Limits to the Evaluation of the Accuracy of Continuous Glucose Monitoring Systems by Clinical Trials
Open accessAbstract
Systems for continuous glucose monitoring (CGM) are evolving quickly, and the data obtained are expected to become the basis for clinical decisions for many patients with diabetes in the near future. However, this requires that their analytical accuracy is sufficient. This accuracy is usually determined with clinical studies by comparing the data obtained by the given CGM system with blood glucose (BG) point measurements made with a so-called reference method. The latter is assumed to indicate the correct value of the target quantity. Unfortunately, due to the nature of the clinical trials and the approach used, such a comparison is subject to several effects which may lead to misleading results. While some reasons for the differences between the values obtained with CGM and BG point measurements are relatively well-known (e.g., measurement in different body compartments), others related to the clinical study protocols are less visible, but also quite important. In this review, we present a general picture of the topic as well as tools which allow to correct or at least to estimate the uncertainty of measures of CGM system performance.
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Most continuous glucose monitoring systems are regularly calibrated with blood glucose monitoring system values.
“In addition, most continuous glucose monitoring (CGM) systems are regularly calibrated with BGMS values.27”
From System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015 (2020) · cites this paper as [27]
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Nagashima, Y., Ehara, K., Ehara, Y., Mitsume, A., Kubo, K., & Mineo, S. (2023) · Nutrients · doi:10.3390/nu15143245 · Cited by 7 · see citing works
Acetone discriminator and concentration estimator for diabetes monitoring in human breath
Boumali, S., Benhabiles, M. T., Bouziane, A., Kerrour, F., & Aguir, K. (2021) · Semiconductor Science and Technology · doi:10.1088/1361-6641/ac0c63 · Cited by 6 · see citing works
Baines, C. R., Vicendese, D., Cooper, D. M. L., McGuiness, W., & Miller, C. (2021) · Diving and Hyperbaric Medicine Journal · doi:10.28920/dhm51.3.240-247 · Cited by 5 · see citing works
Yoshino, S., Yamada, E., Okada, S., Nakajima, Y., Shibusawa, R., Uehara, R., Matsumoto, S., Horiguchi, K., Ishida, E., Saito, T., et al. (2020) · Endocrine Journal · doi:10.1507/endocrj.ej19-0488 · Cited by 5 · see citing works
Continuous Glucose Monitoring in Children and Adolescents with Congenital Adrenal Hyperplasia
Dubinski, I., Pozza, S. B., Debor, B., Nowotny, H. F., Reisch, N., Tschaidse, L., & Schmidt, H. (2023) · Journal of Clinical Research in Pediatric Endocrinology · doi:10.4274/jcrpe.galenos.2023.2023-3-5 · Cited by 3 · see citing works
De–randomized Meta-Differential Evolution for Calculating and Predicting Glucose Levels
Koutný, T., Cioppa, A. D., Falco, I. D., Tarantino, E., Scafuri, U., & Krčma, M. (2019) · Proceedings - IEEE Symposium on Computer-Based Medical Systems · doi:10.1109/cbms.2019.00064 · Cited by 3 · see citing works
Advancements in Continuous Glucose Monitoring: a Revolution in Diabetes Management
Kumar, K. V., Yerraguntla, K. R., Jenne, M. P., Gadi, A., Sepoori, A., Gunda, A., & Gudivada, M. S. (2025) · Biomedical Materials & Devices · doi:10.1007/s44174-025-00396-0 · Cited by 2 · see citing works
A Grid-based Surrogate Safety Measure for Traffic Safety Assessment
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Rusanov, A. N., & Родионова, Т. И. (2024) · Saratov Journal of Medical Scientific Research · doi:10.15275/ssmj2002171
Vijayan, V., Connolly, J., Condell, J. V., McKelvey, N., & Gardiner, P. V. (2024) · IEEE Sensors Journal · doi:10.1109/jsen.2024.3509021
Continuous Glucose Monitoring Metrics Are Failing People With Diabetes MellitusPreprint
Acanfora, M., Ré, F., & Acanfora, L. (2025) · doi:10.22541/au.175382388.82279079/v1
Rusanov, A. N., & Родионова, Т. И. (2024) · Saratov Medical Journal · doi:10.15275/sarmj.2024.0203
Vianney, N. J. M., Mathur, A., Mudireddy, D. R., & Ngenzi, A. (2026) · Scientific African · doi:10.1016/j.sciaf.2026.e03308
A Review on Hybrid Closed Loop Insulin Delivery System
Kuralarasan, S. G. (2025) · Advances in Applied Biological Research · doi:10.48165/aabr.2025.2.2.04
Aberer, F., Hochfellner, D. A., BAUMANN, P. M., Höll, B., Beck, P., Pieber, T. R., & Mader, J. K. (2026) · Biosensors · doi:10.3390/bios16050289
- Authors
- Schrangl, P., Reiterer, F., Heinemann, L., Freckmann, G., & Del Re, L.
- Affiliations
- Johannes Kepler University of Linz (AT)
- Science & Co, 41462 Neuss, Germany
- Universität Ulm (DE)
- Institute for Design and Control of Mechatronical Systems, Johannes Kepler University Linz, 4040 Linz, Austria
- Corresponding author
- Reiterer, Florian
- Venue
- Biosensors
- Publisher
- MDPI AG
- Published
- 2018-05-18
- Volume
- 8
- Issue
- 2
- Pages
- 50
- ISSN
- 2079-6374 (ISSN-L)
- PMC
- PMC6023102
- OpenAlex
- W2804169921
- Cited by
- 46
- References
- 60
- Citations by year
- 2026: 2 · 2025: 4 · 2024: 6 · 2023: 3 · 2022: 7 · 2021: 9 · 2020: 8 · 2019: 6 · 2018: 1
- FWCI
- 4.78
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Biosensors (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- OPen Access Repositorium der Universität Ulm (OPARU) (Ulm University) (submittedVersion, other-oa)
- Universität Ulm, Kommunikations- und Informationszentrum (kiz) (cc-by)
- Funders
- Roche Diabetes Care
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Scientific Measurement and Uncertainty Evaluation
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Keywords
- continuous glucose monitoring, analytical accuracy, reference method, blood glucose, clinical trial design, measurement uncertainty, diabetes mellitus
- MeSH terms
- Clinical Trials as Topic, Glucose, Monitoring, Ambulatory
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