title: A glucose meter evaluation co-designed with both health professional and consumer input.
abstract: Health consumer's input into assessment of medical device safety is traditionally given either as part of study outcome (trial participants) or during post marketing surveillance. Direct consumer input into the methodological design of device assessment is less common. We discuss the difference in requirements for assessment of a measuring device from the consumer and clinician perspectives, using the example of hand held glucose meters. Around 80,000 New Zealanders with diabetes recently changed their glucose meter system, to enable ongoing access to PHARMAC subsidised meters and strips. Consumers were most interested in a direct comparison of their 'old' meter system (Accu-Chek Performa) with their 'new' meter system (CareSens brand, including the CareSens N POP), rather than comparisons against a laboratory standard. This direct comparison of meter/strip systems showed that the CareSens N POP meter read around 0.6 mmol/L higher than the Performa system. Whilst this difference is unlikely to result in major errors in clinical decision making such as major insulin dosing errors, this information is nevertheless of interest to consumers who switched meters so that they could maintain access to PHARMAC subsidised meters and strips. We recommend that when practical, the consumer perspective be incorporated into study design related to medical device assessment.
authors: Diabetes Centre, 550 Hagley Avenue, PO Box 4710, Christchurch, New Zealand. huan.chan@cdhb.health.nz.
authors: Harmony
authors: H
authors: Thompson
authors: Huan
authors: H
authors: Chan
authors: Florence J
authors: FJ
authors: Logan
authors: Helen F
authors: HF
authors: Heenan
authors: Lynne
authors: L
authors: Taylor
authors: Chris
authors: C
authors: Murray
authors: Christopher M
authors: CM
authors: Florkowski
authors: Christopher M A
authors: CM
authors: Frampton
authors: Helen
authors: H
authors: Lunt
mesh_terms: D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation*; D003920:Diabetes Mellitus / Q000097:blood*; D004867:Equipment Design; D006801:Humans; D019095:Point-of-Care Systems / Q000592:standards*; D015203:Reproducibility of Results
chemical_list: D001786:Blood Glucose