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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
120
Participants will receive a set of continuous glucose monitor (CGM) at "24-32 weeks of pregnancy (first set)" and "33 weeks of pregnancy to before delivery (second set)," respectively. CGM wearing instruction will be provided before the first wearing at "24-32 weeks of pregnancy". After completing the first wearing (approximately 14 days after starting to wear), the investigators will provide a glucose monitor report. The second CGM was worn from the 33rd week of pregnancy to before delivery, and another glucose monitor report was given approximately 14 days after starting to wear.
Individual nursing care and consultation for pregnant women with gestational diabetes mellitus, including glucose monitor suggestions, dietary suggestions, emotional support, breastfeeding support.
National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital
Hsinchu, Taiwan
RECRUITINGMaternal Oral glucose tolerance test
Oral glucose tolerance test (OGTT) including fasting, 1-hour, and 2-hour glucose levels.
Time frame: 24-32 weeks of pregnancy, 4-12 weeks postpartum
Maternal glycated albumin
glycated albumin
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Maternal albumin
albumin
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Maternal fasting plasma glucose
fasting plasma glucose
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Maternal insulin
insulin
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Total cholesterol
total cholesterol
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Triglycerides
triglycerides
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
High-density lipoprotein
high-density lipoprotein
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
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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.
Low-density lipoprotein
low-density lipoprotein
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Fetal macrosomia
Fetal macrosomia is defined as a birth weight ≥4,000 g.
Time frame: 4-12 weeks postpartum
Gestational weight gain
Gestational weight gain will be based on pre-pregnancy Body Mass Index (BMI) and classified according to the Institute of Medicine (IOM) recommendations.
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
Depression
Edinburgh Postnatal Depression Scale (EPDS) The EPDS is a 10-item questionnaire. Each item scores from 0-3. The total score is found by adding together the scores for each of the 10 items. The minimum is 0 and the maximum is 30. Scoring above 12 or 13 are likely to be suffering from depression.
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Infant growth curve
infant growth curve
Time frame: 4-12 weeks postpartum
Maternal average fasting plasma glucose
average fasting plasma glucose
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Maternal average plasma glucose, Post-cibum
average plasma glucose, Post-cibum
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Postpartum weight retention
the weight change from pre-pregnancy to a period postpartum
Time frame: 4-12 weeks postpartum
Insulin medications
dosage and insulin form
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Hypertensive disorders in pregnancy
Number of Participants with preeclampsia-eclampsia or gestational hypertension
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
Cesarean Section
Number of Participants with Cesarean Section
Time frame: 4-12 weeks postpartum
Exercise Frequency
Number of exercises per week.
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Health behavior change of glycemic control Scale
A 3-item Likert scale based on the Transtheoretical model, including self-monitoring of glucose level, diet and physical activity. Each item scores from 0-4. A higher score means closer to the action or maintenance stage.
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Health Belief of glycemic control Scale
A 21-item Likert scale based on the Health Belief model includes 5 categories: perceived susceptibility, perceived severity, perceived benefits, perceived barriers and self-efficacy. Each item scores from 0-4. A higher score means higher the individual's beliefs about preventing diseases or maintaining health in perceived susceptibility, perceived severity, perceived benefits and self-efficacy categories. A higher score means higher the individual's barriers to preventing diseases or maintaining health in the perceived barriers category.
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Quality of life assessment
World Health Organization Quality-of-Life Scale:BREF Taiwan Version The scale evaluates four domains of quality of life ("Physical Health," "Psychological Health," "Social Relationships," and "Environment"), and contains four other questions :overall perception of quality of life, general health, dietary ,feel respected. Every domain scores from 4-20. Higher scores mean a better quality of life.
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Glucose monitoring satisfaction Scale
Satisfaction of using continuous glucose monitoring (CGM) or blood glucose meters (BGM) access by Likert scale. A 4-item Likert scale includes 4 categories: ease of use, painful, convenience and overall satisfaction. Each item scores from 1-5. A higher score means lower satisfaction.
Time frame: 33 weeks of pregnancy to before delivery
Perceived benefits and barriers of CGM
Benefits of CGM (BenCGM) and Burdens of CGM (BurCGM) Questionnaires. A 16-item Likert scale includes 2 categories: benefits of CGM and burdens of CGM. Each item scores from 1-5. A higher score means a higher benefit in benefit of CGM category. A higher score means higher burdens in burdens of CGM category.
Time frame: 33 weeks of pregnancy to before delivery