The Impact of Continuous Glucose Monitoring on Maternal and Infant's Outcomes in Gestational Diabetes: Testing the Moderating Effects of Socioeconomic and Cultural Factors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Maternal albumin
研究概览
简要总结
This study will discuss the impact of continuous glucose monitoring on maternal and infant's outcomes in gestational diabetes mellitus, and test the moderating effect of socioeconomic and cultural factors (dietary habits, socioeconomic status and income).
详细描述
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 1:2. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Aged 18 years or above
- •Pregnant women diagnosed with gestational diabetes mellitus
- •Those who are willing to participate in this study
排除标准
- •Those who have been diagnosed with diabetes mellitus "before pregnancy"
- •Those whose skin is likely allergic to some materials such as tapes (signs and symptoms such as redness, swelling, itching, painful, presenting blisters or rashes caused by wearing breathable tapes, patches, etc.)
- •Those who is with abnormal coagulation function
研究组 & 干预措施
Controlled group-Blood glucose meters (BGM) group
The participants will receive structured questionnaires and blood tests (glycated albumin, fasting plasma glucose, insulin, total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein) at 24-32 weeks of pregnancy, 35 weeks of pregnancy to before delivery, and 4-12 weeks postpartum, respectively.
Participants are required to use blood glucose meters (BGM) at "24-32 weeks of pregnancy" and "33 weeks to before delivery". After 14 days of glucose monitoring at "24-32 weeks of pregnancy", a glucose monitor report will be given to the participants. After the 14 days of glucose monitoring at "33 weeks to before delivery ", another glucose monitor report will be given to the participants.
干预措施: Blood glucose meters (BGM) (Other)
Experimental group1-Continuous glucose monitoring (CGM) group
The participants will receive structured questionnaires and blood tests (glycated albumin, fasting plasma glucose, insulin, total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein) at 24-32 weeks of pregnancy, 35 weeks of pregnancy to before delivery, and 4-12 weeks postpartum, respectively.
Participants will receive a set of continuous glucose monitor (CGM) respectively at "24-32 weeks of pregnancy (first set)" and "33 weeks of pregnancy to before delivery (second set)".
干预措施: Continuous glucose monitor (Device)
Experimental group2-Continuous glucose monitoring (CGM) with nursing care group
The participants will receive structured questionnaires and blood tests (glycated albumin, fasting plasma glucose, insulin, total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein) at 24-32 weeks of pregnancy, 35 weeks of pregnancy to before delivery, and 4-12 weeks postpartum, respectively.
Participants will receive a set of continuous glucose monitor (CGM) respectively at "24-32 weeks of pregnancy (first set)" and "33 weeks of pregnancy to before delivery (second set)".
Participants will receive perinatal nursing care for gestational diabetes.
干预措施: Continuous glucose monitor (Device)
Experimental group2-Continuous glucose monitoring (CGM) with nursing care group
The participants will receive structured questionnaires and blood tests (glycated albumin, fasting plasma glucose, insulin, total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein) at 24-32 weeks of pregnancy, 35 weeks of pregnancy to before delivery, and 4-12 weeks postpartum, respectively.
Participants will receive a set of continuous glucose monitor (CGM) respectively at "24-32 weeks of pregnancy (first set)" and "33 weeks of pregnancy to before delivery (second set)".
Participants will receive perinatal nursing care for gestational diabetes.
干预措施: Perinatal nursing care for gestational diabetes (Behavioral)
结局指标
主要结局
Maternal albumin
时间窗: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
albumin
Maternal fasting plasma glucose
时间窗: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
fasting plasma glucose
Maternal insulin
时间窗: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
insulin
Maternal glycated albumin
时间窗: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
glycated albumin
Total cholesterol
时间窗: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
total cholesterol
Low-density lipoprotein
时间窗: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
low-density lipoprotein
Maternal Oral glucose tolerance test
时间窗: 24-32 weeks of pregnancy, 4-12 weeks postpartum
Oral glucose tolerance test (OGTT) including fasting, 1-hour, and 2-hour glucose levels.
Triglycerides
时间窗: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
triglycerides
Fetal macrosomia
时间窗: 4-12 weeks postpartum
Fetal macrosomia is defined as a birth weight ≥4,000 g.
High-density lipoprotein
时间窗: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
high-density lipoprotein
次要结局
- Postpartum weight retention(4-12 weeks postpartum)
- Cesarean Section(4-12 weeks postpartum)
- Insulin medications(24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum)
- Hypertensive disorders in pregnancy(24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery)
- Maternal average fasting plasma glucose(24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum)
- Gestational weight gain(24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery)
- Depression(24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum)
- Infant growth curve(4-12 weeks postpartum)
- Maternal average plasma glucose, Post-cibum(24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum)
- Quality of life assessment(24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum)
- Health behavior change of glycemic control Scale(24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum)
- Exercise Frequency(24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum)
- Health Belief of glycemic control Scale(24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum)
- Perceived benefits and barriers of CGM(33 weeks of pregnancy to before delivery)
- Glucose monitoring satisfaction Scale(33 weeks of pregnancy to before delivery)