Hangaard Stine, Kronborg Thomas, Cohen Sarah Rüdiger, Kofoed-Enevoldsen Allan, Thomsen Camilla Heisel Nyholm, Aradóttir Tinna Björk, Kristensen Sika Nuunu Slobodziuk, Kaas Anne, Bengtsson Henrik, Vestergaard Peter, Dethlefsen Claus, Hejlesen Ole, Jensen Morten Hasselstrøm
Steno Diabetes Center North Denmark, Aalborg University Hospital, Aalborg, Denmark; Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.
Steno Diabetes Center North Denmark, Aalborg University Hospital, Aalborg, Denmark; Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.
Eur J Intern Med. 2025 Jul;137:112-118. doi: 10.1016/j.ejim.2025.05.017. Epub 2025 May 24.
Telemonitoring interventions facilitating adjustments in medication may improve glycemic control more effectively. Hence, the aim of this randomized controlled trial was to explore the effectiveness and safety of telemonitoring compared with standard of care in people with type 2 diabetes (T2D) on insulin therapy.
The trial was a Danish multicenter open-label randomized controlled trial with a threemonth trial period. People with T2D on insulin therapy were randomized (1:1) to telemonitoring (intervention) or standard of care (control) based on the EASD/ADA consensus report. The telemonitoring group used a continuous glucose monitor (CGM), a connected insulin pen, an activity tracker, and smartphone applications throughout the trial period. Hospital staff monitored the telemonitoring groups' data and contacted the participants by telephone repeatedly. The primary endpoint was change from baseline in CGM time in range (3·9-10·0 mmol/L) three months after randomization. An analysis of covariance was used to assess the difference in change from baseline between the telemonitoring and standard of care group.
In total, 331 participants were included and randomized (telemonitoring: 166; standard of care: 165). The observed treatment difference in change from baseline in CGM-TIR was 6·8 % (CI: 4·8, 8·8), and the estimated treatment difference was 13·6 % (CI: 7·2, 20·0) (p = 0·004) in favor of telemonitoring.
The trial demonstrated that telemonitoring is superior to standard of care in T2D for improving glycemic control.
The trial was supported by The Innovation Fund Denmark, Novo Nordisk A/S, and Dexcom, Inc.
促进药物调整的远程监测干预措施可能更有效地改善血糖控制。因此，这项随机对照试验的目的是探讨与标准治疗相比，远程监测在接受胰岛素治疗的2型糖尿病（T2D）患者中的有效性和安全性。
该试验是一项丹麦多中心开放标签随机对照试验，试验期为三个月。根据欧洲糖尿病研究协会（EASD）/美国糖尿病协会（ADA）共识报告，将接受胰岛素治疗的T2D患者随机（1:1）分为远程监测组（干预组）或标准治疗组（对照组）。在整个试验期间，远程监测组使用连续血糖监测仪（CGM）、联网胰岛素笔、活动追踪器和智能手机应用程序。医院工作人员监测远程监测组的数据，并多次通过电话联系参与者。主要终点是随机分组三个月后CGM处于目标范围（3.9-10.0 mmol/L）的时间相对于基线的变化。采用协方差分析评估远程监测组与标准治疗组相对于基线变化的差异。
总共纳入331名参与者并进行随机分组（远程监测组：166名；标准治疗组：165名）。观察到的CGM目标范围内时间（TIR）相对于基线变化的治疗差异为6.8%（95%置信区间：4.8，8.8），估计治疗差异为13.6%（95%置信区间：7.2，20.0）（p = 0.004），支持远程监测。
该试验表明，在改善血糖控制方面，远程监测优于T2D的标准治疗。
该试验由丹麦创新基金、诺和诺德公司和德康公司资助。
