The ADEA (Australian Diabetes Educators Association) recently published a short article in their ADE internal journal which is relevant to DIY loopers. The article (DIY Looping Technologies [PDF copy]) is essentially a status report saying they’re working with the ADS (Australian Diabetes Society, which is the endocrinologists more than the DEs) on a position statement regarding DIY looping, which they hope to publish in 2019.
Some of the issues discussed in the article are indeed things they will want to clarify (such as what level of advice they can legally provide on setting up systems that have not been formally approved by a regulator).
Unfortunately some of the fundamentals of the article are disturbing. They seem to be working off misinformation. Keep in mind that in the “The issues” section of the article they’re outlining the basis of their further work in preparing a position statement. If you don’t get the foundation of a building right, the building will be flawed.
Here’s some commentary on a few of the issues I can immediately see.
“Devices being used are generally old, no longer in warranty and no longer being sold by device companies because they are outdated.“
The first problem with this statement is that it’s not true.
Yes a year ago most loopers were using old out-of-warranty Medtronic pumps. They are only “outdated” because the vendors decided to sell different devices, not because there’s any particular problem with the Paradigm pumps themselves. In fact most of those pumps are still on the TGA’s ARTG (Australian Register of Therapeutic Devices).
But today the population is changing. More and more people (myself included) are looping with current in-warranty insulin pumps.
The second problem with the statement is that it’s not relevant.
Do they want to put out a position statement on the use of old out-of-warranty pumps?
Or do they want to put out a position statement on the use of DIY technologies?
These are completely separate issues.
I’m sure there are many people out there using out of warranty pumps (and not for looping). Not everyone has the health insurance to afford a shiny new pump as soon as the warranty expires on their old one (and some insurers won’t buy new ones immediately anyway).
“Devices are being altered and reprogrammed and therefore not being used in the way they were originally intended and approved for.“
This is simply not true.
We do not alter, reprogram, or otherwise modify insulin pumps to be used for looping.
There is no “hacking” or modification of pumps going on. The pumps are being issued commands by a computer, using functions that were designed into the pumps by the manufacturer (even if they didn’t publicise those functions).
“If a severe adverse reaction occurs to a person who is DIY looping and we are seeing them professionally, who is responsible?“
I would suggest that the answer is not changed by the fact that the person has built some DIY technology to assist in their management of their diabetes.
Who is responsible if someone manually mis-doses insulin while tired or hypo? I’m guessing fingers would be quickly pointed at the person with diabetes. Why would this be different?
Do note that one of the fundamentals of “DIY” looping technology is that the person with diabetes has Done It Themself!
Under “Legal advice” they quote some “preliminary, high-level advice” saying that
The Therapeutic Goods Act 1989 prohibits the supply or promotion of a medical device not included on the Australian Register of Therapeutic Goods.
This is my understanding also. In other words: “so what?”
Remember my earlier statement about these insulin pumps being on the ARTG? The insulin pumps we purchase within Australia legally have to be on the ARTG. And they are.
Some loopers have imported other insulin pumps for their personal use from overseas (whether they brought them with them when moving to Australia, or by importing the device separately). The TGA already has a Personal Importation Scheme that covers the legalities of this.
Well, there really isn’t a conclusion at this point.
I do however invite the members of the ADEA’s working group on this position statement to consult with qualified people such as myself who should be able to help them make informed decisions, and not perpetuate misinformation such as some of the examples I’ve cited above.
I can easily be contacted via this website at any time.