Abstract
Blood glucose measurements help to guide insulin therapy, thus reducing disease severities, secondary complications, and related mortalities. Efforts are underway to allow diabetes patients to experience a more convenient way to measure blood glucose and consequently increase their adherence to regular self-monitoring of blood glucose (SMBG). This study demonstrated a new SMBG system that integrated all components of a glucometer via a smartphone's optical sensing module to detect the colorimetric blood strip and obtains the blood glucose concentration with calculations performed by an application install in the smartphone. To validate the accuracy and applicability of the new SMBG system regarding the ISO15197:2013 accuracy criteria and patient requirements, a clinical trial and usability survey involving participants from different age groups were conducted in collaboration with the China Medical University, where enrolled 120 diabetic patients were asked to operate the new SMBG system to measure their blood glucose concentration, and feedback was obtained from their user experience. The results showed that three different reagent system lots fulfilled the accuracy requirements with values of 97.4-97.5% , and all of the data were within zones A and B of the consensus error grid, which satisfies the ISO 15197:2013 requirement. The usability survey showed that 97.5% of the participants found the operations convenient, and 100% found the design easy for carrying. This new system could lead to improvements in blood glucose monitoring by people with diabetes, and thus, better management of the disease.
Highlights
Obesity, sedentary lifestyles, increasing ages, and unhealthy diets have led to rapid growth in the diabetic population, which amounted to over 425 million people in 2017
The HCT value was checked with the standard machine (BECKMEN LX20) used in the hospital, and the results were recorded on a test result form, which was verified by a trained technician
An optical ray-tracing simulation was performed to determine the best reflection conditions in the integrated detection device for blood glucose (IDDBG), and optimal and uniform illumination on the IDDBG colorimetric blood strip area could be achieved by using a smartphone LCD screen as the light source
Summary
Sedentary lifestyles, increasing ages, and unhealthy diets have led to rapid growth in the diabetic population, which amounted to over 425 million people in 2017. It occurs owing to either insulin deficiency or increased insulin resistance, which leads to high blood glucose [2,3]. Step 7: Read/Note/Record your blood glucose concentration as it appears on the smartphone LCD screen. Once the subject gains confidence in their abilities to perform the required steps (i.e., strip placement, blood application, and reading the display screen), they were requested to demonstrate these tasks to a member of the trial staff. When the subjects finished the blood glucose measurement process, the smartphone’s LCD screen displayed the blood glucose values and these values were recorded. The HCT value was checked with the standard machine (BECKMEN LX20) used in the hospital, and the results were recorded on a test result form, which was verified by a trained technician
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