Development and Evaluation of a Rapid Point-of-Care Blood Glucose Testing Protocol

Thesis Abstract

Diabetes mellitus remains a critical global health challenge, with effective management heavily reliant on timely and accurate blood glucose monitoring. Conventional laboratory-based testing methods, although highly accurate, often involve delayed results, logistical constraints, and limited accessibility in resource-limited settings, thus impeding prompt decision-making and patient care. Consequently, there is an urgent need for the development of robust, reliable, and rapid point-of-care (POC) blood glucose testing protocols that facilitate immediate clinical interventions. This study aims to develop, implement, and evaluate an optimized protocol for rapid POC blood glucose testing suitable for diverse clinical environments. The primary objectives include designing a standardized testing protocol that ensures methodological consistency, assessing the accuracy, precision, and reliability of the protocol in comparison with reference laboratory methods, and evaluating its feasibility and acceptability among healthcare providers. Specifically, the study investigates the correlation between POC device readings and laboratory reference results, determines the protocol's sensitivity and specificity for detecting hypoglycemia and hyperglycemia, and examines user satisfaction and operational challenges in implementation. Employing a mixed-methods research design, the study integrates quantitative and qualitative approaches to provide comprehensive evaluation. The quantitative component involves a cross-sectional study with a sample size of 300 adult patients attending outpatient clinics at a tertiary healthcare facility. Participants are selected through stratified random sampling to ensure representation across different demographic groups. Blood samples are simultaneously analyzed using the POC device specified in the developed protocol and standard laboratory glucose analyzers, with data analyzed using paired t-tests, Bland-Altman plots, and receiver operating characteristic (ROC) curve analysis to assess agreement, accuracy, and diagnostic performance. The qualitative component entails semi-structured interviews and focus group discussions with 20 healthcare providers involved in glucose testing, analyzing responses through thematic analysis to identify operational facilitators and barriers. Validity and reliability of quantitative instruments are ensured through calibration protocols, standardized training, and repeated measures, while qualitative data credibility is enhanced via triangulation and member checking. Expected findings indicate that the newly developed protocol achieves high concordance with laboratory results (correlation coefficient >0.95), exhibits sensitivity and specificity exceeding 90% for clinical thresholds, and reduces turnaround time by an average of 50%. Additionally, healthcare providers report increased confidence in and satisfaction with the rapid testing process, though operational challenges such as device maintenance and staff training requirements are noted. The study demonstrates that the protocol can significantly improve point-of-care glucose assessment accuracy and timeliness, particularly in decentralized settings. This research contributes to the body of knowledge by providing a validated, standardized framework for rapid blood glucose testing that integrates quality assurance measures, operational guidelines, and user-centered considerations. The findings support the adoption of streamlined POC testing protocols to enhance diabetes management, especially in resource-constrained environments. It also offers a basis for policy development and clinical training programs aimed at improving point-of-care diagnostics. The study concludes that the developed protocol is feasible, accurate, and acceptable among healthcare practitioners, recommending its integration into routine clinical practice with appropriate training and quality control measures. Future research should explore the long-term impact of protocol implementation on patient outcomes and healthcare system efficiency, as well as potential adaptation for use with emerging biosensing technologies and handheld devices.