Precision, accuracy, and user acceptance of the OneTouch SelectSimple blood glucose monitoring system
| Autor: | Athena Philis-Tsimikas, Anna Chang, Lupe Miller |
|---|---|
| Rok vydání: | 2012 |
| Předmět: |
Adult
Blood Glucose Male medicine.medical_specialty Accuracy and precision Endocrinology Diabetes and Metabolism Biomedical Engineering MEDLINE Bioengineering Young Adult Patient satisfaction Internal Medicine medicine Diabetes Mellitus Humans Technology Report Aged Blood glucose monitoring Aged 80 and over medicine.diagnostic_test business.industry Blood Glucose Self-Monitoring Reproducibility of Results Repeatability Middle Aged Patient Acceptance of Health Care Surgery Clinical trial Multicenter study Patient Satisfaction Emergency medicine Female business |
| Zdroj: | Journal of diabetes science and technology. 5(6) |
| ISSN: | 1932-2968 |
| Popis: | The OneTouch® SelectSimple™ blood glucose monitoring system (BGMS) is a device for self-monitoring of blood glucose designed for ease of use. Alarms alert subjects to low [20-69 mg/dl (1.1-3.8 mmol/liter)], high [180-239 mg/dl (9.9-13.2 mmol/liter)], and very high [240-600 mg/dl (13.3-33.1 mmol/liter)] blood glucose readings.Repeatability in blood and intermediate precision with aqueous controls were examined using blood from one donor adjusted to different glucose concentrations, and tested with 10 meters and 1 test-strip lot. System accuracy was evaluated with blood samples from 100 diabetes patients tested on 3 test-strip lots, compared with a reference system (YSI 2300 STAT). To test user accuracy, patients (n = 156) and health care professionals (HCPs) tested subject blood with the SelectSimple twice. Health care professionals evaluated subject BGMS technique after a 3-5 day home-testing period. Users evaluated the instructions for use and responded to a user acceptance questionnaire.In repeatability and intermediate precision testing, the SelectSimple BGMS had a coefficient of variation of ≤ 5% or standard deviation of ≤ 5 mg/dl. In the clinical accuracy study, 100% of measurements75 mg/dl (4.2 mmol/liter) were within ± 15 mg/dl (0.8 mmol/liter) of reference value, and 99.6% of measurements ≥ 75 mg/dl (4.2 mmol/liter) were within ±20%. Patients were able to use the BGMS appropriately and evaluated it as easy to use. Acceptance of the SelectSimple BGMS was within predefined limits.In these studies, the SelectSimple BGMS met all criteria for precision, system, and user accuracy, was easy to use, and was well accepted by patients. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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