FDA warning - fatal errors with some glucose test strips
I received a public health notification this afternoon from the FDA. You may get high blood glucose test results if you're using test strips based on GDH-PQQ and you're taking medication that contains non-glucose sugars. Note: this is not a recall, it's a warning.
Any product containing, or metabolized into maltose, galactose or xylose. (Usually over the counter products)
The FDA has provided a list of test strips affected by this warning. These include: many Accu-chek products; Abbott FreeStyle strips, including those for the Cozmo and Omnipod insulin pumps; and TRUEtest strips.
If you're not affected by this warning, it's a good reminder to wash your hands before testing. It's way too easy to get a false high reading because of foodstuff on your fingertips.
You can subscribe to these kinds of warnings but very few of them are related to diabetes devices, just fill out the simple form on this FDA subscription page.
Update: I received several press releases on this issue from various manufacturers of blood glucose test strips. Assuming it's reasonably accurate, the most useful is this document (PDF) from Roche Diagnostics. Table 2 below (click to see it in a readable size) lists some of the drugs that can cause maltose interference, about how many people are using them, and how they're delivered. Most of these drugs are used in hospital settings. From this table it seems like Extraneal users is the group most likely to have people with diabetes, and I'm assuming hospitals have been notified.
Bayer has posted a press release to say that their products are not affected by this warning. I spoke with someone from Agamatrix (makers of WaveSense meters) and their strips are also not affected by this warning as they use glucose oxidase.
I can't find any pictures of this device, but there are various announcements today that the FDA has given formal clearance to Medingo Ltd to market its Solo MicroPump in the US.
On the Medingo site, this device is described as having "two parts: a miniature insulin dispensing patch and a remote control, which allows you to completely personalize and guide your patch for your body’s insulin needs."
I note that Prof. David Klonoff of the Journal of Diabetes Science and Technology is listed as a member of their scientific advisory board. And Amy Tenderich has a post from 2007 that contains about as much information as is available today.
From the barebones information it's hard to tell if this is just a variant on the Insulet OmniPod or something very different. Please let me know if you're aware of any other information.
Update: Medingo will be unveiling the Solo MicroPump at the AADE meeting in early August. They also plan to launch their Solo website at that time. According to Craig Crease, Medingo's Director of Sales, they want to hold off on other information to "create an element of surprise". As I learn more I'll post it here.
Further update: I've posted separately with pictures and details of the Medingo Solo.
You may have noticed that the FDA isn't doing a great job approving new diabetes treatments and diabetes technology.
This isn't accidental, they are tightening requirements in a way that make it much harder to get FDA approval for new diabetes treatments.
With our new president later this month comes a change of FDA leadership. It's an ideal time to try and work to get changes in the FDA.
We've created an online petition and we're asking you to sign. You do not need to have diabetes to sign, so please pass the word on to family and friends.
Amy Tenderich has posted some quotes from Rebecca Killion on the FDA changes. Rebecca is a patient representative on the FDA advisory committee for diabetes related drug.
We, the undersigned, appeal to the leadership of the U.S. Food and Drug Administration (FDA) to reduce barriers to innovation in diabetes treatment development, in the interest of public health.
The FDA's job is to protect the safety of patients in its use of drugs and medical devices and to advance public health by speeding innovations that make medicines and technology more effective, safer and more affordable. That is its mission.
But we believe the FDA has adopted a stance of excessive caution in its regulation of diabetes drugs and technology that is counter to its duty to serve patient needs.
Specifically, it has established new rules that will impair research and innovation into diabetes therapy. (A copy of the letter sent to manufacturers in November 2008 can be found at http://www.diatribe.us/fdaletter (PDF).)
This worries us. For example, new requirements for additional multi-year long-term outcome studies prior to approval for drugs with no cardiovascular signals will assuredly discourage research and innovation to the detriment of public health.
The need for improved treatments for the 24 million Americans with diabetes could not be clearer. Many of the drugs available now have tolerability issues [1]. Poorly controlled diabetes increases the risk of devastating long-term complications, including blindness, end-stage renal disease, amputation, and heart disease. Complications cost our country at least $58 billion per year [2] -over twice what is spent on technology and therapy annually [3].
Nearly 50 percent of patients in the US do not meet A1c goals [4] using current therapies and technologies. No therapy today stops diabetes from advancing. As patients are living longer with diabetes and therapies stop working, the need for new therapies increases. We need better technology and drugs that help slow or avoid long-term complications as well as more therapies that cause fewer side effects1 and last longer. And, despite the epidemic in the number of diabetic patients, no drugs are yet available that can prevent diabetes. Innovative, safe, and effective prevention is the key for people at risk and for cost savings to society.
Ironically, excessive regulatory hurdles ensure the continued use of the very drugs and devices that have proven ineffective for many patients.
There is no value in an ideal diabetes drug or device if the regulatory costs are so great that the product never makes it to market. Make rules reasonable.
Due to the very nature of the severity and prevalence of diabetes, the following leaders within the diabetes community, who have signed this petition, implore the FDA for the immediate creation of a Diabetes Advisory Council, whose goal would be to improve options for patients. This council would include practicing endocrinologists, diabetes educators and others communicating directly with patients. Our experience, focus, and keen awareness of the needs of the diabetes community would be an invaluable resource to the FDA as it faces the arduous process1 of evaluating new diabetes treatments. Our aim is to improve options for patients.
We urge the new FDA leadership to recognize the urgent need for more safe and effective treatment options for diabetes and to reduce barriers to innovation. More treatment options will benefit patients. The disease is progressive. Delays in the availability of new treatments will only result in tremendous cost to public health and the economy. Our recommendation can benefit patients without sacrificing their safety.
Pleasesign this petition and tell others about it. Make your voice heard!
Petition sponsors: Kelly Close: Editor, diaTribe Manny Hernandez: President, Diabetes Hands Foundation; Founder, TuDiabetes Amy Tenderich: Creator and Author, DiabetesMine Allison Blass: Author, Lemonade Life Jennifer Block, CDE: Stanford Medical Center, Stanford University Nancy Bohannon, MD: Director of Clinical Research, CVD Risk Reduction Program, St. Luke's Hospital, San Francisco Bruce Buckingham, MD: Professor of Pediatric Endocrinology, Stanford University Stead Burwell: CEO, Alliance Health Networks, Inc. Priscilla Call Essert: Author, My Life As A Pancreas Gina Capone: Co-Founder, the Diabetes Talkfest Blog Fran Carpentier: Author Diabetes, Day-By-Day on Parade.com Kitty Castellini: Founder, CEO, Producer and Host, Diabetes Living Today - Talk Radio David Edelman: Co-Founder, Diabetes Daily Steve Edelman, MD: Professor of Medicine, University of California, San Diego; Founder, Taking Control of Your Diabetes Bernard Farrell: Author, the Diabetes Technology Blog James S. Hirsch: Author, Cheating Destiny Irl B. Hirsch, MD: Professor of Medicine, University of Washington Lois Jovanovic, MD: CEO and Chief Scientific Officer, Sansum Diabetes Research Institute Francine R. Kaufman, MD: Professor of Pediatrics, Keck School of Medicine, USC; Head, Center for Diabetes, Endocrinology and Metabolism, Childrens Hospital Los Angeles; former ADA President Tom Karlya: Author, Diabetes Dad Rebecca Killion: Diabetes advocate David Mendosa: Diabetes Journalist Kerri Morrone Sparling: Author, Six Until Me Jenny Ruhl: Author, Blood Sugar 101 Lisa Shenson: Diabetes Parent & Advocate Scott Strumello: Author, Scott's Web Log Virginia Valentine, CNS, BC-ADM, CDE, CEO, Diabetes Network, Inc. Albuquerque, New Mexico
Notes: [1] "Glycemic Durability of Rosiglitizone, Metformin, or Glyburide Therapy," New England Journal of Medicine, December 7, 2006. ADOPT, a four-year clinical trial of over 4,000 patients, was designed to test the how long diabetes therapies last. In this trial, 23% of those on sulfonylureas (SFUs) and 38% of those on metformin experienced nausea, diarrhea and/or vomiting from taking the drugs. 10% of those on TZDs, 11% on metformin, and 39% on SFUs experienced hypoglycemia. 7% and 14% of those on TZDs experienced weight gain and edema. 12% on women on TZDs experienced fractures. The trial also found that within five years of starting therapy, 15% of those on rosiglitizone (TZD), 21% on metformin, and 34% on glyburide (a sulfonylurea [SFU]) had fasting blood glucose over 180 (~ roughly equivalent to an 8% A1c), suggesting that even if patients could tolerate the therapy, it wouldn't last longer than a few years for many.
[2] "Economic Costs of Diabetes in the US in 2007," Diabetes Care, March 2008, page 13.
[3] "Economic Costs of Diabetes in the US in 2007," Diabetes Care, March 2008, page 13.
[4] "Is Glycemic Control Improving in US Adults?," Diabetes Care, January 2008, page 81.
Several news sources (including the Washington Post) reported a new analysis that Avandia and Actos may double the risk of bone fractures in women.
This study(PDF) did an analysis of 10 randomized, controlled, trials that evaluated 13,715 people with diabetes who were taking Actos(pioglitazone), Avandia(rosiglitazone), or neither drug. It concluded that these medications reduced bone density in the spine and hips of women. A similar effect was not found for men.
Both of these drugs belong to the Thiazolidinediones class. They are used by people with type 2 diabetes to help control their blood sugar levels.
In an associated commentary(PDF) the Canadian Medical Association Journal asks whether the side effects of these drugs outweigh their benefits. Thiazolidinediones have already been associated with increased risks for heart attack, especially in older adults.
Earlier this year an FDA advisory panel had called for longer term trials of new drugs for type 2 diabetes. Currently these drugs are mainly tested to determine if they help control blood sugar levels.
The trials sound very interesting and it looks like they've made a lot of progress. It's also good to see the interest in diabetes that has been generated due to the artificial pancreas project.
This is because of the recent NIH, FDA, and JDRF 2-day collaborative workshop on the Artificial Pancreas. The sessions were recorded. You can see the video for day one here, and for day two here.
The agencies and people involved seem to be taking a very pragmatic approach to combining the individual technology pieces to this puzzle. All of the required pieces of hardware already exist, the hard part is getting the software to work so that insulin and blood glucose controls can be automatically controlled. Thankfully those involved seem to be working to get a solution that's usable rather than a 'perfect' device. Hopefully the early prototypes will quickly inform folks about ways in which the overall approach can be improved.
The CBS piece mentions that the artificial pancreas may be available in 5 to 10 years.Because of approval and regulatory issues, I would guess this is closer to 10 years out. I hope it's a lot sooner than that.
They're working on developing a closed loop system where readings from a continuous glucose monitor (CGM) are used to directly control an insulin pump. Currently those of us with CGMs and insulin pumps have got an open loop system, we need to take the readings from the CGM and decide whether we need insulin or food.
Clearly this is a difficult problem to solve. How would such a system know if you were sick? What would it do when you're about to exercise? How would it handle changing insulin needs for children who are growing?
Now you have a chance to learn more about this project. On July 21st and 22nd the FDA, NIH and JDRF are holding a public workshop 'focused upon the state of the art in the research and development of an artificial pancreas'.
The meeting will be in Bethesda Maryland at the NIH campus. Building 38A on this map. Space is limited so you do need to register.
I would love to go to this workshop, but I'll be out of the country.
Can I ask you a favor? If you go the workshop can you write up a summary of what's discussed and post it to the blogosphere?
Attribution: The illustration above is from the JDRF site.
The FDA has a new approach for reporting problems with blood glucose meters and continuous glucose monitoring systems (CGMS).
Once a glucose meter or a CGMS goes into widespread use, unforeseen problems may arise because FDA's approval process cannot always detect adverse events that are rare or related to the clinical use of the device or the users’ techniques and skills. FDA also cannot always detect manufacturing problems or problems with the product labeling (including instructions for use) after the device is on the market.
If you use any of these systems they'd like to hear from you when you encounter any of the following type of problems.
Device problems including
reagent or instrument failure
defects in product design
product instability
any other device problems that compromise patient health or safety
failure to perform according to performance characterized in package insert
incorrect test results that cause or contributed to an incorrect patient diagnosis and/or treatment
Use-related problems including
inadequate and/or misleading labeling or confusing user instructions Use-related problems
inadequate packaging or poor package design
any other user problems that compromise patient health or safety
The FDA will hold your identity in strict confidence. This means they won't release it to the public. But they may share it with the maker of the device, unless you request them not to do so.
Finally a way to get attention to system issues that annoy you! Full details on the FDA website.
Dexcom SEVEN is cleared to calibrate with any meter
Dexcom announced today that it had received clearance from the FDA to calibrate its Dexcom SEVEN continuous glucose monitoring system using any approved blood glucose meter.
Once this feature is made available, Dexcom users will no longer need the dreaded six foot plus calibration cable. It'll need a software update to allow input of the glucose meter values. I hope they use a good algorithm to let us input those numbers!
Dexcom expects to make this feature available on new systems by the end of the first quarter of 2008, and to upgrade existing users during the second quarter of 2008.
I know that they've already started trials on their 3rd generation system, but so far there's no news about the upcoming features in the 3rd generation or the likely date for the system.
According to the page the Dexcom SEVEN was approved on May 31st, and a pointer to the approval letter(PDF) is provided. So Dexcom really didn't delay at all before telling us about it.
It's interesting to see the history of the Dexcom filing with the FDA
Filed: June 9, 2006 Amended: July 11, August 4, November 21, November 24, and November 28, 2006, and February 9, April 20, and April 23, 2007
I don't think this amount of filing is unusual, but it gives some insight into the amount of work needed for FDA approval.
Two points in the background notice jump out for me. The first I already knew and the second is a little vague:
Use of acetaminophen-containing medication when the STS-7 sensor is inserted may affect the performance of the device.
The Dexcom STS-7 System must be removed prior to MRI
Does this mean that I need to remove the sensor and the transmitter before an MRI, or that I just need to remove the transmitter? I'll have to clarify that one with Dexcom. Update: I exchanged emails with Dexcom customer support. When having an MRI I need to remove the transmitter and sensor and leave the entire system in another room.
If the FDA only points out issues with acetaminophen, then it appears that use of other drugs doesn't cause issues. That's good, because I've already seen the impact of acetaminophen on the Dexcom STS that I'm wearing and it's not good.
I'm still waiting on my Dexcom SEVEN. I hope to see it in a week or so.
Note: I currently own some shares in Dexcom, I work not to let this ownership influence what I say about the company or its products.
The MedApps system is designed to transmit glucose readings to a central server by way of your cellphone. It's now been approved for over-the-counter use.
The illustration from MedApps all show a OneTouch Ultra meter, but their information claims 'the BluePAL technology wirelessly transmits data from 20 of the most popular glucose devices from 4 of the leading manufacturers'.
They provide a device (Polymap Polytel) that connects to the meter and sends the data via Bluetooth to your cell phone. The cell phone transmits the data to a MedApps central server. The system can be setup to send alerts to healthcare providers based on per-patient thresholds.
It all sounds interesting, but there's a lot of steps from meter to software. Now if all the meter makers agreed on a single data standard, this would all be a little easier.
I know you're going to think that I've lost my mind. Because what I'm complaining about may not seem that important to you. But it is probably a lot more important than you think. So bear with me.
On Tuesday, I went for an eye doctor appointment to see what was going on with my right eye. I've had some blurriness in the central part of my vision for a while. So the doctor decided to take some pictures while injecting a fluorescent dye into me. That way if there are any issues, they'll show up clearly in the camera.
Now being a geek, I thought this was way cool. I asked the man doing the pictures whether I could get copies of them. I figured the kids would be interested in them, and I might post one to the Diabetes Made Visible photo group on Flickr.
Well he mentioned that I'd need to fill out some paperwork and then he could print me some copies. But I didn't want paper copies. I wanted the high resolution photos that I saw on the screen in front of me. So I said, "well I just want to take them home on a Flash drive". His immediate response is "no, you can't take the files".
Now it's not like I'm removing them. I only want a copy. When I pushed him on this, he said they're "scared what you might do with them". Now can you think of something terrible I might do? Print big posters and e-mail to folks causing heart failure? What's possible bad thing could I do with close up pictures of the back of my eyes?
So that's bad data day item #1. Oh, and by the way, there's no significant damage to my eye. So we're just going to keep watch on it (pun intended).
After I got home, I spent some time talking with someone in Dexcom. I'm trying to get one of the new Dexcom SEVEN systems with software, so I can review it.
The response is that right now they're trying to get training ready for the systems. So there are none available for review.
While I was talking with this woman, I asked why Dexcom is making it so hard for us to get to our data. Her response is that it's due to FDA restrictions.
This is bad data item #2.
I'm checking now to see if the FDA remark is actually true. I can't find anything in various advisory committee transcripts about this. I've fired off notes to some contacts within the FDA. I'll let you know what I find out.
Did you read my post about Google and health issues? Now how can we get access to our data if you have 'the' diabetes hospital (Joslin Clinic) saying "you can't have your files". And if the FDA or a device maker is saying "you can't have your data".
I'm just steamed about this!!
How can we improve things with a shrinking supply of endocrinologists, and without access to the facts we need to improve our control?
Grrr!!
Update: I currently use four pieces of diabetes-related software. All of them have the data locked down in some way.
Dexcom: Data encrypted or in binary form (unable to crack -- so far)
OneTouch: Data password protected (easy to crack)
MiniMed: Data password protected (easy to crack)
AgaMatrix: Data password protected (easy to crack)
So I think this is a widespread practice. But I can't figure out why.
The FDA has just launched a new page to track the status of patient studies on newly approved medical devices. This will contain information on studies ordered after a device has been in use for a while.
The page currently has information on studies ordered since January 1st, 2005.
The page will be updated on the 5th of every month. Currently there are 44 studies listed, and none of them are related to diabetes.
The Diabetes Technology Blog is focused on using technology to live life to the full with diabetes. I review new diabetes technology including: blood glucose monitors; continuous glucose monitors; blood sugar meters; diabetes software and living with diabetes.
About Me
Name: Bernard Farrell
Location: Massachusetts, United States
I was born in Ireland and now live in the US.
I have had Type 1 diabetes for over 36 years. I struggle with my blood sugar, the same as most people with diabetes.
I wear a Cozmo 1800 insulin pump and a Dexcom SEVEN Plus CGM to track my blood glucose levels.
I'm blessed by God, and every day brings the possibility of a cure.
Bayer has posted a press release to say that their products are not affected by this warning. I spoke with someone from Agamatrix (makers of WaveSense meters) and their strips are also not affected by this warning as they use glucose oxidase.
They're working on developing a 
