May 22, 2014

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.
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.  


  1. There is still more advocacy work to do. But this is a great step. Congratulations!

  2. Agreed. A great step in the right direction, after the build-up during the past year and especially during the past 8 months. One of the most interesting aspects, too, will be to watch who is named to the steering committee and advisory group and how that actually does interact with manufacturers and FDA. All of that will have a critical impact on determining whether there's enough support behind this program to even start thinking about making it mandatory.

  3. Yes a Very Groovy Step our community can take great pride in helping make a reality.

    Thanks to you both for being such strong supporters with others in the DOC!

  4. What does "supported by Abbott" mean? That they are funding it? That they approve of it? If a meter manufacturer is paying for it, I'm skeptical (as always)

  5. Yes it means initailly funded by. The hope is additional industry players will joint the funding process.

    Funding, particularly at the outset is a tricky business. It is not clearly in FDA's mandate particularly in the current budget state.

    I hope the process receives a more divers portfolio of funding. That it demonstrates an even handed evaluation of post market performance. Personally I think tuning as a percent of market share would be appropriate .

    I also hope that the process becomes mandatory. That is all strip maker have to participate, aka, pay in. And that if there is poor performance it it ground to trigger enforcement actions.

    I am curious how you would fund post market in the current state of affairs.

  6. I guess I need to remember that Surveillance was not built in a day. If/when all meter companies were forced to pay to play, I would feel more comfortable.

    I don't think that Abbott will try any tricky business or anything like that, but one meter company funding what is essentially a meter/strip watchdog group makes me nervous and I assume will make more people skeptical than just me.

    This is an important step for sure, but I lean towards skepticism before I lean towards celebration in all things. :)