The study was conducted between September 2016 and November 2016 at Bombay Maternity and Surgical Hospital, Surat, Gujarat, India.
This was a single center, non-randomized, post-marketing study.
#Eximo online ordering iso
The objective of the present study was to assess performance of EXIMO™, as per ISO 15197:2013 section 8 user performance criteria. The glucose range of EXIMO™ is 20-500 mg/dl. The EXIMO™, BGMS utilises test-strips that contains flavin adenine dinucleotide-glucose dehydrogenase (FAD-GDH) enzyme in combination with a proprietary electron mediators to measure fresh capillary or venous blood glucose levels. Ltd., Vapi, Gujarat, India) is the BGMS which is intended for in vitro diagnostic use by diabetic patients or by healthcare professionals in a clinical environment. Hence, ISO 15197 requires user performance evaluation to confirm if intended users are able to achieve accurate measurement results with the BGMS (based upon instructions of use, without any training or assistance). However, untrained users (patients) may found difficulty in obtaining accurate results if the high-quality BGMS is difficult to handle or if the instructions for use are incomplete or unclear. It should be noted that analytical performance evaluations provide standardized and reproducible information for measurement quality of the BGMS when the measurements are performed by well-trained laboratory personnel. However, Klonoff and Prahalad claim that only 32% (31/98) approved BGMS met analytical accuracy criteria of ISO 15197:2013. In view of advancement in technology and importance of BGMS in the treatment of diabetes, the guidelines were revised in 2013 with more stringent criteria (ISO 15197:2013).
The accuracy of BGMS can be assessed based on the guidelines set forth by ISO 15197:2003 describes requirements of design, safety and analytical performance for BGMS. Īs the information provided from these devices is used for making treatment decisions, the accuracy of the BGMS is prerequisite for the sustained success of diabetes treatment regimen. Hence, the use of the BGMS is widely accepted in clinical practice as a part of diabetes management. Moreover, the blood glucose measurements also guide the treating physician to establish pattern of abnormal glucose levels in order to make changes in treatment regimen. Real-time data obtained through the use of the BGMS reflects the influence of physical activity and diet on blood-glucose levels and thereby motivate the patients for life-style modification. Self-monitoring of blood glucose is an integral component of comprehensive diabetes treatment regimen as it improves glycaemic control and reduces the risks for potential clinical complications associated with poor-glycaemic control.
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