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Diabetes apps: regulation concerns grow

PATIENTS with diabetes should be warned about the potential for insulin dosing errors with glycaemic control smartphone apps, experts warn, as regulators struggle to oversee the rapidly growing sector.

There are over 1500 diabetes apps available online – a number growing faster than any other health care sector, according to Dr Rahul Barmanray and Dr Esther Briganti, Melbourne endocrinologists writing in this week’s MJA.

“Although apps increasingly advise on insulin doses, there is minimal published information on safety and efficacy, despite these apps effectively providing drug treatment recommendations without health care professional oversight,” they wrote.

Most diabetes apps are not listed with the Therapeutic Goods Administration (TGA), but even those that are have not been required to undergo third-party assessment as they are only Class I devices. Dr Barmanray and Dr Briganti wrote that as a result, the Australian public were not receiving the health and safety protection they ought to reasonably expect from the regulator.

A spokesperson for the TGA told MJA InSight it was considering stricter regulation of the sector, consistent with reforms in Europe.

“The new rules [in Europe] capture decision making software like dosage calculators … [These] apps will now be a higher classification requiring third-party certification. Australia is preparing to undertake consultation for similar regulatory reforms,” the spokesperson said.

The new rules align with the categories proposed by an international working group, which included the TGA.

However, the TGA has previously highlighted challenges with regulating the fast-moving medical software sector. In a recent presentation, TGA Medical Officer Dr David Hau highlighted the problem of “feature creep”, in which therapeutic functions are added to new updates without regulatory oversight.

The most popular diabetes apps in Australia are the companion apps to diabetes pumps, which are regulated as part of the entire glucose monitoring or insulin delivery system, Dr Barmanray noted. However, many apps are developed by home-tinkerers.

Simon Carter is a lead software engineer. He has also lived with type 1 diabetes for 29 years. He developed an Australian app when his daughter was diagnosed with the disease. He told MJA InSight that he would not welcome greater regulation of medical apps.

“It is already too costly, and existing regulation is too outdated to capture the nuances offered by apps,” he said.

Mr Carter said that some patients were using the app to guide multiple daily insulin injections, others were using it in conjunction with an insulin pump.

Mr Carter argued that it was “absurd to imply that only doctors or diabetes educators can provide insulin dose advice”.

“My practical experience and self-education far outstrips the content of the 1-year part-time diabetes educator course.

“Diabetes is probably the only disease where the doctor provides a suggested dose and the patient has to tailor that multiple times per day based on food intake, activity level, blood sugar results and other factors,” he said.

“The doctor is not there to provide round-the-clock guidance, and this is why these apps are so important.”

Dr Barmanray and Dr Briganti urged health care professionals to “remain circumspect” about recommending diabetes apps – especially those with therapeutic functions – in the absence of adequate regulatory safeguards.

They cited the largest review of insulin dose calculation apps to date, which found that of 46 apps, only one was without a safety concern.

Some apps had design flaws that made them more prone than others to patients incorrectly entering data, the study found.

Others had fundamental problems with the underlying software, with two-thirds carrying the risk of generating incorrect and hypoglycaemia-inducing outputs despite data being correctly entered.

Dr Barmanray and Dr Briganti warned: “It is unclear who, if anyone, is medico-legally responsible for adverse effects related to app-derived therapeutic recommendations”.

Mr Carter commented: “We take total responsibility for both preventing patients receiving flawed advice from the app, as well as promptly correcting any issues that might occur.”

Professor Jane Speight, Foundation Director of the Australian Centre for Behavioural Research in Diabetes at Deakin University told MJA InSight that patients should treat diabetes apps as “tools with limitations”.

“The very use of the term ‘[dose] calculator’ implies a level of accuracy that may not be appropriate or realistic,” she said. “That said, many people are making such decisions every day based on guesswork or informed by education undertaken at diagnosis. So, I think we need to be realistic that people will try these apps.”

Professor Speight said that there were promising examples of industry and academia now working together to carefully develop diabetes apps with appropriate regulatory considerations.

“The opportunity to reduce the cognitive and psychological burden of managing diabetes is quite considerable,” she said. “However, we do need the reassurance that industry will go through appropriate steps to ensure the safety and effectiveness of these apps before we can recommend them wholesale.”

The TGA encourages users of medical device software, including apps, to report any issues encountered, even if they may be considered “user errors” or fixable by a reboot.

Between 2016 and 2018 the TGA recalled four diabetes apps – three by Roche (Accu-Check) and one by Medtronic (Guardian). Errors in the apps could have led to incorrect bolus insulin advice or to patients not receiving alerts associated with hypoglycaemic or hyperglycaemic events, the TGA warned.

Professor Speight recommended the T1 Resources website, which provides advice and recommendations about apps and other resources for type 1 diabetes.

 

This article was first published by MJA InSight. Read the original version here.

Have we got the causes of type 2 diabetes wrong?

 

The proportion of adults with diabetes around the world has risen from 4.7% in 1980 to more than 8.5% today. More than 422m people now suffer from diabetes – so there is an urgent need to better understand the disease and develop new treatments. However, new research from Heidelberg University in Germany suggests that we may have got the causes of type 2 diabetes wrong. But have we? And if so, how might it affect treatment?

People with diabetes need to carefully monitor their blood-sugar levels. This is important, as it helps to reduce the risk of developing complications, such as heart disease and blindness. But even with good control of blood-sugar levels, people with diabetes often go on to develop further complications, including nerve damage and kidney damage. This suggests that effective treatment of diabetes requires more than simply good control of blood-sugar levels.

Type 2 diabetes – often associated with obesity – happens when the pancreas doesn’t release enough of the hormone, insulin, or the body’s cells don’t react to insulin. (Insulin helps the body use glucose for immediate energy needs or store it for future energy needs.) This means that sugar (glucose) stays in the blood and isn’t used as fuel for energy. The cause of these defects remains controversial.

The latest research, published in Cell Metabolism, suggests that a molecule called methylglyoxal (MG) may cause many of the defects associated with type 2 diabetes. But what does it do?

MG is a reactive metabolite (a byproduct of cells) that leads to the formation of other powerful molecules that are readily able to modify protein, fats and DNA in cells. This typically prevents those molecules from working – and this can then result in cells no longer functioning properly. These events are known to lead to the development of diseases such as atherosclerosis, which can trigger strokes and heart attacks.

MG is formed as a result of metabolic pathways – a linked series of chemical reactions occurring in a cell – that are overactive in diabetes and obesity. So it was previously thought that MG production was the result of obesity and diabetes. However, this new research suggests that MG might also contribute to the development of these conditions.

Using genetic engineering, the researchers turned off the enzyme that breaks down MG in flies. MG then accumulated in their bodies and the flies developed insulin resistance. Later they became obese and as time went on their glucose levels subsequently also became disrupted.

These new findings might help explain why, even with good control of blood-sugar levels, diabetic complications still develop. There are important implications from this work, as this suggests that it might be possible to slow down – or even prevent – diabetes complications from developing through a combination of good glucose control along with MG reduction.

An obese fruit fly from the experiment. Its body fat glowing with green fluorescence.
Aurelio Teleman

What does it mean for diabetes treatment?

While diabetes treatments are often effective at bringing blood-sugar levels down, over time their effectiveness usually decreases. As such there is an urgent need to develop new drugs that work to control diabetes and its complications in different ways.

Most current strategies aim to stop the development of type 2 diabetes by targeting cells and tissues linked to insulin secretion from the pancreas, glucose uptake into cells, or by preventing glucose release from stores in the liver. Together these strategies can help control blood-sugar levels.

The new research, however, suggests that in addition to controlling blood-sugar levels we should also consider additional treatments that work by preventing reactive metabolites, such as MG, from forming. But what would be the best way to achieve this?

Reactive metabolites can lead to extensive damage within cells. There is good news, though, in that there are molecules that can effectively stop these products from forming.

Antioxidants, such as vitamin C and vitamin E, have previously been suggested as possible diabetes treatments. However, studies using this approach have had mixed results. One possible explanation for this is that there are multiple reactive metabolites, not all of which are sensitive to antioxidants.

A new champion may now have emerged, though, in the form of the naturally occurring nutritional supplement called carnosine. This is a molecule that was recently shown to prevent formation of numerous reactive metabolites that are formed from glucose and fatty acids.

The ConversationClinical trials are ongoing, but initial findings are promising. They suggest that carnosine is able to reduce blood-sugar levels, as well as prevent multiple complications that are associated with diabetes. Even better, as this is classified as a dietary supplement rather than a drug, no prescription is needed in order to take carnosine.

Mark Turner, Associate Professor, Nottingham Trent University

This article was originally published on The Conversation. Read the original article.