Point-of-care testing of HbA1c levels in community settings for people with established diabetes or people at risk of developing type 2 diabetes: a systematic review and meta-analysis protocol

INTRODUCTION: Diabetes mellitus has increased in prevalence worldwide and is causing an increasing burden on health services. The best patient outcomes occur with early diagnosis to prevent health complications. Glycated haemoglobin (HbA1c) is used to assess glycaemic control over 3–6 months and inform clinical management. Point-of-care (POC) HbA1c devices can be used in community settings, independent of clinical laboratories. This review aims to evaluate how these devices have been implemented in community settings and what patient outcomes have been documented. METHODS AND ANALYSIS: This protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis guidance. A systematic search was undertaken in October 2022, using the defined PICOS (population, intervention, comparison, outcomes, study type) statement to identify all relevant articles: CINAHL, Cochrane, PubMed, Scopus and Web of Science were searched (updated February 2023). Studies will be included if they report outcomes of community POC testing for HbA1c for people with diabetes or at risk of diabetes. We will review the PROSPERO database and trial registers. Title, abstract screening and full-text review will be carried out by two reviewers. The Cochrane risk-of-bias tool will be used to assess randomised studies and the National Institutes of Health (NIH) Quality Assessment tool for observational cohort and cross-sectional studies. Publication bias will be assessed visually with a funnel plot and statistical approaches if necessary. If a group of sufficiently comparable studies are identified, we will perform a meta-analysis applying a fixed or random effects model as appropriate. We will investigate heterogeneity using visual inspection of forest plots along with review of evaluative approaches such as Χ(2) and the I(2) statistic. Strength of evidence will be assessed using Grading of Recommendations, Assessment, Development and Evaluation. ETHICS AND DISSEMINATION: Ethics approval is not required for this literature review. The results will be disseminated through peer-reviewed publication and conference presentations. Furthermore, this systematic review will be used to inform the design of a community pharmacy-based prediabetes intervention. PROSPERO REGISTRATION NUMBER: CRD42023383784.