You Can Make a Difference

Gabby
By GabbyPA Latest Reply 2016-02-11 13:47:57 -0600
Started 2016-02-10 08:16:08 -0600

If you are currently using multiple devises to manage your diabetes, here is your chance to tell the FDA how you would like to see your different devises communicate with each other. Your meter can talk to your computer or your CGM can speak to your pump. The idea is to get all the device makers to use a common communication system so they will be interchangeable.

If this sounds like something you would like to speak up about, pros and cons, the opportunity is now. The open comments will close March 26, 2016.

"This document will be key for all diabetes devices and their associated communications (e.g., pump talking to a phone, CGM and pump talking to each other, meter sending data to a computer and electronic medical record), and we’ll be interested to see how patients, clinicians, and industry respond. Again, the comment period closes March 26, and FDA does take the comments it receives seriously. Please find the draft guidance here, and comment here if you have thoughts on the document! " - See more at: http://diatribe.org/fda-issues-draft-guidance...


6 replies

Nick1962
Nick1962 2016-02-11 11:53:04 -0600 Report

I’m kind of on the fence on this one. I wholeheartedly agree with the notion of interoperability, I’m not sure asking the government to “mandate” such a thing is the way to go. The article cites early digital camera manufacturers agreeing on the .jpeg format (this is converted in camera from RAW format), but this was done to get more cameras in the hands of the casual picture taker. This also resulted in a lot of mediocre pictures/products. Many professionals still shoot in RAW format because it’s much higher quality.

If we ask the government to put out mandates (like we did for fuel and emissions on cars), we’re basically writing a blank check for device manufacturers to say “yes, it’s more expensive, we have to comply”.

I think this would be better handled between the pharmaceuticals and the computer manufacturers (which has already started). Right now, most pharmas aren’t into writing individual apps for use outside the hospital setting, nor is it lucrative – there are a finite number of users, it’s not like non-diabetics will want this. Apple Medical has a ring to it, but again, limited market.

Gabby
GabbyPA 2016-02-11 12:53:12 -0600 Report

I am with you. The word "mandate" makes my skin crawl. I understand the idea of sharing and of keeping it "in the family" as well. Both paths could be very beneficial in different ways. What I would like to see is if a company decides to keep it to them selves perhaps a gap app would work out. It is complicated and I agree that government should not be regulating it. Your jpeg illustration is a perfect example.

Nick1962
Nick1962 2016-02-11 13:47:57 -0600 Report

I know Dexcom has a CGM app for iPhone and iOS, plus a handy little side app (Dexcom Follow) that allows 5 people to follow your numbers as well. I think that’s a great idea because it adds a certain amount of accountability while offering “kinship” and an over-the-shoulder big brother. Again, not something you and I “Gen Xrs” would buy, but if we don’t change our ways, it’ll be a standard feature for a lot of Millennials soon. Here again, you’re tied to Dexcom and Apple so this appeals to/is available to only to a small market of users. This is the RAW format of the device world.

Type1Lou
Type1Lou 2016-02-10 13:29:13 -0600 Report

My BG meters currently communicate my readings to my insulin pump and I can download my pump stats to obtain both a logbook and trends which is great! I know that Medtronic's Enlite CGM communicates directly with Medtronic's 530G insulin pump but if the CGM were a Dexcom, it would not have that same interface. A universal standard would be wonderful!

trimmer19684
trimmer19684 2016-02-10 11:00:32 -0600 Report

that would be a great idea. I know it would say me a lot of time recording my sugar numbers I do that so I can see for my self what I need to adjust in my eating habits.