Orchestra Pregnancy Observational Study in Poland

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Type 1 Diabetes Mellitus, Pregnancy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CSII<br>Patients using CSII with or without CGM. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Changes in HbA1C from baseline to after delivery. | from preconception phase to 6 weeks after delivery | 
| Percent of Sensor Glucose Values in 70-140 mg/dL | Percent of sensor glucose values between and including 70 mg/dL to 140 mg/dL | During pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Large for Gestational Age (LGA) | Percentage of mothers who delivered LGA babies. The Babies whose weight were greater than 90th percentiles at the gestational age when they were born, were defined as LGA Babies. (reference: Fetal biometry between 20-42 weeks of gestation for Polish population). | after birth | 
| Unhealthy Babies | The number of participants who delivered babies classified as large for gestational age, with congenital malfunction, or who required mechanical ventilation. | from birth to 6 weeks after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes Mellitus - T1DM, Pregnancy, Insulin Pump, Glucose Sensor, Continuous Subcutaneous Insulin Infusion - CSII, Sensor Augmented Pump - SAP, Continuous Glucose Monitoring - CGM