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| Name | Class |
|---|---|
| Medtronic Poland Spółka z ograniczoną odpowiedzialnością | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSII | Patients using CSII with or without CGM. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study subject population is women with Type 1 Diabetes Mellitus at the age of 18-45 who
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| Name | Affiliation | Role |
|---|---|---|
| Jacek Sieradzki, Prof | Cracow Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniwersytecki Szpital Kliniczny w Białymstoku | Bialystok | 15-276 | Poland | |||
| NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36653533 | Derived | Cypryk K, Wender-Ozegowska E, Cyganek K, Sieradzki J, Skoczylas K, Chen X, Cordero TL, Shin J, Cohen O. Insulin pump therapy with and without continuous glucose monitoring in pregnant women with type 1 diabetes: a prospective observational Orchestra Foundation study in Poland. Acta Diabetol. 2023 Apr;60(4):553-561. doi: 10.1007/s00592-022-02020-9. Epub 2023 Jan 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CSII | Patients using CSII, with or without CGM |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CSII | Patients using CSII, with or without CGM |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | HbA1c | Changes in HbA1C from baseline to after delivery. | Participants who have both baseline HbA1C and after delivery HbA1C available. | Posted | Mean | Standard Deviation | HbA1C percentage | from preconception phase to 6 weeks after delivery |
|
|
from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CSII | Patients using CSII, with or without CGM | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fetal heart rate disorder | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial septal defect | Congenital, familial and genetic disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suiying Huang, Statistician | Medtronic Minimed | 818-576-3319 | suiying.huang@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 18, 2015 | Mar 19, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 4, 2017 | Mar 19, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Whole blood, serum, urine samples as required in routine practice before, during and after pregnancy in women with Type 1 Diabetes Mellitus
| 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 |
| Bialystok |
| 15-435 |
| Poland |
| Szpital Wojewódzki w Bielsku Białej | Bielsko-Biala | 43-316 | Poland |
| Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy | Bydgoszcz | 85-168 | Poland |
| Szpital Specjalistyczny w Jaśle | Jasło | 38-200 | Poland |
| NZOZ WITAMED Outpatient Diabetes Clinic | Kielce | 25-035 | Poland |
| Szpital Uniwersytecki w Krakowie | Krakow | 31-501 | Poland |
| Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Łodzi | Lodz | 90-153 | Poland |
| Uniwersytet Medyczny w Łodzi, Klinika Diabetologii | Lodz | 93-338 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 4 Uniwersytetu Medycznego w Lublinie | Lublin | 20-090 | Poland |
| Wojewódzki Szpital Specjalistyczny w Olsztynie | Olsztyn | 10-561 | Poland |
| PSZOZ Wojewódzkie Centrum Medyczne w Opolu | Opole | 45-418 | Poland |
| Clinic of Gynecology and Obstetrics of Marcinkowski Medical University | Poznan | 60-535 | Poland |
| Zakład Opieki Zdrowotnej Poznań-Jeżyce | Poznan | 60-834 | Poland |
| Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej | Rzeszów | 35-301 | Poland |
| Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie im. Marii Skłodowskiej-Curie | Szczecin | 71-455 | Poland |
| Wojewódzki Szpital Zespolony im. L. Rydygiera | Torun | 87-100 | Poland |
| Szpital Kliniczny im. ks. Anny Mazowieckiej Warszawskiego Uniwersytetu Medycznego | Warsaw | 00-315 | Poland |
| Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie | Warsaw | 02-097 | Poland |
| Mazowiecki Szpital Wojewódzki Sp. z o.o. | Warsaw | 03-242 | Poland |
| Wojewódzki Zespół Specjalistycznej Opieki Zdrowotnej | Wroclaw | 50-403 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 1 im prof. Stanisława Szyszko | Zabrze | 41-800 | Poland |
| Zespół Wojewódzkich Przychodni Specjalistycznych w Katowicach | Zabrze | 41-800 | Poland |
| NZOZ MED-ART Poradnie Specjalistyczne Sp. z o.o. | Żory | 44-240 | Poland |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | 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 | Subjects with sensor information during pregnancy | Posted | Mean | Standard Deviation | percentage of available sensor values | During pregnancy |
|
|
|
| Secondary | 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). | Participants who delivered live babies | Posted | Count of Participants | Participants | after birth |
|
|
|
| Secondary | Unhealthy Babies | The number of participants who delivered babies classified as large for gestational age, with congenital malfunction, or who required mechanical ventilation. | Participants who delivered alive babies | Posted | Count of Participants | Participants | from birth to 6 weeks after delivery |
|
|
|
| 481 |
| 181 |
| 481 |
| 11 |
| 481 |
| Truncus arteriosus persistent | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Abortion threatened | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Amniotic cavity infection | Infections and infestations | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Anaemia neonatal | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Apgar score low | Investigations | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | Non-systematic Assessment |
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Atrial septal defect | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Blighted ovum | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Blood pressure fluctuation | Vascular disorders | Non-systematic Assessment |
|
| Bradycardia foetal | Cardiac disorders | Non-systematic Assessment |
|
| Breech presentation | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Caesarean section | Surgical and medical procedures | Non-systematic Assessment |
|
| Cervical incompetence | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Cervical polyp | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Cholestasis of pregnancy | Hepatobiliary disorders | Non-systematic Assessment |
|
| Cholestasis of pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | Non-systematic Assessment |
|
| Cleft Palate | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Colloid brain cyst | Nervous system disorders | Non-systematic Assessment |
|
| Congenital cystic kidney disease | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Congenital infection | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Congenital pneumonia | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Diabetic eye disease | Eye disorders | Non-systematic Assessment |
|
| Diabetic gastropathy | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | Non-systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | Non-systematic Assessment |
|
| Duodenogastric reflux | Gastrointestinal disorders | Non-systematic Assessment |
|
| Eclampsia | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Fallot's tetralogy | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Foetal cardiac disorder | Cardiac disorders | Non-systematic Assessment |
|
| Foetal disorder | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Foetal distress syndrome | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Foetal growth restriction | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Foetal heart rate abnormal | Investigations | Non-systematic Assessment |
|
| Foetal heart rate decreased | Investigations | Non-systematic Assessment |
|
| Foetal hypokinesia | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Foetal macrosomia | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Foetal malformation | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Foetal monitoring abnormal | Investigations | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | Non-systematic Assessment |
|
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | Non-systematic Assessment |
|
| Hyperbilirubinaemia neonatal | Hepatobiliary disorders | Non-systematic Assessment |
|
| Hyperemesis gravidarum | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypoglycaemia neonatal | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Imminent abortion | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Intrauterine infection | Infections and infestations | Non-systematic Assessment |
|
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Ketoacidosis | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Kidney malformation | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Large for dates baby | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Low birht weight baby | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Maternal condition affecting foetus | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Microtia | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Neinatal respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Neonatal infection | Infections and infestations | Non-systematic Assessment |
|
| Neonatal pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Neonatal respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Oedema | General disorders | Non-systematic Assessment |
|
| Oligohydramnios | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Ophthalmia neonatorum | Infections and infestations | Non-systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | Non-systematic Assessment |
|
| Placental insufficiency | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Premature baby | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Premature delivery | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Premature labour | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Preterm premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Prolonged labour | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Renal aplasia | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Renal colic | Renal and urinary disorders | Non-systematic Assessment |
|
| Reproductive tract and breast procedural complications | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Respiratory disorder neonatal | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Stillbirth | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Tachycardia foetal | Cardiac disorders | Non-systematic Assessment |
|
| Threatened labour | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Twin pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Ultrasound Doppler abnormal | Investigations | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection bacterial | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection enterococcal | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection neonatal | Infections and infestations | Non-systematic Assessment |
|
| Uterine contractions during pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Uterine rupture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Vaginal infection | Infections and infestations | Non-systematic Assessment |
|
| Ventricular septal defect | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Viral diarrhoea | Infections and infestations | Non-systematic Assessment |
|
| Vomiting in pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Caesarean section | Surgical and medical procedures | Non-systematic Assessment |
|
| Cholestasis of pregnancy | Hepatobiliary disorders | Non-systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Congenital pulmonary artery anomaly | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Ectopic kidney | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Imminent abortion | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Neonatal pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Retinopathy haemorrhagic | Eye disorders | Non-systematic Assessment |
|
| Umbilical cord vascular disorder | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |