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临床试验 NCT01454700 针对1型糖尿病目前已完成。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
Effect of CSII and CGM on Progression of Late Diabetic Complications IV期 60
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临床试验NCT01454700旨在研究治疗，主要针对1型糖尿病。这是一项IV期 干预性研究试验，试验状态为已完成。试验开始于2011年12月1日，共计划招募60名患者。该研究由Steen Andersen主导，已于2014年12月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2015年1月14日。
简要概括
The purpose of the study is to investigate whether the combination of insulin pump therapy and continued glucose monitoring (CGM) is superior to multiple daily insulin injections to prevent progression of albuminuria in patients with type 1 diabetes
详细描述
80 type 1 diabetic patients with kidney function (GFR > 45 ml/min), but with urine albumin excretion of at least 30 mg/day and HbA1c 7.5-13.0% are randomised to either multiple daily insulin injections (control group) or insulin pump therapy plus continued glucose monitoring (CGM) (intervention group). Patients must be in stable RAAS blockade before entering the study.
Before the study is initiated all patients rec...
显示更多官方标题
The Effect of Sensor-Augmented Continuous Subcutaneous Insulin Infusion Compared to Multiple Daily Insulin Injections in Prevention of Increasing Urinary Albumin Excretion Rate in Type 1 Diabetes Mellitus
疾病
1型糖尿病出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- H-3-2011-122
NCT编号
实际开始日期
2011-12
最近更新发布
2015-01-14
预计完成日期
2014-12
计划入组人数
60
研究类型
干预性研究
试验分期 (阶段)
IV期
试验状态
已完成
关键词
Type 1 diabetes mellitus
Albuminuria
Late diabetes complications
CSII
CGM
Glycaemic control
Albuminuria
Late diabetes complications
CSII
CGM
Glycaemic control
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性CSII plus CGM Patients who has never been treated with insulin pump are randomized to 12 months with insulin pump therapy plus continuous glucose monitoring. | Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM) Randomization to 12 months with CSII plus CGM |
阳性对照Multiple daily insulin injections randomized to 12 months standard/usual insulin regimen (multiple daily injections). (stays on insulin pen). | Multiple daily insulin injections (MDI) Randomization12 months therapy with MDI |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
difference in change in urine albumine excretion from baseline to end of study (12 months) | Urine albumin excretion is evaluated at screening, at entry, after 1,3,6,9, and 12 months. | 12 months |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
difference in change of HbA1c from baseline to 12 months | 12 months | |
difference in change in self-monitored blood glucose (SMBG) measurement 4-point glucose profiles | 12 months | |
difference in change of 24-hour blood pressure | 12 months | |
difference in change of glomerular filtration rate (GFR) | 12 months | |
difference in the occurence or progression of retinopathy | 12 months | |
difference in change of cardiovascular biomarkers of inflammation, lipid metabolism and NT-proBNP | 12 months | |
difference in endothelial cell dysfunction | 12 months | |
difference in carotid intima media thickness (CIMT) | 12 months |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- 18-75 years of age,
- Type 1 diabetes according to WHO criteria,
- Urin albumine > 30 mg/g (albumine/creatinine ratio),
- HbA1c > 7.5 < 13.0%,
- No change in RAAS blocking treatment at least 4 weeks prior to screening.
- Kidney disease other that diabetic nephropathy,
- Recurrence of severe hypoglycaemia or hypoglycaemia unawareness as judged by the investigator,
- Use of insulin pump within 12 months,
- Acute myocardial infarction within 3 months,
- Severe arteriosclerosis as judged by the investigator,
- Heart failure (NYHA class 3 or 4),
- Abuse of alcohol or drugs,
- Any cancer diagnosis unless in remission at least 5 years prior to screening,
- Participation in other intervention studies,
- Pregnant or lactating women,
- Any other disease, condition or type of treatment which - as judged by the investigator - render the patient ineligible to participate in the study.
Steen AndersenMedtronic研究责任方
Steen Andersen, 申办者-研究者, Chief physician, DMSc, Steno Diabetes Center Copenhagen
没有联系数据。
1 位于 1 个国家/地区的研究中心
Copenhagen
Steno Diabetes Center, Gentofte Municipality, Copenhagen, 2820, Denmark