Performance evaluation and regulatory development of Self Monitoring Blood Dlucose devices marketed in Thailand

Abstract

Diabetes is a chronic disease and a public health problem in the world. Caring for patients with diabetes is to control blood sugar levels as close to normal as possible. Performance evaluation of self monitoring  blood glucose (SMBG) devices  is necessary for consumer safety and treatment efficiency. The objectives of this study are to evaluate the precision and accuracy of SMBG devices marketed in Thailand as well as to develop SMBG device regulation. Cross-sectional study was performed on 26 SMBG commercial devices to evaluate precision using the control materials of manufacturers and third parties and to evaluate accuracy by comparing blood glucose  value measured  by SMBG commercial devices (using capillary whole blood of volunteer’s fingertip) and automated routine service analyzer, Cobas 6000® as a laboratory reference method. The intermediate precision result shows that 2 of 25 SMBG devices (8%) reached the acceptance criteria of  %CV ≤ 5 at all glucose levels in case of using third party control material and 13 of 26 SMBG devices (50%) in case of using manufacturer’s control material. The system accuracy result shows that only 3 of 26 SMBG devices (11.54%) reached the minimum acceptable ISO 15197:2013 of ≥ 95% of the measured glucose values fall within criteria, which is more stringent than ISO 15197:2003.

There should be higher level of pre-marketing control for SMBG devices: technical document submission under Article 6(2) of Medical Device Act 2008 and procedure for evaluation of safety and performance of products including label for market approval, which is  in line with international practices and the ASEAN Agreement on Medical Device Directive. SMBG device manufacturer should declare the information how to adjust the device for correct results and provide the control materials covering clinical decision levels to the customer. Post-marketing surveillance should be strengthened including enforcement of mandatory reporting requirements such as adverse effect, device defect, field safety corrective action. Laboratory or testing facilities should also be developed to support pre and post - market activities. Education for correct use of SMBG devices is useful for consumer health care.