Diabetes Multicenter Observational Study (DIAMOND-1-) (DIAMOND-1)
2011年6月8日 更新者：Medtronic Hellas Medical Devices ΑEE
Prospective, Multicenter, Non-interventional Post Market Release Study , to Examine Whether Pump Treatment Combined With the Use of Continuous Glucose Monitoring System is a Mean to Normalize Glycaemic Control.
The purpose of this study is to examine whether pump treatment combined with the use of continuous glucose monitoring system is a mena to normalize glycaemic control.
研究概览
地位
未知
条件
详细说明
In this study, 100 subjects, users of Paradigm 522/722 Infusion Pump and Self- Monitoring Blood Glucose finger sticks for the control of their glucose levels for at least 3 months prior enrollment will participate.
Moreover the subjects won't have achieved the best blood glucose control, with an average HbA1c above 7% and should meet all the inclusion and none of the exclusion criteria.
The HbA1c value for screening purposes can be taken from the medical chart, while in the enrollment visit according to current medical practice of each investigational center, the sample taken for HbA1c measurement will be analyzed centrally by HPLC, in a lab in Germany.
In all enrolled patients a continuous glucose monitoring system will be provided.
Since this is an observational study, the provision of the glucose monitoring system will be based on medical justification and will not be done per protocol requirement.
All subjects will be followed for 3 months according to the current medical practice of each investigational center.
All other visits, e.g.
patient comes into the hospital because of symptoms, will also be recorded as unscheduled visits.
These visits are usually linked to Adverse Events.
研究类型
观察性的
注册 (预期的)
100
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
12年 至 45年 (孩子、成人)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
This is an observational pilot study that does not have a statistically powered primary hypothesis.
The data collected during this study are for the purpose of accumulating information that may generate research ideas and lead to publications.
For this reason a sample size of 100 subjects has been defined.
The statistical analysis will be descriptive statistics and will be described in a separate statistical analysis plan.
Moreover any enrolled patient that has a sensor usage % in the end of the study that is less than 65% will be excluded from the analysis.
描述
Inclusion Criteria:
- Subjects and/or their legal representative must sign the Patient Data Release Form (PDRF).
- Subjects must be aged between 12 and 45 years old.
- Subjects must be pump and Self- Monitoring Blood Glucose fingersticks users for at least 3 months and no more than 9 months.
- HbA1c >7.0% with a measurement no older than three months prior to enrollment.
- Diagnosed T1D at least 1 year before study entry.
- Subjects must be able to understand how to use the Paradigm REAL-Time System and how to adjust and administer corrective treatment.
- Subjects should not have used the sensor in the past.
Exclusion Criteria:
- Hearing or vision impairment so that alarms can not be recognized.
- Alcohol or drug abuse other than nicotine.
- Subjects suffering from severe chronic disease or genetic disorder other than T1D. (i.e. Down syndrome etc.)
- Subjects suffering from allergy.
- Subjects in pregnancy or with desire to conceive during study.
- Subjects participating in other device or drug studies.
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
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
The levels of HbA1c will be investigated on patients combining the pump therapy with continuous glucose monitoring over a period of three months.
大体时间：2 years
|
2 years
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
To evaluate the impact of continuous sensing on the variability of glucose
大体时间：2 years
|
2 years
|
|
To examine the frequency of hypoglycemic events.
大体时间：2 years
|
2 years
|
|
To examine the frequency of ketoacidosis events
大体时间：2 years
|
2 years
|
|
To examine the frequency of Emergency Department visits
大体时间：2 years
|
2 years
|
|
To examine the frequency of hospitalizations
大体时间：2 years
|
2 years
|
|
To examine the duration of hospitalizations
大体时间：2 years
|
2 years
|
|
To evaluate the daily insulin requirements
大体时间：2 years
|
2 years
|
|
To evaluate the % sensor usage
大体时间：2 years
|
2 years
|
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。
调查人员
- 首席研究员：Charalampos Vasilopoulos, Dr.、General Hospital of Athens "Evaggelismos"
- 首席研究员：Christos Zoupas, Dr.、Diagnostic and Therapeutic Center of Athens "Hygeia"
- 首席研究员：Marriana Benroubi, Dr.、General Hospital of Athens "POLICLINIC"
- 首席研究员：Christina Kanaka, Dr.、Children General Hospital " Agia Sofia"
- 首席研究员：Nikolaos Tentolouris, Dr.、General Hospital of Athens "Laiko"
- 首席研究员：Maria Alevizaki, Assoc. Prof.、General Hospital of Athens "Alexandra"
- 首席研究员：Andrianni Gerasimidi, Dr.、Children Hospital "Aglaia Kiriakou"
- 首席研究员：Andreas Melidonis, Dr.、General Hospital of Peiraeus "TZANEIO"
- 首席研究员：Dimitrios Mamoulakis, Dr.、University Hospital of Heraklion
- 首席研究员：Angelos Pappas, Dr.、"Venizeleio - Pananeio" General Hospital of Heraklion
- 首席研究员：Triantafillos Didaggelos, Lecturer、University Hospital of Thessalonica " AXEPA",Α' Propedeutic Pathology Clinic
- 首席研究员：Ioannis Giovos, Assoc. Prof.、University Hospital of Thessalonica " AXEPA" ,Α' Pathology Clinic
- 首席研究员：Emmanouil Pagkalos, Dr.、General University Hospital of Thessalonica "PAPAGEORGIOU",Α' Pathology Clinic
- 首席研究员：Asimina Galli, Ass. Prof.、General University Hospital of Thessalonica "PAPAGEORGIOU",D' Pediatric Clinic
- 首席研究员：Christos Manes, Dr.、General University Hospital of Thessalonica "PAPAGEORGIOU",Β' Pathology Clinic
- 首席研究员：Agathoklis Tsatsoulis, Prof.、General University Hospital of Ioannina
- 首席研究员：Ioannis Chabeos, Lecturer、General University Hospital of Rio- Patra
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
2009年6月1日
研究完成 (预期的)
2011年12月1日
研究注册日期
首次提交
2011年6月7日
首先提交符合 QC 标准的
2011年6月8日
首次发布 (估计)
2011年6月9日
研究记录更新
最后更新发布 (估计)
2011年6月9日
上次提交的符合 QC 标准的更新
2011年6月8日
最后验证
2011年6月1日
更多信息
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- Version 1.0 - 12/Sep/2008
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