Tecnologías innovadoras de diagnóstico y monitoreo glucémico para el seguimiento metabólico del diabético tipo 2: revisión sistemática de la literatura

Authors

Rosa Elisa Cruz Tenempaguay
Lisbeth Josefina Reales Chacón

Abstract

Introduction: Type 2 diabetes (T2D) is a chronic disease with a high global prevalence; its management relies on timely diagnosis and accurate glycemic monitoring. However, evidence regarding innovative technologies is heterogeneous, and these technologies are evaluated using different indicators depending on their clinical purpose. The objective was to evaluate the effectiveness of innovative diagnostic and glycemic monitoring technologies for the metabolic follow-up of patients with type 2 diabetes, distinguishing between those intended for metabolic monitoring and control (glycated hemoglobin [HbA1c], time in range [TIR], time above range [TAR], and time below range [TBR]) and those intended for diagnosis and screening (diagnostic accuracy, analytical concordance, detection rate, and cost-effectiveness). Materials and Methods: A systematic review was conducted following PRISMA guidelines, searching MEDLINE and LILACS (covering the period from September 2023 to September 2026) and using a PICO framework. A total of 1,828 records were identified (1,764 from MEDLINE; 64 from LILACS), and 11 studies were included: nine randomized clinical trials, one cost-effectiveness evaluation, and one method validation study. Results: Risk of bias was assessed using RoB 2, CHEQUE, and QUADAS-2. A narrative synthesis was performed; no meta-analysis was conducted due to heterogeneity. Among the eight monitoring studies, four showed a significant benefit of continuous glucose monitoring (CGM) regarding HbA1c or TIR/TAR compared to the control; one showed a transient benefit; two yielded non-significant results; and one lacked a non-CGM control group. TBR was reported in only a few studies. Diagnosis: In the diagnostic context, a cluster trial showed higher participation and detection rates using point-of-care capillary HbA1c compared to venous HbA1c; an economic model indicated lower costs than fasting glucose, with a similar proportion of correct diagnoses; and a validation study found analytical comparability between different HbA1c methods. Conclusions: No study estimated sensitivity and specificity against a diagnostic gold standard. The findings do not allow for the generalization of effectiveness across all technologies, populations, and durations of use.

References

Association, A. D. (2025). Diagnosis and classification of diabetes: Standards of care in diabetes—2026. Diabetes Care, 48(January), S27–S49. https://diabetesjournals.org/care/article-split/49/Supplement_1/S27/163926/2-Diagnosis-and-Classification-of-Diabetes#1#1

Association American Diabetes. (2025). Diabetes technology: Standards of care in diabetes—2026. Diabetes Care, 48(January), S146–S166. https://diabetesjournals.org/care/article/49/Supplement_1/S150/163922/7-Diabetes-Technology-Standards-of-Care-in

Bailey, T. S., Liljenquist, D. R., Denham, D. S., Brazg, R. L., Ioacara, S., Masciotti, J., et al. (2025). Evaluation of accuracy and safety of the 365-day implantable Eversense continuous glucose monitoring system: The ENHANCE study. Diabetes Technology & Therapeutics, 27(5), 407–411. https://journals.sagepub.com/doi/epub/10.1089/dia.2024.0592

Balungi, P. A., Niwaha, A. J., Nice, R., Rodgers, L., Mubiru, N., Mukasa, R., et al. (2024). Impact of haemoglobin variants on the diagnostic sensitivity of glycated haemoglobin (HbA1c) assay methodologies in sub-Saharan Africa: A laboratory-based method validation study. Pan African Medical Journal, 48(10), 1–13. https://pmc.ncbi.nlm.nih.gov/articles/PMC11214146/

Battelino, T., Danne, T., Bergenstal, R. M., Amiel, S. A., Beck, R., Biester, T., et al. (2019). Clinical targets for continuous glucose monitoring data interpretation: Recommendations from the international consensus on time in range. Diabetes Care, 42(8), 1593–1603. https://pmc.ncbi.nlm.nih.gov/articles/PMC6973648/#s14

Berthoumieux, A., Naqvi, J. B., Zion, S., Napoleone, J., McGill, A., Cerrada, C. J., et al. (2026). A digital diabetes self-management education and support program integrated with continuous glucose monitoring for type 2 diabetes: Randomized controlled trial. Journal of Medical Internet Research, 28(e78321), 1–14. https://pmc.ncbi.nlm.nih.gov/articles/PMC13175446/

Campbell, M., McKenzie, J. E., Sowden, A., Katikireddi, S. V., Brennan, S. E., Ellis, S., et al. (2020). Synthesis without meta-analysis (SWiM) in systematic reviews: Reporting guideline. BMJ, 368, 16890.

Chan, L., Yu, E. Y. T., Wan, E. Y. F., Wong, S. Y. S., Chao, D. V. K., Ko, W. W. K., et al. (2025). Improving type 2 diabetes detection among at-risk individuals—Comparing the effectiveness of active opportunistic screening using spot capillary-HbA1c testing and venous HbA1c testing: A cluster randomized controlled trial. BMC Medicine, 23(1), 190. https://pmc.ncbi.nlm.nih.gov/articles/PMC11959842/

Dávila-Ruales, V., Gilón, L. F., Gómez, A. M., Muñoz, O. M., Serrano, M. N., & Henao, D. C. (2024). Evaluating the precision and reliability of real-time continuous glucose monitoring systems in ambulatory settings: A systematic review. Therapeutic Advances in Endocrinology and Metabolism, 15, 1–24. https://journals.sagepub.com/doi/epub/10.1177/20420188241304459

Diabetes, A. A. de. (2026). Glycemic goals, hypoglycemia, and hyperglycemic crises: Standards of care in diabetes—2026. Diabetes Care, 49(January), 132–149. https://diabetesjournals.org/care/article/49/Supplement_1/S132/163927/6-Glycemic-Goals-Hypoglycemia-and-Hyperglycemic

Ehrhardt, N., Montour, L., Berberian, P., Vasconcelos, A. G., Comstock, B., & Wright, L. A. C. (2025). A randomized clinical trial of a culturally tailored diabetes education curriculum with and without real-time continuous glucose monitoring in a Latino population with type 2 diabetes: The CUT-DM with continuous glucose monitoring study. Journal of Diabetes Science and Technology, 20(5), 1650–1660. https://pmc.ncbi.nlm.nih.gov/articles/PMC11985481/

Federation, I. D. (2026). Día Mundial de la Diabetes: Acción temprana contra la diabetes. https://idf.org/es/news-and-resources/news/wdd-2026-27/

Galindo, R. J., Moazzami, B., Gerges, A., Flores, I., Arevalo, G., Peng, L., et al. (2026). Real-time continuous glucose monitoring among people with type 2 diabetes and end-stage kidney failure undergoing maintenance hemodialysis: A randomized clinical trial. Diabetes Care, 49(9), 1621–1626. https://pmc.ncbi.nlm.nih.gov/articles/PMC13493348/

Hirsch, I. B., Draznin, B., Buse, J. B., Raghinaru, D., Spanbauer, C., Umpierrez, G. E., et al. (2025). Results from a randomized trial of intensive glucose management using CGM versus usual care in hospitalized adults with type 2 diabetes: The TIGHT study. Diabetes Care, 48(1), 118–124. https://pmc.ncbi.nlm.nih.gov/articles/PMC12328254/

Husereau, D., Drummond, M., Augustovski, F., de Bekker-Grob, E., Briggs, A. H., Carswell, C., et al. (2022). Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement: Updated reporting guidance for health economic evaluations. BMJ, 376, e067975.

International Diabetes Federation. (2025a). IDF diabetes atlas: Diabetes in Ecuador. https://diabetesatlas.org/data-by-location/country/ecuador/

International Diabetes Federation. (2025b). IDF diabetes atlas: Diabetes in Europe (EUR). https://diabetesatlas.org/data-by-location/region/europe/

International Diabetes Federation. (2025c). IDF diabetes atlas: Diabetes in South and Central America (SACA). https://diabetesatlas.org/data-by-location/region/south-and-central-america/

Kasujja, F. X., Daivadanam, M., Mayega, R. W., Nuwaha, F., Kusolo, R., & Ekirapa, E. (2025). Glycated haemoglobin versus fasting plasma glucose for type 2 diabetes point of care screening: A decision model cost-effectiveness analysis. BMC Health Services Research, 25(1), 664. https://pmc.ncbi.nlm.nih.gov/articles/PMC12063251/

Lau, D., Manca, D. P., Singh, P., Perry, T., Olu-Jordan, I., Ryan Zhang, J., et al. (2024). The effectiveness of continuous glucose monitoring with remote telemonitoring-enabled virtual educator visits in adults with non-insulin dependent type 2 diabetes: A randomized trial. Diabetes Research and Clinical Practice, 217(211), 111899. https://www.diabetesresearchclinicalpractice.com/article/S0168-8227(24)00809-X/fulltext

Martens, T. W., Willis, H. J., Bergenstal, R. M., Kruger, D. F., Karslioglu-French, E., & Steenkamp, D. W. (2025). A randomized controlled trial using continuous glucose monitoring to guide food choices and diabetes self-care in people with type 2 diabetes not taking insulin. Diabetes Technology & Therapeutics, 27(4), 261–270. https://journals.sagepub.com/doi/10.1089/dia.2024.0579

Martínez Díaz, J. D., Ortega Chacón, V., & Muñoz Ronda, F. J. (2016). Design of clinical questions in evidence-based practice: Formulation models. Enfermería Global, 15(3), 431–438. https://revistas.um.es/eglobal/article/view/239221/195461

Page, M. J., McKenzie, J. E., Bossuyt, P. M., Boutron, I., Hoffmann, T. C., Mulrow, C. D., et al. (2021). The PRISMA 2020 statement: An updated guideline for reporting systematic reviews. BMJ, 372(n71), 1–8. https://www.bmj.com/content/372/bmj.n71

Parsons, S. N., Luzio, S. D., Dowrick, S. C., Dunseath, G. J., Cheung, W. Y., Gibbs, S. L., et al. (2025). Does the short-term use of continuous glucose monitoring enhance diabetes self-management behaviour in type 2 diabetes? The DISCO GM study: A randomised, controlled cross-over study. Diabetes & Metabolic Syndrome: Clinical Research & Reviews, 19(7), 103283. https://www.sciencedirect.com/science/article/pii/S1871402125001006

Samson, S. L., Vellanki, P., Blonde, L., Hirsch, I. B., Hoang, T. D., Isaacs, S. D., et al. (2026). American Association of Clinical Endocrinology consensus statement: Algorithm for management of adults with type 2 diabetes—2026 update. Endocrine Practice, 32(4), 473–518. https://doi.org/10.1016/j.eprac.2026.01.006

Schulz, K. F., Altman, D. G., & Moher, D. (2010). CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. BMJ, 340, c332.

Singh, H., Kumar, R., Singh, A., Agarwal, B. K., Das, R., & Mehta, D. K. (2026). Type 2 diabetes and vascular complications: Current perspectives on pathophysiology and management strategies. Current Pharmaceutical Design, 32, 1–21. http://www.eurekaselect.com/article/153083

Sterne, J. A. C., Savović, J., Page, M. J., Elbers, R. G., Blencowe, N. S., Boutron, I., et al. (2019). RoB 2: A revised tool for assessing risk of bias in randomised trials. BMJ, 366, l4898.

Whiting, P. F., Rutjes, A. W. S., Westwood, M. E., Mallett, S., Deeks, J. J., Reitsma, J. B., et al. (2011). QUADAS-2: A revised tool for the quality assessment of diagnostic accuracy studies. Annals of Internal Medicine, 155(8), 529–536.

Wilmot, E. G., Moore, P., Sathyapalan, T., Choudhary, P., Lim, J. Z. M., Neupane, S., et al. (2026). Continuous glucose monitoring versus self-monitoring of blood glucose in individuals with type 2 diabetes: A randomised, multicentre, open-label, superiority trial. The Lancet Diabetes & Endocrinology, 14(6), 463–474. https://www.thelancet.com/journals/landia/article/PIIS2213-8587(26)00076-8/fulltext