Health Tech World sits down with Glyconics CEO, Dr Kam Pooni, to hear about the affordable, portable and environmentally sustainable future of diabetes screening.
530 million people across the world live with diabetes. That is one in every 10 adults.
The sharp rise in the condition’s prevalence in recent decades is often referred to as a global epidemic that is only predicted to worsen over the coming years.
Exacerbating the risk to global health is the swathes of people who are living with the condition without a diagnosis.
It is estimated that for every person with a diagnosis, there are up to three more that remain undiagnosed.
The wider implications of diabetes are significant.
A major cause of blindness, kidney failure, heart attack, stroke and lower limb amputation, the World Health Organization (WHO) projects it will be the 7th leading cause of death by 2030.
Escaping this major health crisis will rely, in part, on better techniques and systems for early detection.
Traditional screening methods involve blood tests and finger-prick lancets, which come with limitations that have exacerbated health inequalities and left the majority of diabetes patients undiagnosed.
A new era of diabetes screening could be just around the corner
Now on the horizon is a wholly new approach to screening.
The UK-based medical diagnostics company, Glyconics has developed a novel, instant and needle-free alternative to the traditional diabetes blood test.
According to the results of two new studies published at the American Diabetes Association (ADA) annual meeting, the device can instantly reveal an individual’s risk of type 2 diabetes through a non-invasive fingernail reading.
The Glyconics-DS device – which is similar in size to a mobile phone – the device works by using an infrared beam to assess sugar levels which store in the fingernail, and takes just seconds to assess the user’s diabetes risk as ‘normal’ or ‘elevated’.
The tool uses infrared spectroscopy, a technique that has previously been too expensive to roll out on a large scale.
But as the technology has developed, its use in smaller devices has opened doors to numerous possibilities in the healthcare space.
Diabetes screening is one of them.
“The actual principles have been around for a long time, but the issue has been that some of these devices are hundreds of thousands of pounds,” said Dr Kam Pooni, CEO of Glyconics.
“You couldn’t really take that to a primary care setting.
“What’s happened over the last couple of years is these devices have got smaller and cheaper.
“What we’re doing in essence is developing a range of [tools] using spectroscopy as a technique for different areas, including diabetes.”
The two independent pilot studies were conducted across the UK and Spain with contrasting healthcare settings.
The device proved greater than 95 per cent accuracy when identifying people at no immediate risk of diabetes.
“Developing non-invasive systems for population-level screening will be an important tool in changing the paradigm of screening by reducing current barriers and identifying people at risk early,” said Professor Xavier Cos, lead investigator of the study in Spain and chairman of Primary Care Diabetes Europe.
“Early detection and treatment, which are key to better long-term outcomes, require more attention.
“This exciting new approach will shape the pivotal role that primary care plays in the management of diabetes and its long-term outcomes.”
The needle-free device also eliminates the reliance on single-use plastics, reducing waste to zero.
“The use of single-use plastics is huge in healthcare,” Dr Pooni said.
“If we can make a tiny dent in unnecessary blood tests, I think we’ll achieve our aim.”
Breaking down barriers
The portability and affordability of the device are especially pertinent in resource-limited healthcare settings.
Health inequality is widespread, both on a global and national level and is particularly prominent in diabetes care.
In many regions, access to blood tests and specialised screening facilities is limited, leading to delayed or missed diagnoses.
Each cartridge used in a diabetes screening blood test costs around $20 (£15) each.
For people in low-income countries, this cost is a major barrier.
Moreover, in some regions, especially rural areas, traditional blood tests are not always feasible due to the degradation of samples on the journey to the nearest medical facility.
Inequality in diabetes care is especially stark in parts of Africa.
According to the International Diabetes Federation (IDF), Africa has the highest instances of undiagnosed diabetes with as many as 60 per cent of adults currently living with diabetes but unaware that they have it.
The IDF estimates that there are close to 19 million adults in Africa living with diabetes and a further 45 million with Impaired Glucose Tolerance (IGT).
IGT sufferers are at higher risk of developing type-2 diabetes which is preventable or at least manageable through lifestyle if caught early.
In addition to financial and geographical constraints, cultural and historical factors come into play.
“In some low and mid-income countries, there is a big fear about giving blood,” Dr Pooni said.
“It’s a cultural issue. It’s an issue as well, especially in parts of Africa, because of the level of AIDS so people don’t want to give blood.”
With the non-invasive nature of Glyconics-DS, diabetes screening can be done without taking blood and easily integrated into primary care settings, community pharmacies and local healthcare centres to make it more accessible to underserved populations.
The capability of the platform to offer low-cost diabetic screening in developing countries was explored in a feasibility study conducted by the company in 2020.
The project took place in the Democratic Republic of Congo which has the fifth highest incidence of diabetes in Africa. Results from this study are yet to be released.
“We were working with people in the Congo to understand how we could map it out and how you could deploy this,” he added.
“We’re always quite conscious of designing systems that are not just Western-focused.”
Accounting for ethnicity and race in diabetes testing
In 2010, the ADA recommended that the HbA1c test be used for the diagnosis of diabetes.
It remains the most widely used test today, however, ethnicity and race are now known to influence the results of these needle-based diabetes tests.
“Finger prick blood tests are not accurate enough,” Dr Pooni said. “There’s too much variability. We know that for certain ethnicities it doesn’t work.”
Glyconics has sought to address this issue with its novel device. The company chose to conduct part of the recent study in Leicester – a city with a highly diverse population – to prove its efficacy across a wide range of ethnicities, races and ages.
“That was one of the advantages of doing part of the study in Leicester,” Dr Pooni said. “We wanted to go after that ethnicity profile.
“If you think about how hard we made it for ourselves, the fact that we were still achieving that level of specificity was really good.”
Dr Pratik Choudhary, lead investigator of the Leicester-based study and Professor and Honorary Consultant in Diabetes at the University of Leicester, added: “Now we can finally address global inequalities in health and thus identify the millions with undiagnosed diabetes, especially in resource-constrained countries.
“It has also been important to conduct this study in Leicester where screening within our ethnically diverse population is essential for management of diabetes risk and early prevention”.
Glyconics-DS marks a turning point in diabetes screening, offering a non-invasive alternative to identify at-risk individuals at an early stage.
The impact could extend beyond patient outcomes, with potential cost savings to health services and the wider economy, reduced environmental footprints and improved health equity.
The development process is now complete and the key elements needed to launch and scale are in place, Dr Pooni said.
The company is now aiming to obtain CE Marking for the device next year.
Dr Pooni added: “What [we] have is a method and a technology that doesn’t need any single-use plastics, it doesn’t need any processing of the data. You don’t have to take a sample of anyone.
“The real value of it is it can be deployed very quickly and very effectively.
“There is nothing else that needs to be done on the device; the device is ready.
“Now, it’s getting the regulatory part to complete; that is the next key milestone. Then it’s game on.”
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