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

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 measur...

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Main Authors: Sabrina Rhode, Lisa Rogge, Marthoenis Marthoenis, Till Seuring, Hendra Zufry, Till Bärnighausen, Hizir Sofyan, Jennifer Manne-Goehler, Sebastian Vollmer
Format: Article
Language:English
Published: Nature Portfolio 2025-02-01
Series:Communications Medicine
Online Access:https://doi.org/10.1038/s43856-025-00743-8
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author Sabrina Rhode
Lisa Rogge
Marthoenis Marthoenis
Till Seuring
Hendra Zufry
Till Bärnighausen
Hizir Sofyan
Jennifer Manne-Goehler
Sebastian Vollmer
author_facet Sabrina Rhode
Lisa Rogge
Marthoenis Marthoenis
Till Seuring
Hendra Zufry
Till Bärnighausen
Hizir Sofyan
Jennifer Manne-Goehler
Sebastian Vollmer
author_sort Sabrina Rhode
collection DOAJ
description 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 [CI0.95 = −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 [CI0.95 = −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.
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spelling doaj-art-96da7f8f7c12489c9e4fb1e0495c0f892025-02-09T12:52:09ZengNature PortfolioCommunications Medicine2730-664X2025-02-015111010.1038/s43856-025-00743-8Real-world smartphone-based point-of-care diagnostics in primary health care to monitor HbA1c levels in people with diabetesSabrina Rhode0Lisa Rogge1Marthoenis Marthoenis2Till Seuring3Hendra Zufry4Till Bärnighausen5Hizir Sofyan6Jennifer Manne-Goehler7Sebastian Vollmer8Heidelberg Institute of Global Health, Heidelberg UniversityUniversity of Göttingen, Centre for Modern Indian Studies - CeMISDepartment of Psychiatry and Mental Health Nursing, Universitas Syiah Kuala, DarussalamLuxembourg Institute of Socio-Economic Research - LISERZoeinal Abidin Hospital, DarussalamHeidelberg Institute of Global Health, Heidelberg UniversitySyiah Kuala University, DarussalamDivision of Infectious Diseases, Brigham and Women’s Hospital, Harvard Medical SchoolUniversity of Göttingen, Centre for Modern Indian Studies - CeMISAbstract 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 [CI0.95 = −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 [CI0.95 = −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.https://doi.org/10.1038/s43856-025-00743-8
spellingShingle Sabrina Rhode
Lisa Rogge
Marthoenis Marthoenis
Till Seuring
Hendra Zufry
Till Bärnighausen
Hizir Sofyan
Jennifer Manne-Goehler
Sebastian Vollmer
Real-world smartphone-based point-of-care diagnostics in primary health care to monitor HbA1c levels in people with diabetes
Communications Medicine
title Real-world smartphone-based point-of-care diagnostics in primary health care to monitor HbA1c levels in people with diabetes
title_full Real-world smartphone-based point-of-care diagnostics in primary health care to monitor HbA1c levels in people with diabetes
title_fullStr Real-world smartphone-based point-of-care diagnostics in primary health care to monitor HbA1c levels in people with diabetes
title_full_unstemmed Real-world smartphone-based point-of-care diagnostics in primary health care to monitor HbA1c levels in people with diabetes
title_short Real-world smartphone-based point-of-care diagnostics in primary health care to monitor HbA1c levels in people with diabetes
title_sort real world smartphone based point of care diagnostics in primary health care to monitor hba1c levels in people with diabetes
url https://doi.org/10.1038/s43856-025-00743-8
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