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Completed

NCT Number: NCT01779141

Orchestra Pregnancy Observational Study 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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny, Bialystok, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female diagnosed with Diabetes Mellitus Type 1
  • Subject indicated by HCP to start insulin pump therapy (CSII) or sensor augmented pump therapy (SAP) due to the desired or established pregnancy
  • HCP has prescribed the use of Orchestra donated device to the subject independently of the study
  • Signed Patient Informed Consent (PIC)
  • 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
  • Subject has been on MDI for at least 3 months before starting pump therapy

Exclusion criteria

  • Subject was enrolled in the registry earlier, and terminated it (for any reason)
  • Participation in any other interventional clinical trial - currently and/or in the last 3 months before the signature of PIC
  • Subject uses an insulin pump that was not donated by the Orchestra Foundation
  • Pregnant women with longer than 16 weeks of pregnancy/amenorrhea
  • Subjects who need assisted in vitro fertilization
  • Subjects with Diabetes Mellitus Type 2, Gestational Diabetes, MODY or any other type of diabetes than Type 1
  • Subject under the age of 18
  • Subject legally incompetent
  • Subject cannot read or write

Treatment and study plan

Primary outcomes

  1. HbA1c

    Time frame: from preconception phase to 6 weeks after delivery

    Changes in HbA1C from baseline to after delivery.

  2. Percent of Sensor Glucose Values in 70-140 mg/dL

    Time frame: During pregnancy

    Percent of sensor glucose values between and including 70 mg/dL to 140 mg/dL

Secondary outcomes

  1. Large for Gestational Age (LGA)

    Time frame: 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).

  2. Unhealthy Babies

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medtronic MiniMed, Inc.

Industry

Collaborators

  • Medtronic Poland Spółka z ograniczoną odpowiedzialnością

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jan 30, 2013
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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