The Global Diabetes Prevalence Prediction

The global prevalence of diabetes is predicted to rise to 7.8% in 2030, meaning 438 million adults will have diabetes by then. In Southeast Asia, diabetes-related mortality is high. It is estimated to account for more than double the worldwide mortality rate attributed to diabetes.

What is Self-Monitoring of Blood Glucose?

Self-monitoring of blood glucose (SMBG) is a way for people with diabetes to regularly check their blood sugar levels. SMBG is recommended for people with type 1 diabetes and those with insulin-treated type 2 diabetes mellitus (T2DM). There is evidence that SMBG is also helpful for T2DM patients who are not insulin-treated.

The Use of The OneTouch® SelectSimple™ Blood Glucose Monitoring System

The OneTouch® SelectSimple™ blood glucose (BG) monitoring system (BGMS) is designed for easy use. It is activated when a test strip is inserted and has an alarm to alert patients of low, high, and very high BG readings.

Studies have assessed the performance of One-Touch SelectSimple BGMS according to criteria set by the International Organization for Standardization (ISO). The studies looked at repeatability and intermediate precision in a laboratory setting and accuracy and ease of use in a clinical setting.

The Study Method on the Accuracy of the OneTouch SelectSimple BGMS

Studies have been done in compliance with ISO 15197 to test the standard for repeatability and intermediate precision using blood samples from one donor adjusted to five different glucose concentrations and tested with ten OneTouch SelectSimple meters.

To evaluate the intermediate precision of the different glucose meters over time, ten OneTouch SelectSimple meters were used to measure the same aqueous control solution multiple times at low, medium, and high BG levels. Each meter would measure each of the three control solutions twice a day for ten days, meaning each meter took 200 measurements in total. They used the same test strips for all of the meters in this study.

System accuracy was assessed with blood samples from 100 diabetes patients tested on three test-strip lots. Results would be compared against the reference system YSI 2300 STAT. Ten blood samples were taken from each patient for ten BG meter readings using just one fingerstick. These blood samples would be tested on:

• YSI 2300 STAT
• The OneTouch SelectSimple BGMS
• A control meter (OneTouch Select BGMS)

156 participants were asked to complete two site visits with a home-testing period between visits to test user accuracy. During the first visit, each person was given a home-testing kit and was told to use OneTouch SelectSimple BGMS for three to five days. They were not given any training on how to use the meter but were asked to use their regular blood sugar readings from their other meter to make any treatment decisions. On the second visit, a healthcare professional (HCP) evaluated the subject’s BGMS technique. Subjects undertook two BG tests and two additional BG tests conducted by an HCP for reference testing by a technician.

Users evaluated the instructions for use and filled out a user acceptance questionnaire.

The Results

In repeatability and intermediate precision testing, the OneTouch SelectSimple BGMS met the ISO criteria of a coefficient of variation (CV) of less than or equal to 5% or a standard deviation (SD) of less than or equal to five milligrams per deciliter (mg/dL) at BG levels of more than or equal to 100 mg/dl.

In the system accuracy study, 100% of test results that were less than 75 mg/dL were within ± 15 mg/dl of the reference value, and 99.6% of measurements that were greater than or equal to 75 mg/dl were within ±20%. Both results met ISO criteria of greater than or equal to 95%. A consensus error grid analysis (a tool used for assessing clinical accuracy of BG meters for patient self-measurement) showed that all test results that used the OneTouch SelectSimple and the control meter were within zones A or B, consistent with ISO criteria; 598 of 600 or 99.67% of test results fell in zone A. For the user accuracy study, all self-test and HCP results fell within the ISO standard compared with the YSI results.

Subjects were able to correctly use the BGMS, even without further training than the user manual, and evaluated it as easy to learn and use. Acceptance of the SelectSimple BGMS was within predefined limits. Consensus error grids showed that 99.7% (299 of 300) self-test and 98.6% (290 of 294) HCP tests fell within zone A. The other five test results fell within zone B.

The Conclusion

The OneTouch SelectSimple BGMS met the ISO criteria for repeatability, precision, and system and user accuracy. Further, it was easy to use and was well accepted by patients.

Reference

Precision, Accuracy, and User Acceptance of the OneTouch SelectSimple Blood Glucose Monitoring System