[Diabetes-talk] accessible Insulin pumps

Sun Jun 23 20:00:39 UTC 2013

Julie:

At least here in the U.S., FDA approval is needed to market any such device.
And FDA considers the *whole* device, not just the pump *or* the display.
Thus, FDA would have to approve *both* the iPhone or Android app *and* the
pump and/or CGMS system if such is part of the pumping system. There is one
meter in this country that does communicate with an iPhone app. But the app
is not accessible and even if it were to be made so, FDA would insist upon
going through the whole 510(k) process for the accessible version of the
app, i.e., it won't consider the accessibility features of an app as merely
providing an alternative display.

AS for the Prodigy pump, there was an announcement several years ago that
Prodigy was going to "temporarily" cease development of the product.

And Roche has been going to develop at least some kind of new device useful
to the blind and visually impaired ever since 2006 and the "going to" target
date keeps receeding into the future. It's a common-sense inference that
anything that recedes like that is a mirage! (grin)

There has been some intimations on this and other lists that Johnson and
Johnson is developing an accessible pump. However, I have seen absolutely
*no* evidence of such a development and no one I trust has been able to
confirm such development.

The one creditable effort in this regard is by a gentleman, James Kubel, who
spoke at our diabetes seminar last year in Dallas. He has developed the
prototype of a talking remote control that will communicate with most
Medtronics pumps and meters wirelessly. I can send you his presentation via
dropbox if you'd like. You might want to look at <http://www.pump-mate.com>
also. However, he has not been able to get much backing from Medtronics
except at the engineering level and most of the engineers he worked with
were "let go" fromMedtronics. He has asked the NFB for help in trying to get
things moving.

I know the need for an accessible insulin pump is considered desperate by
many and everyone is hoping for such a creature. However, I think we must be
brutally honest with ourselves and face some hard facts:

(1) There is no law, either in the U.s. or elsewhere, to my knowledge, that
mandates that medical equipment such as blood glucose meters, A1C and/or
keton measuring equipment or insulin pumps, be accessible to the blind.

(2) We, the blind (yes, even diabetics), are a very small minority. One of
the consequences of this fact is that it is just not worthwhile for major
diabetes equipment manufacturers to develop accessible equipment. When it
happens, it's gravy to us. But it is unlikely to happen short of a legal
mandate. And in the U.S., the current political climate is unfriendly, to
say the least, to proposals to place *any* mandates on business.

(3) Some have suggested that the national Federation of the Blind itself
develop an accessible insulin pump. It's not going to happen. Why? Because
we're a nonprofit corporation and, as such, owe a fiduciary duty to those
who contribute financially to us. It therefore would be irresponsible in the
extreme, moral as we might believe it to be, to incur the potential medical
liability inherent in the development, approval process and marketing of an
accessible insulin pump.

(4) I have contacts at the FDA and it may ultimately require FDA action to
get things moving here in the U.S. But I'm afraid that, short of some high
muckety in a company such as Roche, Medtronics or Sanofi-Aventis developing
diabetes or one of his/her relations developing it and, more ideally, if
said individual developed diabetic retinopathy or blindness (though this is
not what we would wish for), I'm afraid that we can talk till we're blue in
the face and little will come out of it barring a miracleor a legal mandate.

But we keep trying.

Mike Freeman, President
Diabetes Action Network
National Federation of the blind

-----Original Message-----
From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On Behalf Of
Julie Graham
Sent: Sunday, June 23, 2013 12:00 PM
To: Diabetes Talk for the Blind
Subject: Re: [Diabetes-talk] accessible Insulin pumps

I'm in the Uk, perhaps they have a release date in mind for here and not in 
the USA?
I won't believe it til I have it in my hand.  a lot of pumps are controlled 
by the blood machine? or a remote, would be so easy for someone who knows 
what they are doing to develop an ap for a device which already has speach 
built into it, like an iphone which can send info via bluetooth and so on.
I'm guessing if an engineer student got their hands on a 2nd hand pump they 
could  sort something no bother.
----- Original Message ----- 
From: "Bridgit Pollpeter" <bpollpeter at hotmail.com>
To: "'Diabetes Talk for the Blind'" <diabetes-talk at nfbnet.org>
Sent: Sunday, June 23, 2013 7:46 PM
Subject: Re: [Diabetes-talk] accessible Insulin pumps

> One, I've not heard anything about this pump, nor has my nurse educator,
> who I work closely with on this topic. And two, consider various
> products created with the blind in mind. Most these products are
> developed by sighted people without ever involving blind people in the
> creation and development stages. And what a sighted person deems as
> accessible is usually far from being truly accessible. Prodigy didn't
> have a completely accessible meter at first; it took a couple of trys
> before the current version hit the market.
>
> And any products like this will require FDA approval, and this can take
> years. I wouldn't trust any company claiming a release date unless they
> state it already has the approval, but even then...
>
> Bridgit
>
> -----Original Message-----
> From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On Behalf
> Of Julie Graham
> Sent: Sunday, June 23, 2013 12:13 PM
> To: Diabetes Talk for the Blind
> Subject: Re: [Diabetes-talk] accessible Insulin pumps
>
>
> Vapor ware?  you don't believe these companies will release a talking or
>
> accessible pump?  i'm not too sure about the prodigy one but i've been
> told
> about the Roche INSIGHT pump by my DSN and by the Roche rep for this
> area.
> Perhaps it won't talk but I was told they were working on something to
> be
> released next year which was designed with blind people in mind
> ----- Original Message ----- 
> From: "Mike Freeman" <k7uij at panix.com>
> To: "Diabetes Talk for the Blind" <diabetes-talk at nfbnet.org>
> Sent: Sunday, June 23, 2013 6:06 PM
> Subject: Re: [Diabetes-talk] accessible Insulin pumps
>
>
>>I consider all the examples you cite below complete vapor ware. More
>>later.
>>
>> Mike Freeman
>>
>>
>> On Jun 23, 2013, at 7:58, "Julie Graham" <orvil_7 at yahoo.co.uk> wrote:
>>
>>> I've only just joined this mailing list and was wondering if anyone
>>> had
>>> any info on the IQ pump by prodigy?  when it's to be released or how
> it
>>> works?  Also Roche are to release a new pump in 2014 which has been
>>> designed with the blind and partially sighted in mind or so i'm told.
>>>
>>> Driving me crazy when I get no answer from the companies.
>>>
>>> Any information would be greatly appreciated.
>>>
>>>
>>>
>>> Julie Graham
>>> _______________________________________________
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>>
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