Use of iPro™2 in Real Life Diabetes Management of Type 2 Patients in India
2018年11月8日 更新者：Medtronic Diabetes
The purpose of the India iPro2 study is to demonstrate that iPro2 Continuous Glucose Monitoring System (CGMS) evaluation enables Health Care Professional (HCP)s treating patients in India with type 2 diabetes to get a better understanding of their patient's metabolic fluctuations, and support appropriate therapeutic intervention.
研究概览
详细说明
The study will be designed to demonstrate the value of iPro2 in real-world diabetes management in type 2 patients in India. It will be an interventional post-market, prospective, multi-center study with a data review performed after 30 subjects have completed the trial.
During the course of the study, patients will undergo two iPro2 evaluations:
- First iPro2 test (Visit 1 [application] & 2 [removal])
- Second iPro2 test (Visit 3 [application] & 4 [removal])
Patient and HCP questionnaires will be administered at Visit 1, 2, 3, 4 and 5. These questionnaires aim to assess the impact of an iPro2 evaluation on the physicians understanding of their patient's metabolic fluctuations and its support of therapeutic interventions. They will also investigate the subjects understanding (both pre & post iPro2 evaluation) of the concept of glycemic variability and the importance of compliance to HCP recommendations.
研究类型
介入性
注册 (实际的)
181
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Chennai
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Gopalapuram、Chennai、印度、600086
- Madras Diabetes Research Foundation
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Gujarat
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Ahmedabad、Gujarat、印度、380015
- DIA Care
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Haryana
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Gurgaon、Haryana、印度、122 001
- Medanta
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Kerala
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Trivandrum、Kerala、印度、695032
- Jothydev's Diabetes and Research Centre
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Madhya Pradesh
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Indore、Madhya Pradesh、印度、452010
- TOTALL Diabetes Hormone Institute
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Maharashtra
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Mumbai、Maharashtra、印度、400008
- K.G.N Diabetes and Endocrine Centre
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Mumbai、Maharashtra、印度、400053
- Lina Diabetes Care Centre
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Mumbai、Maharashtra、印度、400058
- Dr.Kovil's Diabetes Care centre
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Mumbai、Maharashtra、印度、400080
- Diab Care Center
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Pune、Maharashtra、印度、411011
- Diabetes Care & Research Center
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Tamil Nadu
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Chennai、Tamil Nadu、印度、600013
- M.V Hospital for Diabetes Research centre
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion criteria:
- Subject is > 18 years to ≤ 70 years of age
- Subject has been diagnosed with type 2 diabetes mellitus for at least 1 year and is currently being treated with an oral anti-hyperglycemic medication and/or insulin
- Subject's A1C > 8.0% to ≤ 10% conducted in the last 4 weeks
- Subject, or legal representative, has signed the study Patient Informed Consent Form (PIC)
- Subject is willing to comply with the study procedures
Exclusion criteria:
- Subject is unable to tolerate tape adhesive in the area of sensor placement
- Subject is pregnant, or is expecting to become pregnant during the course of the trial per Investigator discretion.
- Subject has no experience with SMBG and blood glucose meter use
- Subject has undergone an iPro evaluation during the past 6 months
- Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, rash, Staphylococcus infection)
- Subject is actively participating or planning to actively participate in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks
- Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator
- Subject has unresolved alcohol or drug addiction
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：iPro2 Use
All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests
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Subjects will be recommend changes in therapy regimens.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in A1C at 3 Months
大体时间：3 months
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Descriptive analysis of change in A1C from baseline to end of 3-month study period
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Serious Adverse Device Effects (SADE).
大体时间：3 months
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Evaluation of incidence of SADE during the study.
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3 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Jothydev Kesavadev, MD、Jothydev's Diabetes and Research Centre
- 首席研究员：Mohan V, MD、Madras Diabetes Research Foundation
- 首席研究员：Vijay Viswanathan, MD、M.V Hospital for Diabetes Research centre
- 首席研究员：Ambrish Mithal, MD、Medanta Institute of Clinical Research
- 首席研究员：Manoj Chawla, MD、Lina Diabetes Care Mumbai Diabetes Research Centre
- 首席研究员：Rajiv Kovil, MD、Dr.Kovil's Diabetes Care centre
- 首席研究员：Banshi Saboo, MD、DIA Care
- 首席研究员：Sunil Jain, MD、TOTALL Diabetes Hormone Institute
- 首席研究员：Abhay Mutha, MD、Diabetes Care & Research Center
- 首席研究员：Shehla Shaikh, MD、K.G.N Diabetes and Endocrine Centre
- 首席研究员：Dharmen Punatar, MD、Diab Care Centre
- 研究主任：Scott Lee, MD、Medtronic Diabetes
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年12月1日
初级完成 (实际的)
2014年1月1日
研究完成 (实际的)
2014年4月1日
研究注册日期
首次提交
2013年11月8日
首先提交符合 QC 标准的
2013年11月25日
首次发布 (估计)
2013年11月26日
研究记录更新
最后更新发布 (实际的)
2018年12月4日
上次提交的符合 QC 标准的更新
2018年11月8日
最后验证
2018年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.