Surveillance Success!

Good News!

The Diabetes Technology Society (DTS) this week announced the launch of the DTS Surveillance Program for Cleared Blood Glucose Monitors. This surveillance program will provide independent assessment of the performance of cleared blood glucose monitors following Food and Drug Administration (FDA) clearance against accepted standards, and generate information that can assist patients, healthcare providers, and payers in making the right product selection.

For details please see: http://diabetestechnology.org/surveillance.html

Initially the program is being supported by Abbott but DTS says that other BG Monitor manufacturers are currently looking into coming on board.  They (and I think all of us in the community) would welcome funding from other sources that recognize the importance of and wish to lend their support to surveillance of cleared BG Monitoring systems to obtain information about the performance of these products.

The announcement says there will be patient advocates involved. I asked DTS who that would be and they replied, "Patient advocacy groups will be selected based on recommendations by the Steering Committee and the Board of DTS." I may have thoughts on the matter too. 

Finally I asked, what do we need to do to make surveillance mandatory, because, I assume it will start as voluntary?

DTS's reply was, the program can be made mandatory if a special rule is developed by FDA or if a law is passed by Congress.

So there is still advocacy work to accomplish.  

Access is the point of Advocacy

The prompt for today:

Let’s kick off Diabetes Blog Week by talking about the diabetes causes and issues that really get us fired up. Are you passionate about 504 plans and school safety? Do diabetes misconceptions irk you? Do you fight for CGM coverage for Medicare patients, SDP funding, or test strip accuracy? Do you work hard at creating diabetes connections and bringing support? Whether or not you “formally” advocate for any cause, share the issues that are important to you.

Yes.
All of the above,
and then some.

Diabetes is Big. Policy is Big.

They touch at a lot of different points. Because both are big, often one touch point doesn't know what the other is trying to do.

It would be glorious, for example, if efforts at prevention were connected to the key idea of access via insurance reimbursement for quality education on how to successfully prevent or at least postpone type 2. Great if third party payers looked at education as the investment in saving lives and expenses down the road that it is, sadly it is not always seen that way.

The list of issues in the prompt seem quite different;

• 504 and schools
• Misconceptions
• CGM and CMS
• Special Diabetes Program
• Test Strips
• Connections with peers

I don't see it that way. To me they are all access to issues:

• Access to safe school environments.
• Access to accurate public messages about diabetes.
• Access to treatment and technology to continue to successfully manage diabetes.
• Access to research to better treat diabetes. 
• Access to reliable devices.
• Access to people who can help individuals stay positive and engaged. 

Advocacy is acting to ensure access. What people need access to may, like diabetes, vary. The need to act with and for each other doesn't vary. If we don't act for better diabetes access, who will?

MasterLab - July 2, become a better policy advocate.

Become a stronger champion for effective diabetes policy.

July 2, 2014 7am – 5pmOrlando World Center Marriott

Speakers include:

• Patient advocates from other diseases
• FDA
• Government  and Regulatory Affairs representatives from device and pharmaceutical companies
• Other experts.

Understand the role of patients, empower diabetes advocates:

• Policy, regulatory issues
• What advocacy looks like now and where we can improve.
• How can patients be effective in the policy landscape?

More Information on MasterLab

Diabetes Hands Foundation offers this MasterLab in collaboration with Children with Diabetes (CWD). Registered participants in CWD’s Friends for Life conference are welcome to join the MasterLab as part of their FFL experience at no additional cost. 

Please email Mike@diabeteshf.org for a promo code 

to use for free registration for the MasterLab.

Then register here.

*Stand alone registration for the MasterLab is $50 per person for those not registered  as Friends for Life participants

Yo DOC! How do ya feel about 400?

Comments that is.

We are at 342.

If posts to the FDA docket on personal use glucose meters were held to the 2003 ISO standards for glucose meters, I could claim we have 400 comments and consider that an accurate reflection of 342.   342+20%=410.

That's bogus. Let's get a real 400. Commenting is easy. It takes two minutes.

The docket is open to May 7.
That's one place where a 400 is something to feel good about:

Please:

Comment on the Guidance

Add a Second Comment on Generic Strips

Watch the #DOCasksFDA Chat.