New Kind of Mail - With Stamps!

I just put stamps on letter to my Senators, Congresswoman and the President.

Real snail mail letters based on this Sample Letter at StripSafely.com. 

I am asking my policy leaders to send a staffer to the 9.9.13 Diabetes Technology Society meeting. That aide can help my elected officials understand that there is an issue with test strip accuracy.

You can help. You can write too (Hint: Use the sample!) BUT can you find cooler stamps than these Pixar gems?

One Question, One Community, One Voice

Yesterday I had the pleasure of chatting with Bill Woods at Glu about test strip accuracy. MyGlu has been kind enough to write both this article and dedicate the next two Question of the Day at MyGlu.org to gathering information about how we, the PWD community, feel about meter accuracy.

Please, answer the questions.

I know this will help.

I have been asked by the Diabetes Technology Society to represent patients on a panel at the September 9th meeting on meter accuracy. I am honored to do so. Our replies to these MyGlu questions of the day will give me the chance use the data they gather to speak for us all. One voice from one community answering the one question -  Yes! Accurate Diabetes Testing Matters.

The grip strength these little buggers have...

This article by Bill is simply brilliant. I love this in so many ways but maybe this best, "until you severally underestimate the grip strength these little buggers have!"

Bill talks about the fear of testing and discovering one of the kids may be likely to get T1D. This is real honest stuff, done very well.

Bill - Nothing wrong with having a kid who may get D. Love your reasons for testing.  In the worst case - one gets diabetes, you have a kid with diabetes. So do your folks, me, lots of friends Glu. We're OK. (Well they all are, I am a little iffy.)

Worth the risk 'cause how else can you experience just exactly how much grip strength they actually have?



https://myglu.org/articles/dad-s-and-diabetes

Good FDA Blog on Data Interoperability

Great FDA blog post on data interoperability with devices in the hospital setting. Let move this into the patient world as well as clinical settings.

http://blogs.fda.gov/fdavoice/index.php/2013/08/improving-patient-care-by-making-sure-devices-work-well-together/

I like this part:

• An infusion pump that administers medication to a patient also connects to the hospital’s electronic health record system where the physician inputs orders for specific amounts of medication to be delivered at specific times. If the infusion pump and the electronic health record are not interoperable, with clocks that are synchronized, medication errors could occur. 

Ok what about insulin pumps, cgms, meters and life outside the hospital with diabetes? 

My YDMV post on the topic 

http://www.ydmv.net/2012/01/of-fantasy-diabetes-devices-sheldon.html



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FDA Blog on Gluten Free Labeling

From the FDA:

Gluten-Free Labeling Consumers Can Count On

Posted on August 2, 2013 by FDA VoiceBy: Virginia A. Cox
Celiac disease is a serious health issue that can lead to critical complications if not treated.  

While there is no cure for celiac disease (CD), there is one way to manage it – following a gluten-free diet. The only choice for the up to three million Americans living with CD is to adhere strictly to a gluten-free diet, avoiding proteins that occur naturally in wheat, rye, barley and cross-bred hybrids of these grains. To do otherwise is to risk gradually damaging the intestines, preventing the absorption of vitamins and minerals and leading to a host of other health problems, including nutritional deficiencies, osteoporosis, miscarriages, and cancer. 

Without a standard definition of “gluten-free,” people with gluten-related health problems can never be certain if a food is likely to be tolerated by them. So as a person living with CD for over a decade, I’m delighted to say that today, FDA is mandating a new rule on food labeling that will help people with CD – people just like me –be able to trust what the words “gluten-free” mean on their food purchases. Not only will this help those with CD manage their disease more carefully, but it will also improve life for many others who are gluten intolerant or gluten sensitive. 

More at: http://blogs.fda.gov/fdavoice/index.php/2013/08/gluten-free-labeling-consumers-can-count-on/?source=govdelivery

Voluntary Recall of Specified Lots of Nova Max® Glucose Test Strips

There is a recall notice out today about specific lots of Nova Max® test strips.

Please see details at:

http://www.novacares.com/news/nova-max-recall.php

In part it says:

WALTHAM, Mass. - July 26, 2013 Diabetes Care today announced it is initiating a voluntary recall of 21 lots of the Nova Max Glucose Test Strips distributed both in the USA and outside the continental USA. Nova Max® Plus™ glucose meter kits that include test strips from the recalled lots are also included in this voluntary recall. 

The company has recently determined that some of the blood glucose test strips contained within the indicated Nova Max Glucose Test Strip lots and Nova Max Plus glucose meter kits may report a false, abnormally high blood glucose result. Those who use, recommend clinically, or sell Nova Max Glucose Test Strips for blood glucose testing should immediately discontinue using or distributing glucose test strips from the recalled lots and catalog numbers. 

A false abnormally high blood glucose result could, under certain conditions, result in an insulin dosing error that could lead to a serious health risk requiring immediate medical attention. 

Customers can check to confirm if they have blood glucose test strips from the affected lots by visiting www.novacares.com/news/nova-max-recall.php or by contacting Nova Diabetes Care customer service at 1-800-681-7390. 

No other product or lot number from Nova Diabetes Care is impacted by this recall. Customers can contact Nova Diabetes Care customer service at 1-800-681-7390 to replace their affected test strip lot or meter kit at no charge.

Other reports state the lots are:

Nova Max Test Strip Recalled Lots

Test Strip Lot Number
1020211346
1020411347
1020611348
1020811350
1020211355
1020212032
1020512087
1020212100
1020212101
1020212153
1020712206
1020212207
1020412255
1020212291
1020912292
1020412341
1020213043
1020213074
1020213109

It is Not OK.

Sometimes, I may be prescient. I know that came as a shock to me too.

Back in 2010 I wrote a piece about medical devices approved by the FDA. In it I joked about the OK Meter saying, “No pretensions of greatness at all. It is just OK.”

Maybe it isn’t so OK.

OK Biotech and Prodigy Diabetes care “Aligned Ownership.” In their announcement they were clear about opportunities with Centers for Medicare and Medicaid Services bidding.

Yesterday Prodigy Diabetes Care was disclosed as the recipient of a FDA warning letter in the FDA press release, “FDA alerts companies to stop illegal sale of treatments for diabetes.”

I strongly urge people with diabetes to read that FDA letter.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm360148.htm
In part it says:

Complaint #598 describes an event in which a patient exhibited symptoms of low blood sugar levels after receiving high (260, 169, and 158 mg/dL) blood glucose results when using your firm’s device. Emergency technicians confirmed that the patient had a low blood glucose level of less than 20 mg/dL. The information included for complaint # 598 reasonably suggests that your firm’s device may have caused or contributed to a life threatening injury. An MDR should have been submitted for this complaint.

That said:
Emergency technicians confirmed that the patient had a low blood glucose level of less than 20 mg/dL - And - 

An MDR should have been submitted for this complaint.

That means one was not.

That is NOT OK.

How far below 20mg mg/dl does someone have to go to get a Medical Device Report filed? How much lower can someone go and recover?

 Thanks FDA for the letter.

One question - Does warning mean they are still selling strips to CMS?


If meter accuracy matters to you join the campaign at www.StripSafely.com

iGlucose?

Just saw a link on MacRumors that Apple is hiring folks with health sensor background for the iWatch team. Maybe they should call Terry Gregg and get started on an app for the G5 Dexcom.

May as well pay with the varsity - just saying.

http://www.macrumors.com/2013/07/18/apple-taps-new-hires-in-health-sensors-broad-array-of-internal-experts-for-iwatch-team/

#DSMA Live in Philly

Yo! Philly

Youz should be at 'dis t'ing here. Youz hear?  

Watch to Vote for Scott

Vote Scott.

Watch early and often (and from every IP address you can)

http://scottsdiabetes.com/2013/07/message-exercise-diabetes/



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