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| Name | Class |
|---|---|
| Steno Diabetes Center Odense | OTHER |
| Steno Diabetes Center Copenhagen | OTHER |
| Aarhus University Hospital | OTHER |
| Steno Diabetes Center Nordjylland |
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The goal of this clinical trial is to evaluate the use of glucose sensors in pregnant women with type 2 diabetes to improve insulin regulation, pregnancy and birth outcomes, and enhance quality of life and satisfaction with treatment.
The main questions it aims to answer are:
Researchers will compare the group of women using glucose sensors during pregnancy to a historical control group receiving routine care to see if the sensor improves pregnancy outcomes, glucose control, and birth weights.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sensor use | Experimental | Participants are given a sensor to use during pregnancy until 4-6 weeks post partum |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continous glucose monitoring | Device | Pregnant women with type 2 diabetes are given a sensor < week 14 of their pregnancy and will use it until 4-6 post partum. They will receive training in how to use the sensor, and support when needed. |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c at end of pregnancy (week 36 of pregnancy) | baseline < week 14 of pregnancy, follow up week 36 of pregnancy | |
| child birth weight SD-score | at time of birth |
| Measure | Description | Time Frame |
|---|---|---|
| TIR, TAR, TBR | Percentage of time in time in range, time above range and time below range during their pregnancy. | from enrollment to 4-6 weeks post partum |
| Mean glucose | Sensor specific data |
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Inclusion Criteria:
Exclusion Criteria:
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December 2025 and december 2026
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| OTHER |
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| from enrollment to 4-6 weeks post partum |
| Womens gestational wheight gain | weight gain during throughout pregnancy | from enrollment to birth |
| Hypoglykemia among newborn | Hypoglykemia among newborn | at time of birth |
| Pregnancy related complications | increased blood pressure and preeclampsia | from enrollment to birth |
| Birth related complications | c-section, early birth | at time of birth |
| Problem Areas in Diabetes (PAID) | Diabetes stress | Baseline, week 28, 4-6 weeks post partum |
| World Health Organisation - Five Well-Being Index (WHO-5) | quality of life | Baseline, week 28, 4-6 weeks post partum |
| 12-Item Short-Form (SF12) | Health status | Baseline, week 28, 4-6 weeks post partum |
| Patient Assessment of Cronic Illness Care (PACIC) | Satisfaction with care | Baseline, week 28, 4-6 weeks post partum |
| Glucose Monitoring Satisfaction Survey (GMSS) | Satisfaction with method used for glucose measuring | Baseline, week 28, 4-6 weeks post partum |
| Pregnancy Physical Activity Questionnaire (PPAQ-DK | Physical activity in pregnancy | Baseline, week 28 |
| Diet items from the National Danish Birth Cohort | Pregnancy specific questions related to diet | Baseline, week 28 |
| D004700 | Endocrine System Diseases |