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
1 other identifier
observational
481
1 country
24
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2013
Longer than P75 for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2013
CompletedFirst Posted
Study publicly available on registry
January 30, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedResults Posted
Study results publicly available
July 10, 2019
CompletedFebruary 5, 2020
January 1, 2020
4.3 years
January 28, 2013
April 11, 2019
January 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Large for Gestational Age (LGA)
after birth
Unhealthy Babies
from birth to 6 weeks after delivery
Study Arms (1)
CSII
Patients using CSII with or without CGM.
Eligibility Criteria
The study subject population is women with Type 1 Diabetes Mellitus at the age of 18-45 who * plan pregnancy * are in the early phase of pregnancy, up to the 16th week
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok, 15-276, Poland
NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny
Bialystok, 15-435, Poland
Szpital Wojewódzki w Bielsku Białej
Bielsko-Biala, 43-316, Poland
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168, Poland
Szpital Specjalistyczny w Jaśle
Jasło, 38-200, Poland
NZOZ WITAMED Outpatient Diabetes Clinic
Kielce, 25-035, Poland
Szpital Uniwersytecki w Krakowie
Krakow, 31-501, Poland
Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Łodzi
Lodz, 90-153, Poland
Uniwersytet Medyczny w Łodzi, Klinika Diabetologii
Lodz, 93-338, Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 Uniwersytetu Medycznego w Lublinie
Lublin, 20-090, Poland
Wojewódzki Szpital Specjalistyczny w Olsztynie
Olsztyn, 10-561, Poland
PSZOZ Wojewódzkie Centrum Medyczne w Opolu
Opole, 45-418, Poland
Clinic of Gynecology and Obstetrics of Marcinkowski Medical University
Poznan, 60-535, Poland
Zakład Opieki Zdrowotnej Poznań-Jeżyce
Poznan, 60-834, Poland
Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej
Rzeszów, 35-301, Poland
Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie im. Marii Skłodowskiej-Curie
Szczecin, 71-455, Poland
Wojewódzki Szpital Zespolony im. L. Rydygiera
Torun, 87-100, Poland
Szpital Kliniczny im. ks. Anny Mazowieckiej Warszawskiego Uniwersytetu Medycznego
Warsaw, 00-315, Poland
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
Warsaw, 02-097, Poland
Mazowiecki Szpital Wojewódzki Sp. z o.o.
Warsaw, 03-242, Poland
Wojewódzki Zespół Specjalistycznej Opieki Zdrowotnej
Wroclaw, 50-403, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 im prof. Stanisława Szyszko
Zabrze, 41-800, Poland
Zespół Wojewódzkich Przychodni Specjalistycznych w Katowicach
Zabrze, 41-800, Poland
NZOZ MED-ART Poradnie Specjalistyczne Sp. z o.o.
Żory, 44-240, Poland
Related Publications (1)
Cypryk K, Wender-Ozegowska E, Cyganek K, Sieradzki J, Skoczylas K, Chen X, Cordero TL, Shin J, Cohen O. Insulin pump therapy with and without continuous glucose monitoring in pregnant women with type 1 diabetes: a prospective observational Orchestra Foundation study in Poland. Acta Diabetol. 2023 Apr;60(4):553-561. doi: 10.1007/s00592-022-02020-9. Epub 2023 Jan 19.
PMID: 36653533DERIVED
Biospecimen
Whole blood, serum, urine samples as required in routine practice before, during and after pregnancy in women with Type 1 Diabetes Mellitus
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Suiying Huang, Statistician
- Organization
- Medtronic Minimed
Study Officials
- STUDY CHAIR
Jacek Sieradzki, Prof
Cracow Medical University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 22 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2013
First Posted
January 30, 2013
Study Start
May 1, 2013
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
February 5, 2020
Results First Posted
July 10, 2019
Record last verified: 2020-01