Approved Feedback Needed on Non-Invasive Blood Glucose Monitor Concepts

[tm1769]

Hi everyone,

I am a PhD research student working on developing a non-invasive blood glucose level monitor. We have developed a table-top device that has passed the initial clinical trials. We are, however, now working on developing a wearable form of the device. I have developed several concepts for a wearable device and am trying to collect as much feedback on them before I select one to develop.

This is where I need you're help! What I would like is for each concept to be scored out of 5 (with 5 being the best). I’m really interested in which one you would be more likely to wear/use (the shape/fastening mechanisms are not so important as these will be refined once a concept has been chosen). Also bear in mind that these can be worn while sleeping and will have vibration alarms to wake you if your blood glucose level falls to low.

If you have any extra comments on the concepts that you would like to add please do!

An example answer could be as follows:

• No.2: Rating 4. I like that this device can be used in many locations, however I feel that it would also be easy to loose.

If this is question is in the wrong part of the forum/breaks any rules I apologise and let me know so that I can take it down.

Thanks in advance!

Here are the concepts:


(Alternatively the concepts are available to view here: https://dl.dropboxusercontent.com/u/104095489/Concepts.pdf)

 

[tim2000s]

To be honest, something that took the tattoo sensor type and linked it to a smartwatch is probably the ideal as a non-invasive design, rather than starting from scratch to reinvent the dexcom/apple combination.

Of your options, therefore, I would rate number 4 as a 3, 1 as a 2 and the others a zero. But I also think you need to do a spot of market research as the curve on this is advancing at a fast rate and you need to be aware of the prior art.

You really, really shouldn't be building yet another wearable watch device when there are many smartwatches out there that can provide the functionality you need.

If you could do option 4 with an existing smartwatch and keep the sensor cost reasonable (less than £100 per month) then I would give it a 5.

 

[tm1769]

thanks that's really great feedback!

Yes the sensor will cost much much less than £100 per month. And all the sensors will have bluetooth, so they will all be able to integrate with other smartphones/watches.

The reasoning behind having a "watch-like" display rather than only using a smartphone is due to two reasons:

1. Not all users will have a smartphone - especially elderly users
2. As smartphones are not approved medical devices, this means that they can not be the primary way for the device to display you're result (i.e. an update in software could cause the app used to display the result to have a bug and not function correctly, which would have serious consequences) - I will have to look into the Dexcom system to see how they get around this!

On a side note, the motivation behind concept 2 is that it does not have to be worn continuously, and can be, say, carried in a pocket and used intermittently. Do you think that there are ever times where a user would not want to wear the continuous device and so this would be a benefit? Or would it better just to have two separate devices?

 

[CollieBoy]

I would rate options 2 & 4 most highly due to the lack of sensoring on the wrist, which could be a problem in some areas (Engineers/ HCPs etc)
2 scores highly by being non - permanent , but re-connection could be a problem.
No 4 could be good but trying to keep connection for 6 Mo could be a problem!
1 & 3 could have problems by being watch/wrist based in some jobs and removal /re-connection when watch is rmoved could be a problem

 

[tim2000s]

As smartphones are not approved medical devices, this means that they can not be the primary way for the device to display you're result (i.e. an update in software could cause the app used to display the result to have a bug and not function correctly, which would have serious consequences) - I will have to look into the Dexcom system to see how they get around this!

It's basically the level at which the FDA registers the Apple watch. I think it is given Class II instead of Class III status which means it is far easier to get through the FDA. The sensor is the piece that needs the full FDA review.

 

[tm1769]

ah yes the FDA have in the last month revised their stance on apps displaying medical data ( found here http://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/UCM263366.pdf). Thanks for letting me know!

 

[robertconroy]

We should be monitoring insulin levels that causes insulin resistance.

 

[Flossiealexis]

Hi Tim

I am uk based so cost is not an issue for me personally but a couple of things here. I like the first one the most I am 32 fashion conscious and wouldn't mind having that on my wrist. It's easy to see also which is good. I didn't notice from the design but as long as the screen was illuminated that would be fab. I am not sure about the whole apple watch concept to be honest, I know they are wiring with Dexcom who do specialise in this field I personally wouldn't trust it. Apparently the battery life on them is terrible. I have an animas vibe and I love the technology but hate how big the cgm sensor is so this would be a good option. As with all these things reliability is key and having been diabetic thirty years sometimes it takes a long time to iron out glitches in new devices. I wish you the best of luck though and hope to have one in the future. Sarah Jayne

 

[AloeSvea]

Hi Tim, I'm very pleased to help with such research, as I cannot believe in 2015 we still have so many invasive diagnostics - and who wants fingers full of bleeding, hurting holes?

Concept No. 3: Rating 5. I wear a conventional watch already, so it would be discreet, and would not involve adapting to something too novel, or something else to wear, and it would be very easy to use
Concept No. 2: Rating 3. Next best for me, as is still discreet (thumbs up for underside display), but I would prefer not to wear something specifically for this reason - ie another wrist attachment other than a watch
Concept No 1: Rating 2. As I value discretion so highly this is too obvious and I would run the risk of having 'The Diabetes Police' (ie anyone who recognised a blood glucose reading) comment on me being a T2D, my BG level, and on what I was eating or drinking - which I hate
Concept No. 4: Rating 1. Makes me think of a scuba diving suit for BG readings! I can see how this would suit some, would be high-tech and maybe even fun and exacting, and interesting to use, but too involving for me. I don't even like wearing running shoes

 

[tim2000s]

For anyone who is interested in non-invasive techniques, the healbe gobe is an interesting starting point. The technology doesn't yet work properly, however it is where monitoring will end up.

 

[RichardParis]

I prefer the type 3, more discreet. Now, there is alerady a non ivasive device, http://diatribe.org/abbott-freestyl...itoring-through-utter-simplicity-fingersticks

 

[Spiker]

The reasoning behind having a "watch-like" display rather than only using a smartphone is due to two reasons:

1. Not all users will have a smartphone - especially elderly users

They won't have the illustrated baggy jeans and football shirt either. ;-)

 

[Spiker]

4 is best, I also like 1 and 3 (rating = 2)

It's excellent that the technology is working on a table top. Do you have a link to the technology aspects?

 

[Celsus]

I completely agree with Tim on this one, except I wouldn't even care about the in-between so-so solutions comparing to what I already use today. Make option 4 to connect with one or more of the existing smartwatches from one of the larger brands and keep the sensor cost below £100 per month. Then you have a market winner and 5 points from me!

 

[sp41700]

I prefer the type 3, more discreet. Now, there is alerady a non ivasive device, http://diatribe.org/abbott-freestyl...itoring-through-utter-simplicity-fingersticks

I am not sure I would call the libre sensor non-invasive but taking the readings is certainly non-invasive.

For me the main priorities with any bg measurement system are reliability, accuracy and cost.

All the cgm type systems have a lag. Will your system also have a lag or will it be as up to date as a finger prick test?

I like the idea of seeing the trend of glucose movement as represented on concept 1 and concept 2.

I would like to see the data be able to be downloaded, like we can on the libre software, to see trends etc.

I am currently using a libre which seems like it is similar to concept 4 however my overall preference would be the fitness band concept 1 and 2. I am not sure whether I value the ability to automatically see the bg concept 2 over the discreteness of a button press to get my reading in concept 1. Maybe you could have it so it can be configured both ways

 

[mikeg1964]

Does anyone know if there are any new cgm developments happening soon. The sort of thing I am intrested in is cheaper devices or the nhs making them available. THANKS.

 

[Engineer88]

4 is the only one I'm interested in (rating 5) the other 3 are too restrictive over where they can be worn. I'm a CGM user and find it bad enough I can only really use 3 sites (arms, abdomen)

 

[masinex]

I like the concept idea of 1 and 2 with 4 and 4 scores respectively. However I wouldn't be allowed to wear them at work I don't think. So concept 4 linked to a smart phone with vibrate warnings would be a 5

 

[Fayefaye1429]

Hi Tim

Awesome work!!!
5 for concept 1 for me this is my dream technology you have drawn there!!! One thing I hate but will wear because it's essential is more thing stuck to me. I would prefer to see the readings on it to because to be honest it looks like the watches people wear to loose weight so it blends Io well. I really do t want a watch one as although clever what happens when the watch breaks? Or stops working? Plus I need a ring watch for work so it would be silly as a young woman I would prefer a wrist band concept. Your work reminds me what the concept used in the movie panic room if you have ever seen it. I would say if I had to have the other ones I would go for concept two

 

[robertconroy]

The newest concept in blood glucose monitoring is a contact lense sensor that communicates to your cell phone and can send data to your doctor. I'd try it for sure as I already wear contacts.