Gestational Diabetes Mellitus Clinical Trial
Official title:
The Impact of Continuous Glucose Monitoring on Maternal and Infant's Outcomes in Gestational Diabetes: Testing the Moderating Effects of Socioeconomic and Cultural Factors
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).
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | June 30, 2026 |
Est. primary completion date | June 30, 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Aged 18 years or above - Pregnant women diagnosed with gestational diabetes mellitus - Those who are willing to participate in this study Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital | Hsinchu |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maternal Oral glucose tolerance test | Oral glucose tolerance test (OGTT) including fasting, 1-hour, and 2-hour glucose levels. | 24-32 weeks of pregnancy, 4-12 weeks postpartum | |
Primary | Maternal glycated albumin | glycated albumin | 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum | |
Primary | Maternal albumin | albumin | 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum | |
Primary | Maternal fasting plasma glucose | fasting plasma glucose | 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum | |
Primary | Maternal insulin | insulin | 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum | |
Primary | Total cholesterol | total cholesterol | 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum | |
Primary | Triglycerides | triglycerides | 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum | |
Primary | High-density lipoprotein | high-density lipoprotein | 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum | |
Primary | Low-density lipoprotein | low-density lipoprotein | 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum | |
Primary | Fetal macrosomia | Fetal macrosomia is defined as a birth weight =4,000 g. | 4-12 weeks postpartum | |
Secondary | 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. | 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery | |
Secondary | 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. | 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum | |
Secondary | Infant growth curve | infant growth curve | 4-12 weeks postpartum | |
Secondary | Maternal average fasting plasma glucose | average fasting plasma glucose | 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum | |
Secondary | Maternal average plasma glucose, Post-cibum | average plasma glucose, Post-cibum | 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum | |
Secondary | Postpartum weight retention | the weight change from pre-pregnancy to a period postpartum | 4-12 weeks postpartum | |
Secondary | Insulin medications | dosage and insulin form | 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum | |
Secondary | Hypertensive disorders in pregnancy | Number of Participants with preeclampsia-eclampsia or gestational hypertension | 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery | |
Secondary | Cesarean Section | Number of Participants with Cesarean Section | 4-12 weeks postpartum | |
Secondary | Exercise Frequency | Number of exercises per week. | 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum | |
Secondary | 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. | 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum | |
Secondary | 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. |
24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum | |
Secondary | 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. | 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum | |
Secondary | 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. | 33 weeks of pregnancy to before delivery | |
Secondary | 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. | 33 weeks of pregnancy to before delivery |
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