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Orchestra Pregnancy Observational Study in Poland

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01779141
First Posted: January 30, 2013
Last Update Posted: November 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Poland Spółka z ograniczoną odpowiedzialnością
  Purpose

Purpose:

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.

Objectives:

To assess the benefits of CSII, including SAP, on the maternal glycemic control (HbA1c and Continuous Glucose Monitoring data) 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: 22 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 and Continuous Glucose Monitoring data [ Time Frame: 22 months ]
    To assess the benefits of CSII, including SAP, on the maternal glycemic control


Secondary Outcome Measures:
  • Assessment of prevalence of pregnancy complications and neonatal outcomes [ Time Frame: from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks) ]
    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

Enrollment: 481
Study Start Date: May 2013
Study Completion Date: August 2017
Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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
Criteria

Inclusion Criteria:

  1. Female diagnosed with Diabetes Mellitus Type 1
  2. Subject indicated by HCP to start insulin pump therapy (CSII) or sensor augmented pump therapy (SAP) due to the desired or established pregnancy
  3. HCP has prescribed the use of Orchestra donated device to the subject independently of the study
  4. Signed Patient Informed Consent (PIC)
  5. 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
  6. Subject has been on MDI for at least 3 months before starting pump therapy

Exclusion Criteria:

  1. Subject was enrolled in the registry earlier, and terminated it (for any reason)
  2. Participation in any other interventional clinical trial - currently and/or in the last 3 months before the signature of PIC
  3. Subject uses an insulin pump that was not donated by the Orchestra Foundation
  4. Pregnant women with longer than 16 weeks of pregnancy/amenorrhea
  5. Subjects who need assisted in vitro fertilization
  6. Subjects with Diabetes Mellitus Type 2, Gestational Diabetes, MODY or any other type of diabetes than Type 1
  7. Subject under the age of 18
  8. Subject legally incompetent
  9. Subject cannot read or write
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01779141


Locations
Poland
Uniwersytecki Szpital Kliniczny w Białymstoku
Białystok, Poland, 15-276
NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny
Białystok, Poland, 15-435
Szpital Wojewódzki w Bielsku Białej
Bielsko-Biala, Poland, 43-316
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
Bygdoszcz, Poland, 85-168
Szpital Specjalistyczny w Jaśle
Jaslo, Poland, 38-200
NZOZ WITAMED Outpatient Diabetes Clinic
Kielce, Poland, 25-035
Szpital Uniwersytecki w Krakowie
Krakow, Poland, 31-501
Samodzielny Publiczny Szpital Kliniczny nr 4 Uniwersytetu Medycznego w Lublinie
Lublin, Poland, 20-090
Wojewódzki Szpital Specjalistyczny w Olsztynie
Olsztyn, Poland, 10-561
PSZOZ Wojewódzkie Centrum Medyczne w Opolu
Opole, Poland, 45-418
Zakład Opieki Zdrowotnej Poznań-Jeżyce
Poznan, Poland, 60-834
Clinic of Gynecology and Obstetrics of Marcinkowski Medical University
Poznań, Poland, 60-535
Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej
Rzeszow, Poland, 35-301
Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie im. Marii Skłodowskiej-Curie
Szczecin, Poland, 71-455
Wojewódzki Szpital Zespolony im. L. Rydygiera
Torun, Poland, 87-100
Szpital Kliniczny im. ks. Anny Mazowieckiej Warszawskiego Uniwersytetu Medycznego
Warszawa, Poland, 00-315
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
Warszawa, Poland, 02-097
Mazowiecki Szpital Wojewódzki Sp. z o.o.
Warszawa, Poland, 03-242
Wojewódzki Zespół Specjalistycznej Opieki Zdrowotnej
Wroclaw, Poland, 50-403
Samodzielny Publiczny Szpital Kliniczny nr 1 im prof. Stanisława Szyszko
Zabrze, Poland, 41-800
Zespół Wojewódzkich Przychodni Specjalistycznych w Katowicach
Zabrze, Poland, 41-800
NZOZ MED-ART Poradnie Specjalistyczne Sp. z o.o.
Zory, Poland, 44-240
Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Łodzi
Łódź, Poland, 90-153
Uniwersytet Medyczny w Łodzi, Klinika Diabetologii
Łódź, Poland, 93-338
Sponsors and Collaborators
Medtronic Poland Spółka z ograniczoną odpowiedzialnością
Investigators
Study Chair: Jacek Sieradzki, Prof Cracow Medical University
  More Information

Responsible Party: Medtronic Poland Spółka z ograniczoną odpowiedzialnością
ClinicalTrials.gov Identifier: NCT01779141     History of Changes
Other Study ID Numbers: PL01
First Submitted: January 28, 2013
First Posted: January 30, 2013
Last Update Posted: November 21, 2017
Last Verified: November 2017

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
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs