Clinical trial NCT01779141: Orchestra Pregnancy Observational Study in Poland
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Pregnancy
Keywords: Type 1 Diabetes Mellitus - T1DM
Pregnancy
Insulin Pump
Glucose Sensor
Continuous Subcutaneous Insulin Infusion - CSII
Sensor Augmented Pump - SAP
Continuous Glucose Monitoring - CGM
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
Collaborators: name: Medtronic Poland Spółka z ograniczoną odpowiedzialnością
First posted: 2013-01-30
Enrollment: 481
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: HbA1c
timeFrame: from preconception phase to 6 weeks after delivery
measure: Percent of Sensor Glucose Values in 70-140 mg/dL
timeFrame: During pregnancy
Secondary outcomes:
measure: Large for Gestational Age (LGA)
timeFrame: after birth
measure: Unhealthy Babies
timeFrame: from birth to 6 weeks after delivery
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Białymstoku
city: Białystok
country: Poland
facility: NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny
city: Bielsko-Biala
country: Poland
facility: Szpital Wojewódzki w Bielsku Białej
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
city: Jaslo
country: Poland
facility: Szpital Specjalistyczny w Jaśle
city: Kielce
country: Poland
facility: NZOZ WITAMED Outpatient Diabetes Clinic
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 4 Uniwersytetu Medycznego w Lublinie
city: Olsztyn
country: Poland
facility: Wojewódzki Szpital Specjalistyczny w Olsztynie
city: Opole
country: Poland
facility: PSZOZ Wojewódzkie Centrum Medyczne w Opolu
city: Poznan
country: Poland
facility: Zakład Opieki Zdrowotnej Poznań-Jeżyce
city: Poznań
country: Poland
facility: Clinic of Gynecology and Obstetrics of Marcinkowski Medical University
city: Rzeszow
country: Poland
facility: Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej
city: Szczecin
country: Poland
facility: Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie im. Marii Skłodowskiej-Curie
city: Torun
country: Poland
facility: Wojewódzki Szpital Zespolony im. L. Rydygiera
city: Warszawa
country: Poland
facility: Szpital Kliniczny im. ks. Anny Mazowieckiej Warszawskiego Uniwersytetu Medycznego
city: Warszawa
country: Poland
facility: Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
city: Warszawa
country: Poland
facility: Mazowiecki Szpital Wojewódzki Sp. z o.o.
city: Wroclaw
country: Poland
facility: Wojewódzki Zespół Specjalistycznej Opieki Zdrowotnej
city: Zabrze
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1 im prof. Stanisława Szyszko
city: Zabrze
country: Poland
facility: Zespół Wojewódzkich Przychodni Specjalistycznych w Katowicach
city: Zory
country: Poland
facility: NZOZ MED-ART Poradnie Specjalistyczne Sp. z o.o.
city: Łódź
country: Poland
facility: Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Łodzi
city: Łódź
country: Poland
facility: Uniwersytet Medyczny w Łodzi, Klinika Diabetologii
Study officials:
affiliation: Cracow Medical University
name: Jacek Sieradzki, Prof
role: STUDY_CHAIR
References: