ArticleJournal of diabetes science and technology2020
Meeting the New FDA Standard for Accuracy of Self-Monitoring Blood Glucose Test Systems Intended for Home Use by Lay Users.
Article in Journal of diabetes science and technology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The reliability of using gingival crevicular blood to measure blood glucose and hba1c levels in the dental setting: a systematic review and meta-analysis.Clinical oral investigations · 2024Pooled it
- Blood glucose monitoring devices for type 1 diabetes: a journey from the food and drug administration approval to market availability.Frontiers in endocrinology · 2024Review
- Improving the Accuracy of Continuous Blood Glucose Measurement Using Personalized Calibration and Machine Learning.Diagnostics (Basel, Switzerland) · 2023Article
- 10/10 Accuracy Analysis of a Self-Monitoring Blood Glucose System.Journal of diabetes science and technology · 2021Article
- Clinical Applications of Visual Plasmonic Colorimetric Sensing.Sensors (Basel, Switzerland) · 2020Review
- Integrated Experimental and Theoretical Studies on an Electrochemical Immunosensor.Biosensors · 2020Article
- Analyse Accuracy of Glucose Monitors without any Dedicated Software Package.Indian journal of endocrinology and metabolismArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The OneTouch Verio Reflect blood glucose monitor (BGM) has market clearance in several countries based in part on fulfilling the lay user and system accuracy criteria described in ISO15197:2015. However, the Food and Drug Administration (FDA) does not recognize the accuracy criteria in ISO15197 as a basis for gaining regulatory clearance for these devices. The current study evaluates the BGM using the accuracy guidelines issued by the agency for self-monitoring blood glucose test systems for over-the-counter use. Glucose results were accurate vs comparator over a wide glucose range and met lay user and glucose accuracy criteria at extreme glucose values as described in the FDA guidance.
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What OpenQuestion holds
Registered trials
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 OpenQuestion graph.