How Do I Love DOC, Currently 318 Ways and Counting.

Keep the comments flowing to the FDA Meter Guidance dockets. Currently 211+107 = 318 comments and climbing. 

Want to learn more? FDA is holding a conversation with the DOC. 

http://patientnetwork.fda.gov/get-involved/join-live-chat/ask-fda-diabetes-webinar

Tune in as the DOC to Interviews FDA - Live March 31

Updated with link to regieter and join, see below. 

From FDA:

Please join us for a Patient Network Live Chat! Diabetes: Glucose Monitors and Test Strips

Talk with FDA expert Courtney Lias and Patient Advocate Bennet Dunlap about Glucose Monitors and Test Strips Monday, March 31, 1:30–2:30 pm (EDT)

Talk, share, and connect with the

FDA and the Diabetes Patient Community

• Do you want to learn more about the role of the FDA in the regulation of medical devices, such as glucose meters and test strips, used in the management of diabetes?
  
• Do you want to learn what the FDA is doing to increase the accuracy of blood glucose monitors and test strips?
  When you participate in this friendly online chat, you will:
  

• Enjoy an informal, open discussion with a fellow patient advocate, CDRH subject-matter- expert and others in the diabetes community.
  
• Learn more about the role of the Center for Devices and Radiological Health, specifically the Office of In Vitro Diagnostics and its work to ensure the safety and effectiveness of medical devices used in the management of diabetes.
  
• Get your questions answered about the newest FDA draft guidances, which are proposing new recommendations intended to improve the accuracy and safe use of blood glucose monitoring test systems, giving health care providers and people with diabetes better tools to manage blood glucose levels.
  Whether you want to just listen to the interview to get informed, ask relevant questions to better understand the medical device regulatory process or just speak your mind on the newest draft guidance document.... you should join in the conversation.
  Mark your calendars and be sure to join us on March 31st, 2014.
  

REGISTER – GO HERE
http://patientnetwork.fda.gov/get-involved/join-live-chat/ask-fda-diabetes-webinar

Do this:

To join in come back to the link on the 31st.

http://patientnetwork.fda.gov/get-involved/join-live-chat/ask-fda-diabetes-webinar

Urgent: Arizona - Read Catherine's Piece at ASweetLife

Access to quality care is the path to saving money on the ballooning costs of diabetes care. That is because the real money is gets spent when things go wrong, just consider the ER costs for insulin overdose.

Arizona has an issue with pumps. Apparently there are other states with or considering other such "savings." Investing in quality care, tools and the education needed to use them, is the path to reducing the astronomical cost of complications. Teaching a kid to use a pump and then taking them off it at a age 21 ins a recipe for serious bad outcomes like potentially fatal overdosing of insulin.

Here what Catherine sent in an email:

Yesterday it came to my attention that Arizona's legislature is currently - as in right this moment - in the process of deciding whether to approve a budgetary amendment that would restore insulin pump coverage for the state's adult insulin-dependent Medicaid recipients. (Currently once you turn 21, AZ's Medicaid won't cover your pump, no matter how crucial it is for your care.) If you are transitioning of a pump you know well and on to MDI you most unlikely are preoccupied and least likely to have time advocate for yourself.  And AZ is one of  only two states - other than Alabama - not to provide this coverage.

I am trying to get people from all corners of the DOC to ask their twitter followers to send tweets to the relevant AZ politicians (and journalists) TODAY to encourage them to include this amendment in the House version of the AZ budget. These should be encouraging tweets, not disparaging (at least not at this point!), lest we hurt this budding chance at an amendment the AZ's house..

Can you guys help? I wrote a blog post at ASweetLife with more details (and the relevant twitter handles & email addresses) here:

http://asweetlife.org/catherine/blogs/insulin-pumps/urgent-please-help-arizonas-legislature-protect-poor-people-with-diabetes/35603/

Am I at Risk? Are you?

The American Diabetes Association (ADA) has a quick quiz folks can take to see if they are at risk of type 2 diabetes. Guess what? I am. No big surprise there. I have been for some time and have had some success with improving what I eat and less success with staying active.  I need to step to step up a little more on both.

Curious to see where you stand? Here is a link to the quiz. It is easy, quick and ADA gets a small contribution if you take it. More important, it may give a little inspiraction to make some changes that help you be successful at keeping type 2 in check.

Update:
More at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm389919.htm

What's Missing from HHS Report on Test Strip Costs

A report, just out this month, by the Department of Health and Human Services Office of Inspector General looks at Medicaid costs for diabetic test strips. My search tool couldn't find in it the following words:

 Hypoglycemia, Hyperglycemia, Accurate, Safe

Have a look. It is here. Let me know if I am wrong. (they do say diabetic but not diabetes.) It seems they are missing the real point. Feel free to list any other key words NOT in the report in a comment below. 

I am 100% for saving money. 

To me saving is all about getting the right things at the right prices. Test strips exist so people with Diabetes can manage blood sugar in a safe, target range, minimizing Hypoglycemia and Hyperglycemia. To do that test strips need to be Accurate within the standards for which they were approved. Not all strips preform as approved and there is evidence that suggests some may achieve low prices by failing on quality. 

The cost of diabetes care is not test strips. As Bill Polonsky says, "Well controlled diabetes is the leading cause of nothing." On the other hand, insulin overdose is estimated to puts 97,000 plus Americans in the Emergency Room every year (more than Meth!) at a cost of well over a half a billion dollars. Estimates including the cost of diabetes complications are in the range into hundreds of billions.

To me, the Inspector General's report is the wrong track.  It is penny wise and pound foolish. I suggest that the best thing to do, to save money in diabetes care, is avoiding the big costs of complications by investing in cheap stuff, like accurate strips with the education and support necessary to use them effectively. Sadly I can't think of much that can be done right now about the Inspector General or Medicaid. They take the position that FDA regulates meters and all FDA approved meters are created equal. 

They are not. See http://www.stripsafely.com/strip/

We can do something about test strips, right now. We can comment to FDA's open dockets on new test strip guidance. They are open to April 7, 2014. We can talk about the importance of accuracy, post market evaluations, that only meter meeting new and safe guidelines should be approved to dose insulin and more. To make it easy there are copy and paste comments with a link to the FDA dockets here:

http://www.stripsafely.com/sample-page/guidance/

http://oig.hhs.gov/oas/reports/region5/51300033.pdf 

Moo II / Moo Too. Keep Meters in the ER.

Will there be a blood glucose meter in the Emergency Room? 

I have borrowed ideas from Christel’s blog post on posting comments to the FDA open meter docket. The one with this great picture: 

Articles published last week are timely and relevant to the the professional / in hospital use FDA Meter guidance. Some of the stuff last week was rather startling. What's got me worrying is the remote possibility there will be no blood glucose meter in the ER. 

FDA's in hospital guidance proposes very tight variance standards. There are interesting comments about FDA’s in hospital use guidance posted at diaTribe. I liken the comments to something approximating, "Hey theses are so tough that nobody may make the meters, then what are ya gonna do?" That, combined with the article on emergancy room visit for hypos, I wrote about in this post, are the basis for the following additional comments to the "Prescription Point-of-Care Use" guidance docket. 

Please, feel free to copy them, add you 2¢, and post them to the FDA docket here:

Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use (this refers to the meters healthcare providers use at the office or in the hospital)

http://www.regulations.gov/#!submitComment;D=FDA-2013-D-1445-0001

[Copy]

I am concerned the proposed standards for "Prescription Point-of-Care Use" blood glucose meter may not be not feasible. If so the the result could be a deterioration of in-hospital care for people with diabetes. 

Dr. David Sacks of NIH, Bethesda, MD is quoted by diaTribe saying, “These are incredibly stringent [standards]…I hope that the FDA listens to the complaints, because clearly there will be lots… I think that it’s going to be very difficult for manufacturers to meet these criteria. If they don't make them more lax, there will be no glucose meters approved in the future.”1 

“No glucose meters approved in the future,” is very concerning. 

I worry that if the standard for in clinic/hospital blood glucose meters use is not reachable there will not be devices for inpatient care. No meters may cause delays in emergancy department treatment for people with diabetes. These delays could stem from the need to use slower draw-blood-and-take-it-to-the-lab processes to meet these "incredibly stringent" requirements, as opposed to reasonably rapid finger stick devices in the treatment of patients needing emergancy care. 

Geller et al in a March 10 2014 JAMA article, National Estimates of Insulin-Related Hypoglycemia and Errors Leading to Emergency Department Visits and Hospitalizations, estimate over ninety-seven thousand insulin-related hypoglycemia and errors induced emergancy room visit in the United States annually. Of these 29% result in hospital admission. Additionally "Severe neurologic sequelae were documented in an estimated 60.6% (95% CI, 51.3%-69.9%) of ED visits for IHEs" 2

Time matters, appropriate rapid care is needed to minimize lasting harm from hypos. 

FDA should avoid rules with such possible unintended consequence. Result from this guidance that should be improved accuracy in clinical settings from meters. Maters are a valuable tool in professional care setting just as patients need for accuracy in dosing the very dangerous drug insulin outside the is clinical setting. Both need accurate, economical  and timely devices. 

I agree with diTribe’s conclusion on personal use meters, “We are glad to see the FDA trying to improve glucose meters and look forward to formal adoption of the standards in whatever form they ultimately take... the home use accuracy standards are fairly reasonable and should enhance patient safety.”  I also share their concern that if, “... no meter can meet these new accuracy requirements for healthcare facilities, we will not see any of these innovations make it to the market.”

1 http://diatribe.org/issues/61/new-now-next/3

2 https://archinte.jamanetwork.com/article.aspx?articleid=1835360

[/copy] Go here. [paste]

Moo.

Learn more:
http://theperfectd.com/2014/03/14/moo-moo-moo/
http://www.stripsafely.com/sample-page/guidance/

Meth. or Insulin

“This is rather startling.” 

That was the opening paragraph of an email I received yesterday from Jeff Hitchcock. He’s not easily startled. What had caught his attention was a JAMA paper titled, “National Estimates of Insulin-Related Hypoglycemia and Errors Leading to Emergency Department Visits and Hospitalizations.”

Just like the title says, the paper estimates Emergency Room visits for what is called IHEs or insulin-related hypoglycemia and errors. The authors’ figure is 97,648 IFEs annually, of which 29% result in hospitalization. 

Jeff had started totaling up the costs of all those visits. Emails like this make me think he likes to spin me up. Like I need help?

I found an article that puts the prices on these in another journal. The American Journal of Managed Care. There is a group that is going to be super geeky about costs, right? In, "The Incidence and Costs of Hypoglycemia in Type 2 Diabetes" they say, “costs for hypoglycemia visits were $17,564 for an inpatient admission, $1387 for an ED visit.” (remember ED here being Emergency Department, not the blue pill problem.) 

Easy enough to take the number of visits and multiply it out by the costs and - Son-Of-A... -  hypos are estimated to cost about $640 million a year. 

The JAMA piece goes on to say these IHEs are far more likely to be the elderly. “Insulin-treated patients 80 years or older were more than twice as likely to visit the ED and nearly 5 times as likely to be subsequently hospitalized for IHEs than those 45 to 64 years.” These are they very people who can’t get continuous glucose monitors (CGM) to help warn of hypos, because Medicare says CGMs are not medically necessary. 

I can think of over half a billion reasons why maybe they are needed.

Beyond the money, the JAMA piece says, “Severe neurologic sequelae* were documented in an estimated 60.6% of ED visits for IHEs, and blood glucose levels of 50 mg/dL or less were recorded in more than half of cases (53.4%).” (*I had to look sequelae up too. Thanks wikipedia, “Typically, a sequela is a chronic condition that is a complication of an acute condition that begins during that acute condition.”) So translating that here: Chronic neurologic conditions as a result of the acute event, aka hypos are, disproportionally hitting American seniors. 

That just ain’t right.  

Look at it this way, Drugabuse.gov (I swear this is the citation I’ll drag out) says, “stimulants, including amphetamines and methamphetamine, were involved in 93,562 ED visits.”

Diabetes beats Breaking Bad.

97.8K ED visits for Team Insulin over 93.5k for Meth. et al.  

This is "rather startling." 

YDMV - so your term for what "This is ____" may be more colorful. I trust they will show up in the comments. 

Sources: 

https://archinte.jamanetwork.com/article.aspx?articleid=1835360

http://www.ajmc.com/publications/issue/2011/2011-10-Vol17-n10/AJMC_11oct_Quilliam_673to680

http://www.drugabuse.gov/publications/drugfacts/drug-related-hospital-emergency-room-visits

Will D on Novo's Robo-Pen. very cool.

Will D on Novo's Robo-Pen. very cool.

http://www.diabetesmine.com/2014/03/novo-knocks-it-out-of-the-park-with-new-smart-insulin-pen.html

Yo! DOC - FDA is Listening, Let's Speak Up

Public Policy on Diabetes Needs Our Help, Our Voices.

FDA is listening for our comments about glucose meters 'till April 7. They have two dockets open.

Please comment on FDA’s meter guidance proposals. Open dockets are a very important and rare time that the FDA is explicitly and officially focused on listening. Let’s be heard. Just as important as what we say, is that our community's message is repeated to be clear over voices that may seek to maintain the unacceptable status quo for their proprietary gain.

Through the dockets we can:

• Support FDA’s efforts for higher accuracy.
• Call for the same accuracy in both patient and clinical use.
• Ask that only the new level of accuracy be labeled to dose insulin.
• Suggest that only devices meeting new accuracy levels be considered DME by Medicare.
• Repeat the call for robust post market enforcement.

Learn more about the guidance.

http://www.stripsafely.com/sample-page/guidance/about-guidance/

See how to steps to posting on a FDA docket. (It is easy.)

http://www.stripsafely.com/sample-page/comment2fda/

Here's links to the open dockets and one set of sample comments to post to both.

http://www.stripsafely.com/sample-page/guidance/

The current set rules for glucose meters is from 2003. It may be another decade before we get another chance. These dockets are open to April 7. Now is the time to join the community and speak up.

Please help build momentum for the effort by sharing that you posted to the docket through your favorite social media channels with the hashtag #StripSafely.