We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Orchestra Pregnancy Observational Study in Poland

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01779141
First Posted: January 30, 2013
Last Update Posted: November 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Poland Spółka z ograniczoną odpowiedzialnością
January 28, 2013
January 30, 2013
November 21, 2017
May 2013
August 2017   (Final data collection date for primary outcome measure)
HbA1c and Continuous Glucose Monitoring data [ Time Frame: 22 months ]
To assess the benefits of CSII, including SAP, on the maternal glycemic control
HbA1c [ Time Frame: 16 months ]
Maternal glycemic control
Complete list of historical versions of study NCT01779141 on ClinicalTrials.gov Archive Site
Assessment of prevalence of pregnancy complications and neonatal outcomes [ Time Frame: from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks) ]
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)
  • Pregnancy complications [ Time Frame: During pregnacy and 6 weeks after delivery ]
    Rates of preterm delivery, infant birth weight, neonatal care admissions
  • Neonatal outcomes [ Time Frame: During pregnancy, at delivery and 6 weeks after delivery ]
    • 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)
  • Patient reported outcomes [ Time Frame: 16 months ]
    To evaluate change in patient-reported outcomes using the Hypoglycemia Fear Survey (HFS) and the Diabetes Treatment Satisfaction Questionnaire (DTSQs and DTSQc)
Not Provided
Not Provided
 
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

Purpose:

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.

Objectives:

To assess the benefits of CSII, including SAP, on the maternal glycemic control (HbA1c and Continuous Glucose Monitoring data) 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.

Not Provided
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
22 Months
Retention:   None Retained
Description:
Whole blood, serum, urine samples as required in routine practice before, during and after pregnancy in women with Type 1 Diabetes Mellitus
Probability Sample

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
  • Type 1 Diabetes Mellitus
  • Pregnancy
Not Provided
Not Provided
Not Provided
 
Completed
481
August 2017
August 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
 
NCT01779141
PL01
No
Not Provided
Not Provided
Medtronic Poland Spółka z ograniczoną odpowiedzialnością
Medtronic Poland Spółka z ograniczoną odpowiedzialnością
Not Provided
Study Chair: Jacek Sieradzki, Prof Cracow Medical University
Medtronic Poland Spółka z ograniczoną odpowiedzialnością
November 2017