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Background <p>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.</p> Methods <p>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.</p> Results <p>The results show a mean difference between capillary HbA1c on the test device and the reference method of −0.54 [CI<sub>0.95</sub> = −1.6933; 0.6048] with 5.21% of measurements outside the LoA and a Pearson’s <i>r</i> = 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<sub>0.95</sub> = −0.0331; 0.0511]).</p> Conclusions <p>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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年2月5日

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

摘要

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.