Orchestra Pregnancy Observational Study in Poland

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01779141
• Other study ID #: PL01
• Status: Completed
• Start date: May 2013
• Est. completion date: August 2017

Study information

• Verified date: January 2020
• Source: Medtronic Diabetes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 481
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Pregnancy
• Type 1 Diabetes Mellitus

Locations

Country	Name	City	State
Poland	NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny	Bialystok
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok
Poland	Szpital Wojewódzki w Bielsku Bialej	Bielsko-Biala
Poland	Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy	Bydgoszcz
Poland	Szpital Specjalistyczny w Jasle	Jaslo
Poland	NZOZ WITAMED Outpatient Diabetes Clinic	Kielce
Poland	Szpital Uniwersytecki w Krakowie	Krakow
Poland	Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi	Lódz
Poland	Uniwersytet Medyczny w Lodzi, Klinika Diabetologii	Lódz
Poland	Samodzielny Publiczny Szpital Kliniczny nr 4 Uniwersytetu Medycznego w Lublinie	Lublin
Poland	Wojewódzki Szpital Specjalistyczny w Olsztynie	Olsztyn
Poland	PSZOZ Wojewódzkie Centrum Medyczne w Opolu	Opole
Poland	Clinic of Gynecology and Obstetrics of Marcinkowski Medical University	Poznan
Poland	Zaklad Opieki Zdrowotnej Poznan-Jezyce	Poznan
Poland	Szpital Wojewódzki nr 2 im. Sw. Jadwigi Królowej	Rzeszow
Poland	Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie im. Marii Sklodowskiej-Curie	Szczecin
Poland	Wojewódzki Szpital Zespolony im. L. Rydygiera	Torun
Poland	Mazowiecki Szpital Wojewódzki Sp. z o.o.	Warszawa
Poland	Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie	Warszawa
Poland	Szpital Kliniczny im. ks. Anny Mazowieckiej Warszawskiego Uniwersytetu Medycznego	Warszawa
Poland	Wojewódzki Zespól Specjalistycznej Opieki Zdrowotnej	Wroclaw
Poland	Samodzielny Publiczny Szpital Kliniczny nr 1 im prof. Stanislawa Szyszko	Zabrze
Poland	Zespól Wojewódzkich Przychodni Specjalistycznych w Katowicach	Zabrze
Poland	NZOZ MED-ART Poradnie Specjalistyczne Sp. z o.o.	Zory

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Diabetes	Medtronic Poland Spólka z ograniczona odpowiedzialnoscia

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Changes in HbA1C from baseline to after delivery.	from preconception phase to 6 weeks after delivery
Primary	Percent of Sensor Glucose Values in 70-140 mg/dL	Percent of sensor glucose values between and including 70 mg/dL to 140 mg/dL	During pregnancy
Secondary	Large for Gestational Age (LGA)	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).	after birth
Secondary	Unhealthy Babies	The number of participants who delivered babies classified as large for gestational age, with congenital malfunction, or who required mechanical ventilation.	from birth to 6 weeks after delivery