Evidence map›Paper›PMID 36329636›Full record

ArticleJournal of diabetes science and technology2024

Continuous Glucose Deviation Interval and Variability Analysis (CG-DIVA): A Novel Approach for the Statistical Accuracy Assessment of Continuous Glucose Monitoring Systems.

Manuel Eichenlaub, Peter Stephan, Delia Waldenmaier, Stefan Pleus, Martina Rothenbühler, Cornelia Haug, Rolf Hinzmann, Andreas Thomas, Johan Jendle, Peter Diem and 1 more

Open access · greenAbstract read
In one paragraph

Article in Journal of diabetes science and technology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.7field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 19 citations in OpenAlex.

  1. Article
  2. Performance of a New Continuous Glucose Monitoring System in German Adults Living with Diabetes.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2026
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  7. Diabetes Technology Meeting 2023.Journal of diabetes science and technology · 2024
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  8. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 3 countries.

Manuel EichenlaubInstitut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.ORCID 0000-0003-2150-3160
Peter StephanMannheim, Germany.
Delia WaldenmaierInstitut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.ORCID 0000-0003-3280-2369
Stefan PleusInstitut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.ORCID 0000-0003-4629-7754
Martina RothenbühlerDiabetes Center Berne, Bern, Switzerland.
Cornelia HaugInstitut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
Rolf HinzmannRoche Diabetes Care GmbH, Mannheim, Germany.
Andreas ThomasIFCC Scientific Division - Working Group on Continuous Glucose Monitoring (WG-CGM).ORCID 0000-0002-6549-2793
Johan JendleIFCC Scientific Division - Working Group on Continuous Glucose Monitoring (WG-CGM).
Peter DiemIFCC Scientific Division - Working Group on Continuous Glucose Monitoring (WG-CGM).
Guido FreckmannInstitut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.ORCID 0000-0002-0406-9529
Universität Ulm · DEKantonsarchäologie · CHÖrebro University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe accuracy of continuous glucose monitoring (CGM) systems is crucial for the management of glucose levels in individuals with diabetes mellitus. However, the discussion of CGM accuracy is challenged by an abundance of parameters and assessment methods. The aim of this article is to introduce the Continuous Glucose Deviation Interval and Variability Analysis (CG-DIVA), a new approach for a comprehensive characterization of CGM point accuracy which is based on the U.S. Food and Drug Administration requirements for "integrated" CGM systems.

methodsThe statistical concept of tolerance intervals and data from two approved CGM systems was used to illustrate the CG-DIVA.

resultsThe CG-DIVA characterizes the expected range of deviations of the CGM system from a comparison method in different glucose concentration ranges and the variability of accuracy within and between sensors. The results of the CG-DIVA are visualized in an intuitive and straightforward graphical presentation. Compared with conventional accuracy characterizations, the CG-DIVA infers the expected accuracy of a CGM system and highlights important differences between CGM systems. Furthermore, it provides information on the incidence of large errors which are of particular clinical relevance. A software implementation of the CG-DIVA is freely available (https://github.com/IfDTUlm/CGM_Performance_Assessment).

conclusionsWe argue that the CG-DIVA can simplify the discussion and comparison of CGM accuracy and could replace the high number of conventional approaches. Future adaptations of the approach could thus become a putative standard for the accuracy characterization of CGM systems and serve as the basis for the definition of future CGM performance requirements.

Indexed as

Blood GlucoseBlood Glucose Self-MonitoringContinuous Glucose MonitoringDiabetes MellitusHumansReproducibility of ResultsBlood Glucoseaccuracycontinuous glucose monitoringdeviation intervalsFDA iCGM requirementssensor-to-sensor variability

Identifiers

PMID36329636
PMCPMC11307236
OpenAlexW4308179656

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.