Orchestra Pregnancy Observational Study in Poland

NCT ID: NCT01779141

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 481 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2017-08-31

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.

Conditions

Type 1 Diabetes Mellitus; Pregnancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CSII

Patients using CSII with or without CGM.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Poland Spółka z ograniczoną odpowiedzialnością

INDUSTRY

Sponsor Role: collaborator

Medtronic Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacek Sieradzki, Prof

Role: STUDY_CHAIR

Cracow Medical University

Locations

Uniwersytecki Szpital Kliniczny w Białymstoku

Bialystok, , Poland

NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny

Bialystok, , Poland

Szpital Wojewódzki w Bielsku Białej

Bielsko-Biala, , Poland

Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy

Bydgoszcz, , Poland

Szpital Specjalistyczny w Jaśle

Jasło, , 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 Łodzi

Lodz, , Poland

Uniwersytet Medyczny w Łodzi, Klinika Diabetologii

Lodz, , 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

Zakład Opieki Zdrowotnej Poznań-Jeżyce

Poznan, , Poland

Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej

Rzeszów, , Poland

Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie im. Marii Skłodowskiej-Curie

Szczecin, , Poland

Wojewódzki Szpital Zespolony im. L. Rydygiera

Torun, , Poland

Szpital Kliniczny im. ks. Anny Mazowieckiej Warszawskiego Uniwersytetu Medycznego

Warsaw, , Poland

Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

Warsaw, , Poland

Mazowiecki Szpital Wojewódzki Sp. z o.o.

Warsaw, , Poland

Wojewódzki Zespół Specjalistycznej Opieki Zdrowotnej

Wroclaw, , Poland

Samodzielny Publiczny Szpital Kliniczny nr 1 im prof. Stanisława Szyszko

Zabrze, , Poland

Zespół Wojewódzkich Przychodni Specjalistycznych w Katowicach

Zabrze, , Poland

NZOZ MED-ART Poradnie Specjalistyczne Sp. z o.o.

Żory, , Poland

Countries

Poland

References

Cypryk K, Wender-Ozegowska E, Cyganek K, Sieradzki J, Skoczylas K, Chen X, Cordero TL, Shin J, Cohen O. Insulin pump therapy with and without continuous glucose monitoring in pregnant women with type 1 diabetes: a prospective observational Orchestra Foundation study in Poland. Acta Diabetol. 2023 Apr;60(4):553-561. doi: 10.1007/s00592-022-02020-9. Epub 2023 Jan 19.

Reference Type: DERIVED

PMID: 36653533 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PL01

Identifier Type: -

Identifier Source: org_study_id