Abstract
ObjectivesThis study was performed to estimate diagnostic accuracy of the two commercially available point-of-care tests to identify poor glycemic control defined by HbA1c levels, with high-performance liquid chromatography (HPLC) as a reference.SettingsThe study was carried at two locations, general medical outpatient department of a teaching medical college in Bhopal (urban), and a primary health care centre in a rural area in the state of Madhya Pradesh, India.ParticipantsAll individuals with diabetes mellitus who presented to the health care facility for assessment of glycemic control. We compared HbA1c estimated from two index tests (Hemocue Hb 501, Sweden; SD Biosensor, South Korea) from capillary blood samples with HPLC performed from venous blood, as a reference standard.Primary and secondary outcome measuresDiagnostic properties of index tests such as sensitivity, specificity, positive and negative predictive value and diagnostic accuracy for identifying poor glycemic control were primary outcome measures. Lin’s concordance correlation coefficient (CCC) was secondary outcome measure.ResultsOut of 114 patients, all received reference standard - 103 patients received Hemocue A1C test and 110 patients received SD Biosensor test. Overall both the index tests had similar diagnostic accuracy estimates. The area under the Receiver Operating Curve for SDA1c device was 0.935 (95% CI 0.886-0.983), and for Hemocue device was 0.938 (95% CI 0.893-0.984). The Hemocue device HbA1c value of above 7.0 (positive) correctly predicted poor glycemic control 92% times (81.58% for SD device). There were 4 vs. 11 device failures and 14 vs. 12 failures with SD and Hemocue, respectively. Ambient air temperatures were no different for the device test failures.ConclusionsCommercially available point-of-care tests evaluated in this study are comparable and an acceptable alternative to HPLC-based measurements for the assessment of glycemic control. Tests and device failure rates of both the index tests are similar.
Highlights
Available point-of-care tests evaluated in this study are comparable and an acceptable alternative to high-performance liquid chromatography (HPLC)-based measurements for the assessment of glycemic control
Diabetes is a worldwide health concern characterized by elevated blood glucose levels caused by inadequate pancreatic insulin synthesis and/or decreased insulin sensitivity [1]
The study sought to include all individuals with diabetes mellitus who presented to the health care facility for the assessment of glycemic control
Summary
Diabetes is a worldwide health concern characterized by elevated blood glucose levels caused by inadequate pancreatic insulin synthesis and/or decreased insulin sensitivity [1]. The prevalence of diabetes rapidly rising in India increased from 26.0 million in 1990 to 65.0 million in 2016 [2]. The total number of people with diabetes is projected to rise from 31.7 million in 2000 to 79.4 million in 2030 [3]. The key to avoiding diabetes problems is to keep blood glucose levels within normal limits in addition to lifestyle modifications, blood pressure control, and dyslipidemia management, etc. The reference measure of glycaemic management in people with diabetes is determining the glycated haemoglobin A1c (HbA1c) levels.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
