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A health care professional HCP performed the finger stick lancing and obtained a blood sample, which was tested on: One sample was used to test hematocrit. Additionally, consensus error grids were constructed. An open, nonrandomized study evaluating user accuracy in a clinical setting was conducted at two sites in concord and La Jolla, California, using a protocol and informed consent forms approved by a centralized institutional review board. All participating subjects all had diabetes provided informed consent. Subjects were required to complete two site visits of roughly 1—1.

At visit 1, each subject took an oral reading test Slosson Oral Reading Revised Test 17 and received a home-testing kit. Visit 2 occurred after the home-testing period.

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Each test was performed using a different OneTouch SelectSimple meter. Each subject and HCP used two test strips from each of two different lots. Additionally, the HCP obtained from the subject two separate blood samples for reference testing by a LifeScan technician. Hematocrit was measured in one of the blood samples used for reference testing.

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Consensus error grids were constructed, dividing the plot of OneTouch SelectSimple BGMS values compared with YSI values into five zones, according to the degree of clinical risk posed by an incorrect measurement. Each subject completed two self-administered questionnaires. The instructions for use questionnaire evaluated user understanding of cautions, warnings, and the functionality of the OneTouch SelectSimple BGMS meter.

An acceptable correct response rate was risk dependent. The OneTouch SelectSimple BGMS user acceptance questionnaire included questions regarding ease of use, preference, maintenance, size and shape of the meter, and readability of the meter display. It was analyzed for the proportion of neutral or better responses. Blood sample glucose concentrations were distributed in the range required by the ISO standard data not shown.

One thousand blood samples were tested 10 samples each from patients ; samples with each of three test-strip lots using the OneTouch SelectSimple meter, for a total of samples; using a control OneTouch Select meter; and samples using the reference method. Another samples were analyzed to measure hematocrit. All but two test results of ; Consensus error grid analysis demonstrated that all glucose concentration results obtained with the OneTouch SelectSimple and the control meter fell within zones A or B, consistent with ISO criteria; all but two readings fell in zone A of ; System accuracy of OneTouch SelectSimple using three different test-strip batches: A lot ; B lot ; and C lot The study population comprised subjects, with 80 subjects at each of the two sites.

Four subjects withdrew voluntarily prior to visit 2; therefore, subjects completed the study at two clinical sites. Table 3 summarizes the demographic and baseline characteristics of subjects.

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Each subject self-tested twice and underwent two tests conducted by a HCP, generating subject test results and HCP-performed test results. Retests were performed if insufficient blood or an error message was obtained during the first test, yielding a total of subject test results. A subject self-test and B HCP test data. Y -axis shows the proportion of BGMS results falling within the range denoted by the x -axis.

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Consensus error grids showed that of the self-test The other five test results fell within zone B altered clinical action—little or no effect on outcome Table 4 and Figure 5. A self-tests performed by subjects and B tests performed by HCPs.

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These parameters included the ability to perform 1 basic maintenance tasks, 2 control solutions tests, and 3 alternate-site testing. The risk associated with this particular assessment was low. On the only assessment for which risk of consequences due to error was high ability to read the display correctly , all but two subjects of ; Each time this subject read the result, the meter was in the correct orientation. In all cases, when subjects were asked to recall and reread a display, it was done at a point later in the testing process and in a neutral tone, as if the patient were presented with another task; this was done to avoid signaling that an error had occurred.

Investigators considered these as misreadings; not indicative of a meter design issue. Patient comprehension of the instructions for use as well as patient responses to the user acceptance questionnaire fell within acceptable limits for all parameters. Several questions in the instructions for use questionnaire inquired about subject understanding of the alerts to low, high, and very high BG levels.

Nearly all subjects of ; Regarding recognition of the alarm for a high BG level, of subjects Accuracy of BGMS is crucial, as inaccurate readings could form the basis of incorrect treatment decisions, which could lead to serious consequences.

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The OneTouch SelectSimple BGMS is indicated for use on blood from alternate testing sites, specifically the forearm or palm, as well as on blood from the fingertip. The system employs glucose oxidase technology, which means that results from this meter are not affected by the presence of nonglucose sugars e. User skill is one of the factors that can contribute to erroneous readings in SMBG. Patient education has the potential to improve accuracy. Nearly all responses to the user acceptance questionnaire indicated that the meter was easy to learn and easy to use Use of two visual cues and an auditory cue to signal this is intended to draw patient attention to hyper- or hypoglycemic episodes.

The alarm system was well understood by the test subjects, who indicated in responses to the user acceptance questionnaire that it helped them interpret the meter results In addition, test subjects highly appreciated the ease of use of the system. With its on-meter application that alerts subjects to hyper- and hypoglycemia, this system could be used effectively by individuals with varying degrees of literacy and numeracy.

The studies reported in this article were funded by LifeScan, Inc. Lupe Miller is an employee of LifeScan, Inc. National Center for Biotechnology Information , U. J Diabetes Sci Technol. Published online Nov 1. You can create different lists for all your experiments and share them with collaborators like your lab manager to find, decide and buy products as a team. Access your Shared Lists in the Account link on Thermofisher. You can invite collaborators like your lab manager or procurement staff to any Shared List. They can add more items, leave comments and complete the final purchase.

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Ion OneTouch™ 2 System

Depending on your Supply Center settings you may be able to add the item to cart above else use the Order Non-Stocked Items' tab on the Supply Center home page. It provides scalable template preparation for all Ion semiconductor chips. With its small footprint, the system fits easily on any bench top. For a fully automated workflow, please see the Ion Chef Instrument.

Efficiency and flexibility The Ion OneTouch 2 System integrates multiple manual template preparation steps into a single system. This enables parallel processing of multiple samples per day through modular design. The need for gas is eliminated by the use of a peristaltic pump.



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