There’s a new way for people with diabetes to monitor their blood sugar levels that doesn’t rely on finger prick blood tests. What it does use is a sensor on the arm and the kind of technology used in contactless bank cards.
The new-style monitor licensed for use in the European Union is the FreeStyle Libre by Abbott.
It has just been approved for NHS funding by the NHS Business Services Authority.
Is the new sensor system the same as a continuous glucose monitoring system (CGM)?
It’s not. The company which makes the sensor says: “The FreeStyle Libre System is not a CGM device.” Abbot says it has developed ‘a new category’ of glucose monitoring.
The sensor is designed to be worn for 14 days and is intended to replace blood glucose meters whilst still giving people with diabetes continuous glucose monitoring-like information.
How does it work?
First you have to fix the sensor to the back of your upper arm in a procedure which is said to be no more painful than a typical finger prick test. The sensor is pressed onto a disposable applicator and then the applicator is pushed down firmly to apply the tiny sterile sensor to your upper arm. The sensor goes just under your skin and is connected to a white, water-resistant plastic patch similar in size to a £2 coin.
The sensor monitors glucose in your interstitial fluid – the fluid between your cells – rather than blood glucose levels. The sensor is also fitted with a transmitter that wirelessly transmits results to a special scanner, or an app on your smart phone, to see what your glucose levels are. You hold the scanner, or your phone, close to the sensor for about 3 seconds. You can scan your arm through your clothes.
With a finger prick blood test you get a snapshot of where your blood glucose levels are. With the new sensor every scan shows your current glucose reading, a trend arrow indicating the direction your glucose is heading and the last 8 hours of your glucose history. This lets you know how food, activity and insulin affect your glucose levels – day and night.
Advantages
The benefits of the FreeStyle Libre monitoring system are:
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It’s discrete and convenient
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It takes readings every minute – but you won’t be aware of this
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It gives 8 hours of easy to view glucose history which means patients get more information about the effects of different foods and activity on their glucose levels
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It’s factory-calibrated so it doesn’t require finger prick blood glucose measurements for calibration
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The sensor remains inserted for 14 days
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It stores your readings for up to 90 days
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It provides an easy way to share information with your doctor or diabetes nurse
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It’s approved for children aged 4 to 17 and means parents or carers can manage night-time monitoring with a scan, rather than having to wake children to take a finger prick blood test
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It can be used whether you use an insulin pump, multiple daily insulin injections, other diabetes medications or diet and exercise
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It’s reported to be about as accurate as a CGM.
Disadvantages
It’s not the end of all finger prick tests and there will still be times when they are necessary. For example, when blood glucose levels are rapidly changing, since interstitial fluid glucose levels may not accurately reflect the current blood level, or when the system reports hypoglycaemia or impending hypoglycaemia, or when the patient’s symptoms don’t match the device’s readings.
The FreeStyle Libre does not have any alarms alerting you to the fact your glucose levels are too high or too low, nor does it include a ‘share’ feature to allow for remote monitoring by another person.
Not everyone gets on well wearing the sensor, some find it itches and some have insertion-site reactions.
Has it been trialled?
A 6-month study, published in The Lancet in September 2016, found it significantly reduced hypoglycaemia without raising HbA1c levels in insulin-treated patients with type 1 diabetes, compared with self-monitoring of blood glucose using finger pricks. The research monitored 328 patients with type 1 diabetes from 23 European centres – Sweden, Austria, Germany, Spain and the Netherlands.
The lead researcher, Professor Jan Bolinder, professor of clinical diabetes research at the Karolinska Institute, Stockholm, Sweden, told Medscape: “When the patients started using the Libre device, they instantly tripled their rate of self-monitoring, and this resulted in a marked reduction in time and events spent in hypoglycaemia, time spent in hyperglycaemia, an increase in time spent in optimum range, less glucose variability, and improvements in quality-of-life measurements.”
At the European Association for the Study of Diabetes 2016 Annual Meeting, Dr Thomas Haak, of Diabetes Zentrum Mergentheim, Germany, presented data showing similar outcomes with the FreeStyle Libre system in patients with type 2 diabetes on intensive insulin therapy.
A study published online January 31 in the Archives of Disease in Childhood found the FreeStyle Libre system was accurate, safe and suitable for a broad range of children and young people with diabetes. The study involved 89 children aged 4 to 17 years with type 1 diabetes in 9 UK diabetes centres. Participants were asked to perform four capillary blood glucose tests daily, each immediately followed by a sensor reading.
The company behind the FreeStyle Libre funded the trials.
“Life-Changing”
Reacting to the NHS funding announcement in a statement, Diabetes UK chief executive Chris Askew, says: “Today’s announcement is fantastic news: Not since the transition from urine testing to finger-prick testing has there been such potential to transform the lives of people living with type 1 and type 2 diabetes through technology.
“Flash glucose monitoring can free people living with diabetes from the pain and rigour of frequent finger-prick testing, and puts them in greater control of their condition. In doing so, it has the potential to help prevent a host of devastating long-term complications. Today’s decision is testament to the commitment of campaigners, clinicians and policy makers to making this technology available.
“The challenge now will be that everyone who could benefit from this technology is able to access it where they live. Diabetes UK will be looking to local decision makers to ensure people living with diabetes get proper access to this potentially life-changing technology.”
SOURCES:
Abbott news release
Diabetes UK
FreeStyle Libre website
Medscape
The Lancet: Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial
Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial
BMJ Journals: An alternative sensor-based method for glucose monitoring in children and young people with diabetes
NICE
Diatribe – making sense of diabetes
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