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Home monitoring of HbA1c in diabetes mellitus: A protocol for systematic review and narrative synthesis on reliability, accuracy, and patient acceptability

Introduction Worldwide there are an estimated 463 million people with diabetes. [1] In the UK people with diabetes are offered an annual review including monitoring of Haemoglobin A1c (HbA1c). [2] [3] This can identify people with diabetes who are not meeting their glycaemic targets, enabling early intervention. Those who do not attend these reviews often have higher HbA1c levels and poorer health outcomes. [4] During the Coronavirus disease of 2019 (COVID-19) pandemic, there was a 77% reduction in monitoring of HbA1c in the UK. [5] We hypothesise that people with diabetes could take finger-prick samples at home for the measurement of HbA1c. Method and Analysis We will perform a systematic review of current evidence for capillary blood collected at home for the measurement of HbA1c. We will examine the validity, reliability, safety, and patient acceptability of the use of capillary blood compared with the usual standard of care of venous blood. We will explore variables which affect validity of results. Using core terms of 'Diabetes', 'HbA1c' and 'Capillary sampling' we will search MEDLINE, Embase, CINAHL, Web of Science Core Collection, Google Scholar, Open Grey and other grey literature from database inception until 2021. Risk of bias will be assessed using the 'COSMIN risk of bias tool to assess the quality of studies on reliability and measurement error'. Database searches and data extraction for primary outcomes will be conducted in duplicate. We will produce a narrative synthesis exploring how variables of capillary blood collection impact on validity, as well as exploring the safety and acceptability of patient self-collection. Ethics and Dissemination This review will be submitted for publication in a peer-reviewed open-access journal. We will present our results at both national and international conferences. As a systematic review with no primary participant data or involvement, ethical approval is not applicable. PROSPERO registration number CRD42021225606