The next frontier in diabetes management?

A new glucose monitoring system, currently under development which may greatly improve diabetes management, was unveiled at the recent conference of the European Association for the Study of Diabetes (EASD) in Barcelona .

Abbott Diabetes Care showcased its flash glucose monitoring (FGM) concept at the week-long event. The system incorporates a sensor, which is designed to be worn on the body for a period of 14 days. Unlike current continuous glucose monitoring (CGM) systems, which can only be worn for seven to 10 days, FGM does not require finger-prick calibration to ensure accurate glucose readings. 

The FGM system also incorporates a reader, which is ‘flashed’ or scanned, over the sensor to yield three sets of results: 

• An instant current glucose level reading
• A trend reading, which indicates the direction a person’s glucose levels are moving
• An historic reading, which tracks a patient’s glucose data for the previous eight hours. 

The EASD conference heard that the new technology will allow people with diabetes to quickly and effortlessly capture complete glycaemic information – the reader, which will be powered by rechargeable batteries, may even work through clothing. 

Jared Watkin, divisional vice president of technical operations for Abbott Diabetes Care, said: “Current (continuous glucose monitoring) systems can be relatively painful and cruel in terms of the application of the sensors, so that was definitely a design goal for us, to make it simple and lower pain from a sensor application perspective. Obviously, only doing it every 14 days helps.”

Another aim of the FGM design team was to make the wearable sensor as discrete as possible.

“There was a discussion about the size of the sensor and, certainly, for many people with current CGM systems, the size is something that puts them off wearing the product on their body,” said Mr Watkin. 

“If you’re going to wear a sensor on the body, the smaller the better, so we’ve put some effort when designing this system to have a small, low profile patch.”

Patients and healthcare professionals will be able to upload glucose readings to a PC or Mac from the reader via a USB key, to produce a comprehensive ambulatory glucose profile (AGP) report.

“A quick scan is the way to deliver comprehensive data very quickly (without the pain of finger pricks) and very conveniently. So you can scan the sensor when you want and get that result. If you don’t scan it, you can wait up to eight hours and once you scan it again, you still get all that glucose data that has been collected in that eight hour period,” Mr Watkin said.

“The system has software associated with it that will generate the AGP report and allow both the person with diabetes and their healthcare provider to see what their profile is. The importance is it delivers the comprehensive data that is required for gaining insights that you otherwise wouldn’t get.” 

Ambulatory glucose profiles

Ambulatory glucose profile reports allow diabetes healthcare professionals to make the best treatment decisions for their patients, by providing them with an accurate perspective of glucose changes over time, including diurnal glucose patterns, variability and stability.

These reports also help patients to more easily understand their blood glucose levels and this in turn helps to develop a more productive relationship with their healthcare provider to facilitate better education, and more effective treatment and glucose management, including diet and exercise decisions.

At the EASD conference, Dr Gerry Rayman, diabetes consultant physician from the Diabetes Centre at Ipswich General Hospital, UK, gave a presentation on the SIGN (Sensor and Software use for Improved Glucose CoNtrol in type 1 and type 2 diabetes managed by insulin therapy) Study.

The research aimed to evaluate how AGP reports can help people with diabetes to understand how they can improve glycaemic control.

The 10-week study involved seven subjects from the Ipswich Hospital Group. AGP reports were used in consultations with these patients and the results showed various positive effects of using this approach. These included:

• A reduction in nocturnal hypoglycaemia
• An increased stability of median glucose levels
• A reduction in the frequency of correction doses 
• A greater engagement of patients in the management of their condition.

The SIGN study suggested that AGP reports are valuable for both type 1 and type 2 patients by demonstrating clearly the impact of diet and physical activity on their glycaemic levels and facilitating positive changes in both their lifestyle and treatment. 

Dr Rayman concluded that using AGP in patient consultations is a logical, valuable and graphic way of promoting an understanding of their glycaemic patterns and identifying periods when there is a high risk of hyper- and hypoglycaemia. 

At present there are two available types of glucose monitoring products which allow for the collection of the data that is required to generate useful AGP reports. These are blood glucose monitoring and interstitial fluid (ISF)-based CGM. However, there are strengths and limitations to both.

Appropriate testing using self-monitoring of blood glucose (SMBG) is associated with better glucose management and this method has widespread availability. However, it only provides a single point reading – a low frequency data capture. Furthermore, high or low glucose levels are not easily recognised using this type of monitoring.

The element of pain involved in finger-pricking is also a consideration for SMBG and may prevent patients from consistently taking glucose readings.

“Additionally, overnight data is impractical. It’s very hard to get patients to wake up to test their glucose in the sleeping hours and fill in a report,” said Mr Watkin.

Continuous glucose monitoring (CGM) with its three main components – a disposable sensor, a transmitter and a monitor the size of a mobile phone – enables patients to take glucose readings from the sensor, which are transmitted to the receiver.

Patients who use CGM report a better quality of life compared to those who use SMBG, partly due to the fact that it is more convenient. People with diabetes who use CGM also have fewer worries about forgetting to test. However, this monitoring also requires finger-stick calibration, which patients find painful. 

Other limitations of CGM include cost, accuracy and convenience. If CGM is to become more readily available and accessible, the cost to both the patient and healthcare teams must be reduced. In order to cut the cost to healthcare professionals, the amount of time and effort involved in the process needs to be overcome.

The readings provided by CGM systems need to be more accurate and, in order for this to happen, the convenience of monitoring must be improved. CGM must be incorporated more solidly into the workflow and day-to-day practice of healthcare teams. A simple, comprehensive, common report that is standardised would assist with this, the meeting was told.

CGM can be time-consuming (particularly when it comes to interpreting information) and requires frequent and significant ongoing user interaction.

There is also a higher frequency of false alarms with CGM, which can lead to patients turning off their monitor altogether. This method can also be viewed by some diabetes professionals as too generalised and retrospective.

HbA1c testing is important for monitoring and diagnosing diabetes as it provides an average glycaemic level over a period of several months. However, this method fails to accurately portray daily glucose variability and hypoglycaemic events, which is possible when using the SMBG and CGM monitoring approaches.

According to Mr Watkin, the FGM system can overcome the limitations associated with the HbA1c, SBMG and CGM methods of glucose monitoring.

“From our perspective, we feel an alternative to both blood glucose monitoring and continuous glucose monitoring is required, that will be able to penetrate the whole population of people with diabetes,” he said.

Patient adherence 

Good glycaemic control is critical in reducing the risk of complications in diabetes, including sight loss, nerve damage, kidney failure and amputations. If more people effectively monitored their blood glucose levels, fewer serious complications would result.

Effective and accurate monitoring of blood glucose and good glycaemic control are essential for improving patient outcomes. However, around 60% of people with type 1 and 67% of type 2 diabetes fail to practise effective monitoring due to a range of social and physiological factors.

Patient adherence to self-management requirements remains the biggest challenge in decreasing the burden of diabetes in Ireland and across the rest of the world. The main barriers to patient adherence include: pain, cost, patients growing weary of pricking their fingers, the patient forgetting to test, inconvenience, lack of time and the patient believing that monitoring simply isn’t important.

A complex mix of factors affects the number of people with diabetes who accurately and regularly monitor their blood glucose levels. According to Dr Rayman, FGM has the potential to improve levels of patient adherence to monitoring, while also providing them with improved social and educational support.

Similarly, the fact that the FGM reader can scan the system’s sensor through clothing, will allow night-time readings to be taken without sleep disturbance. This could be useful for the parents of children with diabetes, or healthcare professionals who are monitoring glucose levels of inpatients. 

Realistic alternative

However, considering that current CGM methods have only 3% prevalence among the world’s diabetes population, just how successful will FGM be in terms of patient accessibility? Will the new system come at an affordable cost? It is still in development stages and the cost per patient is as yet unknown. 

Mr Watkin said that clinical trials will be needed to address issues in relation to government reimbursement. 

“The intention of the product is to be a realistic alternative to blood glucose monitoring and, in order to do that, the questions of reimbursement and access become real.”

Conclusion

Technological innovations are already assisting millions of people across the globe to take better care of their general health. New apps and electronic gadgets, such as heart rate monitors, are allowing people to track their daily exercise levels, calorie intake and expenditure, sleep and weight patterns. 

Similarly, wearable technology may have the potential to revolutionise personal diabetes management. It could work to empower people with diabetes, foster a true ‘partnership’ between healthcare professionals and patients, and improve patient adherence to monitoring, the meeting heard.

This, in turn, could lead to improved accuracy in terms of monitoring, enhanced treatment choices and better health outcomes. However, none of this can be achieved if the device is not made available to people with diabetes at an affordable cost.