Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06436326
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-05-22
Brief Title:
The Impact of Continuous Glucose Monitoring on Maternal and Infants Outcomes in Gestational Diabetes
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
The Impact of Continuous Glucose Monitoring on Maternal and Infants Outcomes in Gestational Diabetes Testing the Moderating Effects of Socioeconomic and Cultural Factors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will discuss the impact of continuous glucose monitoring on maternal and infants outcomes in gestational diabetes mellitus and test the moderating effect of socioeconomic and cultural factors dietary habits socioeconomic status and income
Detailed Description:
Background The global prevalence of gestational diabetes mellitus is increasing To reduce the negative impact of gestational diabetes mellitus on maternal and fetal health managing blood glucose during pregnancy is important which also shows the importance of blood glucose monitoring Continuous glucose monitoring CGM is different from traditional blood glucose meters BGM Continuous glucose monitoring is now known to have good control effects in type 1 and type 2 diabetes mellitus However there are still few randomized controlled trials for gestational diabetes mellitus and there are not consistent results In addition blood glucose management conditions vary among groups with different dietary habits socioeconomic status and income Food culture of Taiwan is diverse and it is easy to consume sugar or high carbohydrate foods Continuous glucose monitoring can be more sensitive to measure glucose fluctuations but it is still unknown whether it will have different maternal and infant health effects for groups whose glucose is prone to exceed the target range
Objective To explore the impact of continuous glucose monitoring on the health outcomes of mothers and infants with gestational diabetes mellitus and to test the moderating effect of socioeconomic and cultural factors dietary habits socioeconomic status and income on the relationship between continuous glucose monitoring and the health outcomes among mothers with gestational diabetes mellitus and their infants
Methods This study was a randomized controlled trial It was expected that 120 pregnant women with gestational diabetes mellitus would be randomly assigned to the Control group 40 people using blood glucose meters BGM or the experimental group 80 people using continuous glucose monitoring CGM at a ratio of 12 In the experimental group they would be assigned to the Experimental group1-Continuous glucose monitoring CGM group 40 people or the Experimental group2-Continuous glucose monitoring CGM with nursing care group 40 people The Experimental group2-Continuous glucose monitoring CGM with nursing care group would provide nursing intervention during the perinatal period The outcome variables of the three groups would be tracked and compared with 3 time points which were 24 to 32 weeks of pregnancy 33 weeks of pregnancy to before delivery and 4 to 12 weeks after delivery The primary outcomes were maternal glycemic parameters cardiometabolic risk factors and fetal macrosomia Secondary outcomes included gestational weight depression and infant growth curve
Objective To explore the impact of continuous glucose monitoring on the health outcomes of mothers and infants with gestational diabetes mellitus and to test the moderating effect of socioeconomic and cultural factors dietary habits socioeconomic status and income on the relationship between continuous glucose monitoring and the health outcomes among mothers with gestational diabetes mellitus and their infants
Methods This study was a randomized controlled trial It was expected that 120 pregnant women with gestational diabetes mellitus would be randomly assigned to the Control group 40 people using blood glucose meters BGM or the experimental group 80 people using continuous glucose monitoring CGM at a ratio of 12 In the experimental group they would be assigned to the Experimental group1-Continuous glucose monitoring CGM group 40 people or the Experimental group2-Continuous glucose monitoring CGM with nursing care group 40 people The Experimental group2-Continuous glucose monitoring CGM with nursing care group would provide nursing intervention during the perinatal period The outcome variables of the three groups would be tracked and compared with 3 time points which were 24 to 32 weeks of pregnancy 33 weeks of pregnancy to before delivery and 4 to 12 weeks after delivery The primary outcomes were maternal glycemic parameters cardiometabolic risk factors and fetal macrosomia Secondary outcomes included gestational weight depression and infant growth curve
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None