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.

DAM: Diabetes & Blood Sugar Levels

1154350_32525829A blood sugar or blood glucose level is the number that often gets spouted off by a person with diabetes (or a family member or a medical professional), telling the world how much sugar is rolling around in their body. (It doesn’t really roll so much as swim. Backstroke or doggy paddle? Have no idea.)

For those of you whose beta cells didn’t take early retirement, your blood sugar levels consistently stay between 70 and 130 mg/dl. Doesn’t matter how much you eat, don’t eat, run a marathon, or watch TV all day. Your body does what it’s supposed to do – regulate your blood sugar levels so your body and your brain have the right balance of glucose in your system so you live.

Not quite so easy for those with diabetes. We have to do a little a lot a huge stupidly gargantuan amounts of work to keep our blood glucose levels within a range that is doable.

Let me start off my explanation of blood sugar levels by channeling one of my favorite people, Bennett Dunlap:

“Your Diabetes May Vary.”

Every person with diabetes has their own version of what their optimum blood glucose level range is – and that’s between the PWD (person with diabetes) and their medical team. The various experts have interesting ideas on what should be the right range:

The American Diabetes Association says:

  • Prepranidal (which is a fancy word for before eating a meal) blood glucose: 70-130 mg/dl
  • 1 to 2 hours postprandial (again, fancy word for after beginning a meal) blood glucose: less than 180 mg/dl
  • A1C: Less than 7%

Joslin Diabetes Clinic gets a little more detailed:

  • Fasting blood glucose: less than 100 mg/dl
  • Preprandial blood glucose: less than 110 mg/dl
  • 2 hours postprandial blood glucose: less than 140 mg/dl
  • Bedtime blood glucose: less than 120 mg/dl
  • A1C: Less than 6%

* Note that Joslin says at the bottom of the page that this comes from information obtained from Joslin Diabetes Center’s Guidelines for Pharmacological Management of Type 2 Diabetes.

But wait… it gets more confusing. If you read their Clinical Guidelines for Adults with Diabetes (updated 2/2013), it says this:

  • Fasting blood glucose: 70 to 130 mg/dl
  • 2 hours postprandial blood glucose: less than or equal to 180 mg/dl
  • Bedtime blood glucose: 90 to 150 mg/dl

Then there is the Pre-Existing Diabetes with Pregnancy Clinical Guidelines (updated 6/2011):

  • Fasting and premeal glucose: 60 – 99 mg/dl
  • 1 hour postprandial blood glucose: 100 – 129 mg/dl

These ranges also change for older individuals with Type 1 diabetes, young children with Type 1 diabetes, PWDs who have complications, etc.

The end goal for a person with diabetes is to die happily at a ripe old age with as few complications as possible. Sort of the opposite of: “The person who dies with the most toys, wins.” Having a target blood glucose range is a start, but there’s so much more than just checking blood glucose levels – once you have the number, you need to know what to do with it. I’ll be sharing my thoughts on that in the next few days…