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Orchestra Pregnancy Observational Study in Poland

This study is not yet open for participant recruitment.
Verified April 2013 by Medtronic Poland Spółka z ograniczoną odpowiedzialnością
Sponsor:
Information provided by (Responsible Party):
Medtronic Poland Spółka z ograniczoną odpowiedzialnością
ClinicalTrials.gov Identifier:
NCT01779141
First received: January 28, 2013
Last updated: April 24, 2013
Last verified: April 2013
History of Changes
  Purpose

Purpose:

The aim of this observational study (registry) is to document the use of insulin pump therapy (CSII) and 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.

Objectives:

To assess the benefits of CSII and SAP on the maternal glycemic control; To assess the prevalence of pregnancy complications (rates of preterm delivery, infant birth weight, neonatal care admissions) from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks); To report and assess the potential benefits of SAP or CSII on neonatal outcomes


Condition
Type 1 Diabetes Mellitus
Pregnancy

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 16 Months
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Poland Spółka z ograniczoną odpowiedzialnością:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    Maternal glycemic control


Secondary Outcome Measures:
  • Assessment of prevalence of pregnancy complications and neonatal outcomes [ Time Frame: During pregnancy, at delivery and 6 weeks after delivery ] [ Designated as safety issue: No ]
    Mode of delivery (rates elective and emergency CS, normal), Respiratory distress (1 and 5 minute Apgar scores), Gestational age at delivery, % preterm delivery <37 weeks, Infant birth weight (SD scores and customised birth weight percentile, % large for gestational age (LGA), % small for gestational age (SGA), Neonatal morbidity (treatment for neonatal hypoglycaemia), Neonatal care admission (duration of stay, level of care), Pregnancy related serious adverse events (miscarriage <22 weeks, congenital malformation, stillbirth, neonatal death), Feeding at hospital discharge (breast, bottle, both)


Biospecimen Retention:   None Retained

Whole blood, serum, urine samples as required in routine practice before, during and after pregnancy in women with Type 1 Diabetes Mellitus


Estimated Enrollment: 500
Study Start Date: May 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Women with Type 1 Diabetes Mellitus planning pregnancy or being pregnant until the 16th week of pregnacy

Criteria

Inclusion Criteria:

  • Female Diagnosed with Diabetes Mellitus Type 1
  • Subject indicated by Health Care Provider (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 6 months) or being pregnant within the first trimester until the 16th week of amenorrhea
  • Subject has been on Multiple Daily Injections (MDI) for at least 3 months (before pre-conception phase), except following a miscarriage and trying another pregnancy

Exclusion Criteria:

  • Participation in any other 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
  • Use of contraception during insulin pump therapy
  • Pregnant women with longer than 16 weeks of pregnancy/amenorrhea
  • Subjects who need assisted in vitro fertilization
  • Subjects with Diabetes Mellitus Type 2
  • Subjects with Gestational Diabetes or MODY
  • Subject under the age of 18
  • Subject legally incompetent
  • Subject cannot read or write
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779141

Sponsors and Collaborators
Medtronic Poland Spółka z ograniczoną odpowiedzialnością
Investigators
Principal Investigator: Jacek Sieradzki, Professor Cracow Medical University
  More Information

No publications provided

Responsible Party: Medtronic Poland Spółka z ograniczoną odpowiedzialnością
ClinicalTrials.gov Identifier: NCT01779141     History of Changes
Other Study ID Numbers: PL01
Study First Received: January 28, 2013
Last Updated: April 24, 2013
Health Authority: Poland: Ethics Committee

Keywords provided by Medtronic Poland Spółka z ograniczoną odpowiedzialnością:
Type 1 Diabetes Mellitus - T1DM
Pregnancy
Insulin Pump
Glucose Sensor
 Continuous Subcutaneous Insulin Infusion - CSII
Sensor Augmented Pump - SAP
Continuous Glucose Monitoring - CGM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013