NewNowNext
Roche’s Accu-Chek line recently applied for FDA approval of new, GDH-PQQ-free test strips.
GDH-PQQ Test Strips No Longer a Concern for SMBG Users
On August 13, the FDA made a public health notification that dangerous errors could result from the use of self-monitoring of blood glucose (SMBG) test strips incorporating the GDH-PQQ enzyme, one of the substances found on test strips that acts to measures blood glucose levels. The fatal errors were the result of simultaneous use of drugs that interfered artificially increased blood glucose readings three to 15 times actual levels. These interfering drugs were largely dialysis-related therapies, such as Extraneal, BEXXAR, and Orencia – overall, the FDA estimated the number of patients at risk of inaccurate meter readings to be very small.
Affected meters included Roche’s Accu-Chek, Abbott’s FreeStyle Lite, and Home Diagnostics’ TrueTest; Bayer and Johnson & Johnson’s LifeScan meters use an alternative substance and were never affected by GDH-PQQ concerns). However, at the time of the FDA’s public health notification, all companies using the GDH-PQQ enzyme had already taken action to develop new strips to prevent any errors from occurring – companies assured these will be compatible with current meters. Even if patients are currently using a Roche, Abbott, or Home Diagnostics meter, they can continue to use their meter with confidence as long as they are not using an interfering drug product or therapy (for a full list of interfering therapies, see here
The Next Generation of Weight-Loss Drugs
Pharmaceutical companies are trying to develop diabetes products that do not promote weight gain. As is, several diabetes drugs have been implicated in inducing weight gain – sulfonylureas (such as glimepiride), thiazolidinediones (such as Actos and Avandia), and insulins (although recent insulin analogs greatly reduce the amount of weight gained compared to older insulins). Unfortunately, weight loss drugs have primarily been viewed as cosmetic therapies and have never played a major role in health care; the available drugs also have marginal effects on weight loss (comparable to exercise) and certain unfavorable side effects. However, three companies are in the midst of submitting applications for their new generation of weight-loss drugs to the FDA. The drugs are Qnexa developed by Vivus, Contrave developed by Orexigen, and lorcaserin developed by Arena. We highlight them because they have all been studied in diabetes patients and been shown to have, in certain cases, a dramatic effects on weight loss (7% to 14% weight loss) and a significant reduction in important glucose measures such as the A1c. However, these drugs must still go through a rigorous regulatory process before being approved; if they are, we expect them to reach physician’s offices in 2011 or 2012, so stay tuned…
Bariatric Surgery – The Next Treatment for Diabetes?
In recent years, more physicians are starting to embrace surgery as a therapy for type 2 diabetes. Yes, surgery. You may have heard of “bariatric surgery,” which has primarily been reserved for overweight individuals (defined as a body mass index >35 kg/m2 – calculate yours at www.nhlbisupport.com/bmi/bmicalc.htm) and viewed as a “last resort” procedure to promote weight loss. However, researchers have discovered that these surgeries, which reorganize how food passes through the digestive tract, can have an amazing impact on diabetes. For a majority of individuals with type 2 diabetes who undergo bariatric surgery, diabetes medications such as insulin and oral agents become no longer necessary. There are different types of bariatric surgeries, but the two most common are the “Roux-en-Y gastric bypass” (RYGB) and “Adjustable Gastric Banding.” Both procedures greatly reduce the amount of food one eats, inducing on average about 140 lbs weight loss with RYGB and about 80 lbs with gastric banding. Gastric banding actually squeezes the stomach, whereas the RYGB bypasses a good portion of the stomach and also bypasses some of the gut - decreasing the amount of calories absorbed. Clinical data indicate that the RYGB procedure is more effective for treating diabetes (more than 7 out of every 10 patients discontinue diabetic medications, often within days) and in the right hands may even be slightly safer than the gastric banding technique, in which only about half the patients are able to discontinue medications; however, gastric banding is also gaining in popularity due to the ease and potential reversibility of the procedure.
These surgeries – increasingly called "metabolic surgeries" when performed to treat diabetes rather than induce weight loss – require specialized surgeons and may not be performed in particular hospitals. But the number of providers is growing very quickly. Medical costs currently range from $20,000 to $25,000; however, insurance may be provided depending on the insurance provider and the state. Medicare recently expanded coverage, especially for those attempting to correct another illness, such as diabetes. Like any surgery, bariatric surgery carries risks and may cause additional complications, such as infection, ulcers, and the need for reoperation – mortality rates are typically less than 1%. But if you are interested, you can speak with your primary care physician and start educating yourself on the procedure’s risks and benefits. In the mean time, researchers are working hard to understand the specific mechanisms in hopes of developing a drug that can deliver the same benefit.
Byetta Approved for Stand-Alone Use
Recently, the FDA released a statement on Byetta (Amylin/Lilly’s exenatide) that updated several warnings for the drug as well as expanded its usage. The warnings section includes an update on the risk of pancreatitis (inflammation of the pancreas) and the risk of using Byetta in patients with renal (kidney) impairment. If you are on Byetta and concerned you may be at risk, we urge you to discuss the warning label, http://pi.lilly.com/us/byetta-pi.pdf, with your physician (section 5 includes warnings and precautions). However, we emphasize that these risks have not been clearly associated with Byetta – people with diabetes are inherently at higher risk for pancreatitis and kidney disease, clouding allegations. In addition to updating the warnings section, the FDA also expanded the usage of Byetta. Since its approval, Byetta could only be administered in combination with metformin, a sulfonylurea (e.g., glimepiride, glipizide), a thiazolidinedione (e.g., Avandia, Actos), or a certain combination of these drugs. However, the update allows it to be administered on its own as a stand-alone therapy, not in combination with other drugs. Although this may not significantly change how Byetta is prescribed (metformin still stands strong as the first-line drug of choice for patients with type 2 diabetes, and with good reason) we believe this represents a big step for GLP-1 analogs, the class of drugs to which Byetta belongs. Given the their unique ability to control glucose levels specifically after meals and induce weight loss with a low risk of hypoglycemia, the drugs are certainly gaining in popularity, particularly amongst some leading physicians: A panel of expert endocrinologists (including diaTribe advisory board members Drs. Zach Bloomgarden and Paul Jellinger) convened by the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE) recently promoted the use of Byetta over sulfonylureas as a secondary therapy to metformin. We hope to see even more efficacious and safe GLP-1 analogs in the near future.
Insulet’s OmniPod goes green.
Insulet’s Eco-Pod Program
While disposable pumps may be the future of insulin pumping, many OmniPod users can’t help but envision the mountains of Pods crowding our landfills in years to come. In steps Insulet – in response to customer feedback, the company recently launched the Eco-Pod program, designed to reduce the environmental impact of disposed Pods. Every three months, registered participants receive a pre-paid, pre-addressed bi0-hazard shipping envelope in which to return their used Pods to Insulet. The company then puts the Pods through a complex recycling process, in which the Pods are disassembled, the batteries are broken down, and the precious metals are reclaimed and sold to help recover recycling costs. The remaining Pod casings are then pulverized to reduce their volume before being sent to a landfill. As used Pods are actually classified as both biohazards and medical waste, no components are reused.
While Insulet covers the costs of the disposal process, users are asked to cover shipping costs, which amount to about $3 a month. Once registered, a Pod Disposal Kit is included with each Pod re-order. We certainly support Insulet’s efforts to “go green” – to enroll, contact Insulet’s Customer Care Team at 1-800-591-3455.
A diaTribe triumph: San Francisco’s city hall aglow in diabetes-blue.
World Diabetes Day
On December 20, 2006, the United Nations General Assembly passed resolution 61/225, which designated that every subsequent November 14 would be World Diabetes Day. The resolution recognized that diabetes is a global epidemic and urged all member nations to adopt policies to help prevent diabetes and to improve existing treatment. Of course, we don’t just recognize diabetes on November 14 – every day it affects our lives and the lives of those we love – but World Diabetes Day gives the diabetes community the opportunity to draw attention to this global threat. A particularly visible way that we celebrate is the World Diabetes Day Monument Challenge: landmarks and monuments around the world are illuminated in blue, the color of the International Diabetes Federation’s diabetes symbol. Last year in San Francisco (where we’re based), diaTribe and the American Diabetes Association successfully lobbied to have our city hall lit in beautiful blue lights on the night of November 14 (see our picture)! In total, an amazing 1,108 buildings were lit worldwide, from Canada to Cuba to Kazakhstan. It was a truly overwhelming show of international solidarity that this is a fight we can’t afford to ignore. This year, there are several hundred confirmed monuments already. Here in San Francisco, Johnson and Johnson as well as the JDRF have sponsored lighting the Embarcadero Ferry Building (home of diaTribe’s offices)! We’re very excited, and we will post pictures of the blue Ferry Building after the event.
The DiabetesMine Care Plan at Keas.com
Recently announced, the DiabetesMine Health Account Plan went live at Keas.com, the new interactive web service (founded by former head of Google Health Adam Bosworth) designed to give individuals personalized advice to help them achieve their health care goals. Devised by patient advocate Amy Tenderich (of DiabetesMine blog fame) and Dr. Richard Jackson of the Joslin Diabetes Center, the DiabetesMine Plan provides people with diabetes with detailed care plans, based on entered health data (either manually inputted by the patient or uploaded from external resources such at Quest Diagnostics, Google Health, and Microsoft Health Vault). For example, when users present with high A1c, the plan details multiple care options (e.g., diet changes, exercise, medication change), guiding them through their selected plan of action. The program also explains the finer nuances of many diabetes-related medical tests, such as A1c, blood pressure, and lipid panel.
We’re thrilled by the potential of this service – and especially appreciate Amy’s patient touch! The popular blogger was able to share her thoughts with diaTribe, noting she was most excited by opportunity “to help so many people out there with diabetes who don’t have access to the education and support they need. We truly hope that using a plan like this can help people understand what to do, when, and why.” We couldn’t agree more – access the service now for free at www.keas.com/logon.html?partner=diabetesmine.
Gina Capone, President and CEO of TheDiabetesResource.com
The Diabetes Resource – A One-Stop Shop for All Things Diabetes
Here at diaTribe, we know how difficult it can be to wade through the masses of diabetes-related information sources out there. However, a new website launched in October hopes to help people with diabetes sift through the clutter. TheDiabetesResource.com – founded by diabetes advocate, type 1 diabetes patient, and social media entrepreneur Gina Capone – pools together diabetes resources from around the web, in hopes of serving as a “one-stop shop” for diabetes information. Resources are categorized for easy searching, with topics ranging from diabetes camps, to endocrinologist listings, clinical trials, and diabetes social networks; users can also rank resources, providing comments for other users. The site list diabetes-related events and recent news articles and health tips as well – be sure to stop by and test drive the site on your next diabetes-related search.
The Uncomplicated Guide to Diabetes Complications
The American Diabetes Association’s Uncomplicated Guide to Diabetes Complications
The American Diabetes Association is putting out an expanded third edition of their helpful book The Uncomplicated Guide to Diabetes Complications. In addition to advice about glucose control and early testing, the book provides up-to-date information on the available treatments for every major diabetes complication. The book is divided into 35 chapters (15 of these are new since the last edition) on major parts and systems of the body (and the complications that affect them) and includes an appendix on diabetes medications. Explicit topics covered include eye disease and blindness, kidney disease, nerve damage, heart disease, dementia and Alzheimer’s disease, sexual health, skin and dental problems, diabetic ketoacidosis, lactic acidosis, and stroke, among many others. Even if you were recently diagnosed with diabetes, this book contains helpful information about how to prevent complications, how to look out for the early signs of complications yourself, and how to help your doctor stay on top of this most crucial aspect of your diabetes management. The book can be purchased through many online outlets including the ADA and amazon.com for $18.95.
Bayer and Fit4D Collaborate on Interactive Webinars
Ever get the winter blues? If you're like one member of our team, it may be hard to stay motivated and exercise in the winter months. We checked out the new Bayer and Fit4D webinar series for a session on “Staying Fit in the Winter Months.” A fitness coach and nutrition coach virtually gave tips and tricks for different types of exercises and physical activity to help us stay active year round. They also gave great tips for cold-weather diabetes care – like a reminder to bring fast acting carbs that won't freeze (avoid fresh fruit and energy bars)! We were thrilled to hear Wii (one of our favorites!) recommended to get our activity levels up, but they also suggested Zumba, dance classes, at-home exercise DVDs, indoor sports like swimming and basketball, and snow sports to stay active.
For upcoming webinars and to register to participate in one, check out www.bayerdiabeteswebinars.com. You don't necessarily need a microphone as they recommend; instead, if you have questions or comments, you are able to “raise your hand” virtually and also type in your questions that are answered at the end of the session.
At TCOYD conferences, registrants have the opportunity to hear presentations from leading physicians, amongst other benefits.
The TCOYD 2010 Conference Series
Taking Control of Your Diabetes (TCOYD) is continuing to offer its stellar conference series in 2010. These events – led by renowned endocrinologist, type 1 diabetes patient, and diaTribe advisory board member Dr. Steven Edelman (University of California at San Diego, La Jolla, CA) – offer people with diabetes the chance to hear lectures from leading physicians, participate in on-site health screenings, and speak one-on-one with a range of diabetes specialists. Topics of discussion include the latest research and technology (dear to diaTribe’s heart), diet and exercise tips, and even advice for dealing with insurance issues – mark your calendars for 2010!
- Augusta, GA – February 6th
- Sacramento, CA – February 27th
- Kalispell, MT – March 20th
- Honolulu, HI – April 24th
- Kauai, HI – April 25th
- New Orleans, LA – May 8th
- Raleigh, NC – May 22nd
- Providence, RI – September 11th
- Des Moines, IA – September 25th
- San Diego, CA – October 30th
NOTE: For remaining 2009 conference dates, see our NewNowNext in diatribe #17.