A feedback on a developing portable A1c measuring system?


(Gea) #1

Hello everyone! :wave:
I am a biomedical engineering student currently working with the company Dianax S.r.l. (www.dianax.eu) to develop a handheld, portable system to measure the value of HbA1c.

We want to develop a smart and useful system that can help the management of your pathology, by measuring the A1c value from a single drop of blood, in complete autonomy and everywhere you want. For doing so, we think that your opinion is really important from the very beginning of the design of this instrument.

I am here to ask your thoughts and feedbacks about our developing system. I am proposing you a fast (2-4 minutes max.) and completely anonymous online survey: https://goo.gl/forms/l8ikEiksDaHEsMS62

Feel free to ask me anything and I hope you can see the innovation of this approach, as I do :slight_smile:

PS: I hope this is the right place to post and discuss it! Sorry If I chose the wrong one, I am new here :sweat_smile:

Gea
gea.bianchi@dianax.eu


(joe) #2

@gea_dianax hi Gea

since the current thinking is that glycosylated hemoglobin doesn’t change very quickly, what would be the point of an instant reading or a reading that you would would need to take more often than 1x every 60 days?

The way I understand it, is that blood cells are imprinted with an average blood glucose over the life span of a blood cell. That’s why the a1c, or HbA1c or glycosylated hemoglobin test can be a good measure of “average” blood sugar over what is typically considered a 90 day period. It’s 90 days because a weighted average of blood cell death and removal.

The test is not as useful as people sometime think. Because an a1c is the same number (~5.6% )if you average say 120 mg/dl… but you can average 120 mg/dl and still have daily extremes and lows. the following sets have the same average {40,200,36,204} and {110,130,90,150} there is data that suggests that swings can also contribute to complications.

anyway, there is currently a home, blood drop A1c meter… for example A1c now, I can’t comment on the unit’s accuracy because even our home blood glucose meters are typically inaccurate, I just know they are available and are about . US$19 per test.Are you proposing a better one?

sorry I am not trying to be negative, all apologies if I offended you.


(Dennis J. Dacey, PwD) #3

Hi Gea @gea_dianax,
I commend you for making an attempt to improve the lives of people with TypeOne Diabetes but, in my opinion, an “instant” HbA1c reading may be more detrimental than helpful. As an A1c reading reading is nothing more than an history report a determination every day or week would not add to required hour by hour awareness needed for effective diabetes management.

Certainly the HbA1c might be an effective tool for a PWD to use to see how effective her/his management has been on average during a prolonged period of time but it provides only a limited picture. As disclaimer, I must add that in the early 1970’s I was involved in the project developing glycosylated hemoglobin and relative percentage values - the HbA1c base originally set as “ideal” was 6.5%, not the current 6.0%.

@Joe has provided above several of the reasons I would use to argue that A1c in itself should not be a goal, but rather a report supporting effective diabetes management. Much of what I offer is based on my 60+ years living with and messing up with MY diabetes management.


(sneathbupp) #4

Agree with the others. Instant a1c not as helpful as (to me), a completely non-invasive bg monitoring system. That would be awesome. I know these are in development, but more people working on it, the better.


(Gea) #5

Dear @joe , @Dennis and @ sneathbupp
First of all, thanks so much for your comments, this is well appreciated. . I will attempt to respond to you all in a single post.

You are perfectly right, A1c is the “average” of the glucose content in the blood over a period of 90-120 days; but the aim of our device is not to have a frequent instant measurement of A1c for preventing hypoglicemic or hyperglycemic levels that are both dangerous (this can be done with a glucometer), but a periodic at home measurement with the frequency the guidelines and the doctor are prescribing to assess the adequacy of the drugs and diet prescription.

As far as we know, the ADA Standards of Medical Care in Diabetes 2018 recommend:

  • To perform the A1C test at least two times a year in patients who are meeting treatment goals (and who have stable glycemic control).
  • To perform the A1C test quarterly in patients whose therapy has changed or who are not meeting glycemic goals.

Point-of-care testing for A1C provides the opportunity for more timely treatment changes.

Our device is still in the development phase and has not received clearance from the FDA yet. We hope to demonstrate a very high level of accuracy and reliability compared with lab-based tests, in addition to mobility, connectivity, ease of use, no calibration required, no refrigeration and long shelf life of the test cartridges…Our website www.dianax.eu will be regularly updated as we progress toward commercialization in Europe and in the US.

I hope I have replied at least to some of your doubts!
Have a nice day,
Gea

PS: I would like to add that our tests greatly reduces the amount of blood needed to measure A1c (from a vial to a single drop) :slight_smile:


(joe) #6

hi @gea_dianax I am still confused as to how your effort is different than this one (currently available)?
https://www.amazon.com/A1CNow-System-Monitor-Diagnostics-Diabetes/dp/B00KBZ4Y5G/ref=sr_1_1_a_it?ie=UTF8&qid=1523296060&sr=8-1&keywords=a1cnow#customerReviews

the website looks nice, too


(Dennis J. Dacey, PwD) #7

Gea @gea_dianax, I hope that you didn’t read my message as tpp negative it is just that in my eyes there are other areas I’d rather see explored - such as @sneathbupp 's suggestion which I’ve posted here also for another non-invasive glucose monitor; I “test-drove” the last non-invasive GM a dozen years ago and found it needed improvement. Still waiting.


(Gea) #8

Dear @joe,
The A1cNow is for sure our number 1 competitor in the home testing segment. It is manufactured by Chek Diagnostics (Indianapolis, Indiana) under the followings brands: Chek Diagnostics A1CNow, PTS Diagnostics A1CNow, Walgreen’s At-Home A1C Test, and Wal-Mart’s ReliOn Fast1AC. Originally it was developed and sold by Bayer. There are very mixed opinions on this device. It is complex to use and very much prone to errors. Here is one feedback found on Diabetes.co,.Uk:
(…) First test: all seemed fine, the meter started counting down from 5 minutes, then after 5 minutes…“error”. I thought I did it correctly, but maybe not as it was my first try. Attempt number two: got the blood sample in the thingamajig, shook it up, but some of the fluid leaked out (I think I didn’t insert it properly). I got the test going anyway, but didn’t expect it to work. After 5 minutes: “error” again” (…) Third attempt: this one went perfectly (…) So, I used up three tests to get one result. However, all in all, I’d say it is an ok piece of kit if you have money to waste and really want to test your HbA1c on your own. I’m not yet convinced it can replace real lab tests, but it would be nice if it could (I know the lab tests are paid for by the government, but I don’t like the inconvenience and waiting for results).

I hope this replies to your doubts :slight_smile:
Have a nice day,
Gea


(Gea) #9

Dear @Dennis,
Surely not, your feedback is absolutly appreciated!
I understand your point. Our work is now focused on the A1c measuring system but, who knows, maybe in a future not so far we could widen our research area to non invasive glucose monitoring :slight_smile:
Gea


(Gea) #10

Dear @joe ,
my response to you has been hidden by the forum but I hope it will be restored soon! :sweat_smile:


(joe) #11

I think I fixed it. It should be visible now


(DDrumminMan) #12

I too would question the need for such a device for an average T1 that goes tot he endo once every 4 months. They do an a1c there. It measures over the last 3 months why do it much more than that?

Rant alert >>

It seems that a lot of innovation on the T1 front over the last 15 years or so has all been about gadgets and technology. This stuff helps some what. I recently got a FreeStyle Libre and it helps.

But what we really need it better/cheaper insulin, I want things that make management easier and better. Most of these innovations while helpful require more effort and time and $$$$$$$$$$$$$ and thinking about it.

<< Rant end

Thanks for posting and letting us know what you’re up to!


(Gea) #13

I want to thank you all by heart on behalf of the entire Dianax team.

We have collected many valuable feedbacks and inputs from different continents and we think that your valuable contribution will allow Dianax to create a better device.

Thanks again to each respondent, your interest in our work is priceless!

Dianax is currently working on finalizing the device and the App.
We will keep you posted on progress and availability!

You can follow Dianax on LinkedIn (linkedin.com/company/dianax), Twitter (@Dianax_eu), Facebook (@dianax1) and obviously at dianax.eu :slight_smile: