The Impact of Continuous Glucose Monitoring on Maternal and Infant's Outcomes in Gestational Diabetes
- Conditions
- Continuous Glucose MonitoringGestational Diabetes Mellitus
- Interventions
- Device: Continuous glucose monitorOther: Blood glucose meters (BGM)Behavioral: Perinatal nursing care for gestational diabetes
- Registration Number
- NCT06436326
- Lead Sponsor
- National Taiwan University Hospital
- Brief Summary
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).
- 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 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 120
- Aged 18 years or above
- Pregnant women diagnosed with gestational diabetes mellitus
- Those who are willing to participate in this study
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group1-Continuous glucose monitoring (CGM) group Continuous glucose monitor 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)". Controlled group-Blood glucose meters (BGM) group Blood glucose meters (BGM) 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. Experimental group2-Continuous glucose monitoring (CGM) with nursing care group Perinatal nursing care for gestational diabetes 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. Experimental group2-Continuous glucose monitoring (CGM) with nursing care group Continuous glucose monitor 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.
- Primary Outcome Measures
Name Time Method Maternal albumin 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum albumin
Maternal fasting plasma glucose 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum fasting plasma glucose
Maternal insulin 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum insulin
Maternal glycated albumin 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum glycated albumin
Total cholesterol 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum total cholesterol
Low-density lipoprotein 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum low-density lipoprotein
Maternal Oral glucose tolerance test 24-32 weeks of pregnancy, 4-12 weeks postpartum Oral glucose tolerance test (OGTT) including fasting, 1-hour, and 2-hour glucose levels.
Triglycerides 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum triglycerides
Fetal macrosomia 4-12 weeks postpartum Fetal macrosomia is defined as a birth weight ≥4,000 g.
High-density lipoprotein 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum high-density lipoprotein
- Secondary Outcome Measures
Name Time Method Postpartum weight retention 4-12 weeks postpartum the weight change from pre-pregnancy to a period postpartum
Cesarean Section 4-12 weeks postpartum Number of Participants with Cesarean Section
Maternal average fasting plasma glucose 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum average fasting plasma glucose
Insulin medications 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum dosage and insulin form
Hypertensive disorders in pregnancy 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery Number of Participants with preeclampsia-eclampsia or gestational hypertension
Gestational weight gain 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery Gestational weight gain will be based on pre-pregnancy Body Mass Index (BMI) and classified according to the Institute of Medicine (IOM) recommendations.
Depression 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum 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.
Infant growth curve 4-12 weeks postpartum infant growth curve
Maternal average plasma glucose, Post-cibum 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum average plasma glucose, Post-cibum
Quality of life assessment 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum 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.
Health behavior change of glycemic control Scale 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum 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.
Exercise Frequency 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum Number of exercises per week.
Health Belief of glycemic control Scale 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum 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.Perceived benefits and barriers of CGM 33 weeks of pregnancy to before delivery 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.
Glucose monitoring satisfaction Scale 33 weeks of pregnancy to before delivery 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.
Trial Locations
- Locations (1)
National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital
🇨🇳Hsinchu, Taiwan