Unborn babies test for type 1 diabetes supported by $8m

The first study in the world to

test unborn babies for type 1

diabetes has reportedly been supported by an $8

million funding injection.



University of Adelaide where the national study is being carried out

is the first in the world to test

pregnant women for the probability that

their unborn child may have the

condition.



The funding is being provided by

the Juvenile Diabetes Research

Foundation and the Helmsley

Charitable Trust and comes on

top of a $35 million Federal

Government grant over five

years.

The Foundation's chief executive

Mike Wilson said unlike type 2

diabetes, authorities still did not

know what caused type 1.

"Type 1 diabetes has a very

strong genetic element to it, but

that doesn't determine alone

whether you develop the

disease," he said.

"You need to know what

happens in the environment to

trigger its initiation."



Researchers are hoping to find

out whether environmental

factors trigger the onset of type

1 diabetes.



Type 1 diabetes affects the

body's ability to make insulin,

which controls blood-sugar

levels, and can be developed at

any age though it is most

common in children.



Principal investigator Professor

Jenny Couper said the money

would allow researchers to test

1,400 pregnant women who

have type 1 diabetes, have a

partner with type 1 diabetes or

who have already had a child

develop the disease.

"It's the only study in the world

that is going right back into

pregnancy to look at what is

causing diabetes and what we

could change, most importantly,

to prevent diabetes," she said.

What matters to you about device instructions?

Friends at the FDA called. 

Yes, I have friends there. 

They were looking for thoughts on device labeling and wondered if I could ask around. 

Sure, what are friends for? 

I would love to help funnel back thoughts to them from the DOC, not just my 2¢. It is all very informal but I hope, maybe, we can help them organize their thinking if they get to more formal asking. 

Willing to help?

Background:

Here is the little of what I know, labels are the instructions on how to use a device, what it is intended to do and what to do if there is a problem.  

RAPS aka Regulatory Affairs Professionals Society notes that unlike drugs devices do not have standardized labeling. “Under 21 CFR 801, medical device manufacturers are required to label their products with certain information, but the format and layout of that information is for the most part left up to the discretion of the manufacturer.” 1

Given that devices range from fairly simple to very complex it may make sense not to have a one size fits all standard. My BG meter is not the same level of sophistication as the CAT scanner at hospital, even if both are medial devices.

In this case FDA is asking about home-use devices. In the diabetes world that is a wide range of things from meters, insulin pens, pumps, CGMs, uploading software and more.

In a recent document FDA said this about home-use device labels:

Medical device labeling provides safety information, instructions for use, and/or other necessary information to the user. This labeling can be essential for home-use devices, which are much more likely to be used by lay users, who frequently have not been trained to use such medical devices and who are especially reliant on the instructions for use and other information provided by the device label and package insert.  2

AdvaMed the medical device association in 2013 said, "The development of a standardized Table of Contents (TOC) for device Instructions for Use (IFU) may be a useful tool if adequate allowances are made for the broad range of device types, users and environments."  3

So there we have the RAPS, FDA and AdvaMed, A.K.A. a bowl of Alphabits of regulatory professionals, regulators and industry. 

Notice a key group missing? Me too - Users, AKA patients. Maybe that is why they called. 

Here is my ask - take this quick survey. I made it up - none of it is their's. I’ll summarize the results for my friends at FDA and if you would like to see those too, share your contact information at the end of the survey and I send you what I send them. 

https://www.surveymonkey.com/s/MQ9BKQQ

Thanks

Sources:

1) http://www.raps.org/Regulatory-Focus/News/2015/04/06/21899/How-can-Medical-Device-Labeling-be-Standardized-FDA-Study-Aims-to-Find-Out/

2) https://www.federalregister.gov/articles/2015/04/20/2015-08957/pilot-program-for-center-for-devices-and-radiological-health-electronic-submission-for-home-use

3) http://www.raps.org/focus-online/news/news-article-view/article/3487/industry-to-fda-give-us-flexibility-on-proposed-device-labeling-standards.aspx

Help a Dad asking for better education.

Tom Karlya, aka Diabetes Dad reached out and asked for help getting the word out on a North Carolina diabetes education ask.

I'm happy to help share.

The effort is to help provide education about the symptoms of diabetes so that kids are not sent home entering DKA with a suspected flu or other childhood bug. Tom outlines the issue better than I. Like so many advocacy issues this popped up at the last second. All the more reason we need a strong advocacy database.

http://diabetesdad.org/2015/04/27/today-the-world-changes-but-we-must-act-by-2pm-est-please-help/

Diabetes breakups

I'm sorry. I wish it hadn't come to this, but I'm afraid it's over between us.

I don't know why you are looking so surprised - you must have known this was coming after how things have been between us over the last few weeks.

We've been inseparable for so long now. Hardly a day has gone by in the last 5 years when I've been apart from you. All those times we've shared. All those adventures. All those scrapes we have got through together. And now it's come to this.

I know the polite thing to say is that this is down to me, but we both know that isn't the case here. It's not me, it's you. You've changed - and not in a good way. It's not just me that thinks so. Our friends have noticed the change in you too. And I'm afraid I can't go on living with you like this. You have let me down, when I needed you most. And then when I forgave you and tried to go on as before - you just went and let me down again, and again. And now I hardly even recognise you. I just don't know who you are any more.

Maybe you are looking for someone else? Someone with deeper pockets maybe? I hope you'll find someone for your future, but I know for certain that it isn't me - not while you are behaving like this.

And it breaks my heart, because we have been in this together for so long. Perhaps I came to rely on you too much? There were times when I thought I could accomplish anything as long as you were by my side. But now? Now I'm just waiting to be let down. Waiting to be abandoned. I can't trust you - and I can't be with someone that I can't trust.

I'm not angry I'm disappointed. And angry.

So I'm sorry, but I've found someone else.


For those who have *no* idea what I am going on about... after many years of faithful togetherness it seems that Fruit Pastilles (my pocket-based hypo remedy of choice) have changed their formulation. Over the last fortnight I've had to ditch large parts of several packets which became an unusable gooey mess covered in irremovable tinfoil, occasionally plastered to the inside of my jeans pocket. Nice. The worst discovery was during a training run for my forthcoming 10km road race in support of INPUT. Feeling a bit low and discovering half the remaining pastilles rendered useless 5km from home put me in a pretty tight spot for my run back.

Possibly one of the most inexplicably stupid things I have ever done diabetes-wise

My blood glucose readings, yesterday.

Well... here's a thing. And I still can't actually quite believe that I did what I seem to have done.

The setup
Last night we had a smallish portion of spaghetti as our evening meal. This I realise for many would be a complete no-no, but pasta has typically not been the nightmare for me that it is for many. After little experimentation and tweaking I have managed to work out a reasonably successful strategy so it no longer fills me with dread - we eat it maybe once a month.

My approach (depending on recent results) usually involves a 2.5 hour dual/combo bolus at 60:40 for the calculated dose plus an extra 1u. Previously I'd also needed an extra unit up front too, but had dropped that about 9 months ago following some post-meal dips.

More recently my previously solid post-meal performance has been *slightly* marred by a smallish rise something like 4-5 hours after eating (when the majority of the bolus was waning) so yesterday I decided to rejig my approach a little since I have a Libre sensor in at the moment and can watch what's happening. So last night I went for the calculated dose+1u as 40:60 over 3.5 hours and added the extra unit up front and watched and waited.

Annoyingly I was starting from 8.3, but spaghetti often takes a while to get going for me so I wasn't unduly worried. Stayed pretty steady for the first hour then rose gradually by about 1.5mmol/L towards hour 2. Stupidly during this time I decided to confuse matters by bolusing and nibbling on some snacks that were circulating. By about 3hrs after eating I was 5.2 with vertical down arrows (and DW still chugging away) so I gulped some precautionary Lucozade. Headed off the hypo fine, but then my BG rose and flattened at 8.5-9.5 for an hour and a half (presumably spaghetti kicking in at this point). Then inexplicably at 4.5hrs post-prandial (10.30pm) I had another unexpected BG 'kick' up to something like 11.5 so, getting a little frustrated, I whacked in another unit despite considerable IOB (insulin on board). Sat and waited until midnight and the Libre trace was pretty flat in the 10s-11s - no sign of the 1u or IOB making any impact. Just after midnight I topped-up my IOB to make it the 2u I had intended to go to bed on to counteract the remaining spaghetti fallout.

Just to recap: Spaghetti is usually pretty predictable and not a problem. Added complication of snacking/bolusing/dose stacking/dipping/(over)treating *and* trying a new system all at the same time.

But we've STILL not got to the stupid thing...

The stupid thing
One of the great things about the Libre for me is the ability to see what's going on overnight. And also that if I happen to wake, even for a moment, I can scan and check levels in a way that I simply *do not* do if it requires me to fingerstick test.

I checked at 4am and had been pretty much flatlining around 9.5 since 1am. No insulin left on board. I consulted Artoo who suggested a correction of just over a unit, but I wanted to err on the side of caution so I went for a manual bolus of 0.9u (about two thirds of the recommendation).

I woke three hours later a little groggy and scanned for the Libre to read 'LO'. Artoo showed nearly 2 units of insulin on board.

Ehhhhh????

Checked downstairs via BG meter which confirmed BG was 2.2mmol/L. Bewildered and glugging Lucozade I tried to make sense of the situation...

Checking my bolus history I read that at 4am I had bolused not a cautious 0.9u, but 6.0u. Six units. SIX! My BGs had, not surprisingly, dropped off a cliff around 5.30am.

I simply cannot understand how I managed to do that. Even though one figure is very like an upside-down version of the other, I can't believe I could have made that error as all the buttons etc would be on the wrong side of my robot counterpart if I was holding the pump upside down.

But however it was that I managed to construct that error, there seems no denying that I did it.

And it's not one I'm wanting to repeat any time soon!