A Multi-center Observational Study During Pregnancy for Women With T1DM Treated With the Paradigm Insulin Pumps Donated by the 'Wielka Orkiestra Świątecznej Pomocy' Foundation in Poland
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 481
- 试验地点
- 24
- 主要终点
- Percent of Sensor Glucose Values in 70-140 mg/dL
研究概览
简要总结
The aim of this project is to document the use of insulin pump therapy (CSII), including sensor augmented pump therapy (SAP), before, during and after pregnancy in women with type 1 Diabetes Mellitus benefiting from the Orchestra donation of Paradigm REAL-Time and Paradigm Veo pumps in Poland.
详细描述
The project is designed as a multi-center prospective observational Post-Market-Release study to be conducted in up to 30 centers in Poland.
Total duration of the study per patient will be up to 22 months (up to 12 months pre-conception phase, pregnancy, and 6 weeks after delivery). The optimal study start is the beginning of pre-conception phase, however, pregnant women up to the 16th week of pregnancy can participate in the study too. The study end is 6 weeks after delivery. If conception does not occur within 12-months, the patient's study participation is terminated, and the insulin pump might be taken away from the patient. The following therapy is decided by the investigator. If the pump is not taken away after the 12-month of trial period for conception, the patient can continue insulin pump therapy until the pump is needed for another patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female diagnosed with Diabetes Mellitus Type 1
- •Subject indicated by HCP to start insulin pump therapy (CSII) or sensor augmented pump therapy (SAP) due to the desired or established pregnancy
- •HCP has prescribed the use of Orchestra donated device to the subject independently of the study
- •Signed Patient Informed Consent (PIC)
- •Subject is 18 to 45 years old, planning immediate pregnancy (within the next 12 months) or being pregnant within the first trimester until the 16th week of amenorrhea
- •Subject has been on MDI for at least 3 months before starting pump therapy
排除标准
- •Subject was enrolled in the registry earlier, and terminated it (for any reason)
- •Participation in any other interventional clinical trial - currently and/or in the last 3 months before the signature of PIC
- •Subject uses an insulin pump that was not donated by the Orchestra Foundation
- •Pregnant women with longer than 16 weeks of pregnancy/amenorrhea
- •Subjects who need assisted in vitro fertilization
- •Subjects with Diabetes Mellitus Type 2, Gestational Diabetes, MODY or any other type of diabetes than Type 1
- •Subject under the age of 18
- •Subject legally incompetent
- •Subject cannot read or write
结局指标
主要结局
Percent of Sensor Glucose Values in 70-140 mg/dL
时间窗: During pregnancy
Percent of sensor glucose values between and including 70 mg/dL to 140 mg/dL
HbA1c
时间窗: from preconception phase to 6 weeks after delivery
Changes in HbA1C from baseline to after delivery.
次要结局
- Large for Gestational Age (LGA)(after birth)
- Unhealthy Babies(from birth to 6 weeks after delivery)