There are exciting developments in diabetes technology happening right now, which can help lighten the daily burden of managing the condition. The challenge of making the latest diabetes devices and monitoring more accessible was discussed at ‘Revolutionising Diabetes Care: Celebrating 100 Years of Insulin Therapy’, a recent online conference organised by the Royal College of Physicians and Surgeons of Glasgow. Dr Susan Aldridge reports.
People living with type 1 diabetes are faced with a large number of decisions to make and tasks to do on any given day. “In the words of Professor Simon Heller, ‘type 1 diabetes is the most challenging long-term condition to self-manage,’ and I couldn’t agree more,” said Dr Emma Wilmot, founder of the Diabetes Technology Network UK (DTN-UK). She went on to review the current and future impact of the three types of technology available today to help in the self-management of type 1 diabetes: continuous glucose monitoring, connected pens and closed loop.
In the 100 years since the discovery of insulin, glucose monitoring has transitioned from urine dipstick testing to fingerprick blood testing in the 1970s, which was then the standard of care for many decades. Then, in 2014, the introduction of flash glucose monitoring meant that continuous glucose monitoring (CGM) became affordable and that has led to substantial change.
“If you don’t live with type 1 diabetes, it can be hard to appreciate the difference that CGM can make to your quality of life,” said Dr Wilmot. “Let’s say I want you to drive to Park St in Leeds. I’ll let you have a car and a satnav. No problem? But you can only view your satnav four times during this journey. If that makes you feel a little uncomfortable, that’s great because that’s what we’ve been asking people with type 1 diabetes to do for decades. So what you really want to do is to have unlimited views of your satnav throughout your journey – check where you are, what direction you’re going in and reflect on your journey so far. That’s what continuous access to glucose data allows people with type 1 diabetes to do.”
Clinicians are starting to understand the benefits of CGM for people living with type 1 diabetes – recent research has shown reductions in HbA1c after starting flash monitoring, as well as a decrease in hospital admissions for diabetic ketoacidosis (DKA) and hypoglycaemia, ambulance callouts and severe hypos. “Many international datasets have started to replicate these findings, so as a consequence we’re seeing an increase in access to flash and real-time CGM,” said Dr Wilmot.
However, a key criticism has been that the data from randomised clinical trials came from adults whose glucose was already well-controlled, so there was a call from the National Institute for Health and Care Excellence (NICE) for trials in those with more unstable glucose levels. This led to the Diabetes UK-funded Flash UK randomised controlled trial, which illustrated a 0.5% improvement in HbA1c in the intervention group and an increase in the numbers reaching their target glucose.
The findings led to new NICE guidance in 2022 to offer flash or real-time CGM to adults with type 1 diabetes, depending on their preferences, needs, characteristics and functionality of available devices. “What’s also great is that the ADA/EASD consensus on the management of type 1 diabetes recommends CGM as the standard of care,” said Dr Wilmot. “So there have been huge advances. The challenge now is in delivering CGM.”
In type 2 diabetes, the evidence for CGM is not quite as convincing, so NICE recommends it only in certain circumstances, namely when someone has severe or recurrent hypos, impaired awareness of hypoglycaemia, a disability impairing their ability to self-monitor or needs to do eight or more tests a day.
In the future, a key challenge for clinicians will be choosing a glucose monitoring device. A recent review showed a wide range of new devices coming onto the market – 28 non-invasive optical devices, six non-invasive fluid sampling devices and 31 minimally invasive glucose monitoring devices. Several ‘bloodless’ products are now commercially available. “We, as clinicians, will need to understand what level of evidence is available before we can feel confident offering a device to people with diabetes, as having regulatory approval doesn’t necessarily mean evidence from randomised clinical trials will be replicated in the real world,” Dr Wilmot warned.
The mainstay of insulin therapy is still multiple daily injections. “Even with better glucose monitoring, we’re often left guessing what insulin doses have been given and when,” said Dr Wilmot. While she advises people to record their doses, either in notes or on an app, she acknowledges that this adds to the self-management burden. “In 2023, surely there are better ways of doing this? That’s exactly what connected pens can offer. In the 1980s, the move from insulin vials to pens was a huge leap forward. The next revolution is here, in terms of more pens giving connected data.”
There are many products in development with all the big insulin companies getting involved. Some healthcare professionals may already have experience of the NovoPen 6, which automatically records insulin doses given. Data from Sweden show that connected pens are associated with fewer missed boluses and more time in range.
The technology also has to make sense to the person living with diabetes for wider take-up. Integration with glucose data will be key, as will decision support with bolus calculation, and recording last dose and insulin on board. This will give more useful and meaningful data reports and, of course, bolus reminders will also be useful going forward.
A consultation with someone using a pen is not as meaningful and data-driven as it would be if they were using a pump. “For me, connected pens are that opportunity to bridge the gap between pen and pump with data reports,” said Dr Wilmot. “You have insulin, carbs and glucose data all in one place.”
Before closed-loop systems became commercially available, a lot of tech-savvy people with diabetes built their own systems. While these worked well, healthcare professionals often felt uneasy about DIY closed loop because of the medico-legal implications. However, the US Food and Drug Administration (FDA) has now authorised Tidepool, which is an automated insulin dosing loop built from a DIY system, so there has been rapid progress.
There are now three different closed-loop algorithms commercially available (Medtronic 780G, Tandem Control IQ, CamAPS FX), which are licensed for paediatric use onwards. “For me, the key take-home message is that, across a range of trials, they deliver impressive time in range – generally over 70% – with typically half the amount of hypoglycaemia that you’d see with a pump or multiple daily injections,” said Dr Wilmot. “So I think closed loop is the future – people describe them to me in clinic as being life changing. The future is now and it’s about how we deliver this life-changing technology.”
Dr Wilmot and colleagues have been part of the NHS England closed loop pilot study for people on a pump and flash monitor and having HbA1c above 69 mmol/mol. In her own centre, 63 participants started on closed loop between August and September 2021. She gave an example of a young man who was really struggling and was missing a lot of boluses. In just two weeks on closed loop, his time in range increased from 12% to 51% and his glucose management indicator dropped from 91 to 67 mmol/mol. “This may not be as good as results from the randomised controlled trials, but was certainly enough of an improvement to keep this young man freer of complications than he would have been previously,” said Dr Wilmot.
The data from the NHS England pilot has been analysed by the Association of British Clinical Diabetologists (ABCD), submitted to NICE and submitted for publication. “To give you a flavour of the findings, there are the results from the Midlands – Derby, Nottingham, Leicester – where, across our centres, we’re seeing a 16.7 mmol/mol reduction in HbA1c,” said Dr Wilmot. “I cannot think of another intervention that delivers such a staggering improvement in glycaemic control.”
Data like this is opening the doors to wider access. Closed loop is now to be recommended to over 100,000 people with type 1 diabetes as NICE has published draft recommendations covering those with HbA1c of 64 mmol/mol or above using at least one of either pump, flash monitor or real-time CGM, plus those who are pregnant or planning to get pregnant. “This is absolutely huge,” said Dr Wilmot. “The key focus is going to be delivering this technology to people with diabetes over the decades to come.”
She went on to look at where closed loop systems are going in the future. At the moment, systems are linked, but people will want more flexibility in choosing their sensors and pumps and getting them to talk to one another. In 2019, the FDA authorised the first interoperable automated insulin delivery controller and it’s hoped that many devices will go down that route.
Dr Wilmot would also like to see continual evolution of the shape, size, battery life and physical interactions with closed loop systems. Also on the wishlist is infusion sets improved for convenience and longevity and, of course, key to all this is affordability and reimbursement.
With current closed loop systems, there is still a need to count carbs and have it work out the insulin dose, but there is a lot of work going on internationally to go to fully automated systems. Other developments we may see in the future include algorithms adapted to ultra-rapid insulin, alternative routes of insulin delivery, such as intraperitoneal and multi-hormone closed loops. There could also be additional inputs to closed loop systems such as motion sensing and sensing when the user is having a meal, and sensors that look for additional signals such as ketones, active insulin and lactate.
“I think to realise the potential of diabetes technology, we have to overcome some key barriers,” said Dr Wilmot. “For instance, do we have the workforce to deliver closed loop at scale? We also have significant variation across diabetes services in the uptake of insulin pumps and, if we’re to make closed loop more widely available, this drastically needs to change.”
And, of course, to deliver any of these technologies at scale, healthcare professionals must feel confident in using them. That is one of the key aims of the Diabetes Technology Network UK, which has produced a number of best practice guides (abcd.care/dtn). The Network will continue to make sure the guidance is there to support healthcare professionals who want to increase their confidence in this area.
“My take-home message for you is that for people living with diabetes, basic care has changed dramatically,” Dr Wilmot concluded. “It should now be CGM plus connected pen. We should then be moving forward and, although we typically think insulin pump at the moment, forget that, for we should be thinking closed loop. That’s what’s coming and I’m very excited about it.”
Any opinions expressed in this article are the responsibility of the EASD e-Learning Programme Director, Dr Eleanor D Kennedy.