FDA and the Diabetes Patient Community

Patient Network Live Chat: Diabetes - Glucose Monitors and Test Strips

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Talk with FDA expert Courtney Lias and
Patient Advocate Bennet Dunlap (Yea Bennet!)
about Glucose Monitors and Test Strips

Monday, March 31, 1:30–2:30 pm (EDT) Talk, share, and connect with the

FDA and the Diabetes Patient Community

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Do you want to learn more about the role of the FDA in the regulation of medical devices, such as glucose monitors and test strips, used in the management of diabetes? Do you want to learn what the FDA is doing to increase the accuracy of blood glucose monitors and test strips?

When you participate in this friendly online chat, you will:

Enjoy an informal, open discussion with a fellow patient advocate, CDRH subject-matter-expert and others in the diabetes community.Learn more about the role of the CDRH, specifically the Office of In Vitro Diagnostics and its work to ensure the safety and effectiveness of medical devices used in the management of diabetes. Get your questions answered about the newest FDA draft guidances, which are proposing new recommendations intended to improve the accuracy and safe use of blood glucose monitoring test systems, giving healthcare providers and people with diabetes better tools to manage blood glucose levels.

Whether you want to just listen to the interview, ask relevant questions about the medical device regulatory process or just speak your mind on the newest draft guidance document…. you should join in the conversation.

Register for this event and be sure to mark your calendars and join us on March 31st, 2014.

link to original text on FDA.gov

Weekend Roundup

Happy Blue Friday, I hope you enjoy the weekend and a few of these initiatives, stories and a giveaway.

You take the quiz and a diabetes charity that we all love gets money - nice!

When you take this two minute quiz Novo Nordisk will make a donation to the Diabetes Hands Foundation.

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Help Strip Safely to effect real change in the FDA's meter rules.

from strip safely: "FDA has two draft guidance documents about blood glucose meters that are open for comment until April 7, 2014. A “draft guidance” is basically a preview of what standards the FDA is considering requiring in order for blood glucose meters to be cleared — the law requires that FDA open its draft guidance documents up for comment before publishing a final version. FDA welcomes comments from the public, and so we highly encourage everyone affected by diabetes to submit their considered thoughts." - I did it last night, it's easy and important. Go take a look.

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This week on Arden's Day

We are giving away a pair of diabetes circles shoelaces - easy to enter

This simple pancake recipe is easy on Arden's BGs

Does your DexCom make you sing?

I wrote a piece for Disney about spousal engagement and your child's diabetes management 

diaTribe Petition: Please help

from the diaTribe petition at change.org

At a recent meeting of Oregon’s Health Evidence Review Commission (HERC), the state panel recommended reducing access to test strips for people with type 2 diabetes on the Medicaid-funded Oregon Health Plan (OHP). A new plan would severely restrict access to strips for type 2 patients unless they are newly diagnosed, take insulin, or meet a few other special requirements. For people not taking insulin – which covers the vast majority, about 70% of all type 2 patients – those with an A1c above 8.0% would be entitled to one test strip per week, while those with an A1c below 8.0% would not be provided with any test strips at all. 

This recommendation would severly limit test strips and set a dangerous precedent for other states looking to cut overall health care costs. It's difficult to understand how the HERC imagines people with an A1c below 8.0% will manage their diabetes without test strips, and a test strip every week is hardly meaningful for patients or providers. Furthermore, any cost reductions will likely be more than canceled out in the long-term due to increased complications, hospital visits, and operations that inevitably folow poor control. The decision is currently scheduled for December 5. If you are a person with diabetes or a caregiver, we encourage you to sign this petition and write to Oregon Health Authority’s Director Dr. Bruce Goldberg and the members of the HERC about the importance of having access to test strips and self-monitoring blood glucose.

Read more about the issue and what you can do at diaTribe.org 

Add your name to the petition

Update on 2013-12-11 14:41 by Scott Benner

Your participation made a difference! Read the update from diaTribe.

What is StripSafely?

StripSafely is the initiative to bring awareness to the issue of test strip accuracy. I'm hoping to help bring attention to the StripSafely efforts by helping to make you an advocate for the cause. You are not being asked to make a donation.

If you could just take a moment to read more about the efforts and then follow StripSafely on FaceBook, Twitter and on their website, you'll be supporting people who I completely trust to help the diabetes community have a voice in the fight to change the current levels of accuracy acceptability. I am not affiliated with StripSafely.

Issue - From the StripSafely website:

At a recent public meeting the FDA acknowledged1 that there are some 510(k) cleared blood glucose (BG) meters and strips that do not meet the accuracy standards for which they were approved. There is currently no clear course of action to insure people with diabetes are using blood glucose strips that meet regulatory requirements.

The rest of this statement can be found at this link. 

Who, What, How?

StripSafely is an ad hoc Diabetes Online Community (DOC) collaboration to help the general public understand that there are inaccurate blood glucose test strips. We hope to get folks involved to do something about that. By something, we mean write the FDA, elected officials, and the news media.

The StripSafely campaign was created by Bennet Dunlap who is the site admin. Scott Johnson, Christel Marchand Aprigliano, Kerri Sparling, Cherise Shockley and Kelly Close joined early on and contributed their skills. The campaign is not affiliated with strip manufacturers, the FDA, or any other remotely organized group.

The real work of this project is being done by community members who write letters and blog posts as part of this campaign. See the social media section for these efforts. We would love to feature your letters and blog posts. That’s why there is a form on every page’s sidebars to help you share what you have written.

Thank you for taking the time to find out about StripSafely!

Join The Strip Safely Tweet-In, August 21st at 8pm EST

Strip Safely is headed by my friend and DOC legend, Bennet Dunlap. In my opinion, when Bennet says something is important for me to pay attention to... it's important. I hope you can send some tweets tonight! - Best, Scott

Taken from www.stripsafely.com

On Wednesday, August 21st beginning at 8pm Eastern, we are staging a StripSafely Tweet-In, asking Congress to send aides to the upcoming Diabetes Technology Meeting on September 9th. 

Please join us and add your voice. 

We’ve made it easy. Simply go to the Let’s Tweet page of Stripsafely.com, find your state and click the link listed next to your senators and congressmen. We’ve already created the message – you just need to tweet it out. (Don’t forget the leadership at the top of the page – we can all tweet to them!)

Then, please, get creative and send additional positive messages to help the diabetes community build friends in Congress. Include the hash tag #StripSafely. Feel free to use this link to our letter in your tweets.

Diabetes isn’t partisan about whose life it impacts. We shouldn’t be partisan in seeking support for our health.