Good news for people with diabetes Press rele
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Posted On: 07/28/2017 1:28:56 PM
Good news for people with diabetes
Press release: Ascensia Diabetes Care Deutschland GmbH
New DIN EN ISO standard 15197:2015 for blood glucose meters binding
Not all measuring systems meet the requirements
Stricter DIN EN ISO standard 15197:2015 entered into force on 30 June 2017 the harmonization of the DIN EN ISO standard 15197:2015 and thus a new, stricter quality standard for measuring accuracy of blood glucose measurement systems came into force. High measuring accuracy is the basis for correct and important therapy decisions in everyday life. The more precise the values are, the more stable the metabolism can be, the more accurate dosing of insulin and hypoglycemia is better avoided. The new quality standards can contribute to a higher degree of therapeutic safety in the daily life of people with diabetes, but also displace old, inaccurate systems from the market. Users of Contour ® next blood glucose measurement systems are on the safe side: the systems meet the requirements of the new DIN EN ISO standard 15197:2015 fully.
To date, the quality requirements for blood glucose measurement systems and the system accuracy have been recorded by DIN EN ISO-norm 15197:2003. These were now replaced in June 2017 by a new version, the DIN EN ISO standard 15197:2015, which provides stricter requirements for the system accuracy of blood glucose measurement systems. In the leaked DIN EN ISO standard 15197:2003, the deviations of the glucose concentrations at 95% of the measured results were allowed below 75 mg/dl (4.2 mmol/L) of up to ± 15 mg/dl (0.8 mmol/L) and over 75 mg/dl (4.2 mmol/L) at ± 20%. The new regulation now foresees a deviation of a maximum of ± 15% for glucose concentrations of more than 100 mg/dl (5.6 mmol/L) and up to ± 15 mg/dl (0.8 mmol/L) for glucose concentrations below 100 mg/dl (5.6 mmol/L). This requirement must be met at 95% of all measurement results. 1]
Binding regulation also for the handling of
In order to make blood glucose measurement even safer, the new, stricter ISO standard also defined the user-friendliness as a quality criterion for the first time: in order for a blood glucose measurement system to meet the requirements, people with diabetes must be able to use the blood glucose meter spontaneously if they have only read the instruction manual-a training or instruction by qualified personnel may not be necessary.
Up to one fifth of the measuring systems in Europe does not meet requirements
The new standard for measuring accuracy of blood glucose measurement systems marks an important step in the diabetes care industry for patients, doctors and pharmacists. As a consequence, the new ISO standard also meant that manufacturers of non-compliant blood glucose test strips should not be placed on the market since 1 July and that people with diabetes may need to be reintroduced to new systems. Currently, about 20% of the measuring systems in Europe do not meet the requirements of the new DIN EN ISO standard 15197:2015. [2]
Contour Next family is measuring more accurate than the specifications
With the blood glucose measurement systems of the contour next family, users and HCPS (healthcare professionals) can rely on a particularly high quality in blood glucose measurement: the systems have met the stricter standards of the new DIN EN ISO standard 15197 since their launch: 2015. [3, 4, 5] studies even show that the measurement results of the systems are in an even narrower tolerance range of ± 10% or within ± 10 mg/dl (0.56 mmol/L) and exceed the requirements of the ISO standard. [3, 4, 5] in particular in the critical low-glycemic range (< 70 mg/dl or 3.89 mmol/L), the systems have a particularly high accuracy. 6]
The right measuring system for every user
Regardless of the high quality of blood glucose measurement, Ascensia Diabetes Care's portfolio is particularly easy to use and provides the right blood glucose measurement system for every user. The Contour XT and contour next systems are characterised by a very simple operation-contour next sensor to plug in, apply blood and read the measured value after five seconds. The contour next one blood glucose measurement system offers additional advantages beyond the simple operation, such as an illuminated sensor opening for simple measurement in the dark and the smartlight colour signal, which directly assigns the measured values in colour and enables a quick reaction. [*] The combination of the blood glucose measurement system with the Contour ® Diabetes app also allows the patient to better understand the influence of his everyday habits on blood glucose levels.
They recognize a high-quality blood glucose measurement system
• Fulfilment of all requirements of DIN EN ISO standard 15197:2015
• Proven system accuracy and ease of use by qualified personnel and patients
• No influence of measurement accuracy due to interference factors
translated from
http://www.diabsite.de/aktuelles/nachrichten/...0718b.html
Press release: Ascensia Diabetes Care Deutschland GmbH
New DIN EN ISO standard 15197:2015 for blood glucose meters binding
Not all measuring systems meet the requirements
Stricter DIN EN ISO standard 15197:2015 entered into force on 30 June 2017 the harmonization of the DIN EN ISO standard 15197:2015 and thus a new, stricter quality standard for measuring accuracy of blood glucose measurement systems came into force. High measuring accuracy is the basis for correct and important therapy decisions in everyday life. The more precise the values are, the more stable the metabolism can be, the more accurate dosing of insulin and hypoglycemia is better avoided. The new quality standards can contribute to a higher degree of therapeutic safety in the daily life of people with diabetes, but also displace old, inaccurate systems from the market. Users of Contour ® next blood glucose measurement systems are on the safe side: the systems meet the requirements of the new DIN EN ISO standard 15197:2015 fully.
To date, the quality requirements for blood glucose measurement systems and the system accuracy have been recorded by DIN EN ISO-norm 15197:2003. These were now replaced in June 2017 by a new version, the DIN EN ISO standard 15197:2015, which provides stricter requirements for the system accuracy of blood glucose measurement systems. In the leaked DIN EN ISO standard 15197:2003, the deviations of the glucose concentrations at 95% of the measured results were allowed below 75 mg/dl (4.2 mmol/L) of up to ± 15 mg/dl (0.8 mmol/L) and over 75 mg/dl (4.2 mmol/L) at ± 20%. The new regulation now foresees a deviation of a maximum of ± 15% for glucose concentrations of more than 100 mg/dl (5.6 mmol/L) and up to ± 15 mg/dl (0.8 mmol/L) for glucose concentrations below 100 mg/dl (5.6 mmol/L). This requirement must be met at 95% of all measurement results. 1]
Binding regulation also for the handling of
In order to make blood glucose measurement even safer, the new, stricter ISO standard also defined the user-friendliness as a quality criterion for the first time: in order for a blood glucose measurement system to meet the requirements, people with diabetes must be able to use the blood glucose meter spontaneously if they have only read the instruction manual-a training or instruction by qualified personnel may not be necessary.
Up to one fifth of the measuring systems in Europe does not meet requirements
The new standard for measuring accuracy of blood glucose measurement systems marks an important step in the diabetes care industry for patients, doctors and pharmacists. As a consequence, the new ISO standard also meant that manufacturers of non-compliant blood glucose test strips should not be placed on the market since 1 July and that people with diabetes may need to be reintroduced to new systems. Currently, about 20% of the measuring systems in Europe do not meet the requirements of the new DIN EN ISO standard 15197:2015. [2]
Contour Next family is measuring more accurate than the specifications
With the blood glucose measurement systems of the contour next family, users and HCPS (healthcare professionals) can rely on a particularly high quality in blood glucose measurement: the systems have met the stricter standards of the new DIN EN ISO standard 15197 since their launch: 2015. [3, 4, 5] studies even show that the measurement results of the systems are in an even narrower tolerance range of ± 10% or within ± 10 mg/dl (0.56 mmol/L) and exceed the requirements of the ISO standard. [3, 4, 5] in particular in the critical low-glycemic range (< 70 mg/dl or 3.89 mmol/L), the systems have a particularly high accuracy. 6]
The right measuring system for every user
Regardless of the high quality of blood glucose measurement, Ascensia Diabetes Care's portfolio is particularly easy to use and provides the right blood glucose measurement system for every user. The Contour XT and contour next systems are characterised by a very simple operation-contour next sensor to plug in, apply blood and read the measured value after five seconds. The contour next one blood glucose measurement system offers additional advantages beyond the simple operation, such as an illuminated sensor opening for simple measurement in the dark and the smartlight colour signal, which directly assigns the measured values in colour and enables a quick reaction. [*] The combination of the blood glucose measurement system with the Contour ® Diabetes app also allows the patient to better understand the influence of his everyday habits on blood glucose levels.
They recognize a high-quality blood glucose measurement system
• Fulfilment of all requirements of DIN EN ISO standard 15197:2015
• Proven system accuracy and ease of use by qualified personnel and patients
• No influence of measurement accuracy due to interference factors
translated from
http://www.diabsite.de/aktuelles/nachrichten/...0718b.html
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