August 13, 2009 (Roche Diabetes Care North America) - Recently, the U.S. Food and Drug Administration (FDA) issued a notice about potential errors with select blood glucose monitoring test strips that use technology known as GDH-PQQ, which include ACCU-CHEK® monitors as well as other monitors. The errors occur in a small number of diabetes patients who take certain drugs intravenously or by peritoneal catheter that may increase non-glucose sugars in the bloodstream. The presence of these non-glucose sugars may then result in falsely elevated blood glucose readings. The drugs and therapies available in the U.S. that cause the false readings are listed below:

• EXTRANEAL®
• Octagam® 5%
• WinRho® SDF Liquid
• Orencia®
• Adept® adhesion reduction solution
• HepaGam B®
• Bexxar®

It is important to know that this is not a recall of the ACCU-CHEK blood glucose monitors

The FDA notes that "GDH-PQQ meters and strips are okay to use if you are not using an interfering drug product or therapy" as listed above. For those who are using drugs that contain non-glucose sugars, the FDA recommends the following:

• Do not use GDH-PQQ glucose meters or test strips
• Use another type of glucose monitoring technology and continue to monitor your blood glucose as instructed by your healthcare provider
• Contact your healthcare provider if your results do not reflect the way you feel

Patient safety is important to Roche. ACCU-CHEK products have been proven to provide accurate and reliable results for patients with diabetes, when used as directed in package inserts.

Should you have any additional questions or concerns regarding ACCU-CHEK products, please call ACCU-CHEK Customer Care, available twenty four hours, seven days a week at 1-800-858-8072.

Andreas Stuhr, M.D.
Medical Director, North America
Roche Diabetes Care

August 13, 2009 (FDA) -
For Diabetic patients and/or their caregivers

Advice NEVER use GDH-PQQ* glucose meters or test strips if you are using drug products or therapies that contain certain sugars other than glucose.

*GDH-PQQ stands for glucose dehydrogenase pyrroloquinoline quinoneIssue Diabetic patients who receive drug products or therapies containing certain sugars other than glucose could experience serious, although rare, injuries if they use blood glucose meters with a particular type of test-strip technology. Strips that use this technology, known as GDH-PQQ, will react with certain non-glucose sugars, including maltose, galactose and xylose, and produce a falsely high (elevated) result. If a diabetic patient then takes too much insulin because of this falsely high result, it could lead to abnormally low blood sugar (hypoglycemia), coma, or even death.

Certain patients may be more likely to be using drug products or therapies that contain other sugars, including those who:

• are on peritoneal dialysis
• have recently had surgery

Glucose test strips other than the GDH-PQQ type are not affected by this problem, and can be used by patients taking drug products or therapies that contain non-glucose sugars.

List of GDH-PQQ test strips and their associated meters List of GDH-PQQ Glucose Test Strips

Drug products or therapies with non-glucose sugars

• Extraneal (icodextrin) peritoneal dialysis solution
• Some immunoglobulins: Octagam 5%, Gamimune N 5% **, WinRho SDF Liquid, Vaccinia Immune Globulin Intravenous (Human) and HepaGamB
• Orencia (abatacept)
• Adept adhesion reduction solution (4% icodextrin)
• BEXXAR radioimmunotherapy agent
• Any product that contains, or the body breaks down into, the sugars maltose, galactose or xylose

** Within the U.S., Gamimune N 5% has not been manufactured since December 2005, and no lots are in distribution in the U.S.

Patient concerns If you are taking drug products or therapies that contain certain non-glucose sugars, such as maltose, galactose and xylose, these sugars will produce a falsely elevated glucose result if you are measuring your blood glucose using a GDH-PQQ test strip. If you then use this falsely elevated result to determine your dose of insulin, you could give yourself too much insulin, which could result in dangerously low blood glucose. In addition, if your blood glucose is actually low, it could go unrecognized and untreated because the test result could read higher than it actually is and appear to be within the normal range. In this case, you may not know your blood glucose is low unless you have certain symptoms, including confusion, hunger, nervousness, dizziness, irritability, sweating, heart pounding (palpitations), shaking, unusual fatigue or weakness, or tunnel or darkened vision. Low blood glucose must be recognized and treated promptly to avoid serious complications, such as coma and death.

Recommendations for diabetic patients using interfering drug products or therapies If you are a diabetic patient who uses any of the drug products or therapies that contain certain non-glucose sugars (or care for someone who does), you should:

• NEVER use GDH-PQQ glucose meters or test strips.
• Instead, use another type of glucose monitoring technology and continue to monitor your blood glucose as instructed by your healthcare provider.
• Contact your healthcare provider if your results do not reflect the way you feel.

You may be able to determine the type of glucose monitoring technology you are using by looking at the instructions that accompanied your meter or test strips, or at your meter's box. If you can't tell what kind of technology your meter and test strips use, ask your healthcare provider or pharmacist to help you find out, and/or contact the manufacturer of your meter and test strips.

General recommendations for all diabetic patients

• Continue testing your blood glucose as directed by your healthcare provider.
• Use only test strips specified for your glucose meter.
• Know the type of glucose monitoring technology you are using.
• Know that GDH-PQQ meters and strips should NOT be used if you are using an interfering drug product or therapy.
• Know that GDH-PQQ meters and strips are okay to use if you are NOT using an interfering drug product or therapy.
• Know the medications you are taking and keep a current list of your medications. If you do not have a current list of medications, ask your healthcare provider to provide you with a list.

Reports received by FDA From 1997 - 2009, FDA received 13 reports of death associated with GDH-PQQ glucose test strips in which there was interference from maltose or other non-glucose sugars. The deaths occurred in healthcare facilities. Some reports indicated that serious patient injury, such as low blood glucose (hypoglycemia), confusion, neurologic deterioration, too little oxygen in the tissues (severe hypoxia), brain damage and coma, occurred prior to death.

FDA is working with manufacturers to resolve the problems with GDH-PQQ glucose test strips, and is continuing to monitor adverse events associated with these products.

Questions to ask your healthcare provider

• How do I determine which glucose meter and strips I have?
• Which drugs am I currently taking? Am I taking or receiving an interfering drug product or therapy?
• Should I continue testing my blood glucose with my current meter and strips or should I get a new meter and strips? If so, how do I do this?

For more information see FDA Public Health Notification: Potentially Fatal Errors with GDH-PQQ Glucose Monitoring Technology.

Reporting adverse reactions Consumers may report adverse reactions related to glucose meters or glucose test strips to FDA's MedWatch Adverse Event Reporting Program online, by phone, FAX or mail.

• Online: MedWatch: The FDA Safety Information and Adverse Event Reporting Program
• Phone: 1-800-332-1088
• FAX: 1-800-FDA-0178
• Mail: use postage-paid FDA form 3500 mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787

List of GDH-PQQ Glucose Test Strips
The following test strips (with associated meters) use GDH-PQQ methodology as of August 2009:

Roche Diagnostics:
1. ACCU-CHEK Comfort Curve test strips, for use with:
• ACCU-CHEK Inform meters [model 2001201]
• ACCU-CHEK Complete meters [models 200 and 250]
• ACCU-CHEK Advantage meters [models 888, 831, 850, and 768]
• ACCU-CHEK Voicemate meters [model 0009221]

2. ACCU-CHEK Aviva test strips, for use with:

• ACCU-CHEK Aviva meters [models 525, 535, and 555]

3. ACCU-CHEK Compact test strips, for use with:

• ACCU-CHEK Compact meters [model GF]
• ACCU-CHEK Compact Plus meters [models GP and GT]

4. ACCU-CHEK Go test strips

• ACCU-CHEK Go meters [model GJ]

5. ACCU-CHEK Active test strips

• ACCU-CHEK Active meters [models GG and GN]

Abbott Diabetes Care:
1. Freestyle test strips, for use with:

• FreeStyle meters
• FreeStyle Flash meters
• FreeStyle Freedom meters

2. Freestyle Lite test strips, for use with:

• FreeStyle Lite meters
• FreeStyle Freedom Lite meters

Home Diagnostics:
1. TRUEtest test strips

• TRUEresult meters
• TRUE2go meters

Smiths Medical:
1. Abbott Diabetes Care Freestyle test strips, for use with:

• CoZmonitor blood glucose module (for use with the Deltec Cozmo Insulin Pump)

Insulet:
1. Abbott Diabetes Care Freestyle test strips, for use with:

• OmniPod Insulin Management System

Note: Test strips currently on the market may be distributed under multiple trade names. In addition, manufacturers of GDH-PQQ test strips currently on the market may subsequently change to non-GDH-PQQ methodology. Therefore, healthcare providers (and patients) should refer to device labeling or consult with test strip manufacturers to confirm the type of methodology used.

July 28, 2009 (Institute of Food Technologists) - Long known for its antioxidants, immune boosting and, most recently, antihypertensive properties, black tea could have another health benefit. Black tea may be used to control diabetes, according to a study in the Journal of Food Science, published by the Institute of Food Technologists.Next to water, tea is the second most consumed beverage in the world. Researchers from the Tianjin Key Laboratory in China studied the polysaccharide levels of green, oolong and black teas and whether they could be used to treat diabetes. Polysaccharides, a type of carbohydrate that includes starch and cellulose, may benefit people with diabetes because they help retard absorption of glucose. The researchers found that of the three teas, the polysaccharides in black tea had the most glucose-inhibiting properties. The black tea polysaccharides also showed the highest scavenging effect on free radicals, which are involved in the onset of diseases such as cancer and rheumatoid arthritis.

"Many efforts have been made to search for effective glucose inhibitors from natural materials," says lead researcher Haixia Chen. "There is a potential for exploitation of black tea polysaccharide in managing diabetes."

July 23, 2009 (EurekAlert) - Current research suggests that a diet high in omega-3 fatty acids may help prevent one of the leading causes of legal blindness among the elderly. The related report by Tuo et al, "A high omega-3 fatty acid diet reduces retinal lesions in a murine model of macular degeneration," appears in the August 2009 issue of the American Journal of Pathology.Age-related macular degeneration (AMD), loss of vision in the center of the visual field (macula) due to retinal damage, is one of the leading causes of legal blindness among the elderly. Approximately 10% of people from 66 to 74 years of age will develop some level of macular degeneration, making it difficult for them to read or even recognize faces.

A diet high in omega-3 fatty acids has been found to protect against a variety of diseases including atherosclerosis and Alzheimer's disease. Retrospective studies have suggested that diets high in fish oil or omega-3 fatty acids may also contribute to protection against AMD. A group led by Dr. Chi-Chao Chan at the National Eye Institute in Bethesda, MD examined the direct effect of omega-3 fatty acids on a mouse model of AMD. A diet with high levels of omega-3 fatty acids resulted in slower lesion progression, with improvement in some lesions. These mice had lower levels of inflammatory molecules and higher levels of anti-inflammatory molecules, which may explain this protective effect.

Tuo et al suggest that "a diet enriched in EPA and DHA can ameliorate the progression of retinal lesions in their mouse model of AMD" and that "the results in these mice are in line with the epidemiological studies of AMD risk reduction by long chain n-3 fatty acids." The results "further provide the scientific basis for the application of omega-3 fatty acids and their biologically active derivatives in the prevention and treatment of AMD." In future studies, Dr. Chan and colleagues plan to use this murine model "to evaluate [other] therapies that might delay the development of AMD." Their ongoing projects include the "testing of systematic delivered pharmacochaperones and antioxidative molecules, as well as intraocularly delivered gene therapies."

July 18, 2009 (NYT) - Federal officials may soon require improvements for the glucose monitors used by more than 11 million diabetics in the United States.
The rise in the use of home glucose monitors, even by hospitals, is pushing the action by the Food and Drug Administration, which for decades has followed international standards that allow the devices to be wrong by as much as 20 percent. Such a wide error rate can leave patients vulnerable to severe problems, including seizures, unconsciousness and coma.

In June, the agency pressed the international group that sets the standards to tighten them. If the group refuses to act, the agency "may instead recognize other (higher) performance standards" on its own, according to a June letter from Dr. Margaret A. Hamburg, the agency commissioner.

A change in the international standards is the easiest and best option, officials said. The International Organization for Standardization, which sets the standards, can act quickly and broadly. But the F.D.A. can change the rules itself through a more time-consuming and cumbersome process.

Officials said they would keep pushing until monitor accuracy improves, a promise that diabetes doctors cheered. In a May letter, the American Association of Clinical Endocrinologists formally asked that the agency act on the issue.

"Because of the highly variable quality of the meters and the glucose testing strips in widespread use, the safety of our patients who depend upon those meters is threatened," the letter said.

Khatereh Calleja, a spokeswoman for the Advanced Medical Technology Association, which represents monitor manufacturers, responded, "We think the present standard is working."

Diabetes has been diagnosed in 18 million people in the United States, and another 6 million are estimated to have the disease without knowing it. It is the seventh leading cause of death and costs the United States an estimated $174 billion a year, with the federal Medicare program spending $1 billion on diabetes test strips alone.

Of particular concern to federal officials is the increasing use of home glucose monitors in hospitals. A landmark 2001 study published in The New England Journal of Medicine found that using insulin to maintain low blood sugar levels in critically ill patients, even those without diabetes, reduced hospital deaths by 34 percent - a result so astonishing that hospitals around the world soon adopted the practice.

But instead of buying the highly accurate and expensive glucose monitors used in the study, many hospitals bought cheaper home models never approved for hospital use. More recent studies have shown that critically ill hospital patients whose glucose levels were kept low suffered more problems - the opposite result from 2001.

The difference, F.D.A. officials said, may have resulted because many patients in the second study were checked with home monitors.

"We think this technology is not up to par for some of the protocols we see out there" like hospital treatment of critically ill patients, said Dr. Alberto Gutierrez, deputy director of the agency's in vitro diagnostics office. "We feel passionately that this is an important issue."

Besides having a wide error rate, many home monitors give the wrong result if patients are taking certain drugs like Tylenol or even vitamin C. The Accu-Chek monitors made by Roche can be confounded by drugs commonly used in dialysis. Julie A. Vincent, a Roche spokeswoman, said, "Every blood glucose monitor on the market has some limitation or interferences."

The F.D.A. issued warnings about the drug-related problems, but doctors complain that they have a hard time keeping straight which drugs conflict with which monitors.

"In the hospital setting, you really don't know how many deaths are due to things that may be related to meter accuracy," said Dr. Richard Hellman, a former president of the endocrinology group. "I don't know how common it is, but I don't think it's rare."

A study by government researchers found that when comparing tests from five different popular monitors, results varied by as much as 32 percent. For a class science project recently, Morgan DiSanto-Ranney, 16, of Bishop O'Connell High School in Arlington, Va., bought seven different glucose monitors and had her father, a diabetic, use all of them.

"What I found was that almost all of the meters were off from one another by 60 to 75 points," Morgan said in an interview. Two of the meters - Ascensia Breeze and Ascensia Breeze II, both made by Bayer - differed by an average of 62 points, she said.

Staci Gouveia, a Bayer spokeswoman, said her company's monitors meet federal requirements. "If the F.D.A. standards change, Bayer will work with the F.D.A. to meet their requirements and assure the accuracy and effectiveness of our meter," Ms. Gouveia said.

Morgan's mother is Emilia DiSanto, a staff investigator for Senator Charles E. Grassley, Republican of Iowa. Briefed on Morgan's test and other studies, Mr. Grassley sent a letter to the F.D.A. in June asking officials to review the problem.

As a result of her project, Morgan's father lost faith in glucose monitors. "He doesn't use them as much anymore," she said.

That reaction is exactly what federal officials are hoping to avoid by quietly pressing manufacturers to improve accuracy. Multiple studies make clear that diabetics who routinely use monitors are healthier and suffer fewer serious complications than those who do not.

Manufacturers have long complained that any requirement to improve accuracy would lead them to raise prices, which would discourage use.

"If we decrease the use of meters, you will have some fairly dire consequences to health," Dr. Gutierrez said, but requiring stricter accuracy standards "seems a reasonable and safe practice to do."

Every year, the F.D.A. receives reports of several deaths and thousands of injuries related to glucose monitor failures, but the reports represent only a fraction of the actual toll. Insulin-dependent diabetics slip into unconsciousness once a year on average, and 40 percent suffer seizures or coma in their lifetimes because of low blood sugar levels, according to the American Diabetes Association, which has long advocated stricter accuracy standards for monitors.

"Insulin is a dangerous drug, and if someone makes the wrong decision about its use because of a bad test, they could die," said Dr. David Sacks, an associate professor of pathology at Harvard Medical School.

March 13, 2007 (Newswire) -- Former President Bill Clinton joined global diabetes leaders today in New York City to discuss ways to break the curve of the diabetes pandemic at a forum hosted by Novo Nordisk and supported by the International Diabetes Federation (IDF).

At the first meeting of policymakers, patient organizations, healthcare professionals, and media since the United Nations passed a resolution to address diabetes in December 2006, the discussion explored ways to make diabetes a global health priority and ultimately, improve the way the disease is treated.

Today, 20.8 million Americans -- or seven percent of the population -- have diabetes, at least 10 million of whom are not in control of the condition. It is estimated that one in three American children born in 2000 and beyond will develop type 2 diabetes. Worldwide, an estimated 246 million people have diabetes, a number that is expected to grow to 380 million within the next 20 years if no urgent action is taken. Diabetes accounts for 3.8 million deaths per year globally, similar in magnitude to HIV/AIDS.

The Global Changing Diabetes Leadership Forum hopes to redefine healthcare around the needs of people with diabetes.

"Recognizing that there is not a single answer to the diabetes pandemic, Novo Nordisk hopes to provide a forum for identifying multiple actions at all stages to combat diabetes -- from prevention to the treatment of serious complications," said Lars Rebien Sorensen, president and CEO of Novo Nordisk. "Only by placing the person with diabetes at the center of care and changing how healthcare systems around the world approach the disease can this silent killer be defeated."

Martin Silink, president of the IDF, emphasized that "the reality is that there will not be an automatic increase in funds for diabetes for either prevention or treatment in the short term. In developing countries, which bear 70% of the global burden of diabetes, the solutions will involve increasing access to proven but low-cost therapies."

During the two day Forum, attendees from around the world will participate in a series of workshops and dialogues designed to evoke a provocative debate about how to chart a course for changing diabetes management globally.

March 12, 2007 (BUSINESS WIRE)--Medtronic, Inc. (NYSE:MDT) today announced that the U.S. Food and Drug Administration (FDA) has approved new REAL-Time Continuous Glucose Monitoring (CGM) devices for children and teenagers ages 7-17. Previously approved for only adult patients, Medtronic's REAL-Time CGM will soon be available in specifically designed pediatric models of the MiniMed Paradigm® REAL-Time System and Guardian® REAL-Time System. "This indication reinforces Medtronic's commitment to developing and marketing novel therapies for the millions of Americans with diabetes," says Chris O'Connell, President of Medtronic's diabetes business. "We are particularly excited that children and their families will sleep better at night knowing that REAL-Time CGM is providing a new level of protection against dangerous glucose levels."

Medtronic REAL-Time CGM therapy is clinically proven to help patients monitor and better control their diabetes. Clinical studies have shown that Medtronic REAL-Time CGM therapy can reduce the duration of hypoglycemic events, and lower HbA1c levels by as much as two percentage points. This is significant because as much as 60 percent of hypoglycemic events go undetected by current glucose monitoring standards, and for every one percentage point drop in HbA1c, there is a 35 percent reduction in diabetes-related complications like blindness, amputation and organ failure.

"Diabetes management is especially difficult for pediatric patients, and Medtronic REAL-Time CGM therapy could benefit thousands of children and their families who struggle to maintain control of their disease," says Dr. Bruce Buckingham, director of Pediatric Endocrinology at Lucille Packard Children's Hospital, Stanford University. "By providing real-time glucose values and alarms, patients can now recognize previously undetected glucose fluctuations."

Medtronic REAL-Time CGM technology displays REAL-Time glucose values, trend graphs and directional arrows, allowing patients to discover how diet, exercise, medication and lifestyle affect their glucose levels. With this information, patients can gain valuable insights and intervene earlier to reduce the frequency and severity of high and low glucose levels. The technology alerts patients if their glucose levels fall below-or rise above-preset values. Values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a meter blood glucose measurement may be required. All therapy adjustments should be based on measurements obtained using a home glucose meter and not on Medtronic REAL-Time CGM System values.

Medtronic currently markets the MiniMed Paradigm REAL-Time Insulin Pump and Continuous Glucose Monitoring System - the world's first insulin pump with REAL-Time continuous glucose monitoring. The MiniMed Paradigm REAL-Time System has all of the benefits of CGM plus the added value of precise insulin delivery through the use of insulin pump therapy. The Guardian REAL-Time System, a stand-alone CGM device, will be available later this year.

January 8, 2007 (EurekAlert) WINSTON-SALEM, N.C. -- Scientists have discovered a new source of stems cells and have used them to create muscle, bone, fat, blood vessel, nerve and liver cells in the laboratory. The first report showing the isolation of broad potential stem cells from the amniotic fluid that surrounds developing embryos was published today in Nature Biotechnology."Our hope is that these cells will provide a valuable resource for tissue repair and for engineered organs as well," said Anthony Atala, M.D., senior researcher and director of the Institute for Regenerative Medicine at Wake Forest University School of Medicine.

Atala announced the breakthrough with colleagues from Wake Forest University School of Medicine and Harvard Medical School.

"It has been known for decades that both the placenta and amniotic fluid contain multiple progenitor cell types from the developing embryo, including fat, bone, and muscle," said Atala. "We asked the question, 'Is there a possibility that within this cell population we can capture true stem cells?' The answer is yes."

Atala and colleagues discovered a small number of stem cells in amniotic fluid - estimated at 1 percent - that can give rise to many of the specialized cell types found in the human body. The scientists believe the newly discovered stem cells, which they have named amniotic fluid-derived stem (AFS) cells, may represent an intermediate stage between embryonic stem cells and adult stem cells. They have markers consistent with both cell types.

"It took this long to verify that we had a true stem cell," said Atala, who began the work seven years ago. "These cells are capable of extensive self-renewal, a defining property of stem cells. They also can be used to produce a broad range of cells that may be valuable for therapy."

An advantage of the AFS cells for potential medical applications is their ready availability. The report describes how the cells were harvested from backup amniotic fluid specimens obtained for amniocentesis, a procedure that examines cells in this fluid for prenatal diagnosis of certain genetic disorders. Similar stem cells were isolated from "afterbirth," the placenta and other membranes that are expelled after delivery.

Atala said a bank with 100,000 specimens theoretically could supply 99 percent of the U.S. population with perfect genetic matches for transplantation. There are more than 4 million live births each year in the United States.

In addition to being easily obtainable, the AFS cells can be grown in large quantities because they typically double every 36 hours. They also do not require guidance from other cells (termed "feeders") and they do not produce tumors, which can occur with certain other types of stem cells. The scientists noted that specialized cells generated from the AFS cells included all three classes of cells found in the developing embryo - termed ectoderm, mesoderm, and endoderm. In their high degree of flexibility and growth potential, the AFS cells resemble human embryonic stem cells, which are believed capable of generating every type of adult cell.

"The full range of cells that AFS cells can give rise to remains to be determined," said Atala. "So far, we've been successful with every cell type we've attempted to produce from these stem cells. The AFS cells can also produce mature cells that meet tests of function, which suggests their therapeutic value."

The functional tests included implanting neural cells created from AFS cells into mice with a degenerative brain disease. The cells grew and "re-populated" the diseased areas. In addition, bone cells produced from the stem cells were successfully used to grow bony tissue in mice, and liver cells were able to secrete urea, which the liver produces from ammonia.

The potential to generate a broad range of mature cell types is why many scientists believe stem cells have promise to replace damaged cells and tissue in conditions such as spinal cord injuries, diabetes, Alzheimer's disease and stroke.

January 8, 2007 (Medical News Today) - Since the landmark Diabetes Control & Complications Trial (DCCT) in the early 90's we've all known that average blood sugar levels and tight glycemic control are improved through frequent blood glucose testing and team management with a knowledgeable remote caregiver. Unfortunately, today's blood glucose meters lack the connectivity to facilitate this remote teaming interaction. The result is millions of people left to manage their diabetes in isolation, especially the newly diagnosed. Even with all of the increased sales of diabetes testing supplies, blood sugar control and physician adherence to established standards of care worldwide remain unacceptable by every diabetes organization worldwide including the American Diabetes Association, American Association of Clinical Endocrinologists, American Association of Diabetes Educators and the International Diabetes Federation.

Direct costs of diabetes care in the USA have more than doubled in recent years, according to the Centers for Disease Control & Prevention. "Without any practical means of enjoying the benefits of team management, costs from the current paradigm of test and forget self-care will bankrupt our global economy," says Kevin McMahon, President & CEO of Diabetech. Clinical inefficiencies also stem from this lack of connectivity further driving up costs. Even the recently introduced continuous glucose monitoring devices are not capable of supporting communication with knowledgeable remote caregivers.

Diabetech offers a better answer to patients and the healthcare industry when it comes to an effective model for diabetes care including control for spiralling costs. Diabetech's GlucoMON blood glucose connectivity device ensures glucose meter accuracy and automates the collection and analysis of blood glucose data for use in the team management of diabetes. People typically report drops in their average blood glucose (haemoglobin A1c) levels from 10% - 30% when they use a GlucoMON and even more in some cases. Advanced technology simplifying the process is the key. As Stephen Ponder, MD CDE and Diabetech's Chief Medical Officer likes to say, 'Diabetech makes improvements to self-care and remote patient interventions ridiculously easy'.

Representatives from health plans, self-insured employers and individual participants and their families involved in our various Institutional Review Board approved research trials have been providing feedback culminating in support for the development of a new commercial version of the GlucoMON upgraded for the global market. Based on interim clinical trial results from GlucoMON-enabled intervention programs, payers are already acknowledging a clear path to their Return On Investment (ROI); a pivotal metric that has been difficult for generalist disease management firms to demonstrate.

GlucoMON2 is approximately 80% smaller than the previous GlucoMON making it the smallest and lightest GlucoMON ever. GlucoMON2 also makes the world's easiest way to share blood glucose levels even easier with even more automation designed into the device itself. GlucoMON2 availability is planned for Q3 '2007 and is capable of operating anywhere in the world where there is support for GSM/GPRS networks. The bundled device, airtime and service will be available through payer-sponsored and direct- to-consumer programs. Not only is GlucoMON2 more advanced; it's also more personalized with a variety of designer colors available based on local preferences. Companies interested in distribution and/or establishing programs leveraging GlucoMON2 should contact Diabetech immediately for more information.

Previous generation GlucoMONs have generated over 70 patient-years of device usability and safety data. The original GlucoMON broke new ground in December of 2002 supporting the first end-to-end wireless diabetes management system in the world connecting patients and their extended care teams in real-time. To this day, Diabetech remains the only provider anywhere offering a comprehensive solution encompassing the glucose meter, supplies, long-range wireless management device, wireless network transport, remote control, stored patient records and active informatics including trend identification and feedback - all under one roof.

Our current GlucoMON supports LifeScan®'s Ultra® glucose meter across many clinical trials throughout North America and will continue in its role as a research device. Prior to the launch of the Ultra®2, Diabetech had been evaluating usability of newer glucose meters as candidates for GlucoMON2 integration. We arrived at our decision to support the Ultra2 as the first glucose meter integration to our GlucoMON2 mobile telemetry platform due to its broad patient adoption, unsurpassed quality and the fact that its OneTouch® blood glucose test strips are the most widely reimbursed strip on the market. Likewise, we selected GSM/GPRS as our wireless network backbone due to its broad global footprint and support for high speed data applications in our fourth generation wireless data, voice and video dedicated medical handhelds targeting availability in 2008.

October 17, 2006 (FDA) - The Food and Drug Administration (FDA) announced today the approval of Januvia (sitagliptin phosphate) Tablets, the first diabetes treatment approved in a new class of drugs known as DDP-4 inhibitors that enhances the body's own ability to lower elevated blood sugar. FDA approved Januvia for use in addition to diet and exercise to improve blood sugar levels in patients with type 2 diabetes, alone or in combination with two other commonly prescribed oral diabetes medications, metformin or a PPAR (peroxisome proliferator-activated receptor gamma) agonist, when either of these drugs alone, along with diet and exercise, don't provide adequate blood sugar control.

"For the millions of Americans with type 2 diabetes, who continue to have inadequate blood sugar control, the approval of Januvia marks an important advance in the fight against diabetes," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. "We now have another new option that treats the disease in an entirely new way that can be added to existing treatment regimens to help patients gain more control over their blood sugar levels."

Type 2 diabetes is the most common form of the disease, accounting for about 90 percent to 95 percent of all diagnosed cases of diabetes (20.8 million in 2005). In type 2 diabetes, the body does not produce enough insulin or the cells ignore the insulin. Insulin is necessary to take sugar, the basic fuel for cells, from the blood into the cells. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, nerve damage, and kidney damage.

Januvia prolongs the activity of proteins that increase the release of insulin after blood sugar rises, such as after a meal. Januvia does this by blocking an enzyme (dipeptidyl peptidase IV or DPP-IV) which breaks down these proteins, leading to better blood sugar control.

Januvia was examined in a total of 2,719 patients with type 2 diabetes, in studies lasting from 12 weeks to more than a year. These studies demonstrated improved blood sugar control when Januvia was used alone or in patients not satisfactorily managed with metformin or a PPAR agonist.

The most common side effects in clinical studies were upper respiratory tract infection, sore throat, and diarrhea.