Replies to This Discussion

Permalink Reply by BadShoe on April 7, 2011 at 7:10am

Jim what I understand is that he FDA considers each platform as an extension of the regulated device. Since dosing decisions are made on the information in the programs each has to go through F|DA approval.

It seem batty to me the logical extension is that the pen vs the pencil used to chart BG and dosing would have to be approve.

I think we need to try to find an ear in the FDA and start bending it. Diabetes is truly unique unfortunately the FDA is not motivated by better care they are motivated to avoid being blamed for bad outcomes. Taking no action and preventing action can be played off as being cautious and they cant be blamed form an abundance of caution.

Permalink Reply by Jeff Mather on April 7, 2011 at 10:06am

Diabetes is very different from other diseases, since patients play as large of a role (if not much larger) in dosing decisions as our health care professionals do. In fact, we're fairly unique this way.

At the very least, the FDA needs to define a class of devices and software that allows for the use of data for self management. It's critical that the hardware and biological assay devices give the "correct" values, and it's also important that software exports, loads and displays those values correctly. (So I can see the FDA's oversight interest here.) The FDA should recognize that we already accept a lot of risk when it comes to managing diabetes; some of us are willing to accept a little more, by having complete access to a lot more data, so that we can treat our diseases effectively.

I'm Jeff, and I'm interested in promoting open, accessible data standards for diabetes data.

Permalink Reply by jimt1cgms on April 7, 2011 at 2:27pm

Thanks guys for further explaining this stuff. It sometimes get very confusing.

Did the FDA just recently reduce the requirements for devices that "interface" with medical devices? Would this not help speed certain things up?

And its the pump that has the algorithm to adjust dosing, otherwise its us doing the pencil and paper tricks, okay a little help with a calculator. So why the FDA approval for getting to the data? Are you telling my my little USB dongle for CareLink has FDA approval?

Permalink Reply by Jeff Mather on April 7, 2011 at 3:21pm

Yup. That dongle. The cables that connect to your meter. The CareLink website (I'm 90% sure). Etc.

But we don't want to make a cable. We just want the post-dongle data.

What's this recent FDA rule change you write about?

Permalink Reply by BadShoe on April 7, 2011 at 3:51pm

CareLink just passes FDA for Mac and was announced on Monday by MM.

Permalink Reply by jimt1cgms on April 7, 2011 at 4:00pm

I may have misinterpreted a tweet about this, and I have only skimmed this article,but I believe the gist is:

“By increasing the predictability, reliability, and efficiency of our regulatory pathways, we can help provide better treatments and diagnostics to patients more quickly, stimulate investment in and development of promising new technologies to meet critical public health needs, and increase the global market position of U.S. medical devices,”

http://www.medcitynews.com/2011/01/fda-unveils-plan-for-smarter-510...

Permalink Reply by jrtpup on April 8, 2011 at 4:51pm

The Animus diasend site, and the RF (shudder) dongle also needed to be approved by the FDA. Ugh.

Permalink Reply by Bernard on April 7, 2011 at 10:39am

I've heard of the HL7 standard and Jeff just mentioned the DICOM standard. One problem with both of these standards is that you have to purchase a copy, which is fairly big $$ especially for a startup company. HL7 is definitely the accepted standard in many cases.

Ideally I'd like to define a simple, extensible, standard using an XML file format. I think there's a small set of record types:

1. Blood Glucose measurement. Could be used for both meters and CGMs
2. Medication dosing. Need to cover injectables and tablets.
3. Health information. Am I sick, under stress, etc.
4. Exercise information. Type of exercise, duration, intensity,

Any other suggestions for data records that are specifically diabetes related? I'm assuming there are enclosing records for patient information.

Permalink Reply by Jeff Mather on April 7, 2011 at 10:58am

Excellent suggestion, Bernard.

Two things. DICOM is freely available. NEMA seems to have given up on the idea of getting people to buy five linear-feet of printed standard and now just provide the "blessed" standard as a PDF every year.

And the other is that we should allow as many of the pump events as possible. I don't know what they all mean, but I wrote about the data my pump stores recently. I suspect there's value in having all of that data accessible to app developers.

Oh, and I'm not advocating using DICOM or HL7. Just noting that DICOM provides a model for interoperability and industry-led self-regulation, which doesn't require much FDA involvement.

Permalink Reply by jimt1cgms on April 10, 2011 at 9:52am

I've started thinking of an xsd format based on what Bernard has been saying. If I have time this week, I am trying to plan on building some sample xsd done in a way so that:

Each individual device doesn't have to provide ALL of the xml.
Only the subset of elements for the particular device needs to be presented.

This way the mini bg meters may only need to provide the event date time (Event = BG Reading) and the reading itself

up to the more complex CGM's and their various outputs.

Permalink Reply by BadShoe on April 7, 2011 at 11:18am

I just saw an ADA tweet about 24/7 data tool. see http://bit.ly/ie2Bm5

So silly me tried to call'm to ask about it. Epic fail.

Permalink Reply by BadShoe on April 7, 2011 at 12:27pm

I managed to get through. I consider it a challenge when a gate keeper doesn't let me talk with someone. I a bit of a jerk like that.

Had a nice talk with the communications person who wrote the blog entry (that the operator said didn't work for ADA. and said he was was a him when she is a her.) She is gonna introduce me to the person at ADA involved with the health vault thing.

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