Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Nanchang University, Nanchang, China.
Department of Endocrinology and Metabolism, The Wanjiang Hospital, Dongguan, China.
Postgrad Med. 2024 Jun;136(5):523-532. doi: 10.1080/00325481.2024.2366156. Epub 2024 Jun 13.
This pilot study aimed to prospectively investigate the effects of a wearable monitoring device, based on an Internet management platform, on the comprehensive management of type 2 diabetes mellitus (T2DM) patients.
A total of 120 hospitalized patients with T2DM were enrolled and randomly divided into the control group and the intervention group. Patients in the control group only received conventional diabetes treatments, while patients in the intervention group were provided with a wearable monitoring device in addition to conventional diabetes treatments. Moreover, the wearable device could connect to an Internet platform for diabetes management and upload self-monitoring data. All patients were followed for 3 months. The changes in parameters representing glucose metabolism, blood lipids, renal function, and patient satisfaction were compared between the two groups. All results were analyzed on an intention-to-treat basis.
One hundred twenty subjects met all criteria and agreed to participate in this study. During the follow-up period, 5 and 4 subjects were lost to follow-up in the intervention and control groups, respectively. Compared with the control group, the blood glucose of the intervention group decreased significantly after 3 months ( < 0.05). Subgroup analysis found that females, those younger than 60 years, with baseline glycated hemoglobin A1c (HbA1c) levels of 8% or greater, and patients with good adherence showed significant improvements in HbA1c ( < 0.05). However, there was no significant difference in blood lipid and renal function. The intervention group showed a better adherence rate to blood glucose, comprehensive adherence rate, and diabetes treatment satisfaction ( < 0.05). One subject in the intervention group and two subjects in the control group reported mild hypoglycemia. No other adverse events such as infections and skin allergies occurred in the two groups.
The intervention of a wearable monitoring device based on an Internet management platform significantly improved blood glucose control in T2DM patients, as well as the overall adherence rate and patient satisfaction with treatment.
NCT04973644.
本前瞻性研究旨在评估基于互联网管理平台的可穿戴监测设备对 2 型糖尿病（T2DM）患者综合管理的效果。
共纳入 120 例住院 T2DM 患者，随机分为对照组和干预组。对照组仅接受常规糖尿病治疗，干预组在常规糖尿病治疗的基础上增加可穿戴监测设备，并通过该设备将自我监测数据上传至互联网管理平台。所有患者均随访 3 个月。比较两组患者血糖代谢、血脂、肾功能及患者满意度等参数的变化。所有结果均基于意向治疗原则进行分析。
120 例患者均符合所有纳入标准并同意参与本研究。在随访期间，干预组和对照组各有 5 例和 4 例患者失访。与对照组相比，干预组患者在 3 个月时血糖明显降低（ < 0.05）。亚组分析发现，女性、年龄＜60 岁、基线糖化血红蛋白（HbA1c）水平≥8%、以及依从性好的患者，HbA1c 显著改善（ < 0.05）。然而，两组患者的血脂和肾功能无显著差异。干预组患者在血糖、综合依从性和糖尿病治疗满意度方面的依从率均较高（ < 0.05）。干预组中有 1 例患者和对照组中有 2 例患者报告了轻度低血糖。两组均未发生感染和皮肤过敏等其他不良事件。
基于互联网管理平台的可穿戴监测设备干预可显著改善 T2DM 患者的血糖控制水平，提高整体依从率和患者对治疗的满意度。
NCT04973644。
