Diagnostics (Jan 2024)
Home Haemoglobin Monitoring for the Titration of Erythropoietin-Stimulating Agents in Chronic Kidney Disease: A Pragmatic Pilot Trial
Abstract
Background. No trials of POCT device pathways have been published in the field of anaemia of CKD. We describe the results of a year of use of a novel POCT device with its associated eHealth pathway in the home monitoring of ESA therapy, with the aim of evaluating device performance and pathway feasibility. Methods: We used a POCT device designed for home self-testing, able to measure Hb from a drop of capillary blood (Luma, Entia, UK). Results were shared with HCPs via an associated mobile application. The pilot ran from August 2020 to March 2022 in a single UK renal centre. All adult non-dialysis-dependent-CKD patients on ESAs were eligible for inclusion. Participants were mailed the device and trained remotely. Participants were encouraged to self-test twice weekly for up to 1 year, with data collected on a pragmatic basis. Lab and Luma’s results were compared. Results: Seventeen participants returned comparable datasets (underwent ≥ 4 lab Hb measurements and self-tested for >5 months) with a mean testing frequency of 1.6 tests/wk. 1062 Luma and 113 lab Hb results were analysed. The coefficient of variation (CV) for raw results was 8.3% with a bias of −2.0% and SD 8.5. The percentage of Luma results differing by >10% lab results was 30.9%, dropping to 17.7% using an 8-point-moving-average. Participants stated they preferred Luma to traditional ESA monitoring and recommended the pathway to others. Conclusion: One year of home self-testing with Luma yielded comparable device utility to other POCT haematology analysers derived via HCP testing. Innovative pilot trials such as this form the basis for new empowering and home-based models of care required and desired by patients and HCPs.
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