Orchestra Pregnancy Observational Study in Poland

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Type 1 Diabetes Mellitus

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
• Enrollment (Actual): 481

Contacts and Locations

Study Locations

• Poland
  • Białystok, Poland, 15-276
    • Uniwersytecki Szpital Kliniczny w Białymstoku
  • Białystok, Poland, 15-435
    • NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny
  • Bielsko-Biala, Poland, 43-316
    • Szpital Wojewódzki w Bielsku Białej
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
  • Jaslo, Poland, 38-200
    • Szpital Specjalistyczny w Jaśle
  • Kielce, Poland, 25-035
    • NZOZ WITAMED Outpatient Diabetes Clinic
  • Krakow, Poland, 31-501
    • Szpital Uniwersytecki w Krakowie
  • Lublin, Poland, 20-090
    • Samodzielny Publiczny Szpital Kliniczny nr 4 Uniwersytetu Medycznego w Lublinie
  • Olsztyn, Poland, 10-561
    • Wojewodzki Szpital Specjalistyczny w Olsztynie
  • Opole, Poland, 45-418
    • PSZOZ Wojewódzkie Centrum Medyczne w Opolu
  • Poznan, Poland, 60-834
    • Zakład Opieki Zdrowotnej Poznań-Jeżyce
  • Poznań, Poland, 60-535
    • Clinic of Gynecology and Obstetrics of Marcinkowski Medical University
  • Rzeszow, Poland, 35-301
    • Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej
  • Szczecin, Poland, 71-455
    • Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie im. Marii Skłodowskiej-Curie
  • Torun, Poland, 87-100
    • Wojewódzki Szpital Zespolony im. L. Rydygiera
  • Warszawa, Poland, 02-097
    • Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
  • Warszawa, Poland, 00-315
    • Szpital Kliniczny im. ks. Anny Mazowieckiej Warszawskiego Uniwersytetu Medycznego
  • Warszawa, Poland, 03-242
    • Mazowiecki Szpital Wojewódzki Sp. z o.o.
  • Wroclaw, Poland, 50-403
    • Wojewódzki Zespół Specjalistycznej Opieki Zdrowotnej
  • Zabrze, Poland, 41-800
    • Samodzielny Publiczny Szpital Kliniczny nr 1 im prof. Stanisława Szyszko
  • Zabrze, Poland, 41-800
    • Zespół Wojewódzkich Przychodni Specjalistycznych w Katowicach
  • Zory, Poland, 44-240
    • NZOZ MED-ART Poradnie Specjalistyczne Sp. z o.o.
  • Łódź, Poland, 90-153
    • Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Łodzi
  • Łódź, Poland, 93-338
    • Uniwersytet Medyczny w Łodzi, Klinika Diabetologii

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
CSII; Patients using CSII with or without CGM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Changes in HbA1C from baseline to after delivery.	from preconception phase to 6 weeks after delivery
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Medtronic Diabetes
• Collaborators: Medtronic Poland Spółka z ograniczoną odpowiedzialnością
• Investigators: Study Chair: Jacek Sieradzki, Prof, Cracow Medical University

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: January 28, 2013
• First Submitted That Met QC Criteria: January 28, 2013
• First Posted (Estimate): January 30, 2013

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Pregnancy; Insulin Pump; Type 1 Diabetes Mellitus - T1DM; Glucose Sensor; Continuous Subcutaneous Insulin Infusion - CSII; Sensor Augmented Pump - SAP; Continuous Glucose Monitoring - CGM
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: PL01