Laursen Sisse H, Giese Iben Engelbrecht, Udsen Flemming W, Hejlesen Ole K, Barington Pernille F, Ohrt Morten, Vestergaard Peter, Hangaard Stine
Steno Diabetes Center North Denmark, Aalborg University Hospital, Aalborg, Denmark.
Department of Health Science and Technology, Aalborg University, Gistrup, Denmark.
Pilot Feasibility Stud. 2024 May 22;10(1):83. doi: 10.1186/s40814-024-01509-0.
Maintaining optimal glycemic control in type 2 diabetes (T2D) is difficult. Telemedicine has the potential to support people with poorly regulated T2D in the achievement of glycemic control, especially if the telemedicine solution includes a telemonitoring component. However, the ideal telemonitoring design for people with T2D remains unclear. Therefore, the aim of this feasibility study is to evaluate the feasibility of two telemonitoring designs for people with non-insulin-dependent T2D with a goal of identifying the optimal telemonitoring intervention for a planned future large-scale randomized controlled trial.
This 3-month randomized feasibility study will be conducted in four municipalities in North Denmark starting in January 2024. There will be 15 participants from each municipality. Two different telemonitoring intervention designs will be tested. One intervention will include self-monitoring of blood glucose (SMBG) combined with sleep and mental health monitoring. The second intervention will include an identical setup but with the addition of blood pressure and activity monitoring. Two municipalities will be allocated to one intervention design, whereas the other two municipalities will be allocated to the second intervention design. Qualitative interviews with participants and clinicians will be conducted to gain insight into their experiences with and acceptance of the intervention designs and trial procedures (e.g., blood sampling and questionnaires). In addition, sources of differences in direct intervention costs between the two alternative interventions will be investigated.
Telemonitoring has the potential to support people with diabetes in achieving glycemic control, but the existing evidence is inconsistent, and thus, the optimal design of interventions remains unclear. The results of this feasibility study are expected to produce relevant information about telemonitoring designs for people with T2D and help guide the design of future studies. A well-tested telemonitoring design is essential to ensure the quality of telemedicine initiatives, with goals of user acceptance and improved patient outcomes.
ClinicalTrials.gov, ID: NCT06134934 . Registered November 1, 2023. The feasibility trial has been approved (N-20230026) by the North Denmark Region Committee on Health Research Ethics (June 5, 2023).
在2型糖尿病（T2D）中维持最佳血糖控制具有挑战性。远程医疗有潜力支持血糖控制不佳的T2D患者实现血糖控制，特别是如果远程医疗解决方案包含远程监测组件。然而，针对T2D患者的理想远程监测设计仍不明确。因此，本可行性研究的目的是评估两种针对非胰岛素依赖型T2D患者的远程监测设计的可行性，目标是为未来计划开展的大规模随机对照试验确定最佳远程监测干预措施。
这项为期3个月的随机可行性研究将于2024年1月在丹麦北部的四个直辖市开展。每个直辖市将有15名参与者。将测试两种不同的远程监测干预设计。一种干预措施将包括血糖自我监测（SMBG）以及睡眠和心理健康监测。第二种干预措施将包括相同的设置，但增加血压和活动监测。两个直辖市将被分配到一种干预设计，而另外两个直辖市将被分配到第二种干预设计。将对参与者和临床医生进行定性访谈，以深入了解他们对干预设计和试验程序（如采血和问卷调查）的体验及接受程度。此外，还将调查两种替代干预措施在直接干预成本方面存在差异的原因。
远程监测有潜力支持糖尿病患者实现血糖控制，但现有证据并不一致，因此，干预措施的最佳设计仍不明确。预计这项可行性研究的结果将产生有关T2D患者远程监测设计的相关信息，并有助于指导未来研究的设计。经过充分测试的远程监测设计对于确保远程医疗项目的质量至关重要，目标是实现用户接受并改善患者预后。
ClinicalTrials.gov，标识符：NCT06134934。于2023年11月1日注册。该可行性试验已获得丹麦北部地区健康研究伦理委员会批准（N - 20230026，2023年6月5日）。
