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.
I was reading Forbes magazine this evening and noticed a full right-page advertisement that started with this statement.
3rd Law of Healthonomics Soaring healthcare costs are only the symptoms. You've got to start treating the disease.
The remainder of the advertisement reads.
Most employers are rethinking their responses to escalating healthcare costs. Why? They recognize chronic diseases are the root problem. Example: An employee managing his diabetes might cost $5,000 per year. An employee not managing his diabetes could cost up to $45,000. The win-win here is that by providing employees incentives to lead healthier lives an helping them to manage their chronic diseases, you reduce your healthcare costs. And you'll have healthier employees. Sure beaths the alternative.
The DTCC FAQ page includes the following summary of how the DTCC works:
The Diabetes Ten City Challenge establishes a voluntary health benefit for employees, dependents and retirees with diabetes, provides incentives through waived co-pays for diabetes medications and supplies, and helps people manage their diabetes with help from a pharmacist coach in collaboration with their physicians and diabetes educators.
I like the idea of waiving co-pays for meds and supplies to help with better diabetes management. I just wonder whether this program is aimed at people with all forms of diabetes, or just those with type 2? Given that one of the sponsors is GlaxoSmithKline, I'll bet I'm right. Will is lead to better benefits for insulin pumps and continuous glucose monitors, or will the focus on cost reduction mean these important technologies are less covered?
This program is being tried by a number of employers in the following cities: Charleston/Spartanburg; Cumberland; Chicago; Colorado Springs; Dalton; Honolulu; Los Angeles; Milwaukee; Pittsburgh; and Tampa Bay.
Have you been enrolled in this program and can you give any feedback on how it works for you? I'm interested in seeing if this is the start of a new approach to diabetes care across the country. And I'd love to know whether or not it includes all types of diabetes.
PARADE Magazine (which comes in some Sunday newspapers) is holding this contest where the 8 charities that attract the most individual donations will receive $50,000 and be featured in PARADE magazine article. This is a great opportunity to raise visibility for diabetes research.
To help you donate to JDRF through the Network for Good organization. Your donation can be of any size. You'll have to register with Network for Good to do this (I just did) and then you can donate via Paypal or with a credit card.
To me, this seems like a relatively inexpensive way to raise awareness of the importance of diabetes research and the search for a cure. I hope you'll agree because right now JDRF is not even on the top 10 list for this contest.
Would you be willing to give up some of your life to avoid treatments?
According to a short article in yesterday's Washington Post that's how some folks with Type 2 diabetes feel about their illness.
Those of us with Type 1 don't have that luxury. Giving up insulin for even a short amount of time could literally be deadly. And maybe that's something else to be thankful about. Reading this article reinforces my belief that Type 2 is a much harder disease to live with than Type 1. And I know just how difficult Type 1 is to deal with.
I completely agree with this quote from the article:
The study findings show "that we need to find better, more convenient ways to treat chronic illness," Huang said. "It is hard to convince some patients to invest their time and effort now in rigorous adherence to a complex regimen with no immediate reward, just the promise of better health years from now."
Type 1 diabetes treatment is 'easier' than in the good old days. But then the 'experts' go and change the rules on us, so I feel like I have to work harder at better control. No wonder taking care of diabetes is so tiring!
Update: (August 19, 2007) I'm now using the latest Dexcom, the Dexcom SEVEN. The software that comes with the Dexcom SEVEN (Data Manager 2) has much better support for statistics and it allows you to export the readings in two different formats. This software also works with existing Dexcom 3 systems. Given this solves the problem for me, I'm not doing any more work in trying to understand their crazy data format!
Still no success getting data from my Dexcom STS CGMS. But my recent challenge post about decoding the Dexcom data format seems to have drawn a lot of attention.
Several people have jumped in to have a try at cracking the problem. I sent some e-mails to Dexcom technical support and customer support about this issue. So far, I've received no response. On June 5th I had a conversation with Dexcom which indicated they aren't about to open up the data even in their new version of the software.
I loaded up another Dexcom R2Downloads data file. From looking carefully at the graph in the Dexcom software it seems that there must be at least four types of records in the data stream. These are:
Start of use. With date (MM/DD/YY) and time (HH:MM:SS) values.
Gap in use. With time (HH:MM:SS) value.
Sensor reading. Glucose value, date (MM/DD/YY) and time (HH:MM) values.
Meter reading. Glucose value, date (MM/DD/YY) and time (HH:MM) values.
You can now find on my site two example data files, plus a hand-captured text file containing the values that are probably at the start of one of these data files.
How You Can Help
Maybe you know something about encoding or encryption. These skills may be enough to crack the problem.
If you can't do this, perhaps you can help in an indirect way. And I'll admit this is a little devious. :-)
If you search on Google for Dexcom my blog comes in around the 15th position in the results. I think I might get more attention from Dexcom if my blog came in as the number 1 search term for Dexcom on Google.
Impossible you say? Well, maybe not.
Here's where you come in. Can you post a blog entry on your blog which points to this blog post, and has Dexcom as the word in the link? Maybe write a note explaining that I'm trying to crack this problem for the Dexcom, highlight the Dexcom word and then add http://www.bernardfarrell.com/blog/2007/05/decoding-dexcom-data-format-update.htm as the hyperlink.
This way I'll get the word out about this challenge, plus Dexcom marketing may wake up and realize that this is important to many folks.
Can you tell I'm a little impatient to get to my data? How do you feel about a system that captures data that's important to you, but that doesn't let you get to it? Am I the only one who feels this strongly about this?
Update June 7th 2007: As of today, many people have linked to this post. When you Google search for Dexcom, this post is now about number 8 in the results, which puts me on the first page of Google results for Dexcom. I'm have still to write a letter to Jorge Valdes, VP Engineering, at Dexcom asking him to release the data format so that we can use it to access our data. First I want to hear what they say on the June 11th conference call.
If you'd like to help me, please post about this issue (setting our data free) and link to this blog entry using the word Dexcom, as I've just done here. Thanks.
Note: I currently own shares in Dexcom, I work not to let this ownership influence what I say about the company or its products.
Readers Challenge: Help me decode the Dexcom data format
I've been using a Dexcom STS continuous glucose monitor system for about a month now.
For day to day use, it's really wonderful. I can see highs before they happen and take the edge off them, and I can also watch much more easily for lows and reduce their impact.
But the software continues to be a major annoyance. Basically all it gives me is two very simplistic graphs of the blood glucose data collected by the Dexcom system.
The Glucose Trend graph shows up to one week of glucose readings from the system.
By choosing a smaller number of days, I can see the readings a little more spread out. For me, this makes it easier to look at the values.
However the software shows no summary statistics, and the only way I can actually see that values is by holding my mouse over them.
The other graph is the Modal Day one, which lets me see a number of days worth of data superimposed over a 24-hour period. This makes it a little easier to see patterns.
Again there is no summary data for the selected time period, and I can only look at one time segment at a time. So if I wanted to see what was happening for the last two weekends, I'd need to produce one report for each weekend and then look from one to the other.
OK. Now this is where I ask for your help. I've sent some e-mails to Dexcom asking for more information on how to get the data out of the system. So far, I've heard nothing back. Maybe one of you format hackers can help me in decoding the actual information itself.
Warning, it's fairly technical below this point. And I'm really hoping that someone can help with this problem.
Using some tools such as the wonderful FileMon from SysInternals, I've finally figured out where the receiver data is being stored on my PC. Trust me when I tell you that this is not easy.
For example, on my system, a lot of information is written by the software to various folders in this location: C:\Documents and Settings\Bernard Farrell\Local Settings\Apps\2.0\TO260ZDW.VE3\JGBRCCZA.X12
But the actual receiver data is written into a number of .R2Download files in this location: C:\Documents and Settings\All Users\Application Data\DexCom\DexCom DM - Consumer\ReceiverData\
For example one of them is named {2E6B7BE9-DA8F-42FA-8337-29404D84A829}.R2Download.
The files contain XML structured data, part of which is the readings themselves in some compressed form.
The data is contained in the DataBaseRecords object in this XML file. And from looking at the Signature object later in the file, it may be encoded using some sha1 approach.
I've uploaded the contents of one data file to my server. If you'd like to have a look at the file and see if you can figure out the data portion, then download the data file from here.
And if you can give me any suggestions as to how to decode this, I'd be thrilled.
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.
