ReviewJournal of diabetes science and technology2015
Performance of Cleared Blood Glucose Monitors.
Review in Journal of diabetes science and technology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers.
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
31 citing papers in PubMed.
- Trial
- Continuous Glucose Monitoring and Insulin Informed Advisory System with Automated Titration and Dosing of Insulin Reduces Glucose Variability in Type 1 Diabetes Mellitus.Diabetes technology & therapeutics · 2018Trial
- Recent regulatory developments in EU Medical Device Regulation and their impact on biomaterials translation.Bioengineering & translational medicine · 2025Review
- Post-Market Surveillance Assessment of the Clinical Accuracy of a Blood Glucose Monitoring System with an Improved Algorithm for Enhanced Product Performance.Journal of diabetes science and technology · 2023Article
- Point-of-care microvolume cytometer measures platelet counts with high accuracy from capillary blood.PloS one · 2021Article
- Evidence From a Long-Term, Systematic Post-Market Surveillance Program: Clinical Performance of a Hematocrit-Insensitive Blood Glucose Test Strip.Journal of diabetes science and technology · 2021Article
- Suicide and Self-inflicted Injury in Diabetes: A Balancing Act.Journal of diabetes science and technology · 2020Article
- Continuous Glucose Monitors and Activity Trackers to Inform Insulin Dosing in Type 1 Diabetes: The University of Virginia Contribution.Sensors (Basel, Switzerland) · 2019Article
- Closed-Loop Control with Unannounced Exercise for Adults with Type 1 Diabetes using the Ensemble Model Predictive Control.Journal of process control · 2019Article
- Laboratory Evaluation of Linearity, Repeatability, and Hematocrit Interference With an Internet-Enabled Blood Glucose Meter.Journal of diabetes science and technology · 2019Article
- Postmarket Surveillance of Blood Glucose Monitor Systems Is Needed for Safety of Subjects and Accurate Determination of Effectiveness in Clinical Trials of Diabetes Drugs and Devices.Journal of diabetes science and technology · 2019Article
- Efficacy and Safety of Degludec Compared to Glargine 300 Units/mL in Insulin-Experienced Patients With Type 2 Diabetes: Trial Protocol Amendment (NCT03078478).Journal of diabetes science and technology · 2019Article
- System Accuracy Assessment of a Blood Glucose Meter With Wireless Internet Access Associated With Unusual Hypoglycemia Patterns in Clinical Trials.Journal of diabetes science and technology · 2019Article
- Diabetes Technological Revolution: Winners and Losers?Journal of diabetes science and technology · 2018Article
- Accuracy Beyond ISO: Introducing a New Method for Distinguishing Differences Between Blood Glucose Monitoring Systems Meeting ISO 15197:2013 Accuracy Requirements.Journal of diabetes science and technology · 2018Article
- The Financial Impact of Inaccurate Blood Glucose Monitoring Systems.Journal of diabetes science and technology · 2018Article
- Analysis of "Seven Year Surveillance of the Clinical Performance of a Blood Glucose Test-Strip Product".Journal of diabetes science and technology · 2017Article
- Why the Diabetes Technology Society Surveillance Protocol for Glucose Meters Needs to Be Revised.Journal of diabetes science and technology · 2017Article
- Do the New FDA Guidance Documents Help Improving Performance of Blood Glucose Monitoring Systems Compared With ISO 15197?Journal of diabetes science and technology · 2017Article
- If SMBG Accuracy Is Critical to Patient Safety, Why Are Inaccurate Meters Still on the Market?Journal of diabetes science and technology · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
Abstract
Cleared blood glucose monitor (BGM) systems do not always perform as accurately for users as they did to become cleared. We performed a literature review of recent publications between 2010 and 2014 that present data about the frequency of inaccurate performance using ISO 15197 2003 and ISO 15197 2013 as target standards. We performed an additional literature review of publications that present data about the clinical and economic risks of inaccurate BGMs for making treatment decisions or calibrating continuous glucose monitors (CGMs). We found 11 publications describing performance of 98 unique BGM systems. 53 of these 98 (54%) systems met ISO 15197 2003 and 31 of the 98 (32%) tested systems met ISO 15197 2013 analytical accuracy standards in all studies in which they were evaluated. Of the tested systems, 33 were identified by us as FDA-cleared. Among these FDA-cleared BGM systems, 24 out of 32 (75%) met ISO 15197 2003 and 15 out of 31 (48.3%) met ISO 15197 2013 in all studies in which they were evaluated. Among the non-FDA-cleared BGM systems, 29 of 65 (45%) met ISO 15197 2003 and 15 out of 65 (23%) met ISO 15197 2013 in all studies in which they were evaluated. It is more likely that an FDA-cleared BGM system, compared to a non-FDA-cleared BGM system, will perform according to ISO 15197 2003 (χ(2) = 6.2, df = 3, P = 0.04) and ISO 15197 2013 (χ(2) = 11.4, df = 3, P = 0.003). We identified 7 articles about clinical risks and 3 articles about economic risks of inaccurate BGMs. We conclude that a significant proportion of cleared BGMs do not perform at the level for which they were cleared or according to international standards of accuracy. Such poor performance leads to adverse clinical and economic consequences.
Indexed as
Identifiers
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.