Pregnancy, Type 2 Diabetes
Conditions
Keywords
CGM in type 2 diabetes, CGM in pregnancy
Brief summary
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: * Does the use of glucose sensors during pregnancy lead to a clinically significant reduction in HbA1c by 0.3% at 36 weeks gestation compared to the control group? * Does the use of glucose sensors during pregnancy result in a clinically significant reduction in mean SD-score for birth weight deviation in newborns compared to the control group? 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: * Use a glucose sensor from before 14 weeks of pregnancy until 4-6 weeks postpartum. * Receive training on how to use the sensor and access ongoing support as needed. * Have a follow-up appointment 4-6 weeks postpartum, including a consultation for advice on medical treatment and further management of diabetes after birth.
Interventions
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.
Sponsors
Steno Diabetes Center Odense
Steno Diabetes Center Copenhagen
Steno Diabetes Center Aarhus (SDCA), Aarhus University Hospital
Steno Diabetes Center Nordjylland
Odense University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* pregnant women with type 2 diabetes * attending one of the four centers for pregnancy and diabetes in Denmark * 18 years old or above
Exclusion criteria
* gestationel age 14+0 or above * ekspected birth after end of trial * already using a continous glucose monitor (sensor)
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Womens gestational wheight gain | from enrollment to birth | weight gain during throughout pregnancy |
| Hypoglykemia among newborn | at time of birth | Hypoglykemia among newborn |
| Pregnancy related complications | from enrollment to birth | increased blood pressure and preeclampsia |
| Birth related complications | at time of birth | c-section, early birth |
| Problem Areas in Diabetes (PAID) | Baseline, week 28, 4-6 weeks post partum | Diabetes stress |
| TIR, TAR, TBR | from enrollment to 4-6 weeks post partum | Percentage of time in time in range, time above range and time below range during their pregnancy. |
| 12-Item Short-Form (SF12) | Baseline, week 28, 4-6 weeks post partum | Health status |
| Patient Assessment of Cronic Illness Care (PACIC) | Baseline, week 28, 4-6 weeks post partum | Satisfaction with care |
| Glucose Monitoring Satisfaction Survey (GMSS) | Baseline, week 28, 4-6 weeks post partum | Satisfaction with method used for glucose measuring |
| Pregnancy Physical Activity Questionnaire (PPAQ-DK | Baseline, week 28 | Physical activity in pregnancy |
| Diet items from the National Danish Birth Cohort | Baseline, week 28 | Pregnancy specific questions related to diet |
| World Health Organisation - Five Well-Being Index (WHO-5) | Baseline, week 28, 4-6 weeks post partum | quality of life |
| Mean glucose | from enrollment to 4-6 weeks post partum | Sensor specific data |
Outcome results
None listed