NCT01779141

Orchestra Pregnancy Observational Study in Poland

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 481 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Type 1 Diabetes Mellitus
• Pregnancy

Timeline

• Start date: 2013-05-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2013-01-30
• Last updated: 2020-02-05
• Results posted: 2019-07-10

Locations

24 sites across 1 country: Poland