App dose auto calculation

[Blackers183]

Hi All,
I discovered yesterday that the MHRA (UK) have advised DAFNE Online to remove the insulin dose auto calculation (based on carbs gms, insulin/carbs ratio and current BGL level) from this app otherwise it would be deemed to be a 'medical device'. Unfortunately the developers have had to do this as they (DAFNE graduates who developed and maintained the app in their own time) do not have the resources to go through the expensive and exhausting process to have it registered as a 'medical device'. This was only picked up with the latest update of the app and users are venting frustration on that website forum. A search of the definition of a medical device has come up with a very long EU document which I have not read as yet but this is a really bad decision.

In my view these apps make our (type 1s) lives much easier and the auto calculate is one of their great advantages, this decision will have a serious impact on our lives if it is universally implemented.

I'm going to raise the issue with our state diabetes association, my GP and my endocrinologist, what can you do?

David
Melbourne, Australia

 

[tim2000s]

Was the DAFNE app taking IOB into account?

 

[Spiker]

Not sure that's material Tim. But correct me if I am wrong, could be.

This is depressing but isn't a great surprise. We stand on a threshold between the xDrip and Nightscout approach, opening up software to really rapid growth, vs the FDA style approach that means pump and CGM and other "medical device" software is programmed using techniques from the 1980s - and badly at that. It boils down to risk aversion vs innovation.

Hopefully the fingers cannot be stuck in the dam forever but there will be a rearguard fight before it bursts.

 

[Blackers183]

Hi Tim
The DAFNE app does not take into account IOB as one of the DAFNE 'rules' is not more than 10gms CHO between meals therefore no injections and no IOB calculation, basically main meals only. Other apps I used had this function and I though what a wonderful function provided you got the insulin usage per hour correct, however with minimal CHO between meals my HBA1C has come down quite a bit.
David

 

[Blackers183]

Hi Spriker
I must admit that I have been disappointed at the initial response from my endocrinologist about the advantages of the apps as well as other professionals in the 4 years I have been using an app for managing my diabetes. My endocrinologist I think has changed her mind a bit as she rang months ago to ask what apps I had used so she could refer this to one of her other patients, amused smile after that call.
Even though my state diabetes organisation have run articles with app recommendations they still advertise the small log book which I believe does not help self management one bit. I sincerely hope this is the start of innovation and open thinking.
David

 

[Spiker]

You're in the US? In the UK the health policy organisation NICE identifies dose calculation apps as a promising area for delivering future improvements. Given that you would think they would be more supportive and more active in this area.