October 28, 2015

Of Test Strips, Bidding, and Harm

I have been thinking about test strips. Again - Still. Some of you may know this is a reccuring topic with me. It is, because.., well..., strips matter. 

Test strips are the foundation of good diabetes self-care. People with diabetes, particularly those who use insulin, need to test frequently to manage their blood glucose and make care adjustments, particularly with the insulin. As simple as it sounds test strips are vital to avoiding dangerous low blood sugars from insulin. 

Insulin can be a dangerous drug. An article in the Journal of the AmericanMedical Association estimates that ninety-seven thousand of Americans a year go to the emergency room due to low blood sugars caused by insulin.(1) The journal goes on to says most of those insulin ER visits are seniors, Medicare’s people and that one in three of the ER visits the person is hospitalized. When it is dangerious, it is expensive.

The ninety-seven thousand mentioned cited in that article is MORE than the government estimate of Americans who go to the ER for stimulants including methamphetamines.(2) It is shocking that insulin beats breaking bad as reasons Americans go to the ER. However, the comparison does help put good self-management in perspective. Clearly a goal is the safe use of insulin that helps keep America's, particularly seniors, well while preventing the need for emergency room and avoiding unnecessary hospital admissions cost to Medicare.

We all have heard of medical trials. Trials, because they can impact the participant's health, have strict rules. Some of those rules came about as the result of studies that were unethically done on people without their permission or knowledge.(3) It seems logical that if someone were going to introduce new means of accessing something as critical to maintaining health as test strips that they would follow the trails safety rules.

Unfortunately, that was not the case.

Medicare changed the rules for how beneficiaries get test strips. Medicare tested it in 2011 in nine pilot cities around the country. But they didn’t treat it as a clinical trial or follow safe trail protocols. Maybe because they judged the rules don't apply to them as a government agency. Medicare said it was a huge success, they saved money and there were few complaints and no disruption.

A poster presented at the American Diabetes Association scientific session in June 2015 by skilled academic scientists looked carefully at Medicare’s data. It showed that in the nine pilot cities(4) there was a disruption of patients access to test strips. How and how many strips people with diabetes acquired shifted. In some cases, people on insulin stopped receiving testing supplies. The researchers found an increase in hospitalizations, higher cost, and more mortality in people with diabetes using insulin in the test cities.

I don't know who is right, Medicare, who says there was no harm and extended the program nationwide or the researchers who found statistically significant increase in mortality, hospitalization, and costs in Medicare's data. I am not a scientist, a statistician or a bioethicist. I do want to know if people on Medicare are safe.

Congress is paying the bills. They authorized this experiment. They should find out what the truth and tell us is Medicare program safe? ACT NOW to ask Congress to get to the truth.

(1) Geller AI, Shehab N, Lovegrove MC, et al. National Estimates of Insulin-Related Hypoglycemia and Errors Leading to Emergency Department Visits and Hospitalizations. JAMA Intern Med. 2014;174(5):678-686. doi:10.1001/jamainternmed.2014.136. https://archinte.jamanetwork.com/article.aspx?articleid=1835360

(2) National Institute on Drug Abuse. Drug-Related Hospital Emergency Room Visits Retrieved from http://www.drugabuse.gov/publications/drugfacts/drug-related-hospital-emergency-room-visits

(3) https://en.wikipedia.org/wiki/Belmont_Report

(4) Test sites included Charlotte-Gastonia-Concord (North Carolina and South Carolina); Cincinnati-Middletown(Ohio, Kentucky and Indiana); Cleveland-Elyria-Mentor (Ohio); Dallas-Fort Worth-Arlington (Texas); Kansas City(Missouri and Kansas); Miami-Fort Lauderdale-Pompano Beach (Florida); Orlando (Florida); Pittsburgh(Pennsylvania); and Riverside-San Bernardino-Ontario (California)

Help out DHF and the DOC with a two question survey, Especially T2s

This from my friend Corinna

I wanted to let you know about a project we're working on and ask for your help with a short (2-question) survey. We're working on a Tier 1 PCORI Pipeline to Proposal  project aimed at eventaually looking at the efficacy of peer support delivered online. You know, that thing that the DOC does. 

Would you take a couple of minutes to respond? 

You can find the survey on TuDiabetes at: http://www.tudiabetes.org/forum/t/meet-idocr/48282

Spreading the word would also be appreciated. Please point other PWD, especially those living with Type 2, to this survey. Thanks so much.

With warm aloha,

October 14, 2015

The Big Blue Test - Join by Moving

The Big Blue Test (BBT) starts is Big Blue 7th year. I tell people I treat my T2D with a bicycle and metformin but mostly the bicycle. Mostly the bike because it is more fun and I think is doing me more good. Starting today, I'll send my rides to the Big Blue Test. Here's an adaptation of the BBT announcement:
Today October 14, BBT will begin collecting Big Blue Test entries to help raise money for diabetes charities, but they have made a few changes to the program based on user feedback.

Diabetes Hands Foundation has heard from many of us that during the #BigBlueTest campaign each year you feel more motivated to get up and get active. Now in its seventh year, Big Blue Test is growing beyond its origins as a once yearly movement to inspire participants to get active and help diabetes-charities just in the fall. BBT will now have three windows of collection: fall, winter, and summer.

As you probably know, the Big Blue Test program encourages people to get active for 14-20 minutes and to share that experience on BigBlueTest.orgor by using the iPhone or Android app.

Each entry also helps improve the lives of people with diabetes living in need. During each campaign period, the program's sponsors will donate $1 for each entry logged - up to $10,000 in each window - resulting in $30,000 donated to diabetes charities by the end of summer 2016.

DHF know that exercise is important throughout the year. And they also know that diabetes charities need our support throughout the year, too.

So get up and get active. Log the exercise and help us get to 110,000 entries before November 30th.

Every time you log a Big Blue Test entry betweenOctober 14 and November 30th a $1 donation will be made by our program sponsors to one of two great diabetes-related nonprofits.

Read more about the two charities that will benefit from your sweat: Meet the grantees.

DPAC with Diabetes Connections and Stacey Simms

I had the great privilege of joining Stacey Simms in a conversation about Diabetes, Advocacy and DPAC. Just click below to listen in.

Diabetes Connections with Stacey Simms

DPAC - Diabetes Patient Advocacy Coalition 

Released: Sep 29, 2015
DPAC is a new effort to make it easier for people with diabetes to communicate with policy makers. Co-founder Bennet Dunlap explains how Diabetes Patient Advocacy Coalition works and how we can all take part. 

Read more at https://html5-player.libsyn.com/embed/episode/id/3826551/height/360/width/640/theme/standard/direction/no/autoplay/no/autonext/no/thumbnail/yes/preload/no/no_addthis/no/#GHJpPi83EkwpAtB7.99

October 1, 2015

My Script for FDA

I wish I could tell you what I actually said at FDA's Labeling Workshop. Bellow is the script I worked up. I am at my best when I get up and channel the material and just go with it. It like speaking in tounges or something. The only conscious thought I am aware of when it is happening is to not say "um."

I was off this script by about word 3 but it does, I think, and hope, reflects what I said.

I can tell you that whatever I said, I was well received by individuals participating in the workshop from both FDA and industry. I felt respected and did my very best to contribute relevant patient comments to the proceedings and do so with good humor.

It was a privilege to be invited to represent patients and people with diabetes. As some point, the transcripts will surface and the truth will come out. 'Till then this is my story and I am sticking with it.

Hi, I am Bennet Dunlap. My wife and I have four kids, Let me brag here - Two are out of college, have jobs and insurance! Two live with type 1 diabetes and have done so since the were 7 and 9.  Like 28 or 9 million Americans, I live with type 2 diabetes.

After 3 decades as a banker, I apologize for what I did to the American Economy it was clearly all my fault, I earned master's degree in health communication to serve as an advocate for people with diabetes.
Since I am the first patient here, maybe I can back up and talk a little about what patients want from devices to inform what we want from labeling. It is relevant.

We want to be SAFE. We want the devices to help us be healthy. Ideally while keeping us both safe and healthy devices don’t add too much of an additional burden to our lives.
LABELS help keep us safe; They tell us how to use a device. What we should used it for. How to find help, and what to do if it doesn't work right.
People are going to look for help. Ideally the correct information is easy to find. If not, we will look in other places and, to be honest, some of us are dummies.

We are going to find help when we need it and look for the friendliest way to do that. That friendly place should be the official label. To do that maybe write like you would to a friend and not the plaintiff in a legal proceeding. And no 6 point font some of us have trifocals. (wave glasses to room)

Devices and their instructions are drivers of healthy actions.
Many, devices drive of self-care, including medication dosing.
Diabetes is a great example, PWD use devices to manage and treat daily. For millions of American, including my children, that management includes calculating insulin doses multiple times a day.

Look at that picture. See the meter. It says 110. What you don't see is that The tolerance is +/-20% 95% of the time. 95% of the time means 5% it may be off in the weeds. My kids test and take insulin about five times a day, 365 days a year so that 1800 doses of insulin 5% is 90 doses a year bases off reading outside +/- 20%.

The reality is not ONE meter, sold to patients for self-management use in the USA, is APPROVED to dose insulin. Not one. Yet millions of people like my kids do it EVERY DAY.

What a device is labeled to do matters. There has been one meter approved, that I know of, that was specifically labeled NOT to be used to dose insulin or calibrate a Continuous glucose meter,

We need to flip that around. Labels should explicitly say what a device is to be used for. What it is for is as important as what it is not for to be used for. And that "to be used for" needs to keep up with real world dynamics. So if it is for dosing insulin - say so.

Labels should reflect reality, we do dose insulin, and those devices that are accurate enough to do so should say so.

Technology advances, everywhere but the USA the standard is now +/- 15%. When FDA puts new guidelines out the old stuff should not be allowed to continue to be used to dose insulin and the new device labeling is a tool to do that.

The Patient's job is to use the devices to stay healthy, not figure out which is living up to its approved performance. We can't do that.  FDA should enforce labeling. Peer reviewed studies show there are meters that fail to live up to the +/- 20% 95% of the time

Failing to deliver promised accuracy is Device Regulations VW. The Scientific Journals make it clear there are devices failing to deliver +/- 20%. Even when FDA ups the guidance to something new, these VW TDI of the glucose meter world will be no the road - that is approved and for sale. Some insurance buyers who look the only price will continue to select them over more competent devices. I fear this will include Medicare.  My question here is intended use labeling if it doesn't get the VW TDI OFF THE MARKET?

Other things will go wrong.

Look things go wrong.
I saw a FACEBOOK Avatar picture of A PWD's that said ERR 5. A very common message that meant the meter didn't get enough blood. Things wrong enough that we can joke about it.

Patients need to know where to go to get help and where to go if the if the help doesn't.{pause}. help…. We need to know how to report errors - So error can be fixed.

If you listen to patients, you hear a lot of stories of calling a device company and being told a device error is the patient's fault. It may well be, some of the time, but the strong feeling is some device companies doesn't report errors because they choose to see the error as the customer's fault. Nobody is perfect if a company has no device error reports that is a bright red flag that they are far from perfect.

FDA has an app for that. I’m a smart enough guy. I struggle with the app. When we talk about better labels a constantly easy app would help - a lot.

We patients need consistent, easy to use, instructions on what to do to report so FDA can use the reports. By consistent I meant manufacturers can't double talk it, personally I am for dictated language by FDA on error reporting. Including what information makes the report useful and how to file it outside of the company's reporting structure. The ethical companies are reporting already; one has to wonder about the VW of the medical device world.
Failing to report is a safety issue.

Remember safety? I started this thing talking about safety.

Zero reports of errors are madness.

Speaking of madness.

JAMA estimates 97,000 Insulin-related ER visits for lows, aka overdosing insulin. NIH estimates 93k er visits for all stimulants including methamphetamines. That insulin beats Breaking Bad is nuts, and it cost us all.

I took the JAMA numbers and the Journal of Managed care’s cost estimates and it over a half billion. I was a banker $640 million is almost real money. - Mostly seniors so we are all paying for that via Medicare.

But enough of my silly rants, I felt it would be useful to survey people with diabetes, quick biased poll.
The top 8

Quotes from the survey:

Think about who your end users are - it may include children, and granted parents will likely be there helping them, but sometimes it's a school nurse who does not have extensive Diabetes device expertise. 

Almost anyone should be able to pick up the instructions and "get it" with relative ease.

I know it is impractical, but after the first few months of using the devices, I don't look at the printed information. Can there be a way to cut out the cost of printing labels on " refills”?

Please don't use this as an excuse to increase packaging or costs.

I get very frustrated when I have pump sets coming with HUGE manuals every time I buy them