Orchestra Pregnancy Observational Study in Poland

Completed

• Conditions: Pregnancy; Type 1 Diabetes Mellitus

• Registration Number: NCT01779141
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2013-01-28
• Study First Submitted QC: 2013-01-28
• Study First Posted: 2013-01-30
• Study Start: 2013-05
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Results First Submitted: 2019-04-11
• Results First Submitted QC: 2019-07-08
• Results First Posted: 2019-07-10
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 481

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent of Sensor Glucose Values in 70-140 mg/dL	During pregnancy	Percent of sensor glucose values between and including 70 mg/dL to 140 mg/dL
HbA1c	from preconception phase to 6 weeks after delivery	Changes in HbA1C from baseline to after delivery.

Secondary Outcome Measures

Name	Time	Method
Large for Gestational Age (LGA)	after birth	Percentage of mothers who delivered LGA babies. The Babies whose weight were greater than 90th percentiles at the gestational age when they were born, were defined as LGA Babies. (reference: Fetal biometry between 20-42 weeks of gestation for Polish population).
Unhealthy Babies	from birth to 6 weeks after delivery	The number of participants who delivered babies classified as large for gestational age, with congenital malfunction, or who required mechanical ventilation.

Trial Locations

Locations (24)

Uniwersytecki Szpital Kliniczny w Białymstoku; 🇵🇱 Białystok, Poland

NZOZ WITAMED Outpatient Diabetes Clinic; 🇵🇱 Kielce, Poland

NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny; 🇵🇱 Białystok, Poland

Szpital Specjalistyczny w Jaśle; 🇵🇱 Jaslo, Poland

Samodzielny Publiczny Szpital Kliniczny nr 4 Uniwersytetu Medycznego w Lublinie; 🇵🇱 Lublin, Poland

Szpital Wojewódzki w Bielsku Białej; 🇵🇱 Bielsko-Biala, Poland

Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy; 🇵🇱 Bydgoszcz, Poland

Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie im. Marii Skłodowskiej-Curie; 🇵🇱 Szczecin, Poland

Wojewódzki Szpital Zespolony im. L. Rydygiera; 🇵🇱 Torun, Poland

Wojewódzki Zespół Specjalistycznej Opieki Zdrowotnej; 🇵🇱 Wroclaw, Poland

Szpital Uniwersytecki w Krakowie; 🇵🇱 Krakow, Poland

Wojewódzki Szpital Specjalistyczny w Olsztynie; 🇵🇱 Olsztyn, Poland

PSZOZ Wojewódzkie Centrum Medyczne w Opolu; 🇵🇱 Opole, Poland

Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie; 🇵🇱 Warszawa, Poland

Mazowiecki Szpital Wojewódzki Sp. z o.o.; 🇵🇱 Warszawa, Poland

Zakład Opieki Zdrowotnej Poznań-Jeżyce; 🇵🇱 Poznan, Poland

Clinic of Gynecology and Obstetrics of Marcinkowski Medical University; 🇵🇱 Poznań, Poland

Samodzielny Publiczny Szpital Kliniczny nr 1 im prof. Stanisława Szyszko; 🇵🇱 Zabrze, Poland

NZOZ MED-ART Poradnie Specjalistyczne Sp. z o.o.; 🇵🇱 Zory, Poland

Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej; 🇵🇱 Rzeszow, Poland

Szpital Kliniczny im. ks. Anny Mazowieckiej Warszawskiego Uniwersytetu Medycznego; 🇵🇱 Warszawa, Poland

Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Łodzi; 🇵🇱 Łódź, Poland

Zespół Wojewódzkich Przychodni Specjalistycznych w Katowicach; 🇵🇱 Zabrze, Poland

Uniwersytet Medyczny w Łodzi, Klinika Diabetologii; 🇵🇱 Łódź, Poland