July 28, 2014

Let’s Put on a Show! (aka FDA has open dockets)

FDA has a docket open seeking public comment on Medical Device Data Systems (MDDS.)

What is that you ask? Good question.

A MDDS is a systems that, in the FDA words, facilitates, “the electronic transfer or exchange of medical device data from a medical device, without altering the function or parameters of any connected devices.” In other words provide second screens for information. FDA is proposing lessening the regulatory process for MDDS as they introduce little additional risk. I agree.

For people with diabetes this may mean seeing our information on additional screen such as our phones. Go FDA!

The guidance speaks directly to mobile.

It is unclear how CGM data is viewed for this data. FDA specifically draws a line at active patient monitoring in the guidance. They don’t exactly say what that is. In my view is that is meant to be in clinic critical care monitoring, not patient self monitoring such as CGM.

I hope to help FDA make that distinction by sharing my views. I would love some company helping FDA see how PWD feel about information.

So far there are two (2) comments on the FDA docket. That seems hardly enough.

One of the keys to successful advocacy is getting attention. I have talked a lot about how much I love the paper Back to Basic as a model for diabetes advocacy. Now the book is a block buster summer movie. (OK part of the paper is in this Youtube video from MasterLab.)

In my view one way the diabetes community can get attention is to speak up in droves when FDA is listening. MDDS isn’t the sexiest subject in the world, neither are food labels (http://diabetesadvocates.org/tell-fda-your-thoughts-on-the-proposed-nutrition-fact-label-by-aug-1/) but if we don’t show up when the policy makers are listening how can we claim we need to be heard?

Please comment on food labels. The docket is open to August 1.

Comment on MDDS, it is open August 25.

Let’s get policy makers attention. Let’s put a show making of comments into the dockets.

July 15, 2014

Novartis Joins With Google on BG Contact Lense

From the NY Times:

Novartis Joins With Google to Develop Contact Lens to Monitor Blood Sugar 
LONDON — Google announced on Tuesday a partnership with the European drug maker Novartis to develop a smart contact lens with the potential to monitor the wearer’s blood sugar levels.


KISS Advocacy - ThePrefect D

I love the piece, the KISS of Diabetes Advocacy by Christel over at the Perfect D.

Her's is spectacular show of how advocacy can be simple and how it can be effective. The more of us who jump in the simpler it can be, In a counting game winners tally up the score. That is what diabetes needs to help avoid the untended consequences of poor public policy.

What sets this piece apart is she makes her case in an upbeat, face painted Rock 'N Roll way.

Advocacy can be fun, as a choice of attitude and Christel's is on the money.

Here's the link, surf on over and have a look.


Stanford research develops news way of diagnosing T1D.

From the SF Chronicle:
A Stanford University team has developed a small invention to spot an increasingly large health problem: Type 1 diabetes. 
The palm-size chip can analyze a few blood drops and diagnose the disease in new diabetics, as well as identify people who are at risk of developing the disease, the scientists say. They are filing for a patent, seeking federal regulatory approval and helping to form a startup to commercialize the chip, which they say works more quickly and is cheaper than existing diagnostic tools. 


July 7, 2014

Jerry the Smart Bear IndieGoGo

Look everyone needs a smart bear, iBear, scholar bear or in the case of T1 kids a friend they can care for.

Jerry has a crowd source opening today. Jump in. Everyone needs a bear.

This is how I imagine Jerry graduating.

Jump in:

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