Real-world smartphone-based point-of-care diagnostics in primary health care to monitor HbA1c levels in people with diabetes

verfasst von

Sabrina Rhode, Lisa Rogge, Marthoenis Marthoenis, Till Seuring, Hendra Zufry, Till Bärnighausen, Hizir Sofyan, Jennifer Manne-Goehler, Sebastian Vollmer

Abstract

Background: The lack of accurate and affordable monitoring of glycated hemoglobin (HbA1c) is a common issue among patients with diabetes in low- and middle-income countries. We aimed to test a tablet- and smartphone-based point-of-care (TSB POC) device against a local laboratory-based measure of HbA1c for monitoring diabetes under real-world conditions. Methods: For this cross-sectional clinical method applicability study, capillary and venous blood was collected in duplicate and analyzed at local primary health care centers. For a heterogeneity test, the tests were performed by an expert, and by a team of local nurses. The study was conducted in a multicenter design in rural and urban Aceh, Indonesia in 2019, and included a total of 533 adults. We mainly used Bland-Altman plots to assess the number of readings within the 95%-limits of agreement (LoA) and Deming regressions. Results: The results show a mean difference between capillary HbA1c on the test device and the reference method of −0.54 [CI_0.95 = −1.6933; 0.6048] with 5.21% of measurements outside the LoA and a Pearson’s r = 0.91 in the Deming Regression. There is no significant difference in test concordance between local nurses and the expert (4.23% versus 5.13% results outside the LoA [CI_0.95 = −0.0331; 0.0511]). Conclusions: TSB POC for analysis of HbA1c is an acceptable alternative for accessible monitoring of diabetes patients under these conditions. This method could provide access to high-quality diagnostic decisions through regular and cost-effective HbA1c monitoring directly in healthcare facilities, thus providing better access to essential health services.

Organisationseinheit(en)

Institut für Arbeitsökonomik

Externe Organisation(en)

Ruprecht-Karls-Universität Heidelberg
Georg-August-Universität Göttingen
Universität zu Lübeck
Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU Erlangen-Nürnberg)
Universitas Syiah Kuala
Luxembourg Institute of Socio-Economic Research (LISER)
Zoeinal Abidin Regional General Hospital (RSUDZA)
Harvard University

Typ

Artikel

Journal

Communications Medicine

Band

5

ISSN

2730-664X

Publikationsdatum

05.02.2025

Publikationsstatus

Veröffentlicht

Peer-reviewed

Ja

ASJC Scopus Sachgebiete

Öffentliche Gesundheit, Umwelt- und Arbeitsmedizin, Innere Medizin, Epidemiologie, Medizin (sonstige), Beurteilung und Diagnose

Ziele für nachhaltige Entwicklung

SDG 3 – Gute Gesundheit und Wohlergehen

Elektronische Version(en)

https://doi.org/10.1038/s43856-025-00743-8 (Zugang: Offen)