000 years diabetes has been recognized as a devastating and deadly disease. In the first century A.D. a Greek, Aretaeus, described the destructive nature of the affliction which he named "diabetes" from the Greek word for "siphon." Eugene J. Leopold in his text Aretaeus the Cappodacian describes Aretaeus' diagnosis: "...For fluids do not remain in the body, but use the body only as a channel through which they may flow out. Life lasts only for a time, but not very long. For they urinate with pain and painful is the emaciation. For no essential part of the drink is absorbed by the body while great masses of the flesh are liquefied into urine."
The first time I presented medical research findings, I was not yet a physician. The year was about 1975. I was in my early forties and a mid-career engineer. The forum was a scientific symposium on diabetes. At the time, I felt that I had discovered the holy grail of diabetes care and was eager to share what I had learned.
My daughter Lauren was five days shy of her twelfth birthday when she was diagnosed with type 1. We were blessed with a child who could and did take the lead in her recovery and care. She never had any "teen diabetic rebellion" and never adopted a "why me?" mentality. Her health has been great, and her last A1c was 6.7%. With all the hormonal changes that can affect a teenage girl's body and thus change her insulin requirements, Lauren has always stayed on top of her care and never lost her fantastic personality.
The members of the AADE are an impassioned group who genuinely want to make a difference in their patients' lives. It was an ideal place for me to be, especially because I had a concern of my own: Why am I getting red dots every time I inject? Every educator I asked went right to work examining the problem and investigating my behavior, truly wanting to help. Unfortunately, they are dwindling in number each year, while patients are increasing in number, making their work ever more demanding.
Diabetes educator Mary M. Austin reported that many people are paying for blood glucose test strips even though their insurance plans would cover them. "There is a lot of misunderstanding," she said. For example, a client of Austin's got a free meter at a health fair. He then paid for strips on his own for six months, until he found out that his insurance plan would cover them if he got a prescription for the strips from his healthcare provider.
I’ve always been a pretty good traveler. I simply checked the weather at my destination and packed accordingly. Easy. Then I learned that I had diabetes, and suddenly even weekend trips required an intense amount of additional preparation.
Let me start with my maternal grandmother, Helen. Helen had diabetes and lived to the age of 73. We all assumed that she didn’t do a good job with it, as we would often find candy wrappers under her bed. When it came to taking care of herself, Helen was my mother’s role model.
The FDA has cleared the OneTouch UltraLink wireless meter as the only meter certified by Medtronic to wirelessly communicate with its diabetes management products in the United States. The meter uses Medtronic-certified wireless technology to transmit glucose readings directly to MiniMed Paradigm insulin pumps and the Guardian® REAL-Time continuous glucose monitoring system. This makes bolus dosing more accurate and easier for patients compared to the manual entry of blood glucose readings.
Fifteen-year-old Californian Laura Miller, a brittle diabetic, and her mother, Gillian, thought they had a strong case when they asked Blue Cross in late 2007 to pay for a continuous glucose monitor for her.
Over the course of the year, we meticulously update all our charts to bring you
the most accurate information about hundreds of products, services, and
medications. Now we've gathered every one of those charts, from humble lancets
to sophisticated continuous glucose monitors, into one handy place.
This morning, a major meter manufacturer announced that its blood glucose meters
will now operate on Microsoft's HealthVault. HealthVault is an online service
that allows a patient to store and manage his health records without paying a
Frost & Sullivan, whose mission is to research and analyze new market opportunities for corporate growth, has some happy news about the diabetes epidemic: It's creating a huge demand for glucose meters and strips in Asia.
According to Pulse, the UK's leading medical weekly, a review of the evidence has concluded that for type 2s on oral medication whose A1c's are below 7.5%, blood glucose monitoring offers "little advantage and may increase the likelihood of hypoglycemia."
We recently wrote about a study which concluded that blood glucose meters are a waste of time for people with type 2 diabetes who are not using insulin ("Is Using a Meter a Waste of Time for Type 2s?"). Our readers vehemently disagreed with that conclusion.
Everyone knows that for meter manufacturers, a meter is simply a
means of selling a lifetime of strips. The Eocene blood glucose
meter is no different in that respect, but it does have something
extra to offer.
Two new meters that purport to measure your blood glucose without a fingerstick are currently in the works–again. The road to a non-invasive meter is one that many have traveled before, but no one, thus far, has ever reached the market.
Meters have come a long way since 1969, when the first meter went on the market. The meter measured the amount of light reflected off a Dextrostix, a paper strip that turned various shades of blue, depending on blood glucose level, after a large drop of blood was placed on it and then washed off.
Milpitas, CA, March 30, 2007 – LifeScan, Inc., maker of OneTouch® Brand Blood Glucose Monitoring Systems, is offering customers that own one of several models of OneTouch Brand Systems a no-charge meter upgrade to one of the company's latest, most innovative meters.(1)
Medtronic has received FDA approval for pediatric models of both of its REAL-Time continuous
glucose monitors, the MiniMed Paradigm REAL-Time System and the Guardian REAL-Time System.
Previously approved only for adults, both pediatric models will be appropriate for kids ages
Distributed by Diagnostic Devices Inc. (DDI), of Charlotte, North Carolina, Prodigy is
a talking glucose meter. According to DDI, the Prodigy line of glucose meters are all
“affordable, accurate, and easy-to-use.”
A German company has developed the world’s first blood glucose
meter that can wirelessly transmit your blood glucose test results.
The GlucoTel is the first meter to support Bluetooth wireless
Medtronic MiniMed has linked an insulin pump with a continuous
glucose monitor. Approved by the U.S. Food and Drug Administration
in April, the pump part of the combination is already available. The
company expects the monitor component to be available by the end of
What’s New LifeScan, Inc., a Johnson & Johnson company, has
introduced its OneTouch Ultra2 Blood Glucose Monitoring System.
LifeScan says the new meter is designed to help diabetics see the
impact of their food and portion choices on their blood glucose
Bayer Diabetes Care of Tarrytown, New York, announced
that its Ascensia Breeze blood glucosemonitoring system
received an ease-of-use commendation and a product
seal from the Arthritis Foundation. According to Bayer
Diabetes Care, Ascensia Breeze is the first blood
glucose meter to be recognized by the Arthritis
Foundation for a design that is user-friendly for the
more than eight million Americans with arthritis
who also have diabetes.
As David Mendosa points out in his feature article this month, ‘The Year of the Meter,’ 2006 is barely more than half over and we have already an abundance of new blood glucose meters. Well, it’s not only meters that are in abundance this year, but other diabetes drugs, devices and technologies as well. So much so, that there haven’t been enough pages in Diabetes Health to cover all of the new products.
On January 31, 2006, GenExel-Sein, Inc., of Buffalo Grove,
Illinois, announced it had received U.S. Food and Drug
Administration 510(k) clearance for its Duo-Care device, which
combines a home-use blood glucose monitor with a wrist blood
pressure monitor—eliminating the need for two separate devices.
On March 13, 2006, Abbott Diabetes Care of Alameda, California,
announced that it has received 510(k) clearance from the U.S. Food
and Drug Administration to market its FreeStyle Freedom blood
glucose-monitoring system for consumer use.
The continuous glucose sensors of today that will in time lead to
development of an artificial pancreas are getting a tremendous boost
from the Juvenile Diabetes Research Foundation International (JDRF). The
boost is the organization’s commitment of up to $6.5 million
dollars this year and next.
Abbott Diabetes Care is already looking beyond continuous sensing. More than
two years ago it asked the U.S. Food and Drug Administration to approve its
FreeStyle Navigator Continuous Glucose Monitor; that application is still
Not everyone with diabetes leads an active
lifestyle and tests often. But my guess is that
the readers of this magazine are on the go
more than most people and monitor their
blood glucose when they are away from
Diabetes researchers at the American Diabetes Association’s 65th Annual
Scientific Sessions in San Diego made thousands of presentations this year. Of
the 2,851 available abstracts, 55 were about blood glucose testing. That’s a
small percentage of the total. But after winnowing through them, I found lots of
Do disappointing blood glucose results make you feel like a failure? Don’t let them. They aren’t report cards, and you can’t pass or fail. These numbers are not there to hurt you, but to help direct you.
A dozen companies market blood
glucose meters in the United States,
but Accu-Chek, by Roche Diagnostics, is
number one in sales both in the United
States and worldwide. They were also one
of the first brands of blood glucose meters.
The original Accu-Check bG came out in
If you want to know how well you are
controlling your diabetes, you have had only
two options. You can check your current
blood glucose level with a meter, or you can
check your average over the past two or
three months with an A1C test.
Now there’s a third and quite promising
option—the GlycoMark test.
It’s news whenever a new blood glucose
meter becomes available. Two new blood
glucose meters from a new company is even
bigger news. The biggest news is that one of
these new meters works with a device that
automatically uploads your readings to family
or healthcare professionals—all without
using a computer.
When we think about Medtronic MiniMed,
insulin pumps usually come to mind. That
makes sense, because MiniMed was among
the first to market an insulin pump and today
dominates the U.S. market with more than a
70 percent share.
Glucose monitoring systems that
continuously plot the course of blood
glucose promise much greater control over
blood glucose levels. Detecting when you
are going low is just one benefit, but it is the
most immediate reward.
Lancing devices are critical tools for
obtaining blood samples for glucose
measurement. While good diabetes management
requires frequent blood testing, the
pain and inconvenience involved in
lancing can prevent a person with
diabetes from undertaking the appropriate
number of daily blood glucose tests.
The accuracy—or typically the lack thereof— of blood glucose meters is a big concern of mine. I have written several articles on this topic. But first of all, you have to know if your meter is precise.
Q: I just noticed that my strips are code 10, but I forgot to change my meter, which is still set at code 2. My meter is a LifeScan OneTouch Ultra. I don’t know how many bottles of strips I have gone through at this wrong setting. Have my readings been too low, or too high? And by how much have they been off?
A few years ago, the International Diabetes
Center in Minneapolis, Minnesota, compared
meter systems. What I remember most about the
comparison was the cost of blood glucose test
strips—they were so close.
Roche, best known for its Accu-Chek family of blood-glucose monitors, made an offer in February 2003 to buy Disetronic's insulin pump division. A decision on the purchase should be finalized in May or June if Disetronic's shareholders accept Roche's tender offer of two nonvoting Roche equity securities and a price of 670 Swiss francs (about $490 U.S. dollars) per share.
As a diabetes researcher, exercise physiologist and individual with type 1 diabetes, I am always curious about how the latest diabetes technology fits into an exercise program. Exercise is, after all, one of the three cornerstones of diabetes management, along with diet and medication.
Becton, Dickinson and Company, of Franklin Lakes, New Jersey, best known for its insulin syringes, has entered the blood-glucose meter market with two products: the BD Logic blood-glucose monitor and the BD Latitude Diabetes Management System.
Insulin-to-carbohydrate (I:C) ratios, which are used to calculate the insulin doses people with diabetes need for specific amounts of food containing carbohydrate, are an important part of any intensive diabetes management program.
Reasons for choosing a particular blood-glucose meter are as varied as the users. Some users want it simple, some want all the bells and whistles and many want something in between—as long as the meter and strips are affordable and accurate. Not to mention fast!
Software designed to help children who are newly diagnosed with type 1 diabetes learn how to manage their condition is available from dbaza, Inc., of Pittsburgh, Pennsylvania, for use by both individuals and professionals.
If you test your blood glucose regularly, you probably think you have a pretty good idea of how high or low your numbers rise and fall during a typical day and night. However, what if you had 288 blood-glucose readings every 24 hours, instead of only a handful?
Knitters know that, for a perfect match, you need to buy all the yarn for a project from the same dye lot to eliminate subtle changes in color that can make your solid red sweater come out looking like it has stripes. The reason? Minute changes in dyes that cause just the slightest difference in hue.
Knitters know that, for a perfect match, you need to buy all the yarn for a project from the same dye lot to eliminate subtle changes in color that can make your solid red sweater come out looking like it has stripes. The reason? Minute changes in dyes that cause just the slightest difference in hue.
When I worked as a consultant for one of the "Big 5" consulting firms a few years ago, I was always traveling around the country to different destinations. At each destination, I was confronted with decisions that affected my diabetes management-or lack thereof.
Parents who wanted to see GlucoWatch Biographers on the wrists of their children with diabetes received good news on August 28, 2002, with the announcement that the U.S. Food and Drug Administration had approved the GlucoWatch for use with children ages 7 to 17. The device received earlier FDA approval for adults with diabetes in April 2002.
LXN Corporation, which made the InCharge blood-glucose meter, GlucoProtein test strips (which measure fructosamine levels) and InCharge Glucose test strips, has recalled all GlucoProtein test strips, discontinued all its products and ceased operations.
Researchers in Canada studying barriers to self-monitoring of blood glucose discovered that—surprise!—people who were given free strips tested more often than those who had to pay for them. An added benefit of more frequent testing was better blood-glucose control.
A former Wal-Mart pharmacist with diabetes who closed the store's pharmacy in Chadron, Nebraska, while he ate lunch is not covered under the Americans With Disabilities Act (ADA), the 8th U.S. Circuit Court of Appeals confirmed in a July 2002 ruling.
Researchers in Chicago, Illinois, using the Medtronic MiniMed Continuous Glucose Monitoring System (CGMS) conclude that the variable glucose profiles generated during endurance competitions such as marathons "indicate the need for intensive and accurate glucose monitoring."
Imagine being able to pop a blood-glucose testing device into your personal digital assistant (PDA), put blood on the strip and store the results in the PDA. Now you can do just that, thanks to U.S. Food and Drug Administration approval of two such devices in mid-June 2002.
It happens. After three and a half years and more than 10,000 tests, my meter screen displayed a glitch. So I called the company, explained to the rep what had happened and was told I would be sent a new meter.
Whether or not people with diabetes can test in public places is a nonissue. Every person with diabetes is entitled to his or her respective life, liberty and pursuit of good blood-glucose control—despite the occasional stare of a passerby.
Measuring blood-glucose levels with a sample drawn from the forearm using the Sof-Tact meter made by Abbott/MediSense will yield the same results as fingerstick testing, say researchers in Massachusetts. The researchers also found that the hematocrit (Hct)—the percentage of whole blood that is composed of red blood cells—was significantly higher in the forearm blood samples than in fingertip blood samples, according to the study published in the February 2002 issue of Diabetes Care.
A noninvasive blood-glucose monitor has long been awaited. People with diabetes do not look forward to monitoring their blood glucose every day, as it involves pricking their fingers to obtain blood samples.
The Accu-Chek Advantage blood-glucose meter could sometimes save a test result incorrectly in its memory feature, Roche Diagnostics has announced. The incorrect storage of a reading in the meter's memory could occur once every seven days.
Sometimes I sit and dream of the things I could buy and the places I could visit—if only I didn't have all the expenses that go with having diabetes. Topping the list of those expenses are blood-glucose testing strips. In less than one minute after you take one out of the container, you throw about 70 cents—more or less—into the trash.
With winter weather approaching, many of us take precautions to handle worsening driving conditions: we install snow tires, pack our trunks with sandbags and ease up on the accelerator when the roads turn slippery.
For decades, people with diabetes have known the drill: prick your finger, get a good-sized drop of blood, apply the drop of blood to a meter, wait for the result and adjust your insulin, eating or exercise regimen accordingly.
MiniMed's Continuous Glucose Monitoring Device was used to measure the prevalence of nighttime hypoglycemia (BGs below 40 mg/dl) and associate the occurrence of nighttime hypos and interstitial glucose levels every five minutes in a study of 47 children with diabetes.
Many new technologies have recently become available to help manage type 1 diabetes. Among these, insulin pumps and continuous glucose monitors are proving to have great benefit, even in young children.
Carla Elliot liked to keep busy. A bright and outgoing 14-year-old girl, Carla involved herself in as many activities as she could. Whether it was swimming, cheerleading, softball, 4-H club meetings or simply running around the neighborhood, Carla was there.
Cygnus, Inc. of Redwood City, California, has finally completed its long journey to receiving FDA approval for its GlucoWatch Biographer. People with diabetes, however, should expect to wait until the end of 2001, or later, before being able to purchase one.
The U.S. Food and Drug Administration recently approved the One Touch Ultra blood-glucose monitoring system. Manufactured by LifeScan of Milpitas, California, the One Touch Ultra offers a number of features to support better diabetes management.
On November 28, 2000, Bio-Rad Labratories announced that its new instrument for measuring HbA1c levels, called Micromat II, was chosen for use in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. The ACCORD trial is aimed at reducing cardiovascular disease in people with type 2 diabetes. The test will be used to measure the patients HbA1c levels at 60 different test sites throughout the U.S. and Canada.
On December 15, 2000, after a three-year government investigation, LifeScan, Inc., a Johnson & Johnson company, entered a plea of guilty to three misdemeanor charges relating to a federal government investigation of its SureStep Blood Glucose Meter. LifeScan will pay a fine of $29.4 million and an additional $30.6 million in civil settlement to the government.
The blood glucose (BG) meter is the "single most important thing" in the life of a person-type 1 and 2-with diabetes, says Jane Seley, RN, CDE, MPH, MSN, GNP, a doctoral candidate at New York University.
Home Diagnostics, Inc (HDI) of Ft. Lauderdale, Florida, announced on December 13, 2000 that in less than one year, several top retailers have started co-branding with its Prestige Smart System (PSS) blood glucose monitor. The result, according to a HDI press release, has allowed customers to save on diabetes testing supplies.
TheraSense, Inc. of Alameda, California, received word on December 13, 2000 that its FreeStyle blood glucose monitor has received FDA clearance for testing on the upper arm, thigh, calf and anywhere on the hand. The FDA had recently cleared the FreeStyle for testing on the forearm.
On November 20, 2000, Abbott Laboratories of Bedford, Massachusetts announced it had received U.S. Food and Drug Administration marketing clearance for its Sof-Tact. This diabetes management system, according to Abbott, is the first automated glucose monitor to offer lancing, blood collection and glucose testing with a single press of a button.
Whether you realize it or not, most blood sugar meters store information about the tests you perform and also let you recall the date and time that you checked your blood sugars. Some meters keep track of the "control" and "checkstrip" quality control tests done to ensure the accuracy of your meter. More advanced meters even store additional data such as events like low blood sugar symptoms, insulin doses, activity levels, the amount of food consumed or even your HbA1c levels.
If you ever think, "I never go anywhere without my meter; it's like my wallet," think again. How many of us have forgotten our wallets? If it is prudent to own spare car keys, why not own a spare meter? Why not own two meters, one for the home and a spare meter for your workplace? If you exercise at the gym regularly, keeping a third spare meter in your locker is also advisable.
A small Italian trial tested the accuracy of two popular blood glucose monitors at an altitude of nearly 10,000 ft. The Glucometer Elite II and the LifeScan One Touch II were tested on six type 1s who all had good glycemic control and no diabetes-related complications. The readings from the meters were compared to the results from venous blood samples. The findings were reported in the January issue of Diabetes Care.
An advisory panel of the U.S. Food and Drug Administration (FDA) unanimously recommended approval of the GlucoWatch monitor on December 6, 1999. The advisory panel, which approved the GlucoWatch monitor with conditions, said that the monitor could offer a tremendous benefit by measuring glucose far more often than blood tests can.
Kumetrix Inc., a privately held medical device company located in Union City, California, recently announced that it will receive $194,000 in state funds to further develop its painless blood glucose (BG) monitoring device.
Biocontrol, one of many hopeful developers of a noninvasive glucose monitoring device, will link with the Joslin Diabetes Center in Boston. Joslin researchers will conduct clinicals trials for approval of Biocontrol's Diasensor 2000, a device that measures glucose levels with spectroscopy (technology using infrared light).
Choosing a glucose meter is like choosing a home. You have your dream home in your head, but it does not exist in the real world, just like a noninvasive meter. Then, even among the existing homes, what you really want, (for most of us) you cannot afford. Similarly, the meter that has all the features you are looking for may not be covered by your health insurance. Yet, just when you've given up hope, it all comes together and you find the one you want. After some work, your home, and your meter, become sources of protection and comfort. Most importantly, your meter becomes your lifeline.
Imagine if a free glucose meter showed up at your door. You'd be thrilled, right? Well, it happened to David Fogarty, but he wasn't thrilled. This Berkeley, California, father was fuming mad. Fogarty's HMO, Health Net, sent a free Precision Q.I.D. meter to his 11-year-old son, Lucas, and to all its other members with diabetes. The catch was, Health Net would soon stop covering strips for Lucas's One Touch Profile.
MiniMed's continuous glucose monitor appears to have passed through the first phase of FDA approval. An advisory panel, which makes initial recommendations to the entire agency, voted unanimously to recommend approval to the entire FDA.
This installment in the meters, strips and glucose testing series discusses temperature and humidity and their effects on meter and strip functioning. For comments, contact Sharon Kellaher at (800) 234-1218.
People who have trouble getting adequate samples may fumble less with a new product, the SampleMate, from Chronimed. Made from elastic, the SampleMate tightens up the top of the finger to keep a good amount of blood there until a drop is drawn.
Visually impaired people with diabetes now have a glucose monitor, called the Accu-Chek Voicemate, that talks them through their tests. Manufactured by Eli Lilly and Company and Roche Diagnostics, the Voicemate's voice tells people their blood sugar levels and which type of insulin they are using.
Cygnus Inc. has an idea for a painless glucose meter which will resemble a wrist watch. Calling it the GlucoWatch (R) monitor, Cygnus is searching for a business partner to market the product here in North America. Although the product is not finalized, GlucoWatch is expected to have a skin pad, known as the AutoSensor, which measures glucose concentration with an electric current. Cygnus cannot yet specify an availability date.
Enlisting your personal computer in your diabetes care plan can give you a comprehensive, objective picture of your glycemic control. MediSense offers its glucose data management system, Precision Link, for use with its Precision Q.I.D., Precision Q.I.D. Pen, MediSense 2 and MediSense 2 Pen glucose monitors.
Many people are dissatisfied with a new interim Medicare policy. The policy was considered to be a breakthrough for Medicare patients because for the first time it will cover patients who are not being treated with insulin injections. Prior to July 1, 1998, these patients were not covered by Medicare for their diabetes testing supplies.
The U.S. Food and Drug Administration claims that the Johnson & Johnson company is failing to adequately warn the public about the dangers of using certain defective SureStep blood glucose meters. As reported in DIABETES HEALTH (see "290,000 SureStep Meters Recalled," July 1998, p. 10), J&J recently began recalling its SureStep meters sold before August 1997. The monitors failed to measure blood sugar levels in excess of 500 mg/dl. At such levels, the meters display an "ER 1" error message instead of the glucose concentrations.
Johnson & Johnson's LifeScan is voluntarily recalling and replacing its SureStep glucose meters sold before August 1997. The monitors failed to measure high blood sugar levels in excess of 500 mg/dl. At such levels the meters display an, "ER 1" error message instead of the glucose concentration. The problem, which is software related and not in the machine itself, does not exist in units sold after August 1997.
Technical Chemicals and Products Inc. in Pompano Beach, Fla., unveiled its new noninvasive TD Glucose Monitoring System at a meeting sponsored by NASA, the Juvenile Diabetes Foundation and the National Institute on Diabetes and Digestive and Kidney Diseases.
Could there be more than beauty in the eye of the beholder? How about an accurate blood glucose reading? That's what Visionary Medical Products Corporation (VMPC) in Carson City, Nevada, is hoping for - a noninvasive test that will determine BG levels through minute blood vessel changes in the retina.
Several companies are actively working on technologies to improve blood sugar testing and thereby capture a share of the two- to three-billion dollar blood sugar testing market. The goal is to make testing easier, more convenient and, the hope of many, continuous without sticking the finger. Here are some of the companies trying to become the first to offer improved testing and how they plan to do it:
MiniMed Inc. is petitioning the FDA for clearance to produce and market its continuous subcutaneous glucose sensor. The company hopes for approval in 1998. MiniMed expects to utilize the sensor for a series of products - the first two being a physician diagnostic device and alarm product to warn people with diabetes of dangerously low glucose levels.
In November, President Clinton signed the "Food and Drug Modernization Act of 1997," a new law intended to streamline the regulatory process and improve the regulation of medical devices. One section of the law specifically advocates Congress to encourage the development of safe and effective noninvasive blood glucose meters.
Glucose monitors have come a long way since the hulking, brick-sized meters of the seventies. Now, new technology has created smaller and lighter monitors the size of pagers. However, people with diabetes everywhere are still feeling the pain of testing. When will painful finger pokes no longer be necessary?
Once the DCCT results were published showing the benefits of tight control, the importance of self-monitoring to a successful diabetes control regimen was solidified. The BG diagnostics market has boomed as a result. United States revenues for 1997 are expected to top out at $877.2 million, and by the year 2004, they are expected to reach $2.25 billion.
Looking for a bloodless, painless way to test for glucose levels, researchers have turned to the skin. Between the layers of skin is a fluid called dermal interstitial fluid (ISF) that, according to a report in September's Diabetes Care, contains enough glucose to be an accurate measure of BGs.
Boehringer Mannheim is currently developing a blood glucose monitoring system that it hopes will measure BGs continuously and as painlessly as possible. Boehringer would like to see its minimally-invasive product, the Komo System, on the market by the year 2000.
The supreme importance of daily blood glucose (BG) monitoring for proper blood sugar control is well documented. It is quite possibly the single most important step that individuals with diabetes can take to reduce their chances of developing complications.
Is your blood glucose meter giving you accurate readings? Testing under certain circumstances may be giving you misleading results. While most users expect accurate readings from their meters at all times, recent studies have found that many meters on the market today are inaccurate during hypoglycemia and when used at high altitude.
Almost immediately after complaining to a congressional subcommittee that it was unfairly treated by the FDA during its first 510(k) submission, Biocontrol Technology, Inc. announced that it submitted a new revised 510(k) pre-market notification for its Diasensor 1000 non-invasive glucose sensor.
Selling stock has been a lifeline for Biocontrol Technology, Inc. With no revenues to speak of, it's been the only way the Indiana, Pennsylvania-based company has been able to raise the millions it's spent over the last decade developing its experimental blood monitoring machine for diabetics.
The new Accu-Chek Instant is now the fastest blood glucose monitor available. The 12-second test is quicker than other meters whose tests take anywhere from 20 to 45 or more seconds to produce a result.
Biocontrol Technology, Inc. has been receiving a great deal of attention regarding its Diasensor 1000 non-invasive blood glucose meter. Stockholders have been calling the (DIABETES HEALTH) office asking if we know what is going on with Biocontrol-when will the device be ready to market?
Vision care for people with diabetes is critical because disturbances of normal sight are common. Until recently it was thought that vision changes were the result of damaging changes in the structure of the eye.
Why would patients veto a device that can monitor glucose levels without the need for blood? Because they had to put the device in their ear. Though technically non-invasive, focus groups found the process unappealing.
We all know that one of the best things we can do for ourselves is monitor our blood glucose levels. Of course, the meter we select to help us is vital. In fact, comparing meters is like comparing new cars-it's nice to know what other people are buying.
Metabolic Control Matters. These words by Dr Richard Eastman, director of the the diabetes program of the National Institutes of Health were meant to introduce the results of the Diabetes Control and Complications Trial 1, a 10 year study in almost 1500 patients that demonstrated a tight correlation of excellent control of blood glucose and a dramatic reduction in the risk of the complications of diabetes. This study leaves little room for doubt: if you want to prevent the devastating complications of diabetes you need to bring your blood glucose as close to normal as possible.
New developments in technology and manufacturing techniques have brought a new level of sophistication among lancets. The consumer now has more questions than ever about choosing the right lancet. In light of this, DIABETES HEALTH has compiled a comprehensive look at the lancets currently on the market, and their differences.
As clearly demonstrated by the DCCT, blood glucose monitoring is a critical element in the maintenance of normal blood glucose levels. Cygnus Therapeutic Corporation in Redwood City, California is working on a new non-invasive glucose monitoring system that could dramatically change the way people with diabetes monitor their glucose levels. Unlike the current procedure, which measures the level of glucose in the blood based on blood samples drawn from the fingertips, the new system is non-invasive, and utilizes interstitial fluid rather than blood.
In a 28-week behavioral weight control program, 22 obese patients with non-insulin dependent diabetes (NIDDM) were recruited to determine the effects of self blood glucose monitoring (SBGM) in diabetes management. For the first eight weeks, all the participants met in weekly support groups. After eight weeks, the original group was divided in two, with the first half continuing the support groups, and the second adding SBGM and dietary carbohydrate counting. While the results in weight loss were identical for both groups, the study revealed that people in the support group experienced a substantial decline in HbA1c levels, followed by a rapid "rebound," while in the second group, HbA1c levels consistently declined. The results of the study suggest that SBGM and carbohydrate counting should be recognized as important tools in the management of non-insulin dependent as well as insulin-dependent diabetes.
Near-infrared, as you have no doubt heard, is supposedly a technology that allows the taking of a blood glucose reading without the need for a blood sample. The theory is simple: when you shine light on your hand, it passes through it and comes out on the other side (take a flashlight and put it up to your hand: if you look at it from the other side you'll see your hand glowing red). By analyzing the changes in the wavelengths of light after it has passed through an object, it is possible to determine the chemical makeup of that object. Every substance has a spectrum of light that it will absorb and emit; so in theory you can tell just how much glucose is in the blood by analyzing the intensity of the spectrum it emits.
I'm sure you've heard about the non-invasive blood glucose sensors that everyone in the diabetic meter business is talking about; it is, after all, big news. The ability to take accurate glucose readings without the traditional finger-stick would be a blessing to people with diabetes. The estimated $500 million prize going to the inventor of such a device would be a blessing to whichever company produces the first one. The obstacles involved, however, insure that whoever wins it will have to work long and hard.
Dr. Alan Marcus is a diabetes specialist who practices in Laguna Hills, California. He is also a medical advisor to MiniMed Technologies and a spokesperson for Novo Nordisk Insulin. Dr. Marcus also serves as Assistant Clinical Professor of Medicine for the USC School of Medicine.
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