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.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- The levels of HbA1c will be investigated on patients combining the pump therapy with continuous glucose monitoring over a period of three months.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The levels of HbA1c will be investigated on patients combining the pump therapy with continuous glucose monitoring over a period of three months.
时间窗: 2 years
次要结局
- To evaluate the impact of continuous sensing on the variability of glucose(2 years)
- To examine the frequency of hypoglycemic events.(2 years)
- To examine the frequency of ketoacidosis events(2 years)
- To examine the frequency of Emergency Department visits(2 years)
- To examine the frequency of hospitalizations(2 years)
- To examine the duration of hospitalizations(2 years)
- To evaluate the daily insulin requirements(2 years)
- To evaluate the % sensor usage(2 years)