NCT00272064已完成3 期
Optimisation of Insulin Treatment of Type 2 Diabetes Mellitus by Telecare Assistance for Self Monitoring of Blood Glucose (SMBG).
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Changes of glycosilated haemoglobin (HbA1c)
研究概览
简要总结
- The primary objective of the present study is to verify the superiority of Telecare program vs. standard SMBG program in terms of mean HbA1c value (- 0,5%) at end-point.
- The secondary objectives of the study are the assessment of: total daily dose of insulin, changes in glycaemic and lipid profile, frequency of hypoglycaemias, changes in weight, health-related quality of life, cost-effectiveness of Telecare program vs. common ambulatory program; general safety (adverse event profile, other routine laboratory parameters).
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
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Other
Telecare system
干预措施: Insulin glulisine (Drug)
1
Other
Telecare system
干预措施: Insulin glargine (Drug)
1
Other
Telecare system
干预措施: Metformin (Drug)
2
Other
Self Monitoring Blood Glucose (SMBG)system.
干预措施: Insulin glulisine (Drug)
2
Other
Self Monitoring Blood Glucose (SMBG)system.
干预措施: Insulin glargine (Drug)
2
Other
Self Monitoring Blood Glucose (SMBG)system.
干预措施: Metformin (Drug)
结局指标
主要结局
Changes of glycosilated haemoglobin (HbA1c)
时间窗: At least 12 weeks from baseline (visit 3)
次要结局
- Changes in fasting plasma glucose(At each visit)
- Changes in plasma insulin levels(At each visit)
- Change of Self-monitoring of Blood Glucose (SMBG)(for the total study duration)
- Mean Amplitude Glucose Excursion (MAGE)(for the total study duration)
- Change in lipid profile(V1 (screening) and V5 (end of treatment))
- Body weight - Body Mass Index(V1 (screening), V3 (start of titration), V4 (after 12 weeks of treatment), V5 (end of treatment), V6 (end of follow-up))
- Total daily dose of insulins (glargine and glulisine)(At each visit (starting from V2 for glargine and from V3 for glulisine))
- Health related Quality of Life(V2 (start of titration), V4 (after 12 weeks of treatment), V5 (end of treatment))
- Hypoglycemic episodes(for the total study duration)
研究者
研究点 (1)
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