If you, or someone you know, is living with insulin-dependent diabetes, you may have heard the term ‘looping’ thrown around lately. But what does it mean?
For the unacquainted, looping is a method of insulin-delivery through a pump that uses a CGM to automatically adjust how much insulin the pump releases. The CGM data then loops back to the insulin pump.
In February 2019, the first hybrid closed-loop system – the Medtronic MiniMed 670G – became commercially available in Australia.Working alongside the Guardian3 CGM, the 670G pump automatically adjusts insulin levels according to the user’s blood glucose levels. The result is a greater time in their target glucose range.
The 670G is currently being used in a nationwide trial of a hybrid closed-loop system, which also comprises a continuous glucose monitor and a maths program. Researchers from the Children’s Diabetes Centre at the Telethon Kids Institute in Perth are leading the paediatric arm of the trial. “The system automatically controls (blood glucose levels) and delivers the required insulin and by doing so, keeps people safer as it prevents their BGL from going too high or too low,” explains Dr Mary Abraham, technology research leader at the Children’s Diabetes Centre and paediatric endocrinologist at Perth Children’s Hospital.
“It’s a bit like the development of a self-driving car – without the system you have to check your own BGL, so it’s something you have to spend every part of your day thinking about.
“The object of the hybrid closed-loop system is to take some of that thinking away and improve glycaemic control.”
All medical technology undergoes a highly rigorous approvals process that can take as long as 10 years.
This process ensures the risks with a new medical device are reduced and that safety is proven.
In the DIY space, build-it-yourself looping systems are a growing trend among the Australian type 1 and insulin-dependent community. Inspired by the #WeAreNotWaiting movement in the USA, DIY looping was born out of frustration among those living with, or impacted by, type 1 or insulin-dependent diabetes who decided to take matters into their own hands and create a build-it-yourself technology that would make it easier to manage the condition.
DIY looping involves the user building a system that uses existing pumps and CGM technology to customise their needs.
The system is then linked to open-access algorithms, which work to deliver insulin doses based on the CGM readings.
LOOPER’S EXPERIENCE: ‘WHY I DO IT’.
Melbourne blogger David Burren, who has been living with type 1 diabetes for 37 years, became a looping convert – or looper as they often call themselves – about two years ago.
“I wear a CGM, with the data being fed into software which decides whether I need more or less insulin,” he says. “The bit that ‘closes the loop’ is when I enable the automatic adjustments where the software tweaks my insulin pump every five minutes.
“In the early days, looping was only possible with some specific old models of Medtronic pumps, but today there are two pumps that can be bought new in Australia which can also be used with these systems. The manufacturer doesn’t sell them for that purpose, but the tools to do so are available online.”
For David, looping has helped him feel more in control of his diabetes.
“If I’m sick and my blood glucose has been riding high, the system will already have been feeding me more insulin by the time I notice the trend and change my settings,” he explains. “If I grab a snack and take it with me intending to bolus for it before eating it, there’s a reasonable chance that I’ll remember that detail 15 minutes after I’ve eaten it.
“That’s always been the case, even before looping. But now, especially if the snack wasn’t super sweet, the system will have already detected the rise and mostly dealt with it.”
He adds that improved sleep is the biggest change noticed by loopers.
“No more overnight waking to go and raid the fridge for hypo snacks, and then having less energy at the start of the day,” he says.
David says the online community of DIY loopers is often the first point-of-call for those who want to know more about building their own system.
“By definition you can’t get someone else to build it for you, as they would then be supplying you with an unapproved medical device,” he says. “But there is lots of information online from other people who have built their own, with quite clear guides as to how it was done.
“The phrase ‘It’s Do It Yourself, but not Do It Alone’ is very appropriate. There is a large community of people helping each other along.”
While there is growing anecdotal evidence among the type 1 and insulin-dependent community around the success of DIY looping technology, due to a lack of evidence-based research it has also drawn some concerns about its safety.
Currently in Australia, DIY looping systems are not approved by the Therapeutic Goods Administration as its safety has not been tested in rigorous trials. As a result, many health professionals in the diabetes space, such as endocrinologists, cannot endorse DIY looping for their patients. The main concerns surrounding DIY looping technology is that, not only is it unregulated for safety and effectiveness, but it is considered “experimental” and still carries the risk of the user’s BGLs falling outside the target range, potentially leading to hypoglycaemia.
The benefits of an approved hybrid closed-loop system is the technical and medical support available to users. Like all technology, the better the user’s input and understanding of it, the better the results. It should also be noted that no technology is hands off – all systems need glucose calibrations and user intervention.
Earlier this year, Diabetes Australia released a position statement on DIY technology such as looping, stating:
“Diabetes Australia does not endorse these technologies for people with diabetes; they are not approved technologies and are highly experimental. Any person using a DIY technology solution does so at their own risk.”
In line with Diabetes Australia, Diabetes WA does not endorse the use of DIY looping but recommends that people who are considering this method are fully informed about the risks involved and continue to see their healthcare professional for ongoing support and care.