National forsøgsordning Med Glukosesensorer Til Type 2-diabetes: Glukosesensorer Til Gravide Med Type 2-diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- HbA1c at end of pregnancy (week 36 of pregnancy)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women with type 2 diabetes
- •attending one of the four centers for pregnancy and diabetes in Denmark
- •18 years old or above
排除标准
- •gestationel age 14+0 or above
- •ekspected birth after end of trial
- •already using a continous glucose monitor (sensor)
研究组 & 干预措施
Sensor use
Participants are given a sensor to use during pregnancy until 4-6 weeks post partum
干预措施: continous glucose monitoring (Device)
结局指标
主要结局
HbA1c at end of pregnancy (week 36 of pregnancy)
时间窗: baseline < week 14 of pregnancy, follow up week 36 of pregnancy
child birth weight SD-score
时间窗: at time of birth
次要结局
- Diet items from the National Danish Birth Cohort(Baseline, week 28)
- Mean glucose(from enrollment to 4-6 weeks post partum)
- Birth related complications(at time of birth)
- Problem Areas in Diabetes (PAID)(Baseline, week 28, 4-6 weeks post partum)
- TIR, TAR, TBR(from enrollment to 4-6 weeks post partum)
- Womens gestational wheight gain(from enrollment to birth)
- Hypoglykemia among newborn(at time of birth)
- Pregnancy related complications(from enrollment to birth)
- World Health Organisation - Five Well-Being Index (WHO-5)(Baseline, week 28, 4-6 weeks post partum)
- 12-Item Short-Form (SF12)(Baseline, week 28, 4-6 weeks post partum)
- Patient Assessment of Cronic Illness Care (PACIC)(Baseline, week 28, 4-6 weeks post partum)
- Glucose Monitoring Satisfaction Survey (GMSS)(Baseline, week 28, 4-6 weeks post partum)
- Pregnancy Physical Activity Questionnaire (PPAQ-DK(Baseline, week 28)