Orchestra Pregnancy Observational Study in Poland

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. Identifier: NCT01779141
Recruitment Status : Completed
First Posted : January 30, 2013
Last Update Posted : March 9, 2018
Medtronic Poland Spółka z ograniczoną odpowiedzialnością
Information provided by (Responsible Party):
Medtronic Diabetes

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.

Condition or disease
Type 1 Diabetes Mellitus Pregnancy

Detailed Description:

The project is designed as a multi-center prospective observational Post-Market-Release study to be conducted in up to 30 centers in Poland.

Total duration of the study per patient will be up to 22 months (up to 12 months pre-conception phase, pregnancy, and 6 weeks after delivery). The optimal study start is the beginning of pre-conception phase, however, pregnant women up to the 16th week of pregnancy can participate in the study too. The study end is 6 weeks after delivery. If conception does not occur within 12-months, the patient's study participation is terminated, and the insulin pump might be taken away from the patient. The following therapy is decided by the investigator. If the pump is not taken away after the 12-month of trial period for conception, the patient can continue insulin pump therapy until the pump is needed for another patient.

Study Type : Observational [Patient Registry]
Actual Enrollment : 481 participants
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
Study Start Date : May 2013
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

CSII, including SAP
The devices to be used in the study are the Paradigm REAL-Time (722) insulin pump, including the sensor augmented Paradigm® Veo (754) system (insulin pump + Enlite sensor + MiniLink transmitter);

Primary Outcome Measures :
  1. 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 :
  1. 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) ]
    To assess the prevalence of pregnancy complications and neonatal outcomes with the usage of CSII, including SAP

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT01779141

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
Bydgoszcz, 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 Diabetes
Medtronic Poland Spółka z ograniczoną odpowiedzialnością
Study Chair: Jacek Sieradzki, Prof Cracow Medical University

Responsible Party: Medtronic Diabetes Identifier: NCT01779141     History of Changes
Other Study ID Numbers: PL01
First Posted: January 30, 2013    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

Keywords provided by Medtronic Diabetes:
Type 1 Diabetes Mellitus - T1DM
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, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs