N/A
Completed N=481
Orchestra Pregnancy Observational Study in Poland
Source: ClinicalTrials.gov NCT01779141 ↗Enrolled (actual)
481
Serious AEs
37.6%
Results posted
Jul 2019
Primary outcomePrimary: HbA1c — -0.8 HbA1C percentage
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c |
-0.8 | — |
| PRIMARY Percent of Sensor Glucose Values in 70-140 mg/dL |
67.62 | — |
| SECONDARY Large for Gestational Age (LGA) |
74 | — |
| SECONDARY Unhealthy Babies |
99 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01779141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.