Pregnancy, Type 1 Diabetes Mellitus
Conditions
Keywords
Type 1 Diabetes Mellitus - T1DM, Pregnancy, Insulin Pump, Glucose Sensor, Continuous Subcutaneous Insulin Infusion - CSII, Sensor Augmented Pump - SAP, Continuous Glucose Monitoring - CGM
Brief 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.
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.
Interventions
None listed
Sponsors
Medtronic Poland Spółka z ograniczoną odpowiedzialnością
Medtronic Diabetes
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 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 | During pregnancy | Percent of sensor glucose values between and including 70 mg/dL to 140 mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Large for Gestational Age (LGA) | after birth | 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). |
| Unhealthy Babies | from birth to 6 weeks after delivery | The number of participants who delivered babies classified as large for gestational age, with congenital malfunction, or who required mechanical ventilation. |
Countries
Poland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CSII Patients using CSII, with or without CGM | 481 |
| Total | 481 |
Baseline characteristics
| Characteristic | CSII | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 481 Participants | — |
| Age, Continuous | 30.42 years STANDARD_DEVIATION 4.04 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Poland | 481 participants | — |
| Sex: Female, Male Female | 481 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 481 |
| other Total, other adverse events | 11 / 481 |
| serious Total, serious adverse events | 181 / 481 |
Outcome results
Primary
HbA1c
Changes in HbA1C from baseline to after delivery.
Time frame: from preconception phase to 6 weeks after delivery
Population: Participants who have both baseline HbA1C and after delivery HbA1C available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII | HbA1c | -0.8 HbA1C percentage | Standard Deviation 1 |
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
Time frame: During pregnancy
Population: Subjects with sensor information during pregnancy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII | Percent of Sensor Glucose Values in 70-140 mg/dL | 67.62 percentage of available sensor values | Standard Deviation 10.59 |
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).
Time frame: after birth
Population: Participants who delivered live babies
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CSII | Large for Gestational Age (LGA) | 74 Participants |
Secondary
Unhealthy Babies
The number of participants who delivered babies classified as large for gestational age, with congenital malfunction, or who required mechanical ventilation.
Time frame: from birth to 6 weeks after delivery
Population: Participants who delivered alive babies
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CSII | Unhealthy Babies | 99 Participants |