April 29, 2014

Yes, Who is accountable? FDA Notice on Generic Strips

StripSafely asked Who is Accountable for generic test strips.  Apparently it is not a academic question. FDA today release a warning titled, "FDA Safety Communication: Shasta Technologies GenStrip Blood Glucose Test Strips May Report False Results"

From that release:
Identify whether you are using GenStrips glucose test strips. The strips may be packaged in green and white packaging with the GenStrip name on top, similar to those shown below.

For People with Diabetes:
  • Discontinue use of GenStrip Blood Glucose Test Strips.
  • Obtain alternative glucose test strips that are designed for use with the LifeScan OneTouch family of glucose meters.
  • Ask your pharmacist or contact your diabetes care provider if you need help determining which test strips to use with your glucose meter.
  • As always, be aware of symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia). If you experience symptoms of either high or low blood sugar, contact your diabetes care provider for advice on treatment.


4/30 Update: Please see this MarketWatch report on the issue. GenStrip's Acquiring company states they will replace strips.  http://www.marketwatch.com/story/decision-diagnostics-responds-to-shasta-technologies-fda-safety-warning-letter-2014-04-30

Help FDA understand how generic strips can be part of their new guidance structure. Comment to the dockets and ask for clear rules to protect PWD. Copy and paste the draft comments from StripSafely below to the FDA docket HERE.


I find many encouraging ideas in the FDA’s draft guidance. Its tighter accuracy standards (particularly in the hypo range) are a big step forward. The new emphasis on test strip lot release criteria will lead to better quality control, and the requirement for front-of-package accuracy information will make clear that the quality of blood glucose meters varies – and allow users to make informed choices.


Third Party Strips – Who is Accountable?
In the introduction to its proposed guidance on blood glucose meters, FDA speaks of self-monitoring blood glucose test SYSTEMS (SMBGs – caps mine.) This terminology is important because of its clearly implied meaning:  a meter and its strips are a complete system, designed to be used together.
Why is this important?
There are several reasons:
One is liability. When a third-party manufacturer makes test strips for a meter it is unclear who should be responsible for maintaining the system’s integrity and who would be held accountable in the case that something goes wrong:  the meter company, the strip company, caregiver or the patient.
Generic strips are approved for use with meters sold before specific dates. The data a meter is sold is not always clear. Patients need clarity.
FDA draft guidance speaks of third-party strips starting at line 990 of the over the counter draft guidance (1050 of POC) saying. “We strongly recommend that agreements between the third-party strip manufacturer and the meter manufacturer are in place to ensure that the third-party strip manufacturer is made aware of any design changes to the meter. In cases where this is not possible, the third-party strip manufacturers should sufficiently address, in their submission, how they will mitigate the risk of incorrect results due to meter design changes.”
That is not an academic issue. Insulin is a very dangerous drug that puts over 97,000 American in the emergency room each year.  A recommendation is not enough.  The FDA’s final guidance on blood glucose meters and strips should require formal agreements (and plans) between meter manufacturers and third-party strip manufacturers as part of the criteria used for clearance. Until these standards are in place, third-party strips should not be considered part of a system. Without bing part of a system the should not be cleared for sale. Patient lives are at stake.

Additional third party strip considerations

RESPONSIBILITY – I hope FDA clearly defines who is responsible/liable when an adverse event occurs as a result of the use of a third-party strip.
ACCURACY – Third-party strips should be be held to the same standards of accuracy as all blood glucose test strips. Accuracy should advance. Strips that fail to meet new accuracy standards set by this guidance should be rapidly phased out of the market.
POSST MARKET SURVEILLANCE  - There should be a program in place to ensure the quality and accuracy of all meters and strips, including third-party, after the meters and strips have been cleared for sale
RECALL – Recalls of all strips and meters are an important post market protection. Options to recall must stay open and include third-party strips. In the case of a recall communication to users of a SYSTEM are important. Clear guidance should be in place to ensure that the safety of patients using systems that include third-party strips is not compromised.
MDR – The FDA should require all strip and meter manufacturers to establish clear procedures for Medical Device Reporting in the event of adverse events related to these meters or strips. Third-party strips will add complexity to the submission process; before they are allowed to enter the market, third-party strip manufacturers must establish a clear, robust and simple process for tracking and submitting MDR.
DME – The FDA should make clear in its guidance documents that systems of meters and strips (including third-party) that do not meet the FDA’s stated accuracy requirements cannot be considered durable medical equipment (DME) and thus should not be eligible for reimbursement by CMS or other payers.
THERAPY ADJUSTMENTS Therapy Adjustments: the FDA should also make clear that if a meter and strips cannot be used to “make therapy adjustments” — meaning to dose insulin or calibrate a CGM — then they are, by definition, not a blood glucose meter  (or strip) and cannot be considered DME (and thus cannot be reimbursed as such).
LABELING: Who is going to be responsible for keeping an accurate and up-to-date list of which third-party strips work with which meters? Until this issue is clarified, third-party strips should not be cleared for sale.
Until all of these issues are addressed, third-party strips cannot be considered parts of a self-monitoring blood glucose test system, and should not be cleared for sale.

April 23, 2014

Dear Newbies

Welcome to the type 1 parents club. (Including but not exclusively, Usher and family) I am so sorry you have joined but glad at least you are here. The locals call here, the DOC  (we pronounce each letter for Diabetes Online Community.)

I kinda know how you may feel. I have been through it. Twice, yes two kids with type 1.  But you Diabetes May vary and you anxiety at diagnosis is your own.

If diabetes has taught me anything it is to try to have empathy for others, other parents of kids with diabetes, other people with type 1, type 2, what we call type 3 (other parents and caregivers.) In time, I hope you get to the place where you can see empathy as a blessing.

You ain't there now. You ain't meant to be. Don't sweat it. There are a bunch of stages of loss, you are gonna deal with them. That is 100% normal.

Type 1 diabetes is a family thing. No parent likes putting insulin into a child, the child typically isn't a huge fan of it either. All try to be brave. Siblings face as much stress as anyone, through less parental attention and care and loving fear for their brother or sister. As you work diligently to learn to care for you child with diabetes, work as just as hard to show the non D-kids how much you care for them and the love all they bring to the family. Life has many demands, diabetes will add to them, for now bring all you can to your family - you will find a new normal.

Learn about Children With Diabetes Friends for Life.

There at Friends For Life, families share the magic of "getting it." Everyone "get its." No matter how much or how little anyone knows there are new things to learn and new friends to walk with you.

Your family needs people walking with them. Diabetes is hard. It is relentless. It is best managed with a little help from your friends. Nothing against your existing friends, they are wonderful people I am sure, few will appreciate that behind what you project as normal is the ever present reality of diabetes care. A few may prove they weren't true friends, such is life.

The diabetes community will embrace you, peer support makes diabetes care much less stressful. Join the forums at CDW, join #DSMA chat on Wednesday nights 9:00 easter on twitter. Let other walk with you. You can do this.

Over the years YDMV has created a collection of Newbie posts, most are silly. There are here if you need them. There are also a few focused on that "why me" stage, those are here.  What really matters is we, a community who gets it, are here and here and here and here.... well way to many places to list, but all are here for every newbie, parent, adult, child, teen, caregiver and friend living with diabetes.

Welcome to the club. Sorry you are here. 

April 22, 2014

I can’t get no....

Family history can be cool.

The baby here is my dad. The Navy officer my granddad Vernon,  Fred C. Dunlap my great grandfather is on the left. The awesome 'stache in the middle is George W. Dunlap my Great Great Grandfather. He was on the receiving end of Pickett's Charge. For his sake, and all the rest of us that have come after, that small stone wall at the "high water point" is looking real good.

Some place in that picture, is a history of type 2 diabetes. It may suggest full on T2D, for me, is just a matter of time. I am what some folks call “Pre” type 2.  Nothing against the family history, I want to stay on the “Pre” side of the T2D time line.

I could use a stone wall of my own.

I have made changes in how I eat and some of what I do. I can still do better. My fasting numbers have been creeping up, so my Doc. and I chatted.

I want to know more about continuing to “pre”venting what seems like just a matter of time. I have concerns about medication, one I take may elevate blood sugar. I worry that metformin, as an glucose management medication entry point, may be an issue with my less than stone wall stomach. (If I look at meds the wrong way, I get queazy. One reason why I don’t like to take meds at all.)

At first a dynamic that was proactive about glucose management rather than reactive had Doc a little off his game but he bounced back quickly. I wanted to start with education. He was game but...

I needed to see what my insurance covers.

Joy! What is more fun than calling the insurance company?
(Sarcastic comments welcome, _____ is more fun than calling the insurance company.)

Here's the thing. I have had some success with A1C. Like I said some call it “Pre.” I am more aligned with Riva on "Pre" not being a real thing. Still, I am less than some thresholds of full on T2D. Like my insurance company's. They say by their measure it ain’t high enough. I can’t get no education.

Ever notice how many tunes have Doctor in the lyrics? All those songs about doctors and this is what rings in my head.

I can't get no, oh no no no
Hey hey hey, that's what I say
I can't get no, I can't get no
I can't get no education
No education, no education, no education

April 16, 2014

Yay Team!

At the risk of sounding like one of the Borg collective from Star Trek Star Trek: The Next Generation, I was 6 of 17. One of a diverse group of people who spoke at the Afrezza ADCOM meeting.

It was an interesting day. It overstate things, possibly wildly, but I’ll describe the day as MannKind spoke about the wonders of their insulin and FDA showered upon it a lack of love. Pubic speakers talked of a need for options. The panel considered risk, patient needs and in what the called a difficult choice voted almost unanimously for the drug. 

I don’t know what FDA will do, approve it or not. They have to July 15.  

I do know that those who spoke with me were a fascinating group that spanned the cross section of the diabetes community.  There were a number of physicians who treat PWDs, CDEs who teach PWDs, ADA and JDRF that represent PWDs, and a mix of type 1, type 2 and type 3 (caregivers) people who live with diabetes.

I have not seen as wide a mix at any previous FDA meeting. Nor I had not seen anything like Manny Hernandez’s video presentation, bringing views into the room from a champion who could not be there physically. He spoke of reactions to the drug at tuDiabetes and estudiabetes. He spoke in Spanish, with subtitles when representing Spanish speaking American. That was an appropriate first in my experience. 

Through the diversity of speaker, the message could not have been clearer if we had sat down and scripted it out. In fact one public speaker commented about that, noting that we had not. 

There is not one best way to manage diabetes. People with diabetes need more options to consider with their health care professionals. 

Doctors and patients should consider care plans that reflect individual lifestyles, fears and aspirations. There is an emotional component to care, some folks are afraid or needles. Some shy away from the stigma of injecting in a restaurant, plane or other public place. Some fear hypoglycemia. Others reached unprecedented control with an ultra fast acting insulin.  

Following the public comments, it seemed that in addition to the critical safety issues, the panel also considered the psycho - social aspect of diabetes self care.  All too often, it seems to me, these are overlooked with words like adherence and compliant.

I hope the panel would have had those discussions without the hour of public comments. In the hand full of these meeting I have attend, that as not been the case, certainly to the extent we saw on April 1. 

I hope this was not some twist of April Fool’s Day fate. I hope that the broad community of physicians, CDEs, Big Advocacy and individual PWDs will continue speak in one voice because more options means better care. 

No doubt, the idea of options will need to be better appreciated by third party payers. We can help. Advocacy, just like good diabetes care, work best with a team, doctors, educators and advocates all working with and for patients. 

April 10, 2014

Forget the Taxes, FFL Scholarships Application are Due 4/15

OK don't mess with the IRS. I was only kidding. No need to send the black helicopters. 

Monday on DSMA Live 'Rents Lorraine and I chatted with Jeff Hitchcock about all kinds of stuff including Friends for Life (FFL). Go have a listen. At the end we talked about FFL scholarships for families, young adults and adults. The deadline to apply to the Diabetes Scholars Foundation for scholarships to FFL in Orlando is postmarked by APRIL 15th. 

Scholarships cover room and registration (not transportation) for families, young adults (18-24) and adults. Young adults are paired with another young adult in the hotel rooms for support and nighttime safety. 

When it come to FFF, Here is what is important.
When it come to FFF, Here is what is important.

Please also make plans to support the

FDA has Trending List. DOC is On It

Howdy DOC.

We're trending.

No not anyplace super cool. At regulations.gov. Yeah, they have that and here we are:

The SMBG docket is open to May 7. Let's keep it up. Draft comments here: http://www.stripsafely.com/sample-page/guidance/

Y'know, maybe this super cool.

Update 4.11.14.
Like any trend, we fell off. That isn't to say we can't get back.
StripSafely has new comments you can send about third party strips
and who is responsible for what.  Sent them, even if you have sent
other comments already It is our health, we have a say.

April 8, 2014

Good News: Arizona and Insulin Pumps

Arizona Legislature reaches budget compromise. 

Scroll down far enough and you see this:

"It also adds funding under the state's Medicaid program for insulin pumps."

Congratulations to the P.W.D. in Arizona and ADA for helping the legislature lead on the value of better diabetes care. 

Of Automobiles and Insulin Delivery

I applaud the New York Times for caring to write about type 1 technology. I would encourage them to take a little more time to better understand the subject next time. I'll try to help. Since we are all Americans here, lets use a metaphor we all understand - cars. Fuel efficient small foreign cars, so maybe not something we all understand.

In the 1970s I drove a VW Beatle. It had been my mom’s. It would go anywhere, including places my friend Ric broke his jeep. One year for Christmas I got a hand full of Craftsman tools and rebuilt the engine and clutch. Bugs were easy enough to fix anyone with tools could do it.  

Coming home from college one weekend, I was cut off on a highway and skidded into a gas station sign. The car was totaled. I was nearly so too. The impact of my face cracked the steering wheel and popped the windshield out. The Glass flew across the service station and landed unbroken. I remember the gas station guys talking about seeing the glass fly and marveling that it didn’t break, from my semi conscious state waiting for the ambulance. 

I still like small cars. I have a Mini. It has a host of features my Bug lacked; anti lock breaks, a host of front and side air bags, crumple zone construction, good seat belts, power steering and much more.

I bring all this up to point out the value of current automotive technology verses 1970s technology. It would be easy to say that both the Beatle and the Mini do the same job. They get me from point A to point B in relatively the same mix of shifting, steering, breaking and being a little weary of bigger vehicles. In that context the newer car’s significantly higher cost could be seen an extravagance. 

Modern cars are significantly safer (even if they don’t go up Jeep trails like a Bug.) 

I think there is a parallel to diabetes technology. Modern diabetes technology looks like it is doing the same job as the 70s stuff. 

It isn’t.

Modern insulins allow a better if not perfect parallel of physiologic insulin. Pumps provide a better delivery system and allow delivery to be programed to daily rhythms. Continuous sensing can alert patients to changes and prevent dangerous lows and highs. 

Yes, this stuff cost more than 1970’s stuff. Cost isn’t the question, value is. Air bags are mandated because some cars are gonna crash. Antilock breaks, crumple zone construction, side impact doors, safe fuel systems etc all cost more. The value is in safer roads, lives saved. 

See where I am goin’ here? 

The story of technology is the value it brings. Computers cost more than pencils, ruled notebooks and movable type presses. The New York Times assembles the paper with computers, because they bring value. We drive safer cars for the value. People with type 1 diabetes can be more productive members of society due to the value of effective technology.

Sent via email to: Elisabeth Rosenthal NYT. (without the cool images, what can ya do.) 

ps. Neither my Bug of Mini looked the good but the colors are right. 

April 5, 2014

Co-Pay or Fad Diet

I found this comment fascinating.  Maybe the solution is both meds and a non fad diet. I can't say. YDMV. Food for thought. Pun intended.
It seems like every week our patients come to us with a new diet plan or a 1 minute exercise routine that will make them drop 25 lbs in the first week. It amazes me that these patients won't pay a 20 dollar copay for a diabetes med but they will spend hundreds of dollars on diet plans, food coaches. fitness trainers and precooked meals. Often these programs or coaches think that their plan will work for our patients without knowing the first thing about diabetes. = David Joffe, Diabetes in Control 

April 3, 2014

I was 6 of 17 at FDA's ADCOM on Afrezza

I was one of a large group of public voice who spoke the the Afrezza ADCOM hearing April 1. It was an privilege to be part of the amazing range of patients, doctors, science officers, CDEs, seventeen of us in all speaking up for people with diabetes. I felt it was an unusually powerful set of presentations. My personal favorite was Adam Brown. His comment about the short comings of A1C were fantastic. Adam's point was very much inline with Aaron Kowalski's, he said that being in range is often a passing state between highs and lows. Many of us spoke about hypos while other spoke to the need to lower the anxiety level associated with needles. 

Maybe all were my favorites. The power came from the diversity of presenters and uniformity of message - People with diabetes need more and better insulin options. I wish I could reproduce them all. I can't.

Here are my notes. 

Hello I am Bennet Dunlap. I have no relationship with the sponsor. I am the father of two type 1 children and I work to be successful in managing my type 2 diabetes. As an advocate I created the StripSafely campaign for accuracy in diabetes testing tools, work with other programs and recently was a PCORI infrastructure reviewer.

As a parent caregiver and person with diabetes. I appreciate the panel's individual commitments to work with FDA to help layperson like myself understand the nuanced risks medications. When considering those nuances I urge you to remember that there is significant risk in the diabetes status quo. Insulin is a very dangerous drug. It is not a cure. It is a treatment, self administered by millions of laypersons in the wild.

Just a few weeks ago JAMA published estimates of emergancy room visits and hospitalizations caused hypoglycemia. The estimate is over NINTY SEVEN THOUSAND American a year go to the Emergence Room because of insulin and 29% are admitted. The American Journal of Managed Care, a publication that is going to be super geeky about costs, estimate the “costs for hypoglycemia visits.”

The cocktail napkin arithmetic of EVENTS times COSTS works out to $645 Million for insulin overdose every year. Seniors over 80 are twice as likely to visit the ER and five times more likely to be admitted.

The JAMA article points to two real world reasons for ER visits. Less food consumption and taking the wrong insulin. An insulin, such as todays candidate, that is sufficiently fast acting that it can be taken with or after a meal, can be balanced to the food actually eaten. vs insulin taken in anticipation of what may be eaten. Bolus insulin taken in a uniquely different way from basal insulin can help address confusing types.

Insulin options can help individuals and their care teams create personalize treatments plans. As you look at risk do please not overlook the real world reasons for ER TRIPS in the wild.

Let me put that risk into a March Madness perspective. NIH estimates that stimulants including methamphetamine, are involved in 93k ED visits annually. Insulin is responsible for 97k. I don’t know who picked Duke to loose in the first round but that isn't the only bracket madness this year. : 

That insulin beats breaking bad in ER visits is a real world signal that innovative insulins are desperately needed.

Citations Citations  are appropriate so there they are.
Thank you for your diligence in bringing innovative insulins SAFELY to market.

National Estimates of Insulin-Related Hypoglycemia and Errors Leading to Emergency Department Visits and Hospitalizations
Andrew I. Geller, MD; Nadine Shehab, PharmD, MPH; Maribeth C. Lovegrove, MPH; Scott R. Kegler, PhD; Kelly N. Weidenbach, DrPH; Gina J. Ryan, PharmD, CDE; Daniel S. Budnitz, MD, MPH
AMA Intern Med. March 10, 2014. doi:10.1001/jamainternmed.2014.136

The Incidence and Costs of Hypoglycemia in Type 2 Diabetes
Brian J. Quilliam, PhD; Jason C. Simeone, PhD; A. Burak Ozbay, PhD; and Stephen J. Kogut, PhD
AJMC.com. October 10, 2011 http://www.ajmc.com/publications/issue/2011/2011-10-vol17-n10/AJMC_11oct_Quilliam_673to680#sthash.iHj0bkb9.dpuf

DrugFacts: Drug-Related Hospital Emergency Room Visits 
NIH, National Institute on Drug Abuse

National Diabetes Statistics
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), 2011