Tagged: blood glucose meters

Procrastinators Unite… Tomorrow!

1267744_87396573You still have time, you procrastinator you.

The docket that FDA has open on blood glucose test strips has been extended to May 7th. You can use the “Ain’t Got No Time For That” method that I came up with for all of us to comment and kick the number over the 400 comment goalpost. (Or more than 400? Be still, my beating heart.)

Even if you have commented, no one is telling us that you can’t comment more than once, so please bring your thoughts about generic/third party test strips.

Third party test strips are not made by the monitor manufacturer, so who’s responsible if there’s a need for adverse event reporting? Who do we call to report it?  Until there’s a clear cut ruling on this, it’s a Wild West sort of world.

Want to learn more about third party test strips and inspiration for your comment? Head on over to Stripsafely.com and read up. (There’s also a great article on this very topic and details about the companies offering generic strips at Diabetes Mine. A definite must read.)

I know that you’re not a procrastinator, but I’m sure that you know someone who might be. Can you do the 26 million people with diabetes a favor today and reach out to someone in your community (with diabetes or not) and ask them to do you a solid?

Diabetes doesn’t procrastinate. We shouldn’t either…

 

"Do it. Do. It. DO IT!!!"

I am quoting my daughter when she wants me to complete something for her: opening a jar, getting art supplies off the top shelf, or putting tofu and ketchup on a plate for lunch. (The Kid has some eclectic food combinations.)

But today, I’m saying this to you. Two minutes of your day can help all of those with diabetes. How?

This:

Keep Test Strips Available              View in browser
[TURN IMAGES ON: StripSafely - Accurate Diabetes Testing Matters. Please Turn Images On.]
Got two minutes to help shape the future of accurate diabetes testing? 

 

FDA is looking for comments about new draft glucose meter rules in two open dockets. Open dockets are a unique opportunity where the FDA is focused on listening to the public – we need them to hear us. 

The current rules for glucose meters are from 2003. It may be another decade before FDA asks for public comment on meter rules.
We have until April 7th.

 

DC is a town where the number of messages matters. Many comments, even if they are repetitive, will help the diabetes community be heard.

Other interests will lobby for their views. We must speak up for our views. Our health. Our lives. 

 

How can you help?
We’ve made it easy with sample comments, a step-by-step guide to commenting to a FDA docket, and additional guidance information. 

1. Review the sample comments here:http://www.stripsafely.com/sample-page/guidance/

2. Use the step-by-step guide to post comments to the dockets:http://www.stripsafely.com/sample-page/comment2fda/

3. Share this email with everyone you know.
Twitter Facebook MySpace Digg StumbleUpon Delicious

Now is the time for the community to speak up. The more comments left on the dockets, the more support we give the FDA to make the changes needed for accurate diabetes testing. 

These dockets are only open until April 7
Don’t let another decade go by with inaccurate diabetes testing. 

Thanks and StripSafely,
Bennet & Christel

 

P.S. Want to learn more about the guidance? Check this out: 

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

 

 

So, please. Do it. Do. It. DO IT!

And thank you.

Warning Label

mr-yuk-300x300It’s no secret how I feel about blood glucose meter accuracy: without it, I’m dead.

Blood sugar monitoring devices have become the linchpin in diabetes care. The number shown on a screen is what determines how much insulin I take, whether or not I eat 15 grams of carbohydrates, and in conjunction with a continuous glucose monitor, whether my blood sugar is going up or down. In the days before home blood glucose testing, it was a total shot in the dark as to whether you were “in range”, because urine testing wasn’t accurate. (Then again, neither was the insulins that were used.)

That’s why I’m a vocal advocate for the StripSafely campaign, bringing awareness of the need to tighten standards and help those who have sway over accuracy and accuracy enforcement of blood glucose testing systems. Since it began this summer, StripSafely has made an impact with the FDA and we are continuing to work with those who want to help ensure we get the accuracy we deserve.

A First For The FDA

When a device manufacturer wishes to bring a blood glucose monitoring system to market, it has to submit paperwork to the FDA showing that it’s met the requirements and standards for the device in question. If it already has a device approved, it’s an easier process with less paperwork, basically showing a comparison to the existing device and highlighting any differences.

A recent approval for a device manufacturer came with something never seen in the diabetes device market: a warning label on every test strip box insert, user manual, and meter box. (I’ve redacted the name of the meter because, you know, bears.)

CAUTION

Blood Glucose Meter Accuracy is the most important criteria in determining glucose meter quality. The {meter name redacted} is less accurate than most other blood glucose meters sold today. The {meter name redacted} does not provide reliable accuracy readings beyond the following margins of error:

For glucose concentrations < 75 mg/dL, 95% of the results shall be within ± 15 mg/dL.

For glucose concentrations > 75 mg/dL, 95% of the results shall be within ± 20%.

DO NOT USE THE {meter name redacted} TO CALCULATE INSULIN DOSAGES.
DO NOT USE THE {meter name redacted}TO CALIBRATE CONTINUOUS GLUCOSE MONITORS
And on every test strip box:
The {meter name redacted} is less accurate than most other blood glucose meters sold today.
DO NOT USE THE {meter name redacted} TO CALCULATE INSULIN DOSAGES.
DO NOT USE THE {meter name redacted}TO CALIBRATE CONTINUOUS GLUCOSE MONITORS
*Want to learn more? Visit this post at StripSafely: Thanks, FDA.

Why Would You Use A Less Accurate Meter?

Goodness gracious. So, for any person with diabetes who uses insulin (or may have to use insulin in the future, for those Type 2s currently on meds or on lifestyle modifications), you are cautioned by the FDA not to use this product. Why even bother purchasing it when you have other options? If you know that something is not accurate – and that accuracy does matter, why even bring it to market?

Money. Yeah. The meter and the strips are cheap, but what’s the real cost?

Health. Inaccurate blood glucose reading can result in wrong dosing decisions. It can result in hospitalizations. It can result in death.

I’m obviously not the target market for this meter, but I’m concerned that those who are looking to save on healthcare costs (or those who are under Medicaid or Medicare and are bound by whatever CMS approves), will not have a choice in whether or not they have to use it.

Mr. Yuk

The warning label is my most favorite holiday gift from the FDA so far. (Perhaps I’ll make a suggestion to the FDA that the warning label should have a Mr. Yucky face on it, which stood for poison when I was a kid.) I’m hoping that the manufacturer in question recognizes that this is an opportunity to either fix the accuracy of their product – or cut their losses and not bring it to the U.S. market.

Based on past history, however, the company may well just suck it up and stick the warning labels on their product, all for the sake of making a buck. And to that, I say this:

People with diabetes, we’ve got the FDA and StripSafely on our side.

 

Game on.

Oregon's Diabetes Death Squad: HERC

773209_26624240Your health care professional walks into the room, plunks a file on the table, and grimaces at you.

“Your A1C is 7.5. Your fasting blood glucose level is 143.

You have Type 2 diabetes.

Here’s a prescription for a blood glucose meter and test strips. You don’t need insulin or medications right now. Let’s see how that goes. Check your blood glucose level with the meter and I’ll see you for a follow-up. 

Oh, wait. You have Oregon Health Plan. Hmm… Yeah, go ahead and use the meter and the 50 strips that you are permitted to have, but after you’ve used up those 50 strips, you’re on your own. You want to continue to check your blood glucose level? Buy your own strips.” 

This is not fiction. This is what Oregon thinks is completely appropriate for those who must use the state health care plan, which is funded by Medicaid. The rationale behind the Oregon’s Health Evidence Review Commission (HERC) recommendation, handed down yesterday in a public meeting:

  • People with T2 diabetes who aren’t on insulin or oral meds don’t need to check
  • It’ll save a bunch of money because these people don’t test anyway
  • Randomized clinical trials prove that daily blood glucose testing doesn’t make a difference in A1C levels
  • Hey, Kaiser Permanente is doing it and no one has died. 

The Facts About This Recommendation

Here’s the report from the Bend Bulletin. Please raise your tray table and extinguish all smoking materials before you read it.

If you’re curious as to what the public had to say (and what HERC pretty much ignored and said wasn’t important), you can sift through pages and pages here.  (p. 46 – 75). The responses from HERC would be comical, if they weren’t real.

The response to a Registered Nurse and Diabetes Educator from Eugene, OR who shared her thoughts about the impact that self blood glucose monitoring has on her patients:

Thank you for your comment. HTAS appreciates the perspective you bring to diabetes education, but finds the lack of effect of SBMG on patient outcomes more compelling. 

Their responses to the American Diabetes Association, Endocrinologists, Nurse Practitioners, and patients were all dismissive and condescending. The HERC relied on very little data from randomized clinical trials that did not take into account the educational component needed to incorporate SBMG (self blood glucose monitoring) into a T2’s daily life. (Want to know which trials? Delve deep into the link above (before p. 46’s public comments) and ta-da.)

Meet Oregon’s Diabetes Death Squad

 This group of people is the Oregon Diabetes Death Squad, who made a recommendation that people with Type 2 diabetes on Oregon’s Health Plan (OHP) don’t need to know what their blood sugars are on a daily basis. Because, you know, their own doctors can’t be trusted to know better.

Would you like to know what qualifications HERC has to make this important, life-changing decision (and in my mind, one that will cost them significantly more in the long run in emergency room and complication treatments)? They must all work with people with diabetes on a daily basis, right?

Wrong.

Here’s the bios from the Health Evidence Review Commission Members page:

  • Gerald Ahmann, MD, –  recently retired hematologist/oncologist.
  • Wiley Chan, MD, – internal medicine physician and Director of Guidelines and Evidence-based Medicine for Kaiser Permanente Northwest.
  • Alissa Craft, DO, MBA, – pediatrician specializing in neonatal and perinatal medicine and Medical Director for Samaritan Health Plans.
  • Irene Croswell, RPh, – retail pharmacist.
  • Lisa Dodson, MD, – family physician.
  • Leda Garside, RN, BSN, MBA, – Clinical Nurse Manager.
  • Mark Gibson – Former fire fighter and current Director of the OHSU Center for Evidence-based Policy.
  • Vern Saboe, DC, – chiropractic physician.
  • Som Saha, MD, MPH, – general internist at the Portland VA Medical Center.
  • James Tyack, DMD, MAGD, – dentist.
  • Beth Kaplan Westbrook, PsyD, – clinical psychologist.
  • Susan Williams, MD, – orthopedic surgeon.

For those of you keeping score, we have a psychologist, a former firefighter, a dentist, two chiropractors, and a pharmacist on HERC. How likely are those individuals to deal with people with diabetes on a daily basis? Unless they have a personal connection, they do not treat Type 2s as a member of a health care team.

Of the remaining members of the HERC, I wouldn’t bet the farm on extensive daily interaction with people with diabetes unless there is a personal connection. (Please note: I don’t have a farm, but if I did, I would raise naughas. For their hide, of course.)

 Stopping The Future Carnage

I truly hope that this recommendation is not implemented. Is there anything we, as a community – or as humans – can do?

Yes.

Why is this important? Why should you care?

Because…

Your state might be next.

Your insurance company might be next.

Your Type 1 diabetes might be next.

Your health might be next, even if you don’t have diabetes.

We are all on the firing line.

 

 

 

DAM: Diabetes Symptoms

Main_symptoms_of_diabetesI knew that I had diabetes before I was officially diagnosed. Sitting in class, reading Time magazine, I came across a PSA print advertisement from, I believe, the American Diabetes Association. On a blackboard style background, bold, chalky white letters asked me to check off any diabetes symptoms I might have:

  • Excessive Thirst – A gallon of milk, seven glasses of water, and a jar of pickle juice one afternoon? I was always thirsty.
  • Frequent Urination – My teachers told me to stop raising my hand and “just go”. Hey, free hall pass. I’ll take it.
  • Blurred Vision – I thought I just needed new glasses. (I wanted new glasses. Mine were not fashionable.)
  • Dry Skin – I kept a small bottle of Clinique moisturizer in my pocket and slathered my face all the time. There was a dry patch that wouldn’t go away, no matter what I did to it.
  • Fatigue – Once a kid who bounced everywhere, I had begun napping after school. And on weekends. And on the bus.
  • Unexplained Weight Loss – 12 1/2 years old. 64 pounds at diagnosis. I looked gaunt.
  • Excessive Hunger – A yogurt and crackers for snack? No more. Clear the refrigerator.

I checked them all off in my head, but because I had no idea how serious and deadly untreated diabetes can be, I didn’t tell anyone. I assumed that it was something that was no big deal.

It’s a huge deal. I consider myself lucky. My blood glucose level was in the 400s when I was finally diagnosed. I was coherent and upright and able to function. I have met others whose families wondered if their children would ever wake up from a diabetic ketoacidosis coma in the ICU.

Additional Type 1 Diabetes Symptoms

Additional Type 1 diabetes symptoms that need immediate attention from an emergency room include:

  • Fruity breath (It can smell like Juicy Fruit mixed with nail polish remover; it’s the body trying to clear itself of ketones – a toxin -through the respiratory system.)
  • Nausea and vomiting
  • Difficulty breathing, almost to the point of hyperventilation
  • Confusion/Unconsciousness

Additional Type 2 Diabetes Symptoms

Additional Type 2 diabetes symptoms include:

  • Tingling in hands and feet (It can be painful – or not)
  • Wounds or infections that don’t heal quickly, if at all
  • For women, frequent yeast infections

Type 2 diabetes symptoms may not present as “acute”, but if you have any of these (and others listed above), it’s still important to see a medical professional for diagnosis. Don’t delay…

If you have any of these symptoms (Type 1 or Type 2) or if a friend or a family member has mentioned any of them in casual conversation, or if you’ve noticed any of these symptoms in someone you care about, please get them to a medical professional for testing  and possible diagnosis as soon as possible.

You can help save a life.

These days, Time magazine isn’t left in a classroom for someone to read…