A Randomized Study Comparing Usual Diabetes Care Management to Telemetric Home-based Monitoring of Glucose and Blood Pressure in Patients With Diabetes (TELEGAP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 254
- 主要终点
- Fructosamine
研究概览
简要总结
The study is a two-arm, parallel-comparison, single-blind, randomized controlled trial, and will be offered to Kaiser Permanente members aged 18 - 75 years old who present to the Santa Rosa Diabetes Care Management Center with Type 2 diabetes mellitus. Participants will be randomly assigned to one of two treatment arms. The telemedicine group or the group receiving usual care (the control group).
This study hopes to show the usefulness of this telemonitoring technology and more specifically, to assess whether this device improves markers of control of diabetes, glycemic control, and cardiovascular risk factors
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 75 years old,
- •diagnosis of type 2 diabetes mellitus for at least 1 month,
- •eligible for and referred to the diabetes care management program,
- •HbA1c values in the range: 7.5% to 10.5%.
排除标准
- •Weight > 330 lbs,
- •estimated glomerular filtration rate (GFR) < 45,
- •unstable coronary artery disease,
- •severe peripheral vascular disease which restricted exercise,
- •end-stage liver disease,
- •undergoing treatment for cancer,
- •pregnant or not using appropriate birth control,
- •no broadband internet access in their homes.
研究组 & 干预措施
Usual Care
This arm received usual care from the diabetes care managers
Telemonitoring Device
Patients in this arm received a telemonitoring device installed in their homes
干预措施: Telemonitoring Device (Device)
结局指标
主要结局
Fructosamine
时间窗: 6 weeks
Change from baseline to 6 weeks in serum fructosamine levels
glycosylated hemoglobin
时间窗: 6 months
change from baseline to 6 months in serum HbA1c levels
次要结局
- blood pressure(6 weeks and 6 months)