Community pharmacy based point-of-care testing for early detection of undiagnosed type 2 diabetes mellitus: a study protocol

Background: Type 2 diabetes mellitus (T2DM) remains substantially underdiagnosed worldwide, contributing to delayed treatment and increased risk of long-term complications. Community pharmacies are highly accessible healthcare settings and may play a critical role in early case detection through structured screening programs. This study protocol aims to evaluate the implementation of point-of-care testing (POCT) for diabetes screening in community pharmacies and its potential to identify undiagnosed T2DM among adult pharmacy visitors in Irbid Governorate, Jordan. Methods: This study will employ a two-phase design. In phase one, a cross-sectional screening will be conducted among adults without a prior diagnosis of diabetes visiting selected community pharmacies. Participants will be assessed using the Finnish Diabetes Risk Score (FINDRISC). Individuals classified as high or very high risk will proceed to phase two, which involves glycated haemoglobin (HbA1c) measurement using a National Glycohemoglobin Standardization Program (NGSP)-certified point-of-care analyzer. Participants with abnormal HbA1c results will be referred to general practitioners (GPs) for diagnostic confirmation. They will be followed for six months to assess referral outcomes, treatment initiation, and changes in glycemic control. Descriptive, inferential, and multivariate regression analyses will be conducted. Results: The study is expected to determine the proportion of individuals at high risk for T2DM and the prevalence of previously undiagnosed dysglycaemia detected through pharmacy-based POCT. It will also describe referral patterns, confirmation rates of T2DM diagnosis, treatment initiation, and glycaemic outcomes over a six-month follow-up period. Conclusion: Community pharmacy - based diabetes screening integrating FINDRISC assessment and POCT HbA1c testing has the potential to enhance early detection of undiagnosed T2DM and improve referral pathways within primary healthcare systems. Findings from this study may inform future large-scale implementation of pharmacist-led screening programs and contribute to national diabetes prevention strategies.