National Trial of CGM in Pregnant Women With Type 2 Diabetes

Официальное название

National forsøgsordning Med Glukosesensorer Til Type 2-diabetes: Glukosesensorer Til Gravide Med Type 2-diabetes

Обзор

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.

Вмешательства

• Устройство continous glucose monitoring
  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.

Первичные конечные точки

• HbA1c at end of pregnancy (week 36 of pregnancy) [Срок оценки: baseline < week 14 of pregnancy, follow up week 36 of pregnancy]
• child birth weight SD-score [Срок оценки: at time of birth]

Вторичные конечные точки (12)

• TIR, TAR, TBR [Срок оценки: from enrollment to 4-6 weeks post partum]
• Mean glucose [Срок оценки: from enrollment to 4-6 weeks post partum]
• Womens gestational wheight gain [Срок оценки: from enrollment to birth]
• Hypoglykemia among newborn [Срок оценки: at time of birth]
• Pregnancy related complications [Срок оценки: from enrollment to birth]
• Birth related complications [Срок оценки: at time of birth]
• Problem Areas in Diabetes (PAID) [Срок оценки: Baseline, week 28, 4-6 weeks post partum]
• World Health Organisation - Five Well-Being Index (WHO-5) [Срок оценки: Baseline, week 28, 4-6 weeks post partum]
• 12-Item Short-Form (SF12) [Срок оценки: Baseline, week 28, 4-6 weeks post partum]
• Patient Assessment of Cronic Illness Care (PACIC) [Срок оценки: Baseline, week 28, 4-6 weeks post partum]
• Glucose Monitoring Satisfaction Survey (GMSS) [Срок оценки: Baseline, week 28, 4-6 weeks post partum]
• Pregnancy Physical Activity Questionnaire (PPAQ-DK [Срок оценки: Baseline, week 28]

Критерии участия

Критерии включения

• pregnant women with type 2 diabetes
• attending one of the four centers for pregnancy and diabetes in Denmark
• 18 years old or above

Критерии исключения

• gestationel age 14+0 or above
• ekspected birth after end of trial
• already using a continous glucose monitor (sensor)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06903728 · CGM til gravide med T2D

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗