Type 1 Diabetes MellitusNCT01779141
Orchestra Pregnancy Observational Study in Poland
An observational study of Type 1 Diabetes Mellitus and Pregnancy, run by Medtronic MiniMed, Inc. at 24 sites in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Type 1 Diabetes Mellitus, Pregnancy
- How many people
- 481 participants
- Where
- 24 sitesPoland
- Study dates
- May 2013to Aug 2017
- How long will I take part?
- 22 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Subject under the age of 18
- Subject legally incompetent
- Subject cannot read or write
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Poland24 sites
Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok, 15-276
NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny
Bialystok, 15-435
Szpital Wojewódzki w Bielsku Białej
Bielsko-Biala, 43-316
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168
Szpital Specjalistyczny w Jaśle
Jasło, 38-200
NZOZ WITAMED Outpatient Diabetes Clinic
Kielce, 25-035
Szpital Uniwersytecki w Krakowie
Krakow, 31-501
Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Łodzi
Lodz, 90-153
Uniwersytet Medyczny w Łodzi, Klinika Diabetologii
Lodz, 93-338
Samodzielny Publiczny Szpital Kliniczny nr 4 Uniwersytetu Medycznego w Lublinie
Lublin, 20-090
Wojewódzki Szpital Specjalistyczny w Olsztynie
Olsztyn, 10-561
PSZOZ Wojewódzkie Centrum Medyczne w Opolu
Opole, 45-418
Clinic of Gynecology and Obstetrics of Marcinkowski Medical University
Poznan, 60-535
Zakład Opieki Zdrowotnej Poznań-Jeżyce
Poznan, 60-834
Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej
Rzeszów, 35-301
Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie im. Marii Skłodowskiej-Curie
Szczecin, 71-455
Wojewódzki Szpital Zespolony im. L. Rydygiera
Torun, 87-100
Szpital Kliniczny im. ks. Anny Mazowieckiej Warszawskiego Uniwersytetu Medycznego
Warsaw, 00-315
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
Warsaw, 02-097
Mazowiecki Szpital Wojewódzki Sp. z o.o.
Warsaw, 03-242
Wojewódzki Zespół Specjalistycznej Opieki Zdrowotnej
Wroclaw, 50-403
Samodzielny Publiczny Szpital Kliniczny nr 1 im prof. Stanisława Szyszko
Zabrze, 41-800
Zespół Wojewódzkich Przychodni Specjalistycznych w Katowicach
Zabrze, 41-800
NZOZ MED-ART Poradnie Specjalistyczne Sp. z o.o.
Żory, 44-240
About this study
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
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.
Read the detailed description
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.
- Conditions
- Type 1 Diabetes Mellitus, Pregnancy
- Keywords
- Type 1 Diabetes Mellitus - T1DM, Pregnancy, Insulin Pump, Glucose Sensor, Continuous Subcutaneous Insulin Infusion - CSII, Sensor Augmented Pump - SAP, Continuous Glucose Monitoring - CGM
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CSII | Patients using CSII with or without CGM. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Changes in HbA1C from baseline to after delivery.
Measured: 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
Measured: During pregnancy
Secondary outcomes (2)
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).
Measured: after birth
Unhealthy Babies
The number of participants who delivered babies classified as large for gestational age, with congenital malfunction, or who required mechanical ventilation.
Measured: from birth to 6 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 481 participants (actual)
- Target duration
- 22 Months
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic Poland Spółka z ograniczoną odpowiedzialnością
- Responsible party
- Sponsor
- Investigators
- Jacek Sieradzki, Prof, Study chair, Cracow Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779141
- Sponsor's protocol ID
- PL01
- Status last verified
- Jan 2020
- First submitted
- 28 Jan 2013
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 36653533
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01779141
- Acronym / sponsor ID
- PL01
- Conditions
- Type 1 Diabetes Mellitus, Pregnancy
- Keywords
- Type 1 Diabetes Mellitus - T1DM, Pregnancy, Insulin Pump, Glucose Sensor, Continuous Subcutaneous Insulin Infusion - CSII, Sensor Augmented Pump - SAP, Continuous Glucose Monitoring - CGM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 481 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medtronic Poland Spółka z ograniczoną odpowiedzialnością
- Study start
- May 2013
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 30 Jan 2013 (estimated)
- Results
- Posted 10 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 22 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CSII | – | –Patients using CSII with or without CGM. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HbA1c
Time frame: from preconception phase to 6 weeks after delivery
Changes in HbA1C from baseline to after delivery.
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
2 secondary outcomes
Large for Gestational Age (LGA)
Time frame: after birth
Unhealthy Babies
Time frame: from birth to 6 weeks after delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36653533Cypryk 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacek Sieradzki, Prof study chair
Cracow Medical University
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus and Pregnancy, run by Medtronic MiniMed, Inc. at 24 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: from preconception phase to 6 weeks after delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01779141, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.