Clinical Performance Evaluation of Continuous Glucose Monitoring Systems: A Scoping Review and Recommendations for Reporting
Open accessAbstract
The use of different approaches for design and results presentation of studies for the clinical performance evaluation of continuous glucose monitoring (CGM) systems has long been recognized as a major challenge in comparing their results. However, a comprehensive characterization of the variability in study designs is currently unavailable. This article presents a scoping review of clinical CGM performance evaluations published between 2002 and 2022. Specifically, this review quantifies the prevalence of numerous options associated with various aspects of study design, including subject population, comparator (reference) method selection, testing procedures, and statistical accuracy evaluation. We found that there is a large variability in nearly all of those aspects and, in particular, in the characteristics of the comparator measurements. Furthermore, these characteristics as well as other crucial aspects of study design are often not reported in sufficient detail to allow an informed interpretation of study results. We therefore provide recommendations for reporting the general study design, CGM system use, comparator measurement approach, testing procedures, and data analysis/statistical performance evaluation. Additionally, this review aims to serve as a foundation for the development of a standardized CGM performance evaluation procedure, thereby supporting the goals and objectives of the Working Group on CGM established by the Scientific Division of the International Federation of Clinical Chemistry and Laboratory Medicine.
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It is very difficult to compare the performance of CGM systems tested in different studies, and the reported accuracy of available CGM systems is highly variable.
“As a consequence, it is very di ffi cult to compare the performance of CGM systems tested in di ff erent studies, and the reported accuracy of available CGM systems is highly variable [26].”
From Point-of-care testing: state-of-the art and perspectives (2025) · cites this paper as [26]
In many non-iCGM-approved CGM devices, accuracy studies published in peer-reviewed journals are scarce or have many limitations.
“Moreover, in many non-iCGM-approved CGM devices, accuracy studies published in peer-reviewed journals are scarce or have many limitations.”
From Importance of FDA-integrated continuous glucose monitors to ensure accuracy of continuous glucose monitoring (2025) · cites this paper as [29]
Nonadjunctive CGM provides valuable information on glucose levels and is indicated to replace information obtained from standard BGM, without requiring verification, and to aid daily and long-term diabetes-related treatment decisions, such as insulin dosing.
“Nonadjunctive CGM provides valuable information on glucose levels and is indicated to replace information obtained from standard BGM, without requiring verification, and to aid daily and long-term DM-related treatment decisions, such as insulin dosing (Table 2).7,15,17-19,24,29,35”
From Importance of FDA-integrated continuous glucose monitors to ensure accuracy of continuous glucose monitoring (2025) · cites this paper as [29]
Critical appraisal of publicly available accuracy studies reveals that many indications for several non-iCGM-approved CGM devices outside the United States may not be necessarily based on publicly available accuracy data, but only on non-public data sets submitted to regulatory agencies.
“Unfortunately, critical appraisal of publicly available accuracy studies reveals that many indications for several non-iCGM-approved CGM devices outside the United States may not be necessarily based on publicly available accuracy data, but only on non-public data sets submitted to the regulatory agencies.28,29”
From Importance of FDA-integrated continuous glucose monitors to ensure accuracy of continuous glucose monitoring (2025) · cites this paper as [29]
Other areas that should be specified include the testing protocol, the selection of comparator samples and methods, and the statistical analysis.
“Other areas that should be specified according to their articles include the testing protocol, the selection of comparator samples and methods, and the statistical analysis.”
From Importance of FDA-integrated continuous glucose monitors to ensure accuracy of continuous glucose monitoring (2025) · cites this paper as [29]
Studies presenting accuracy of CGMs should ideally be based on whether the study was published in a peer-reviewed journal, whether the population was clearly defined by DM type and demographics, and whether it represented the target population.
“They stated that studies presenting accuracy of CGMs should ideally be based on whether the study was published in a peer-reviewed journal, whether the population was clearly defined by DM type and demographics, and whether it represented the target population.”
From Importance of FDA-integrated continuous glucose monitors to ensure accuracy of continuous glucose monitoring (2025) · cites this paper as [29]
For many non-iCGM-approved entrants, the body of evidence is scarce, insufficient, or lacking for accuracy and for glycemic outcomes (time in range, time above range, time below range, coefficient of variation).
“Furthermore, the body of evidence is scarce, insufficient, or even lacking for many non-iCGM-approved entrants, in terms not only of accuracy, but also of glycemic outcomes (i.e., time in range, time above range, time below range, coefficient of variation).20-23,29”
From Importance of FDA-integrated continuous glucose monitors to ensure accuracy of continuous glucose monitoring (2025) · cites this paper as [29]
Manufacturers of many non-iCGM-approved devices sold outside the United States have not published robust accuracy data or randomized controlled trial data to support their use.
“By contrast, the manufacturers of many non-iCGM-approved devices sold outside the United States have not published robust accuracy data or randomized controlled trial data to support their use.”
From Importance of FDA-integrated continuous glucose monitors to ensure accuracy of continuous glucose monitoring (2025) · cites this paper as [29]
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References 173 · Cited by 86
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- Authors
- Freckmann, G., Eichenlaub, M., Waldenmaier, D., Pleus, S., Wehrstedt, S., Haug, C., Witthauer, L., Jendle, J., Hinzmann, R., Thomas, A., Eriksson Boija, E., Makris, K., Diem, P., Tran, N., Klonoff, D. C., Nichols, J. H., & Slingerland, R. J.
- Affiliations
- Universität Ulm (DE)
- University of Bern (CH)
- Örebro University (SE)
- Roche Diabetes Care GmbH (Germany) (DE)
- IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
- KAT General Hospital of Attica (GR)
- University of California Davis Medical Center (US)
- San Mateo Medical Center (US)
- Vanderbilt University Medical Center (US)
- Isala (NL)
- ORCID
- Venue
- Journal of Diabetes Science and Technology
- Publisher
- SAGE Publications
- Published
- 2023-08-20
- Volume
- 17
- Issue
- 6
- Pages
- 1506-1526
- ISSN
- 1932-2968 (ISSN-L)
- PMC
- PMC10658695
- OpenAlex
- W4386019785
- Cited by
- 86
- References
- 173
- Citations by year
- 2026: 26 · 2025: 36 · 2024: 22 · 2023: 2
- FWCI
- 3.10
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Diabetes Science and Technology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Bern Open Repository and Information System (University of Bern) (submittedVersion)
- Funders
- Diabetes Center Berne
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hyperglycemia and glycemic control in critically ill and hospitalized patients
- Keywords
- continuous glucose monitoring, reporting recommendations, diabetes mellitus
- MeSH terms
- Blood Glucose, Diabetes Mellitus, Type 1, Humans, Blood Glucose Self-Monitoring
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