Self-monitoring of Blood Glucose in Patients With Type 2 Diabetes Mellitus Who Are Not Using Insulin. A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Glycemic control; HbA1c at baseline, 3 months, 6 months, 9 months and 1 year (endpoint)
研究概览
简要总结
Self-monitoring of blood glucose (SMBG) is one of the important instruments in diabetes management. Most patients with type 1 diabetes and patients with type 2 using insulin, frequently measure their blood glucose in case of possible hypoglycemia, but also to evaluate the insulin treatment and get information about how to change the insulin regimen, if necessary. Without SMBG it is almost impossible to achieve this goal.
The purpose of this study is to determine if self-monitoring in patients with type 2 diabetes not using insulin results in better glycemic control.
详细描述
Study Objectives:
Primary: What is the effect of SMBG in patients with type 2 diabetes who are not using insulin on Glycemic control (as measured with glycosylated hemoglobin (HbA1c)?
Secondary: What is the effect of SMBG in patients with type 2 diabetes who are not using insulin on the following parameters:
- Health status
- Diabetes related complaints
- Patient satisfaction
- Cumulative incidence of (necessity to start) insulin therapy / maximum dosage of oral blood glucose lowering drugs
- Dosage of oral blood glucose lowering drugs
- Bodyweight (BMI)
Two treatment protocols are proposed. Treatment A consists of self-monitoring of blood glucose and treatment B consists of usual care. Patients in the A-group are instructed to measure their blood glucose values 4 times a day (1 fasting plasma glucose concentration and 3 post-meal glucose concentrations), two times a week, on one week day, and one weekend day (no more, no less). Patients should record these glucose values in a diary. Patient will get one page with information in Dutch. No further education than for handling the device and interpreting the values is given, so that besides this intervention, there will be no differences compared with the control group like other forms of education.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •HbA1c 7 - 8,5% at previous and present annual check-up
- •Use of 1 or 2 different oral blood glucose lowering drugs
- •In case of two oral blood glucose lowering drugs, they should not both have a maximum dosage
- •Sufficient knowledge of the Dutch language to understand the requirements for the study
排除标准
- •Change in oral blood glucose lowering drugs in the past three months
- •Use of insulin
- •Use of device for self-monitoring of blood glucose at the start of the study, or in the preceding 6 months
结局指标
主要结局
Glycemic control; HbA1c at baseline, 3 months, 6 months, 9 months and 1 year (endpoint)
时间窗: baseline, 3 months, 6 months, 9 months and 1 year (endpoint)
次要结局
- Quality of life; score on scale at baseline, 6 months and endpoint(baseline, 6 months and endpoint)
- Diabetes related complaints; score at baseline, 6 months and endpoint(baseline, 6 months and endpoint)
- Treatment satisfaction; score on scale at baseline, 6 months and endpoint(baseline, 6 months and endpoint)
- Incidence of (necessity to start) insulin therapy; at endpoint(anywhere during the study)
- dosage of oral blood glucose lowering drugs; at baseline, 6 months and endpoint(baseline, 6 months and endpoint)
- bodyweight; Bodymass index at baseline and endpoint(baseline and endpoint)
研究者
Nanne Kleefstra
MD PhD
Medical Research Foundation, The Netherlands