Comparator Data Characteristics and Testing Procedures for the Clinical Performance Evaluation of Continuous Glucose Monitoring Systems
Recommendations
As issued by the authors
At least 7.5% of comparator blood glucose (BG) concentrations <70 mg/dL (3.9 mmol/L) and at least 7.5% >300 mg/dL (16.7 mmol/L)
At least 7.5% of BG-RoC combinations indicate fast BG changes with impending hypoglycemia and at least 7.5% with impending hyperglycemia
A study protocol and testing procedure for manipulating glucose levels are suggested to collect comparator data with these characteristics
Original publication
Comparator Data Characteristics and Testing Procedures for the Clinical Performance Evaluation of Continuous Glucose Monitoring Systems. Diabetes Technol Ther. Published 2 February 2024. doi:10.
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