The Diabetes teleMonitoring of Patients in Insulin Therapy (DiaMonT) Trial: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 331
- 试验地点
- 2
- 主要终点
- CGM time in range
研究概览
简要总结
The trial is an open-label randomized controlled trial. Patients with T2D on insulin therapy will be randomized to a telemonitoring group (intervention) and a usual care group (control). The telemonitoring group will use various devices at home. Hospital staff will monitor their data for a period of three months.
详细描述
The DiaMonT trial is an open-label randomized controlled trial with a trial period of three months conducted. The trial will be conducted in two sites in Denmark: Steno Diabetes Center North Jutland and Steno Diabetes Center Zealand. Patients with T2D on insulin therapy will be randomized (1:1) to a telemonitoring group (intervention) or a usual care group (control). The telemonitoring group will use an insulin pen, an activity tracker, a CGM, and a smartphone application throughout the trial period. Hospital staff (lab technicians and nurses) will monitor the telemonitoring groups' data and contact the subjects by telephone repeatedly throughout the trial period. The usual care group will use a blinded CGM the first and last 20 days of the trial and will use a blinded insulin pen for the entire period. The usual care groups' data will not be monitored during the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years
- •T2D diagnosis for ≥ 12 months
- •Residence in Region North Denmark or Region Zealand
- •In treatment with insulin
- •Being able to use a smartphone along with the other devices to be used in the trial
- •Able to understand and read Danish.
排除标准
- •Pregnancy or breastfeeding,
- •Major surgery planned during the trial period
- •Participation in other trials
- •Terms that, in the opinion of the investigator or subinvestigators, render the participant unfit to conduct the trial, including lack of understanding of the trial or lack of physical or cognitive ability to participate
结局指标
主要结局
CGM time in range
时间窗: At baseline to three months after randomization
Change in CGM time in range (3,9-10,0 mmol/L)
次要结局
- Time below CGM range(At baseline to three months after randomization)
- Total daily units of insulin(At baseline to three months after randomization)
- Concentration of HbA1c(At baseline to three months after randomization)
- Time above CGM range(At baseline to three months after randomization)
研究者
Peter Vestergaard
MD, professor
Aalborg University Hospital