System Accuracy Assessment of a Blood Glucose Meter With Wireless Internet Access Associated With Unusual Hypoglycemia Patterns in Clinical Trials.
Andreas PfütznerFiliz DemircikValeria KirschJohannes PfütznerStephanie StroblMina HannaJan SpatzAnke H PfütznerPublished in: Journal of diabetes science and technology (2019)
The 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.
Keyphrases
- clinical trial
- blood glucose
- end stage renal disease
- glycemic control
- ejection fraction
- newly diagnosed
- chronic kidney disease
- prognostic factors
- peritoneal dialysis
- transcription factor
- healthcare
- randomized controlled trial
- clinical practice
- open label
- combination therapy
- liquid chromatography
- mass spectrometry
- study protocol
- insulin resistance
- patient reported
- low cost