Orchestra Pregnancy Observational Study in Poland

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Medtronic Poland Spółka z ograniczoną odpowiedzialnością
Sponsor:
Information provided by (Responsible Party):
Medtronic Poland Spółka z ograniczoną odpowiedzialnością
ClinicalTrials.gov Identifier:
NCT01779141
First received: January 28, 2013
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

Purpose:

The aim of this observational study (registry) is to document the use of insulin pump therapy (CSII) and 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.

Objectives:

To assess the benefits of CSII and SAP on the maternal glycemic control; To assess the prevalence of pregnancy complications (rates of preterm delivery, infant birth weight, neonatal care admissions) from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks); To report and assess the potential benefits of SAP or CSII on neonatal outcomes


Condition
Type 1 Diabetes Mellitus
Pregnancy

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 16 Months
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Medtronic Poland Spółka z ograniczoną odpowiedzialnością:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    Maternal glycemic control


Secondary Outcome Measures:
  • Assessment of prevalence of pregnancy complications and neonatal outcomes [ Time Frame: During pregnancy, at delivery and 6 weeks after delivery ] [ Designated as safety issue: No ]
    Mode of delivery (rates elective and emergency CS, normal), Respiratory distress (1 and 5 minute Apgar scores), Gestational age at delivery, % preterm delivery <37 weeks, Infant birth weight (SD scores and customised birth weight percentile, % large for gestational age (LGA), % small for gestational age (SGA), Neonatal morbidity (treatment for neonatal hypoglycaemia), Neonatal care admission (duration of stay, level of care), Pregnancy related serious adverse events (miscarriage <22 weeks, congenital malformation, stillbirth, neonatal death), Feeding at hospital discharge (breast, bottle, both)


Biospecimen Retention:   None Retained

Whole blood, serum, urine samples as required in routine practice before, during and after pregnancy in women with Type 1 Diabetes Mellitus


Estimated Enrollment: 500
Study Start Date: May 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Women with Type 1 Diabetes Mellitus planning pregnancy or being pregnant until the 16th week of pregnacy

Criteria

Inclusion Criteria:

  • Female Diagnosed with Diabetes Mellitus Type 1
  • Subject indicated by Health Care Provider (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 6 months) or being pregnant within the first trimester until the 16th week of amenorrhea
  • Subject has been on Multiple Daily Injections (MDI) for at least 3 months (before pre-conception phase), except following a miscarriage and trying another pregnancy

Exclusion Criteria:

  • Participation in any other 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
  • Use of contraception during insulin pump therapy
  • Pregnant women with longer than 16 weeks of pregnancy/amenorrhea
  • Subjects who need assisted in vitro fertilization
  • Subjects with Diabetes Mellitus Type 2
  • Subjects with Gestational Diabetes or MODY
  • Subject under the age of 18
  • Subject legally incompetent
  • Subject cannot read or write
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779141

Locations
Poland
Uniwersytecki Szpital Kliniczny w Białymstoku Recruiting
Białystok, Poland, 15-276
Contact: Beata Telejko, MD    +48 602 399 997    telejkob@poczta.onet.pl   
Principal Investigator: Beata Telejko, MD         
NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny Recruiting
Białystok, Poland, 15-435
Contact: Malgorzata Arciszewska, MD    +48 501 700 730    wizumalgorzata@arciszewska.eu   
Principal Investigator: Malgorzata Arciszewska, MD         
Szpital Wojewódzki w Bielsku Białej Recruiting
Bielsko-Biala, Poland, 43-316
Contact: Iwona Petrulewicz-Salamon, MD    +48 696 484 620    ipetrulewicz@hospital.com.pl   
Principal Investigator: Iwona Petrulewicz-Salamon, MD         
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy Recruiting
Bygdoszcz, Poland, 85-168
Contact: Alina Sokup, MD    +48 509 217 662    alinasokup@o2.pl   
Principal Investigator: Alina Sokup, MD         
Szpital Specjalistyczny w Jaśle Recruiting
Jaslo, Poland, 38-200
Contact: Marta Gorczyca-Pluta, MD    +48 604 637 952    martagp@poczta.onet.pl   
Principal Investigator: Marta Gorczyca-Pluta, MD         
NZOZ WITAMED Outpatient Diabetes Clinic Recruiting
Kielce, Poland, 25-035
Contact: Grażyna Majcher-Witczak, MD    +48 604 630 953    witczak@canea.com.pl   
Principal Investigator: Grażyna Majcher-Witczak, MD         
Szpital Uniwersytecki w Krakowie Recruiting
Krakow, Poland, 31-501
Contact: Przemysław Witek, MD    +48 609 968 989    przemyslawwitek@yahoo.co.uk   
Principal Investigator: Przemysław Witek, MD         
Samodzielny Publiczny Szpital Kliniczny nr 4 Uniwersytetu Medycznego w Lublinie Recruiting
Lublin, Poland, 20-090
Contact: Beata Matyjaszek-Matuszek, MD    +48 604 302 289    bmm@2com.pl   
Principal Investigator: Beata Matyjaszek-Matuszek, MD         
Wojewódzki Szpital Specjalistyczny w Olsztynie Recruiting
Olsztyn, Poland, 10-561
Contact: Joanna Rutkowska, MD    +48 605 602 160    rutkowskaj@wp.pl   
Principal Investigator: Joanna Rutkowska, MD         
PSZOZ Wojewódzkie Centrum Medyczne w Opolu Recruiting
Opole, Poland, 45-418
Contact: Wanda Urbanska, MD    +48 506 267 679    wanda_u@op.pl   
Principal Investigator: Wanda Urbanska, MD         
Zakład Opieki Zdrowotnej Poznań-Jeżyce Recruiting
Poznan, Poland, 60-834
Contact: Dorota Pisarczyk-Wiza, MD    +48 502 041 751    wizus@wp.pl   
Principal Investigator: Dorota Pisarczyk-Wiza, MD         
Clinic of Gynecology and Obstetrics of Marcinkowski Medical University Recruiting
Poznań, Poland, 60-535
Contact: Ewa Wender-Ożegowska, Prof    +48 501 276 060    ewaoz@post.pl   
Principal Investigator: Ewa Wender-Ożegowska, Prof         
Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej Recruiting
Rzeszow, Poland, 35-301
Contact: Joanna Kedzierska, MD    +48 502 222 391    joanna.kedzierska@onet.eu   
Principal Investigator: Joanna Kedzierska, MD         
Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie im. Marii Skłodowskiej-Curie Recruiting
Szczecin, Poland, 71-455
Contact: Jaroslaw Ogonowski, MD    +48 608 221 899    jogonowski@interia.pl   
Principal Investigator: Jaroslaw Ogonowski, MD         
Wojewódzki Szpital Zespolony im. L. Rydygiera Recruiting
Torun, Poland, 87-100
Contact: Elzbieta Szymanska, MD    +48 601 644 766    elzbieta-szymanska8@wp.pl   
Principal Investigator: Elzbeita Szymanska, MD         
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Recruiting
Warszawa, Poland, 02-097
Contact: Malgorzata Puchta, MD    +48 604 498 013    mpuchta@interia.pl   
Principal Investigator: Malgorzata Puchta, MD         
Szpital Kliniczny im. ks. Anny Mazowieckiej Warszawskiego Uniwersytetu Medycznego Recruiting
Warszawa, Poland, 00-315
Contact: Aneta Malinowska-Polubiec, MD    +48 609 493 935    anetapolubiec@interia.eu   
Principal Investigator: Aneta Malinowska-Polubiec, MD         
Mazowiecki Szpital Wojewódzki Sp. z o.o. Recruiting
Warszawa, Poland, 03-242
Contact: Izabela Razna, MD    +48 608 652 646    driza@tlen.pl   
Principal Investigator: Izabela Raźna, MD         
Wojewódzki Zespół Specjalistycznej Opieki Zdrowotnej Recruiting
Wroclaw, Poland, 50-403
Contact: Dariusz Sowinski, MD    +48 501 424 165    drdariuszsowinski@gmail.com   
Principal Investigator: Dariusz Sowinski, MD         
Samodzielny Publiczny Szpital Kliniczny nr 1 im prof. Stanisława Szyszko Recruiting
Zabrze, Poland, 41-800
Contact: Edyta Cichocka, MD    +48 606 943 038    sedyta@mp.pl   
Principal Investigator: Edyta Cichocka, MD         
Zespół Wojewódzkich Przychodni Specjalistycznych w Katowicach Recruiting
Zabrze, Poland, 41-800
Contact: Marta Wróbel, MD    +48 606 873 060    wrubella@o2.pl   
Principal Investigator: Marta Wróbel, MD         
NZOZ MED-ART Poradnie Specjalistyczne Sp. z o.o. Recruiting
Zory, Poland, 44-240
Contact: Violetta Szostek-Gawel, MD    +48 501 616 115    vszostekgawel@gmail.com   
Principal Investigator: Violetta Szostek-Gawel, MD         
Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Łodzi Recruiting
Łódź, Poland, 90-153
Contact: Elektra Szymanska-Garbacz, MD    +48 600 435 885    etkag@op.pl   
Principal Investigator: Elektra Szymanska-Garbacz, MD         
Uniwersytet Medyczny w Łodzi, Klinika Diabetologii Recruiting
Łódź, Poland, 93-338
Contact: Katarzyna Cypryk, Professor    +48 502 150 273    kcypryk@mp.pl   
Principal Investigator: Katarzyna Cypryk, Prof         
Sponsors and Collaborators
Medtronic Poland Spółka z ograniczoną odpowiedzialnością
Investigators
Principal Investigator: Jacek Sieradzki, Professor Cracow Medical University
  More Information

No publications provided

Responsible Party: Medtronic Poland Spółka z ograniczoną odpowiedzialnością
ClinicalTrials.gov Identifier: NCT01779141     History of Changes
Other Study ID Numbers: PL01
Study First Received: January 28, 2013
Last Updated: May 30, 2014
Health Authority: Poland: Ethics Committee

Keywords provided by Medtronic Poland Spółka z ograniczoną odpowiedzialnością:
Type 1 Diabetes Mellitus - T1DM
Pregnancy
Insulin Pump
Glucose Sensor
Continuous Subcutaneous Insulin Infusion - CSII
Sensor Augmented Pump - SAP
Continuous Glucose Monitoring - CGM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014