Glycaemic control at risk? - Impact of temperature, humidity and other physical factors on the analytical quality of point of care testing of blood glucose, a systematic review protocol

Abstract Background Diabetes is a chronic metabolic disease characterized by increased blood glucose concentration. Self-monitoring of blood glucose (SMBG) is a corner stone in lowering the risk of vascular complications of diabetes and requires reliable measurements by the blood glucose meter and test strips (BG System). Environmental factors as temperature, humidity, altitude, and electromagnetic radiation may affect the measurement of blood glucose to a level that might compromise the glycaemic control. Manufactures often restrict the validation and approved use a limited span of environmental conditions and there is a considerable risk of exposing the equipment to temperature outside the range recommended by manufacturers. This systematic review aims to explore, aggregate, and present the current knowledge of the effect of environmental factors on the quality of results measured by BG systems. Methods Relevant studies will be found by using a comprehensive search strategy in the following databases: EMBASE, PubMed, CINAHL, Academic Search Premier, SweMed+, DANS Easy and Cochrane Library. The search strategy will assess if there is an impact on precision and accuracy of BG systems under varying environmental conditions compared to precision recommended by manufacturers. Both authors will screen titles and in case of disagreement, the study will be included for screening by abstract. After screening of all titles, the procedure will be repeated for screening and reading of abstracts. Full text of papers selected by abstract will be assessed according to in- and exclusions criteria. Homogenous results will be pooled and summarized statistically for meta-analysis. Narrative synthesis will be performed for heterogeneous data that cannot be pooled for meta-analysis. Reporting will follow the Preferred Items for Systematic Reviews and Meta-Analysis 2020 (PRISMA 2020). The risk of bias will be evaluated by choosing an appropriate tool from acknowledged institutions I.e., Joanna Briggs Critical Appraisal for Systematic Reviews Checklist tools or the Critical Appraisal Skills Program (CASP). Discussion This systematic review protocol utilizes rigorous methodology to provide a comprehensive search for outcomes of the impact of environmental factors on BG systems. The outcomes will be examined, and a summary of the current knowledge will be provided.