The digital health game

Diabetes is stressful. Stress makes it worse. Both ‘fight’ and ‘flight’ take energy, so hormones like cortisol and adrenaline actively inhibit the uptake of insulin, which pushes up blood sugar levels. This feels bad enough for a non-diabetic in a situation they can’t resolve with their feet or fists, but for a person with diabetes stress can easily result in further illness. In the short term, elevated blood sugar levels can lead to hyperglycaemia, meaning nausea, headaches, tiredness, blurred vision, and weight loss, as well as recurring bladder and skin infections. Prolonged high blood sugar levels can increase the risk of life-altering complications like neuropathy and retinopathy.

Unhelpfully, the knowledge that failing to control stress levels might eventually result in blindness or the loss of a foot doesn’t do much to lower them. And while just having diabetes might seem like enough of a problem by itself, treating and managing it can often add to the strain. Living with the condition means learning to dose and deliver one’s own insulin using needles and mathematical calculations – adding that tang of exam anxiety to the toxic hormonal mix.

If only that were all. When they’re first diagnosed, type one diabetics are often already very ill. Sufferers, who are usually first impacted as children and young teenagers, might only be spotted after they’ve lost a great deal of weight and no longer have the strength or energy to get through a school or workday. The diagnosis itself can also be very isolating, catalysing a range of mental health issues for youths yet to develop a stable sense of who they are. Depression is three times more common in people with type one diabetes than the general population.

“If you’re a person with type one diabetes, it’s overwhelming to be thrown into it immediately,” explains Soren Smed Østergaard, Novo Nordisk’s VP of digital health. “And if you’re a person with type two, then it’s overwhelming to move from taking a pill a day to having to measure your blood sugar and dose the correct amount of insulin.” Even in these cases, the impact of the realisation that one has become what Østergaard calls a quote-unquote “real” diabetic is hard to overstate: people with type two are also twice as likely to have depression as non-diabetics.

“Then there’s the worry that if you take too much insulin it can be detrimental to your health, and if you take too little you may have complications later in life,” he continues – and even if it doesn’t contribute to clinical levels of depression, diabetes isn’t exactly a confidence booster. “So people get scared. It’s like being a line dancer; if you take a wrong step, the consequences can be severe. And you feel that.”

Indeed, in 2012, Novo Nordisk’s second ‘Diabetes Attitudes, Wishes and Needs’ study found that 39% of people with diabetes feel their medication routine affects their ability to live a normal life. Almost two thirds (65%) of those surveyed also noted that their condition negatively affected their physical health, while 46% felt their emotional well-being suffered.

“People spend a lot of time with diabetes in their head,” says Østergaard. “It’s mentally consuming, and it’s not something anyone wants; it's not something that they've chosen, and they will do anything to be rid of it. You spend your time on it because you have to – and therefore you want to make sure it takes up as little time as possible.”

Digital dosage

Novo Nordisk believes digital therapeutics can help with that. Instead of leaving diabetics to the Sisyphean task of calculating the right amount of insulin for each of their injections, Østergaard’s team is currently trialling an app that uses blood sugar measurements and a simple question about recent hypoglycaemic episodes to automatically titrate users to the optimal dose.

In Østergaard’s view, this sort of dose guidance solution should be a cheap and effective way to share out and build on the improvements advanced devices like smart insulin pens have brought to diabetes management. According to a 2020 Novo Nordisk-led study into the use of these pens (which record the timing and dose of insulin injections and can integrate them with glucose monitors) by type one diabetics in Sweden, they can increase mean discounted life expectancy by 0.9 years. They can also increase adjusted life years by 1.15 – while saving a combined €45,318 per patient compared with standard care. And that’s without directly addressing the stress and strain of dose calculation.

“Digital therapeutics are a lot of things, but what we’re aiming for right now is to make sure that people dose correctly and at the correct time,” Østergaard explains. “People are struggling with complying with therapy, of putting action on their intention, essentially. Maybe maths wasn’t your favourite subject in school, so you’re worried whether you’re calculating your dose correctly, which makes you hesitant to make changes.” Or, in the worst cases, you might try to avoid the hassle by simply skipping doses. “Therefore, you need reassurance, you need support – or at least many people could benefit from that.”

Digital therapeutics don’t just simplify diabetes management for patients and healthcare systems, either. Compared to molecules, apps are remarkably easy to develop, and if they’re designed and trialled to ensure they work safely with drugs that have been proven to effectively treat diseases and promote health, they can greatly magnify a pharmaceutical company’s impacts at minimal cost. “We’re making sure we don’t just get half of the benefits of a drug,” notes Østergaard.

Of course, ensuring even a simple app like the one Novo Nordisk is trialling for diabetes meets regulatory requirements and patient needs is a much bigger ask than making a typical habit tracker or calculator available to download. “It’s simple to understand and simple to programme,” admits Østergaard, “but what we have to do is comply with a lot of documentation to satisfy regulatory authorities that this is safe and tested before we give it to patients.

“That’s the team we’re setting up. The hard part is not the coding: we could probably code the app in two weeks. But testing and ensuring that it’s safe and documenting exactly how it works so we know that it is safe in all situations – that takes a long time.”

For Østergaard, that means melding a tech culture that valorises moving fast and breaking things into a pharmaceutical one that has absolutely no tolerance for mistakes or failures that could result in patient safety issues. He compares the plight of a digital therapeutic developer with that of early social media entrepreneurs. Although Mark Zuckerberg (the originator of the ‘move fast and break things’ credo) specifically made Facebook for university students, there was no requirement for him to concern himself with the dangers – and the stresses – that could arise from its use by the rest of society. Digital health companies, by contrast, need to obsess over people not using a product for its intended purpose, and either find ways to prevent that from happening, or ensure that no dangerous situation can arise from it. “Basically, we need to find developers that also like to do documentation,” Østergaard laughs. “They’re a little bit hard to find: they prefer to develop.”

Simple solutions

Those difficulties aside, Østergaard is clear on the benefits of the science-led and risk-averse attitude for which pharma is known, and believes it gives companies like Novo Nordisk a clear advantage over tech- and brand-focused start-ups that focus exclusively on digital therapeutics. This isn’t the consumer world, where “80% of people will choose Coke and 20% will choose Pepsi” even though blind taste tests almost always find that people have no real preference for one or the other.

“What a lot of these new start-ups are struggling with in digital therapeutics is that they have not proven that they're delivering improved health outcomes, more health,” he explains. By contrast, pharma can use digital therapeutics synergistically within its model of new innovative medicines. “We are saying, when you use our medicines, which have a proven benefit, with a digital therapeutic, then you get more health. That’s what society is interested in getting, so, to have a place in the digital health game, you need to document by proven scientific methods, that, versus, the alternative, your product delivers more health.”

People with chronic health issues don’t choose their conditions like they do phones or customise them like social media profiles, so digital therapeutics still need to be therapeutics first. The perceived benefits of being associated with a particular brand – of picking either Coke or Pepsi – are meaningless when it comes to coping with something like diabetes.

Østergaard is adamant on this. “If you’re paying for medicine, you should only pay for something with a real benefit. And it’s the same for society, if they’re making medicines or digital therapeutics available for people to use, it should be because they have a proven effect.” If people with diabetes couldn’t tell whether their medicines and therapeutics had a real impact on their health, they’d just be extra stressors.

“And it’s not just for Nordisk and diabetes: morally, this is something we should engage ourselves in as an industry,” Østergaard concludes.

“From a societal point of view, we need to ensure, especially in chronic disease, that people are optimally using the medicines that are developed to help them cope and live long lives free of complications.”

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