Development and clinical trial of a smartphone-based colorimetric detection system for self-monitoring of blood glucose.

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.