Efficacy and Safety of an Intelligent Insulin-Dosing Decision Support System for Glycemic Control in Patients With Type 2 Diabetes: A Randomized Controlled Study

This study evaluates an intelligent insulin dosing decision support system designed to support basal insulin titration in adults with type 2 diabetes. The system operates on an internet-of-things platform that synchronizes glucose data and insulin dose records from a smart glucometer and an insulin logging device to a cloud-based server. Patients and clinical staff access the system through a mobile interface, which enables real time data transmission, automated dose calculation, and remote supervision.

The system contains four major components. The first component is a comprehensive assessment module that collects demographic information, clinical characteristics, and a full panel of islet function indicators including fasting glucose, postprandial glucose, glycated hemoglobin, fasting insulin, and multiple C-peptide values. A validated hypoglycemia risk prediction model classifies each participant into low, intermediate, or high risk categories. Competency in insulin injection and dose verification is assessed using a standardized questionnaire.

The second component determines the initial basal insulin dose. This calculation follows guideline recommendations and incorporates the islet function results and hypoglycemia risk category to generate an individualized starting dose.

The third component evaluates insulin sensitivity and glucose response patterns. Continuous transmission of glucose values and insulin doses allows the system to estimate the participant's insulin sensitivity level and to update these estimates as additional data are obtained.

The fourth component produces dose adjustment recommendations. Titration is structured into three time-based phases with clearly defined monitoring frequencies and clinical review points. During the initial titration phase from day three to day fourteen, fasting glucose is measured daily and the system generates dose recommendations every three days using the mean of the most recent fasting glucose values. Nurses review glucose patterns and safety concerns on day four and at the end of the first week, while physicians perform dose verification on day four. During the stable titration phase from week three to week twelve, fasting glucose is measured every three days and the system generates weekly dose recommendations based on the most recent value. Nurses conduct follow up assessments and provide stepwise guidance at week one, week two, week four, week eight, and week twelve. Physicians review system-generated recommendations at the same time points. During the long term maintenance phase from week thirteen to week twenty four, fasting glucose is measured weekly and the system continues to produce weekly dose recommendations. Participants who demonstrate sufficient accuracy in dose verification by week twelve may be authorized to review system-generated dose units independently from week thirteen onward under remote supervision. Physicians complete a final evaluation at week twenty four.