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Orchestra Pregnancy Observational Study in Poland

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ClinicalTrials.gov Identifier: NCT01779141
Recruitment Status : Completed
First Posted : January 30, 2013
Last Update Posted : March 9, 2018
Sponsor:
Collaborator:
Medtronic Poland Spółka z ograniczoną odpowiedzialnością
Information provided by (Responsible Party):
Medtronic Diabetes

January 28, 2013
January 30, 2013
March 9, 2018
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) ]
To assess the prevalence of pregnancy complications and neonatal outcomes with the usage of CSII, including SAP
  • 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
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.

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.

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
CSII, including SAP
The devices to be used in the study are the Paradigm REAL-Time (722) insulin pump, including the sensor augmented Paradigm® Veo (754) system (insulin pump + Enlite sensor + MiniLink transmitter);
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
481
500
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 Diabetes
Medtronic Diabetes
Medtronic Poland Spółka z ograniczoną odpowiedzialnością
Study Chair: Jacek Sieradzki, Prof Cracow Medical University
Medtronic Diabetes
March 2018