NCT00284232已完成4 期
Randomized Controlled Trial Studying the Metabolic Effects of Accurate Blood Sugar Results and Education in Type 1 Diabetes
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- HbA1c %
研究概览
简要总结
A randomized controlled trial in patients with type 1 diabetes, assessing the metabolic effects of accurate blood sugar results and education. A systematic approach in self-monitoring blood glucose will improve metabolic control in type 1 diabetes patients. Education in SMBG combined with a high analytical quality instrument for SMBG, introduced in a systematic and thorough way will improve HbA1c by 0,5% and keep it over a period of 9 months.
详细描述
- Written informed consent 130 patients with type 1 diabetes to be included
- age 18-70
- HbA1c of 8% or higher, variation in HbA1c over the last 18 months sholuld be <1,5%
- Treated with multiple insulin injections or insulin pumps
- Variation in weight less than 5kg within last year
- Using SMBG on a daily basis
- Mental capacity and stability to participate
- No hypoglycemia unawareness
- No likelihood that patient will drop out or not perform according to protocol
- Continious recruitment from the outpatient clinic at Stavanger University Hospital from October 2004-October 2005
- 9 months follow-up
- Possible 12 month extension after initial
- Intervention group receives new SMBG instrument, education and advice on treatment changes at baseline, 1,2,3,6 and 9 months. Control group continues regular care following national guidelines of Norway. This includes visits usually every 3-6 months at the outpatient clinic and possibly with their GP in addition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Hba1c 8% or higher, less than 1,5% variation within last year
- •Age 18-70
- •Multiinjections or insulin pumps
- •Stable weight (<5kg variation last year)
- •Mentally stable
排除标准
- •Hypoglycemia unawareness
- •Mental incapacity
结局指标
主要结局
HbA1c %
时间窗: 9 months
次要结局
- Frequency of SMBG(9 months)
- New learning points for patients(9 months)
- Confidence in new instrument quality(9 months)
- Measurement quality of blood glucose instrument(9 months)
- Satisfaction(9 months)
- Hypoclycemic events(9 months)
研究者
研究点 (1)
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