Patient-Centered Application of Α-Amylase-Based Enzymatic Time-Temperature Indicator for Real-Time Insulin Monitoring in Koronadal City

Insulin stability remains a major concern in tropical regions where elevated ambient temperatures may compromise its therapeutic efficacy. This study evaluated the potential application of an α-amylase-based enzymatic time–temperature indicator (TTI) for real-time insulin monitoring in Koronadal City, Philippines. The study investigated the physicochemical properties of α-amylase relevant to TTI development, examined the relationship between TTI color change and insulin degradation above 25°C, assessed patient usability, and compared the prototype with a commercially available vaccine vial monitor (VVM). A mixed-methods approach combining laboratory experimentation and descriptive survey design was employed. Enzymatic activity was evaluated under varying temperature and pH conditions, while insulin and TTI samples were monitored for 28 days using UV-Visible spectrophotometry and Turbidimetric analysis. Patient-centered usability was assessed through structured questionnaires among diabetic participants. Results showed that α-amylase exhibited optimal activity at 45°C and pH 7, with progressive decline in activity at higher temperatures. The enzymatic TTI demonstrated a strong negative correlation with insulin degradation (r = −0.84, p < 0.001), indicating that visible color changes reliably reflected cumulative thermal exposure. Participants also reported high usability, clarity of interpretation, and increased confidence in insulin safety monitoring. Comparative analysis revealed that the α-amylase-based TTI performed comparably with commercial VVMs under controlled conditions. These findings suggest that the proposed enzymatic TTI is a practical tool for monitoring insulin stability in hot-climate settings and may support safer insulin storage practices in resource-limited communities.

Keywords

α-amylase, time-temperature indicator, insulin stability, patient-centered monitoring, Koronadal City

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Patient-Centered Application of Α-Amylase-Based Enzymatic Time-Temperature Indicator for Real-Time Insulin Monitoring in Koronadal City

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