Jan 23, 2017 Learn more about the features of your OneTouch Verio Flex® blood glucose meter and the steps to setting up your meter correctly. Before using the OneTouch Ve. And for the three times I have used a Accu-Chek meter, to have one of those be a flop does not leave a good first impression. Accu-Chek was happy to mail me a replacement tube of test strips, but the representative couldn’t really advise as to how to prevent this problem in the future.

J Diabetes Sci Technol. 2011 Nov; 5(6): 1602–1609.

Published online 2011 Nov 1. doi: 10.1177/193229681100500638

PMID: 22226284

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Abstract

Background

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.

Methods

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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.

Results

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 measurements <75 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.

Conclusions

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.

Keywords: accuracy, blood glucose meter, intermediate precision, OneTouch SelectSimple, repeatability

Introduction

Global prevalence of diabetes in adults is predicted to rise from 6.6% in 2010 to 7.8% in 2030, and affect 285 million and 438 million people, respectively.¹ Diabetes accounts for an estimated 6.8% of global all-cause mortality among adults.² Sony dsc h300 user manual pdf download.

In Asia, prevalence of type 2 diabetes mellitus (T2DM) has increased rapidly over a relatively short time period:^,4 from 2.5% in 1994 to 9.7% in 2010^, in China, and from 13.9% in 2000 to 18.6% in 2006 in Chennai, India (an urban area). The International Diabetes Federation predicts that the number of adults with diabetes in Southeast Asia will rise from 58.7 million in 2010 to 101 million in 2030, with the estimated prevalence climbing from 7.0% to 8.4%.⁸ Perhaps not surprisingly, diabetes-related mortality is high in Southeast Asia. Diabetes is estimated to have accounted for 14.3% of deaths among adults in 2010—more than double the proportion of mortality attributed to diabetes worldwide.^2,8

Several authorities acknowledge the benefit of self-monitoring of blood glucose (SMBG) by patients with diabetes. Glucose meters should not be used to diagnose diabetes, and may have limited values for screening purposes.^– Self-monitoring of blood glucose is recommended in patients with type 1 diabetes and in those with insulin-treated T2DM.¹¹ Evidence regarding the value of SMBG in noninsulin-treated T2DM patients is mixed,^11, but guidelines support its value under certain circumstances.^– There are accepted international standards for assessing BG meter accuracy; these standards are currently under review, and narrower performance criteria are anticipated.^14,

The OneTouch® SelectSimple™ BG monitoring system (BGMS) (Figure 1) has no coding steps or buttons because it is designed for ease of use. The meter turns on when a test strip is inserted. It has an alarm alerting patients 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)] BG readings.

OneTouch SelectSimple BGMS.

Present studies have evaluated the performance of the One-Touch SelectSimple BGMS according to criteria published by the International Organization for Standardization (ISO).¹⁴ Specifically, studies assessed repeatability and intermediate precision in laboratory settings as well as accuracy and ease of use in a clinical setting.

ISO 15197 defines repeatability as “precision under repeatability conditions,” i.e., precision under essentially unchanged conditions. Precision is the “closeness of agreement between independent test results obtained under stipulated conditions.” Intermediate precision is “intended to measure precision in conditions leading to variability representative of actual use.” Accuracy is “closeness of agreement between a test result and the accepted reference value.”

Methods

Repeatability and Intermediate Precision Studies

Repeatability and intermediate precision studies were performed in compliance with ISO 15197.¹⁴ For repeata-bility testing, blood samples from one donor were adjusted to five different glucose concentrations [40, 100, 130, 200, and 300 mg/dl (2.2, 5.6, 7.2, 11.1, and 16.7 mmol/liter)], and tested on 10 OneTouch SelectSimple meters (10 times per meter) for a total of 100 repetitions per glucose level. All evaluations used test strips from the same lot number. Mean, standard deviation (SD), and coefficient of variation (CV) were calculated at each glucose concentration.

To evaluate intermediate precision by a user across multiple days with the same meter and reagent system lot, 10 OneTouch SelectSimple meters measured aqueous control solutions at low [30–50 mg/dl (1.7–2.8 mmol/liter)], medium [96–144 mg/dl (5.3–8.0 mmol/liter)], and high [280–420 mg/dl (15.5–23.3 mmol/liter)] glucose levels. Each meter measured each of the three control solutions twice daily for 10 days, for a total of 200 measurements per glucose level. Test strips for OneTouch SelectSimple were taken from the same lots as in the repeatability study.

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Acceptability criteria for the repeatability and intermediate precision studies were within-lot precision ≤5.0% CV at BG levels ≥100 mg/dl (5.6 mmol/liter) or ≤5.0 mg/dl (0.3 mmol/liter) SD at glucose levels <100 mg/dl (5.6 mmol/liter).

System Accuracy

Both system and clinical accuracy were defined as the extent to which the OneTouch SelectSimple meter measurements agree with those of the reference method, the YSI 2300 STAT analyzer. To assess system accuracy, data from fresh capillary blood samples from 100

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