Point-of-Care testing of HbA1c levels in community settings for people with established diabetes or people at risk of developing diabetes: A systematic review and meta-analysis.

BACKGROUND: Glycated haemoglobin (HbA1c) measurement using Point of Care (POC) testing may be of huge utility, providing convenient testing for early diagnosis and regular monitoring of hard-to-reach patient groups. This systematic review aimed to identify evidence for the successful deployment of these devices to improve patient outcomes in diabetes. METHODS: A systematic review and meta-analysis was undertaken in February 2023, to identify all relevant articles: (CINAHL, Cochrane, PubMed, Scopus, and Web of Science). Studies were included if they reported outcomes of community POC testing for HbA1c for people with diabetes or at risk of diabetes. The Prospero database and trial registers were searched. Only English language articles were included. Title, abstract screening and full text review was carried out by two reviewers (AG/AR). The Cochrane risk of bias tool for randomised studies and the NIH Quality Assessment tool for observational cohort and cross-sectional studies were used. Publication bias was assessed visually using funnel plot and statistical assessment. We performed a meta-analysis on appropriate studies, applying a fixed effect model. We investigated heterogeneity using visual inspection of forest plots along with evaluative approaches (χ2, I2). Strength of evidence was assessed using GRADE. FINDINGS: 24 studies fulfilled the criteria to be included in the narrative synthesis and 5 could be included in quantitative analysis. 13 studies evaluated HbA1c POC testing in non-diabetic patients, 9 reported results for diabetic patients and 2 included both groups. The narrative synthesis was constructed around 6 key themes: increased test access, diagnosis of people who would otherwise go undiagnosed, intervention/lifestyle change, POC testing effect on HbA1c and glycaemic control, follow-up time and patient satisfaction. INTERPRETATION: The available published data supports the proposed use of POC devices in a community setting, with positive effects on diabetic care with limited evidence that patients can achieve better glycaemic control.

Implementation of point-of-care HbA1C instruments into community pharmacies: Initial development of a pathway for robust community testing.

BACKGROUND: Point-of-care (POC) analysers in community settings can provide opportunistic and regular HbA1c monitoring. Community pharmacies in NHS Scotland are utilised by populations at greatest risk of type two diabetes (T2D). This study describes initial development of an HbA1c pathway using a POC analyser in community pharmacies. METHODS: The Abbott Afinion analyser was compared in (i) NHS Tayside's Blood Sciences Service and (ii) community pharmacies from four Scottish Health Boards. A side by side comparison with standard operating procedures for HbA1c quantification using 80 T2D patient venous samples. The machine was implemented into 11 community pharmacies and 144 samples obtained from patients for comparison to their recent laboratory HbA1c. Four focus groups examined themes around the intervention and an exit questionnaire was administered. RESULTS: Laboratory assessment verified the efficacy of the POC test machine. The value for level 1 quality control was 44 mmol/mol and the mean during testing 42.7 mmol/mol. The greatest percent coefficient of variation (cv) was within-run for both levels of quality control material, at a value of 1.63% and 1.62%, respectively. The analyser performed robustly within the pharmacy assessment, with a mean difference of 1.68 and a standard deviation of 0.71 (CV 0.423). Patients with T2D reported positive experiences of using a pharmacy. The focus groups identified an appreciation of the convenience of pharmacies and of the longitudinal relationships with pharmacy staff. CONCLUSION: POC HbA1c analysers can be successfully established in community pharmacies. The target patient group responded positively to the opportunity to use a pharmacy service.

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 Χ2 and the I2 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.