A new method of nanotech-based insulin delivery which can be taken as a tablet is providing hope that people with type 1 diabetes might soon be closer to a needle-free alternative. Researchers at the University of Sydney are leading the way in this development of 鈥榮mart insulin鈥.
Fourteen-year-old Jasmine鈥檚 family remembers the day she was diagnosed with type 1 diabetes.
鈥淚 was diagnosed when I was five,鈥 Jasmine says. 鈥淚 had to learn how to inject myself five times a day 鈥 every time I ate breakfast, lunch or dinner or had a snack.听
Her father, Anvij, recalls the moment he heard the news.
鈥淚 got a call at work from Jasmine who was with my wife at听the hospital, saying, the doctor here thinks that I have type 1 diabetes,鈥 Anvij says.听鈥淚t changed Jasmine鈥檚 life, and it changed our family鈥檚 life. I had to become a twenty-four seven parent in a way that I could never have imagined.鈥
Jasmine had to grow up fast, learning how to count carbohydrates and to self-administer insulin 鈥 at home and at school.
鈥淓very time I ate it was a worry,鈥 Jasmine says. 鈥淚 would wonder if my blood sugars would go high, or would they go low?鈥 Jasmine says.
Type 1 diabetes is relentless. It doesn鈥檛 stop and it鈥檚 something you have to live with every day, every minute, every hour of your life
Diabetes is a chronic condition that arises when the pancreas doesn鈥檛 produce enough insulin, a hormone that regulates blood sugar levels.听An estimated听听globally听鈥 听鈥 like Jasmine 鈥 live with type 1 diabetes in Australia.
University of Sydney researchers, Dr (BSc (Hons) 鈥13, PhD 鈥17) and Professor 听(BSc (Hons) 鈥00, PhD 鈥03), decided to focus on developing an oral form of insulin when they heard from clinicians that there was a real need for an alternative to injections.
Clinicians told them of children and older people living with diabetes who struggled to manage their insulin injections safely and independently, as they often didn鈥檛 have anyone at home to help. In some cases, patients were delaying their treatment, resulting in further complications. In others the issue was preventing them from going home from hospital, as their insulin management plan would need in-home nursing support
In addition to the challenges of self-administration, when insulin is injected, it floods the body with the hormone indiscriminately. Side-effects such as hypoglycaemia 鈥 a low-blood-sugar event that results when too much insulin has been injected 鈥 can be life-threatening.听
鈥淭ype 1 diabetes is relentless. It doesn鈥檛 stop and it鈥檚 something you have to live with every day, every minute, every hour of your life,鈥 Victoria says.
An oral form of insulin would allow people who use it to manage their diabetes to be treated by simply taking a pill 鈥 even eating a piece of chocolate with insulin embedded in it 鈥 rather than being dependent on insulin injections.
鈥淲e decided to devote our time to developing successful oral insulin technology to help people with diabetes have more control over their condition,鈥 Nick explains.
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Professor Victoria Cogger and Dr Nick Hunt decided to focus on developing oral insulin technology. Photo: Al Richardson.
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LinkSmart insulin is designed to automatically activate when your blood sugar gets too high.
With cost being one hurdle, another huge challenge facing development in the past, has been the low percentage of insulin that tends to reach the bloodstream when taken orally.
Victoria, with Professor David Le Couteur AO (MBBS 鈥81), in collaboration with UiT Norway Arctic University, discovered many years ago that it was possible to deliver medicines via nano-carriers to the liver. Now the team are applying this technology to insulin.听
The tablet they are developing uses a type of nanoscale material that is one-10,000th鈥痶he width of a human hair. The material acts in a similar way to an acid-resistant coating on a tablet, which protects it from being destroyed by stomach acids.
But in this case the coating is wrapped around individual insulin molecules. They become 鈥榥ano-carriers鈥 鈥 acting like a courier to ferry insulin molecules through the body to the places it needs to act.
However, the greatest strength of the nanoscale material developed by the University of Sydney team, is that it is 鈥榮mart鈥
鈥淪mart insulin is designed to automatically activate when your blood sugar gets too high,鈥 Nick says. 鈥淲hat it can do is control itself, based on your body鈥檚 needs.鈥
It reacts to the body鈥檚 blood sugar levels, which avoids the risk of hypoglycaemia. The pill鈥檚 coating dissolves and releases the insulin only where there is a high concentration of blood sugar 鈥 it doesn鈥檛 release the insulin in low-blood-sugar environments.
Developing 鈥榮mart鈥 oral insulin has taken 20 years of targeted scientific investigation across disciplines. It has involved biomedical researchers, clinicians, chemists, physicists and engineers, many from the University of Sydney鈥檚 Nano Institute and Charles Perkins Centre. Australia鈥檚 national science agency, CSIRO, developed the insulin-coated nanoparticles for toxicology studies in animal models.
Victoria, Nick and David also co-founded , a spinout pharma-biotech company, which focuses on developing nanotechnology platforms for the delivery of therapeutic peptides, proteins, antigens and RNA.
The University of Sydney supports researchers to 鈥榮pin out鈥 their research intellectual property into companies, like Endo Axiom, through mentoring, funding and advice. This helps researchers to bring their innovations to market and speeds up their transition from lab to patients.听
Dr Nick Hunt with sample insulin pills that are set to enter phase 1 human clinical trials in 2025. Photo: Al Richardson.
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LinkOral insulin has the capacity to change the lives of people living with type 1 diabetes
Promising results have paved the way for the orally administered insulin to enter phase 1 human clinical trials this year, with the aim to be in the market by 2030.听
Nick and Victoria are excited about the momentum their project is gaining 鈥 and optimistic about the future.
鈥淥ral insulin has the capacity to change the lives of people living with type 1 diabetes,鈥 Victoria says. 鈥淲ith this tablet we hope that we can improve their lives and make their futures vastly more exciting.鈥
For Jasmine, who now uses a pump via a cannula to help her to monitor blood sugar readings, the prospect of being able to take insulin as a simple tablet is particularly appealing.
鈥淚t would change my life massively,鈥 Jasmine says. 鈥淭he pill would help me regulate my blood sugar levels. It would take all that worry on my mind during the day 鈥 and give me the freedom I didn鈥檛 have before.鈥
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