Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Excellence center in Diabetes, Hormones and Metabolism, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
Diabetes Obes Metab. 2024 Nov;26(11):5233-5238. doi: 10.1111/dom.15870. Epub 2024 Aug 19.
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.
通过远程医疗（远程 iPDM）评估综合个性化糖尿病管理（iPDM）在血糖控制方面的有效性。
一项为期 6 个月的单中心、开放标签、前瞻性随机对照试验纳入了年龄在 18-65 岁之间、糖化血红蛋白（HbA1c）水平为 7.5%-10.5%、接受胰岛素治疗的 2 型糖尿病患者。远程 iPDM 组通过基于云的远程监测平台接受研究者进行的胰岛素调整，为期 6 个月（从第 0 周到第 12 周每周监测血糖，从第 13 周到第 24 周每月监测）。对照组进行自我监测和胰岛素调整。主要结局是两组患者在 24 周时的 HbA1c 变化差异。次要结局包括 12 周时的 HbA1c 变化、空腹血糖、体重、体重指数（BMI）、24 周时达到 HbA1c<7%的个体比例、24 周时 HbA1c 降低>0.5%的个体比例以及低血糖事件的发生率。
共有 151 名参与者入组，平均年龄为 53.36±8.08 岁，糖尿病病程平均为 12.38±8.47 年。基线时的 HbA1c 为 8.47±0.76%。两组患者的 HbA1c 均从基线下降至 12 周和 24 周。12 周时，远程 iPDM 组的 HbA1c 自基线降低了-1.2%（95%CI -1.42 至-0.98），对照组降低了-0.57%（95%CI -0.79 至-0.36）。远程 iPDM 组与常规治疗组在 12 周时的 HbA1c 平均差异为-0.63%（95%CI -0.94 至-0.32；p<0.001）。24 周时，远程 iPDM 组的 HbA1c 自基线降低了-1.14%（95%CI -1.38 至-0.89），对照组降低了-0.49%（95%CI -0.73 至-0.25）。远程 iPDM 组与常规治疗组的 HbA1c 平均差异为-0.65%（95%CI -0.99 至-0.30；p<0.001）。两组间体重、BMI 或低血糖事件无显著差异。
远程监测可支持胰岛素治疗的 2 型糖尿病患者的 iPDM 护理模式。它提高了糖尿病护理的效率，改善了 12 周时的血糖控制，并维持了 24 周时的血糖控制。
