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After December 2018, we will be moving elements from the doctorportal newsletter to MJA InSight newsletter and rebranding it to Insight+. If you’d like to continue to receive a newsletter covering the latest on research and perspectives in the medical industry, please subscribe to the Insight+ newsletter here.

As of January 2019, we will no longer be sending out the doctorportal email newsletter. The final issue of this newsletter will be distributed on 13 December 2018. Articles from this issue will be available to view online until 31 December 2018.

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.

Seven apps and online tools to help in the fight against burnout

 

If you’re a doctor experiencing burnout, depression or suicidal feelings, nothing beats seeking professional help. But some online tools may help to reduce the odds of these outcomes, say the authors of a new systematic review.

The review authors, from the University of California, say only a minority of health professionals seek treatment for burnout, often due to concerns over confidentiality, stigma, career implications and time constraints. Apps and web tools, although no replacement for professional help, may nonetheless circumvent some of these barriers.

The authors searched PubMed for studies evaluating stress, burnout, depression and suicidality prevention and identified seven online tools and apps that they say could serve as a starting point to improve coping with stressors in the workplace. They add that the next steps involve adapting digital health strategies to specifically fit the needs of doctors and other healthcare providers.

Here are their top seven digital resources:

Breathing

  1. Breathe2Relax:  An app which provides breathing exercises to help users learn a stress management skill called diaphragmatic breathing. This has been shown to decrease the body’s stress response, and help with mood stabilisation, anger control, and anxiety management.

Meditation

  1. Headspace: This app guides users through meditation sessions. Meditation has been shown to reduce depressive symptoms.
  2. Guided audio files from the University of California San Diego: Online resources with guided meditation audios that including mindfulness-based stress reduction techniques.

Cognitive Behavioral Therapy

  1. MoodGYM: An online cognitive behavioral therapy program shown to reduce suicidal ideation in interns.
  2. Stress Gym: Another online program with step-by-step stress management guides.

Suicide Prevention

  1. Virtual Hope Box: an app that helps users with coping, relaxation, distraction, and positive thinking.
  2. Stay Alive: This app provides customized safety plans, breathing and grounding exercise tutorials. It also features an online forum.

You can access the systematic review here.

Doctorportal hosts a dedicated doctors’ health service providing support and information about burnout, depression and suicide prevention in the medical community.

For support and information about suicide prevention, call Lifeline on 13 11 14