How are severe and non-severe hypoglycaemic episodes defined?
Hypoglycaemia is the term used to describe a lower than normal blood sugar level. There are a number of things that actually need to be formally defined in order for a hypoglycaemic episode to be diagnosed. According to the “Whipple’s triad,” a patient needs to have symptoms of hypoglycaemia, an abnormally low blood sugar level, and when they eat something sugary, it should resolve. These criteria apply to both severe and non-severe hypoglycaemia.
There's also a type of hypoglycaemia that is so severe, the patient requires assistance from a third party – not just because they don’t want to get up and get some juice, for example, but because they are suffering from cognitive impairment that is preventing them from managing this themselves. This is because a very low blood sugar level can have a serious impact on the brain.
In what way is the economic impact of hypoglycaemia calculated?
We’ve considered this question recently, and here at Novo Nordisk we’ve developed the Local Impact of Hypoglycaemia Tool (LIHT) to provide estimates of the cost of severe and non-severe hypoglycaemia in the United Kingdom for T1D and T2D adult patients on insulin.
The economic impact is calculated based on epidemiological data, insulin usage, healthcare unit costs and utilisation, which can be applied to a geographical or user-defined population (for example, to specific CCGs in the UK).
The aim is to really understand the economic burden of hypoglycaemia, because from what we have seen, this burden is not fully recognised, despite it being very real.
The LIHT health economic model was developed by Witesh Parekh, health economist at Novo Nordisk. LIHT is designed to aid clinicians and NHS budget holders in identifying the economic burden of hypoglycaemia within their local patient population, and to demonstrate the savings that can be made by reducing the incidence of hypoglycaemia. The model is flexible and can incorporate local real-world data.
We hope that, based on this data and knowledge, clinicians and NHS practitioners can make appropriate decisions and choices so that the healthcare community has the right educational programs and the best possible therapies available for patients.
Please can you outline the figures that were recently presented at the European Association for the Study of Diabetes (EASD) Annual Meeting?
First data from the Local Impact of Hypoglycaemia Tool (LIHT) presented at this year’s EASD indicated that the direct annual costs to the NHS for patients who have had hypoglycaemia is £363.6 million. That's quite a substantial amount.
The LIHT model estimates the full range of costs for hypoglycaemic episodes, which can reach up to £2,195 for a severe episode, where the patient has been brought to A&E via an ambulance and requires hospitalisation. This cost could increase substantially with an extended stay in hospital.
The average direct cost per hypoglycaemic episode was calculated as £189.20 for a severe episode in patients with T1DM, £419.38 for a severe episode in patients with T2DM, and £12.73 for a non-severe episode.
Furthermore, these are only the direct costs to the healthcare system and these calculations do not take into account the indirect costs to society caused by the effects of hypoglycaemia.
Were you surprised by these figures and how do they compare to previous estimates?
We were of course aware that hypoglycaemia presents a challenge, but we were quite surprised by the estimates this year. Actually, we were wondering whether we had done something wrong and whether we had inflated and increased the numbers. But, when the team looked at the actual data put in, the estimates are actually quite conservative.
Other estimates have been based on national or global figures and not as much effort as this has gone into looking at local health economies, so we're really understanding what needs looking at out there.
Why is the economic burden of hypoglycaemia likely to be underestimated?
I think one reason is simply that the burden is not sufficiently recognised and reported. There was a time when we used to accept that lots of people died from infectious diseases and that death was just an accepted outcome of being sick with such a disease. We don't accept that anymore because today we can actually treat patients and we expect better for patients.
I think that for many years we have accepted that hypoglycaemia is simply a necessary challenge when patients are being treated for diabetes. A large global study (the Hypoglycaemia Assessment Tool or HAT study) investigated hypoglycaemia and we now know that its incidence is significantly under-reported because patients are not being asked about it.
The study included data for almost 30,000 insulin-treated patients with diabetes across 24 countries and showed the importance of identifying the impact of hypoglycaemia and taking some actions to manage common diabetes communications.
What are the main reasons why patients may not report episodes of hypoglycaemia?
One thing we have found is that although people with diabetes often fear hypoglycaemia, one in five patients feel that hypoglycaemia is not really important enough to discuss during appointments with their healthcare professional and one in ten are worried about wasting their healthcare professional's time. Patients may also be under-reporting because they are worried about losing their driving license.
We’ve seen previously that only between 15 and 25 percent of all hypoglycaemic events actually end up being discussed with the healthcare professional. So, patients are not telling their doctors and the doctors are not asking.
To help improve discussion and awareness of hypoglycaemia, Novo Nordisk has launched a campaign called “TALK Hypos” in collaboration with Diabetes UK. The campaign has launched to coincide with Hypo Awareness Week (29 September–5 October 2014). Over a hundred and forty hospitals have signed up to take part, ensuring all hospital staff understand hypoglycaemia – what it is, how it affects patients, and what we should actually do about it.
TALK is actually an acronym for “think, ask, learn, and keep track”. The "think" part refers to how patients should know what hypoglycaemia is and be aware if they are suffering from a “hypo”.
The "ask" part is aimed at ensuring patients ask doctors and nurses about hypos as a regular part of patient consultation.
The "learn" part refers to how education is key in terms of understanding the risks of hypoglycaemia, what causes it, and how the right balance between diet, exercise and medication can help prevent it.
Finally, the “keeping track” simply refers to how patients should monitor their condition, so they can identify whether problems are occurring and discuss these with their healthcare professional.
What can healthcare professionals do to help?
I think healthcare professionals can do a lot. Firstly, of course, they need to initiate the discussion. We learned from the HAT study, that patients often don’t recognise that it's important to report hypoglycaemic events.
Healthcare professionals should therefore make sure they are actively educating patients to ensure they understand what a hypoglycaemic event is, how to record it, and how to report it so that the appropriate therapy options can be discussed.
What impact would the reduction of the incidence of hypoglycaemia have?
First of all, there’s the economic impact, because we can see just how much hypoglycaemia costs, but the really important impact would be on the individual patient, because these hypoglycaemic episodes really debilitate patients and affect their quality of life.
Some of the worst hypoglycaemic episodes that occur are those that happen during the night-time. They completely ruin patients’ quality of sleep and increase work absenteeism, because patients feel so unwell the following day.
We also know that the long-term impact of hypoglycaemic events is not good, because “hypo begets hypo.” At EASD, Professor Stephanie Amiel gave a very nice overview of how to define hypoglycaemia and also highlighted how all sorts of data exist to show that once a patient experiences hypoglycaemia, they become less able to recognise when they are experiencing it in the future.
Also, if patients have reached a stage where they cannot recognise their hypoglycaemia, then they have to be reported to DVLA as they shouldn’t be driving, so there are plenty of reasons for avoiding hypoglycaemia.
How would this reduction be achieved?
First of all, healthcare professionals could help by mapping the extent of the problem in their local health community so that the economic impact can be evaluated. That would offer us an opportunity to offset the cost and impact on patients and to consider appropriate and structured patient educational programs. This would improve patient care and the use of therapies, which could be made more beneficial to patients if they were based on individual patient assessment.
What are Novo Nordisk’s plans for the future with regards to reducing the incidence of hypoglycaemia?
I think the important contribution we are making is trying to understand the problem properly by consolidating the documents and evidence that exist out there. Then, we need to make sure we continue to make new and innovative therapies that can be used on the right patients, at the right time and in the right way.
We simply need to support patients in the long-term by delivering better glycemic control, without increasing the risk of hypoglycaemia and the associated complications.
Where can readers find more information?
People can visit the website www.novonordisk.co.uk for more information.
If there are any healthcare professionals or NHS stakeholders who are deciding on projects and are interested in finding more about the LIHT model, then they can get in touch with Witesh Parekh at [email protected], who is the lead developer and Health Economist at Novo Nordisk.
About Dr Klaus Henning Jensen
A Copenhagen native, Klaus Henning Jensen started his career working as a medical doctor in a hospital setting. An entrepreneur at heart, he drew from his background in physics and business administration to co-found a device company - successfully developing a new type of surgical screw for ostesynthesis of hip fractures. Klaus’ career at Novo Nordisk spans almost a decade and is rooted in Global Medical Affairs. He has held a series of Medical Director and Vice President roles with responsibilities cutting across the entire diabetes portfolio – medical devices, Victoza®, Tresiba®, Ryzodeg® and Xultophy®, as well as other GLP-1 and insulin treatments – with medical and scientific responsibility for the R&D of several of these products. He now sits on the UK & Ireland leadership team as Head of Clinical, Medical and Regulatory.
Tirzepatide significantly reduces weight and diabetes risk in patients with obesity and prediabetes