MEDICAL DEVICES Keep on track
John Shillingford, director of clinical operations at Afon Technology, discusses the developments in blood glucose measurement.
now a key factor in controlling the overall cost to society, with an emphasis on the patient being a fundamental factor in their own disease management. Self-monitoring of blood glucose levels has become a crucial beneficial part of managing diabetes. It is part of an individual’s day-to-day routine, as it can help with necessary lifestyle and treatment choices as well as monitoring for symptoms of hypoglycemia and hyperglycemia. An individual with diabetes is required to monitor their blood glucose level several times a day. The time each day a patient has blood glucose within normal limits – time in range – has been recognised as a key parameter in managing the disease. Although the new generation of minimally invasive glucose monitors has obviated the need for frequent finger-prick blood samples, there have been problems with both uptake and compliance. Younger patients find the patches obtrusive and uncomfortable, and skin irritation has led to discontinued use. The ongoing evolution of blood glucose devices has naturally required the development and update of guidelines that the regulators – both the FDA and EU regulators – require for successful approval of these devices. The regulators require compliance to ISO 15197:2013 for continuous blood glucose monitoring. This is the newest standard for glucose-monitoring devices and systems for self-testing. Compared with its ancestor, ISO 15197:2003, the new standard has tighter accuracy requirements that new devices will have to follow. The new standard requires that, compared with a reference laboratory method, 95% of the blood glucose results be within ±15mg/dL for glucose concentrations less than 100mg/dL or ±15% at glucose concentrations of 100mg/dL or more. Additionally, 99% of the
T
he rapid worldwide increase in diabetes is a challenge to healthcare systems globally. The management of the condition is
readings have to be inside of zones A and B of the Parkes (Consensus) Error Grid for type 1 diabetes.
In development Regarding outcomes and measures of accuracy, an outcome measurement to be considered, which is reported in several references, refers to mean absolute relative difference (MARD) between actual blood glucose level – measured by a gold standard methodology – and is estimated by the algorithm of the medical device.
“Self-monitoring of blood glucose levels has become a crucial beneficial part of managing diabetes. It is part of an individual’s day-to-day routine, as it can help with necessary lifestyle and treatment choices as well as monitoring for symptoms of hypoglycemia and hyperglycemia.”
A number of devices have been developed
to measure blood glucose using interstitial fluid. Dexcom has now released its Dexcom G6 version – approved by the FDA in March 2018. The Dexcom G6 is indicated by the FDA for use as both a stand-alone CGM and for integration into automated insulin dosing (AID) systems. The Abbott Libre Freestyle Flash 14-day system was released in 2018 and, as with Dexcom, is indicated as a stand-alone CGM. These systems have a sensor with microneedles that are attached to the upper arm where it remains for 14 days. The data is collected in a smart data system, for example, a smartphone. Both systems are approved to replace glucose measurements using fingertip blood samples and require attachment with an
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