Insulin Nation posted a nice summary of a panel discussion at this year's American Diabetes Association meeting in Boston. I won't repeat all of the detail - you can read it here - but there are a couple of things in it that might be worth reflecting on particularly the FDA's views.
I think it was helpful to hear JDRF (in the shape of Aaron Kowalski, their Chief Mission Officer) suggest that above target HbA1C in children with T1D is not usually down to neglect or deliberate non-compliance, but, more likely, down to the tools available for the job in this highly variable age group. I will hold my hands up and say that, on occasions, particularly in the middle of the night or after days without much sleep, I am guilty as charged and make the odd poor decision on when and how to correct but apart from that there's a heck of a lot of peddling to be done as a parent of a little one with T1D: some days you know you've done a good job and others you just feel it made no difference at all (of course it did, but the effect might seem marginal when the sensor trace resembles an ECG output). We know many others in the same boat.
There is a long history in both pharma and medical devices of testing and approving in adults initially - this is a combination of ethical (some the medicines and devices will not work as planned and could put subjects at risk), practical (variability in disease and response in children is greater and it's harder to get reliable feedback from little ones...) and financial (your adult patient population is generally larger). So I was particularly interested to see a very interesting quote from the FDA (Dr. Stayce Beck, the FDA’s diabetes device program chief, to be precise) saying that they, the FDA, would like to see AP approved in children first. However, the AP companies are apparently (not surprisingly) wanting to see approval for adults first. The FDA cannot pass a morale or ethical judgement on this - it just has to review the evidence presented, as would the MHRA over here in the UK, but they may be able to flex their muscles on proven safety in a younger population when it comes to approving. Medtronic, for example, appear to be testing the accuracy of the Enlite 3 sensors (can't wait to get hold of these for use with our 640g...) in 14 year olds and up, and yet the on-line user groups are full of people on CGM (or all types) with small children who are having problems (if anyone has come across an Enlite 3 trial in children - i.e. 2 years and up - then please drop me a comment).
And that leads me on to mention the pesky CGM sensors - the discussion apparently stated that in AP trials with children at home, the AP system was only available overnight for 2 out of 3 nights, with the majority of issues behind that 1 in 3 failure being a lack of accurate Sensor Glucose (SG) readings. Now, as a sleep deprived parent, I'd still take the 2 in 3 nights of automation, providing -providing - I felt I could trust it. And to really bring AP to children, particular young children who are not hypo aware, parents are going to have be convinced that the CGM sensor and SG algorithm can be trusted and that, arguably, is something that no one has been able to deliver across the little T1D population on existing sensor technologies. The first manufacturer to present such a device would be a good position to clean up in the little T1D marketplace.
[Thanks to INPUT for flagging the original Insulin Nation article]
No comments:
Post a Comment