Meeting the New FDA Standard for Accuracy of Self-Monitoring Blood Glucose Test Systems Intended for Home Use by Lay Users.

Publisher: Sage Country of Publication: United States NLM ID: 101306166 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1932-2968 (Electronic) Linking ISSN: 19322968 NLM ISO Abbreviation: J Diabetes Sci Technol Subsets: MEDLINE

Publication: 2014- : Thousand Oaks, CA : Sage
Original Publication: Foster City, CA : Diabetes Technology Society

Blood Glucose/*metabolism ; Blood Glucose Self-Monitoring/*instrumentation ; Blood Glucose Self-Monitoring/*standards ; Device Approval/*standards ; Diabetes Mellitus, Type 1/*diagnosis ; Diabetes Mellitus, Type 2/*diagnosis ; Monitoring, Ambulatory/*instrumentation ; Monitoring, Ambulatory/*standards ; United States Food and Drug Administration/*standards; Adolescent ; Adult ; Aged ; Aged, 80 and over ; Biomarkers/blood ; Diabetes Mellitus, Type 1/blood ; Diabetes Mellitus, Type 2/blood ; Female ; Germany ; Humans ; Male ; Materials Testing ; Middle Aged ; Predictive Value of Tests ; Reproducibility of Results ; Time Factors ; United States ; Young Adult

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. Clinicaltrials.gov NCT03851549 .

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Keywords: accuracy; blood glucose; blood glucose meter; blood glucose strips; self-monitoring of blood glucose

ClinicalTrials.gov NCT03851549

0 (Biomarkers)
0 (Blood Glucose)

Date Created: 20200216 Date Completed: 20211012 Latest Revision: 20211012

20221213

PMC7753858

10.1177/1932296820906184

32059615