The Importance of Blood Glucose Self-Monitoring for Diabetes Treatment Effectiveness

One essential technique for evaluating how effective your diabetes treatment or glycemic control, like food and exercise, is working is through self-monitoring of blood glucose (SMBG). The information you get can help you make decisions about your diabetes treatment plan. Studies have shown that when people with diabetes use SMBG, they often have lower levels of glycated hemoglobin. This finding means they have better control of their blood sugar levels overall. Using SMBG can also help improve outcomes, no matter what type of diabetes you have or what treatment you are using.

Many different diabetes mobile applications (apps) can help you manage your diabetes. These apps can help you track real-time information on your blood sugar, insulin, diet, exercise, and medications. Some of these apps require manual logging of data, which can be inconvenient and prone to errors. The results you get from your blood sugar tests must be accurate to make the best decisions about your diabetes management, like proper nutritional intake and drug dosing.

What is the Contour® Next ONE Blood Glucose Monitoring System?

The Contour®Next ONE blood glucose monitoring system (BGMS) is a new system that features a blood glucose meter designed for use with Contour™Next test strips. This easy-to-use glucose meter can wirelessly transmit blood sugar levels to a smartphone device via Bluetooth® connectivity. The system is designed to sync with the Contour™ Diabetes app on a smartphone or tablet.

The new BGMS was tested in two separate studies. The first study looked at the analytical accuracy of the BGMS in a laboratory setting. The second one tested BGMS performance and ease of use. Both studies were assessed based on International Standardization Organization (ISO) 15197:2013 criteria for BGMS accuracy.

The Study Method on the Accuracy of BGMS

For the first study, to test the accuracy of the BGMS, a clinical laboratory drew capillary blood samples from the fingertips of 100 subjects in duplicate using 3 test strip lots. From the 100 participants, blood samples from 85 individuals were tested without modification; from ten people, their blood samples were glycolized to lower glucose levels; and from five people, their blood samples were supplemented with a 20% concentrated glucose solution to increase the glucose level.

Before and after BGMS testing, blood from the same fingertip was collected to obtain plasma, which was assayed in duplicate on a Yellow Springs Instrument (YSI) 2300 STAT Plus™ laboratory glucose analyzer to produce reference values. Fingertip blood was also collected to measure hematocrit.

For the second study, to test user performance, 332 subjects performed a self-test using the BGMS by drawing a blood sample from the fingertip, which was repeated within five minutes by a site staff member. Immediately after that, each subject would lance his palm for an alternate test using the BGMS, followed by a site staff member lancing the subject’s fingertip to perform a meter test. Venipuncture was performed only on subjects with diabetes, and blood was tested by study staff with the BGMS and the YSI analyzer. All capillary blood meter results were compared to the capillary blood YSI reference results, and venous meter results were compared to the venous blood YSI reference results. A questionnaire was provided to assess user feedback on ease of use.

The Results

In the laboratory study, all of the combined results for the 3 test strip lots met ISO 15197:2013 Section 6.3 accuracy criteria, with 98.3% of results within 10% of the YSI reference values.

In the clinical study, the BGMS demonstrated a high level of accuracy regardless of whether testing was performed by study staff or by subjects who had never used this BGMS previously and had no training other than the product instruction manual. The results even exceeded the ISO 15197:2013 Section 8 accuracy criteria.

Questionnaire results showed that most subjects considered the system easy to use.

The Conclusion

These studies demonstrate that the new Contour®Next ONE BGMS is easy to use and its accuracy exceeded ISO 15197:2013 criteria in laboratory and clinical settings.

Reference

A New, Wireless-Enabled Blood Glucose Monitoring System that Links to a Smart Mobile Device: Accuracy and User Performance Evaluation