ArticleJournal of diabetes science and technology2019
System Accuracy Assessment of a Blood Glucose Meter With Wireless Internet Access Associated With Unusual Hypoglycemia Patterns in Clinical Trials.
Article in Journal of diabetes science and technology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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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.
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Who cites it
7 citing papers in PubMed.
- Assessment of analytical performance of a glucometer in Indian adults at a tertiary care hospital.BMC endocrine disorders · 2025Article
- Real-World Evidence of Point-of-Care Glucometers: Enhanced Passive Surveillance and Adverse Event Reporting Status in Korea and the United States.Annals of laboratory medicine · 2023Article
- Impact of Blood Glucose Monitoring System Accuracy on Clinical Decision Making for Diabetes Management.Journal of diabetes science and technology · 2023Article
- How conclusive is the CONCLUDE trial?Diabetologia · 2020Article
- 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
- 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
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn recent randomized clinical trials, an unusual reporting pattern of glycemic data and hypoglycemic events potentially related to an internet enabled blood glucose meter (MyGlucoHealth, BGM) was observed. Therefore, this clinical study was conducted to evaluate the system accuracy of the BGM in accordance with the ISO15197:2015 guidelines with additional data collection.
methodsTo investigate system accuracy, 10 of 3088 devices and 6 of 23 strip lots, used in the trials, were selected by a randomization procedure and a standard repeatability assessment. YSI 2300 STAT Plus was used as the standard reference method. The samples were distributed as per the ISO15197:2015 recommendations with 20 additional samples in the hypoglycemic range. Each sample was tested with 6 devices and 6 strip lots with double determinations.
resultsOverall, 121 subjects with blood glucose values 26-423 mg/dL were analyzed, resulting in 1452 data points. In all, 186/1452 readings (12.8%) did not meet the ISO acceptance criteria. Data evaluated according to the FDA guidelines showed that 336/1452 (23.1%) readings did not meet the acceptance criteria. A clear bias toward elevated values was observed for BG <100 mg/dL (MARD: 11.0%).
conclusionsThe results show that the BGM, although approved according to standard regulatory guidelines, did not meet the level of analytical accuracy required for clinical treatment decisions according to ISO 15197:2015 and FDA requirements. In general, caution should be exercised before selection of BGMs for patients and in clinical trials.
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