For many type 1 diabetes sufferers, the lengthy approval process for artificial pancreas technology has led them to make their own devices. But it’s a move that could have complicated legal ramifications for their treating physicians. By Michele Tydd.

DIY diabetic systems

Renza Scibilia wears a continuous glucose monitor on her arm, which is connected to her pump and and iPhone. Her DIY system allows the devices to “talk” to each other.
Renza Scibilia wears a continuous glucose monitor on her arm, which is connected to her pump and and iPhone. Her DIY system allows the devices to “talk” to each other.

More than 118,567 people live with type 1 diabetes in Australia, according to the latest National Diabetes Services Scheme snapshot from June this year. Their pancreas produces little or no insulin, which is the hormone that moves blood glucose into the cells for energy and storage, and they must rely on various modes of insulin delivery from syringes to smart pens to pumps to keep blood glucose levels within a normal range. Each day is a constant but necessary juggling act to reduce the damage the disease can do to the eyes, kidneys and nerves. Unlike type 2 diabetes, lifestyle plays no role in the onset of the disease and there is no known cure.

For those with the condition, breakthrough artificial pancreas technology has been developed and is awaiting Australian government approval from the Therapeutic Goods Administration (TGA). Sometimes referred to as a closed-loop system, the device will be distributed by Medtronic and is expected to become available later this year for about $8000.

But already a grassroots movement is circumventing regulatory red tape to allow diabetics access to the long-awaited technology, with diabetics, or a member of their family, now able to use free online instructions to build a device that works in a similar way to the commercial unit.

The use of the technology is not illegal but, because it involves hacking commercially available pumps and blood glucose monitors, it has created uncertainty and confusion among many health professionals about how to safely continue treating DIY patients.

Known as the WeAreNotWaiting movement, the group is part of a bold global community made up of diabetics – and the parents of juvenile diabetics – who are heavily reliant on medical devices to manage their condition but frustrated by the lengthy regulatory approval process for new devices, which can take years.

The movement began in the United States in 2012 when diabetes advocates began voicing dissatisfaction over not just the long wait for regulatory approval, but also their desire for more control over what they could do with those commercial devices.

The #WeAreNotWaiting label was adopted at a meeting at Stanford University in 2013 to convey those sentiments.

Now three DIY artificial pancreas systems are being used in Australia, all with settings that can be changed to suit individual needs and preferences.

“It’s not a set-and-forget device but the increase in automation it offers – in checking blood glucose sugars and dispensing insulin – has given me back at least an hour a day of my life and improved my diabetes management,” says Melbourne’s Renza Scibilia, who has been using a system she built a year ago.

In response to the growing number of people using DIY systems, Diabetes Australia in August this year became the first peak body in the world to release a positional statement on the movement.

The statement noted that – at time of writing – the DIY community comprised about 100 people but “the numbers are growing each week”.

While Diabetes Australia does not endorse the DIY method, which it describes as experimental and risky, it acknowledges the frustrations diabetics face in managing their condition and the limitations of current technology.

“There will always be some people who accept a level of risk and choose to take the DIY approach. These people should continue to receive support and care from their diabetes health-care professional and the health system,” the statement reads.

Many health professionals, however, are jittery about the legal implications arising from treating such patients.

“We don’t support the DIY approach,” says the chief executive of the Australian Diabetes Society, Associate Professor Sof Andrikopoulos, an endocrinologist and researcher from Melbourne University.

“There is little evidence it is any better than using the pump in the conventional way. I’ve had a lot of worried endocrinologists coming to me because it raises a raft of medico-legal issues. They don’t want to turn their backs on their patients but at the same time they don’t want to risk their professional registration or their own professional integrity.”

Andrikopoulos agreed that there were some endocrinologists who were enthusiastic about the DIY technology. “But,” he adds, “only until something goes wrong.”

His fear is that if a mishap does occur, it will not only harm the patient but will also have repercussions for the health professional.

“Somebody could be driving along and have a hypo [low blood glucose reaction] and crash their car, which has happened in the past,” he says, by way of example. “But if they’re using a hacked pump, where does that leave the doctor?”

Andrikopoulos says it is a quandary that has led to the formation of a working party to explore ways members, including nurse educators, can continue treating DIY patients without putting themselves at risk.

“Until then we’re leaving it to individual health professionals to make their own decisions,” he says.

Scibilia, who has had diabetes for 20 years and built her own artificial pancreas a year ago, says the arrival of the commercial version is not likely to significantly slow the momentum of the WeAreNotWaiting community.

“I know of a number of people in the DIY world in the US who tried the commercial version when it came out last year but who decided to go back to their DIY system because they found the algorithm to be more aggressive, and they have more control over the settings,” she says.

Scibilia uses a system that is run from an app she built on her iPhone, integrating an insulin pump, a continuous glucose monitor and a matchbox-sized communication device that allows all the devices to “talk” to each other. The algorithm on the app automates insulin delivery.

“The pump will decrease insulin if the sensor is saying my blood glucose is going below my self-set target, preventing hypoglycaemia or low blood glucose. There are pumps and sensor systems available in Australia now that already have that functionality. But my DIY system also increases insulin at the other end to prevent high blood glucose levels,” says Scibilia.

This interoperability between devices, which is built into the DIY system, is what many users see as the key to its success.

Scibilia believes the DIY movement has nothing to do with thumbing its nose at commercial device developers. “We have the utmost respect for device companies who are continually doing their research and development … We just wish it would happen faster and they would listen to us a bit more and respond to what we want.”

She recognises the DIY system is not for everybody but the number of people who are capable of making the shift are growing and many, like her, are overjoyed with the results.

“There are over five million hours worldwide now ticked up by people with diabetes using the DIY systems that shows improvement in management, so the argument put up by some that it is not safe or effective is falling away,” says Scibilia. This figure, recorded by high-profile American DIY advocate and researcher Dana Lewis, was updated on September 19 to 6.7 million hours.

The DIY movement, which some believe has potential to spread beyond diabetic patients, concerns the Medical Technology Association of Australia.

“As an industry we’d be concerned by patients having to resort to DIY devices,” says an association spokesman.

He says the industry spends enormous amounts of money researching, testing and evaluating products before and after receiving market access from the TGA to ensure products are safe and effective.

“Much of the feedback that spurs the creation of the next generation of innovative products comes from physicians who share with manufacturers their real-world experiences,” he says. “As health-care systems increasingly shift to putting the patient at the centre of care, we would anticipate industry will be even better placed to fulfil their needs.”

This article was first published in the print edition of The Saturday Paper on October 6, 2018 as "DIY dilemmas".

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Michele Tydd is an Illawarra-based freelance journalist.

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