Objectives and methods of the ORCHESTRA FOUNDATION Registry study: a multicenter observational study of the use of insulin pump therapy in pregnant women with type 1 diabetes mellitus in Poland.

Background. The ORCHESTRA FOUNDATION Registry study was a prospective, multicenter, observational, post-market study investigating the use of an insulin pump with or without continuous glucose monitoring (CGM) [i.e., sensor-augmented pump (SAP) or sensor-integrated insulin pump (SIP)]; before, during, and after pregnancy, in women with type 1 diabetes mellitus (T1DM). Methods. Study participants enrolled in 24 centers, in Poland, and contributed intake and follow-up data for up to 22 months (i.e., up to 12 months pre-conception, throughout pregnancy, and 6 weeks after delivery). Participants who were already pregnant were enrolled up to the 16th week of pregnancy. Investigated outcomes included HbA1c before and during pregnancy, and serious adverse events (e.g., severe hypoglycemia, diabetic ketoacidosis, miscarriage, and hospitalization due to any bleeding or any symptoms suggesting premature delivery). Routine clinical data including maternal weight, body mass index, and daily insulin use were also recorded. The insulin delivery devices used in the study were the MiniMed™ Paradigm™ REAL-Time insulin pump with CGM (via the MiniMed Sof-sensor™ sensor) or without CGM, and the MiniMed Paradigm Veo™ with CGM (via the Enlite™ sensor). Results. Study enrollment began in May 2013 and the last patient completed the study in August 2017. Conclusions. The ORCHESTRA FOUNDATION Registry study provides an opportunity to assess the effects of automated insulin delivery in pregnant women with T1DM using insulin pumps with or without continuous glucose monitoring.Background. The ORCHESTRA FOUNDATION Registry study was a prospective, multicenter, observational, post-market study investigating the use of an insulin pump with or without continuous glucose monitoring (CGM) [i.e., sensor-augmented pump (SAP) or sensor-integrated insulin pump (SIP)]; before, during, and after pregnancy, in women with type 1 diabetes mellitus (T1DM). Methods. Study participants enrolled in 24 centers, in Poland, and contributed intake and follow-up data for up to 22 months (i.e., up to 12 months pre-conception, throughout pregnancy, and 6 weeks after delivery). Participants who were already pregnant were enrolled up to the 16th week of pregnancy. Investigated outcomes included HbA1c before and during pregnancy, and serious adverse events (e.g., severe hypoglycemia, diabetic ketoacidosis, miscarriage, and hospitalization due to any bleeding or any symptoms suggesting premature delivery). Routine clinical data including maternal weight, body mass index, and daily insulin use were also recorded. The insulin delivery devices used in the study were the MiniMed™ Paradigm™ REAL-Time insulin pump with CGM (via the MiniMed Sof-sensor™ sensor) or without CGM, and the MiniMed Paradigm Veo™ with CGM (via the Enlite™ sensor). Results. Study enrollment began in May 2013 and the last patient completed the study in August 2017. Conclusions. The ORCHESTRA FOUNDATION Registry study provides an opportunity to assess the effects of automated insulin delivery in pregnant women with T1DM using insulin pumps with or without continuous glucose monitoring