Abstract

To evaluate the effectiveness of integrated personalized diabetes management (iPDM) through telemedicine (tele-iPDM) with regard to glycaemic control. A 6-month single-centre, open-label, prospective randomized controlled trial enrolled insulin-treated patients with type 2 diabetes, aged 18-65 years with glycated haemoglobin (HbA1c) levels of 7.5%-10.5%. The tele-iPDM group received insulin adjustment by investigators through a cloud-based telemonitoring platform for 6 months (blood glucose monitoring reviewed weekly from Weeks 0 to 12 and then monthly from Weeks 13 to 24). The control group performed self-monitoring and insulin adjustment. The primary outcome was the difference in HbA1c change from baseline between the two groups at 24 weeks. Secondary outcomes included changes in HbA1c at 12 weeks, fasting plasma glucose, body weight, body mass index (BMI), the percentage of individuals achieving HbA1c <7% at 24 weeks, the percentage of individuals with an HbA1c reduction of >0.5% at 24 weeks, and incidences of hypoglycaemic events. A total of 151 participants were enrolled, with a mean age of 53.36 ± 8.08 years and a mean diabetes duration of 12.38 ± 8.47 years. The baseline HbA1c was 8.47 ± 0.76%. The mean HbA1c decreased from baseline to 12 and 24 weeks in both groups. At 12 weeks, HbA1c reduction from baseline was -1.2% (95%CI -1.42 to -0.98) in the tele-iPDM group and -0.57% (95%CI -0.79 to -0.36) in the control group. The mean difference in HbA1c between the tele-iPDM and usual care groups at 12 weeks was -0.63% (95%CI -0.94 to -0.32; p < 0.001). At 24 weeks, HbA1c reduction from baseline was -1.14% (95%CI -1.38 to -0.89) in the tele-iPDM group and - 0.49% (95%CI -0.73 to -0.25) in the control group. The mean difference in HbA1c between the tele-iPDM and usual care groups was -0.65% (95%CI -0.99 to -0.30; p < 0.001). There were no significant differences in body weight, BMI, or hypoglycaemic events between the two groups. Telemonitoring can support the iPDM care model in individuals with insulin-treated type 2 diabetes. It improves the efficiency of diabetes care, enhances glycaemic control at 12 weeks, and sustains glycaemic control at 24 weeks.

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