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临床试验 NCT01072565 针对2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
Modal Day Analysis of Self Monitoring Blood Glucose Versus Continuous Glucose Monitoring 91
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临床试验NCT01072565是一项针对2型糖尿病的干预性研究试验，试验状态为已完成。试验开始于2010年2月1日，共计划招募91名患者。该研究由HealthPartners Institute主导，已于2012年1月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2015年11月26日。
简要概括
The purpose of this study is to evaluate the effectiveness of Self Monitoring of Blood Glucose (SMBG) for clinical decisions related to the management of type 2 diabetes and to determine the benefit of using Continuous Glucose Monitoring (CGM) for clinical diabetes management.
官方标题
Optimization of SMBG Employing Modal Day Analysis: Examining Clinical Decision-making Processes Using Blinded FreeStyle Navigator Continuous Glucose Monitoring System (CGM)
疾病
2型糖尿病其他研究标识符
- 03914-09-C
NCT编号
实际开始日期
2010-02
最近更新发布
2015-11-26
预计完成日期
2012-01
计划入组人数
91
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
已完成
关键词
Type 2 Diabetes
A1c
Continuous Glucose Monitoring
Blood Glucose
A1c
Continuous Glucose Monitoring
Blood Glucose
主要目的
治疗方法
分配方式
随机
干预模型
析因设计
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 |
|---|---|
阳性对照SMBG Only You will measure your blood glucose 4 times daily by finger sticks using a blood glucose meter and you will also wear a CGM device. The CGM measurements will be blinded (neither you nor the study doctor will be able to see the CGM measurements until your final study visit). Only your SMBG measurements will be considered to help manage your diabetes. Your medications will be changed or adjusted based on your HbA1c and...显示更多 | SMBG to guide clinical decisions The investigator will base clinical decisions on A1c and modal day analysis of SMBG. |
阳性对照SMBG and CGM You will measure your blood glucose 4 times daily by finger sticks using a blood glucose meter and you will also wear a CGM device. The CGM measurements will be downloaded at each study visit and will be considered along with your SMBG measurements to help manage your diabetes. Your medications will be changed or adjusted based on your HbA1c and/or glucose readings with a goal to achieve an HbA1c level of 7%. | SMBG and CGM The investigator will base clinical decisions on A1c, modal day analysis of SMBG and CGM data. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Evaluate the efficacy of SMBG for clinical decisions related to the management of type 2 diabetes. | Three, six and nine months. |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Determine the incremental benefit of CGM for clinical decision-making. | Three, six and nine 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
- Male or female subjects ≥18 and ≤75 years of age
- Clinical diagnosis of diabetes
- Diabetes duration ≥ 1 year
- HbA1c ≥7.2%
- Diabetes can be treated with any therapy including medical nutrition therapy alone and any pharmaceutical therapy
- Taken prednisone or cortisone medications in the previous 30 days
- Currently pregnant or planning pregnancy during the study period
- Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
- Unable to follow the study protocol
- Unable to speak, read and write in English
HealthPartners Institute- International Diabetes Center at Park Nicollet
没有联系数据。
1 位于 1 个国家/地区的研究中心
Minnesota
International Diabetes Center, Minneapolis, Minnesota, 55416, United States