Clinical trial NCT06436326: The Impact of Continuous Glucose Monitoring on Maternal and Infant's Outcomes in Gestational Diabetes
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gestational Diabetes Mellitus
Continuous Glucose Monitoring
Keywords: Gestational Diabetes Mellitus
Continuous Glucose Monitoring
Health Interventions
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maternal Oral glucose tolerance test
timeFrame: 24-32 weeks of pregnancy, 4-12 weeks postpartum
measure: Maternal glycated albumin
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
measure: Maternal albumin
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
measure: Maternal fasting plasma glucose
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
measure: Maternal insulin
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
measure: Total cholesterol
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
measure: Triglycerides
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
measure: High-density lipoprotein
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
measure: Low-density lipoprotein
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
measure: Fetal macrosomia
timeFrame: 4-12 weeks postpartum
Secondary outcomes:
measure: Gestational weight gain
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
measure: Depression
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
measure: Infant growth curve
timeFrame: 4-12 weeks postpartum
measure: Maternal average fasting plasma glucose
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
measure: Maternal average plasma glucose, Post-cibum
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
measure: Postpartum weight retention
timeFrame: 4-12 weeks postpartum
measure: Insulin medications
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
measure: Hypertensive disorders in pregnancy
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
measure: Cesarean Section
timeFrame: 4-12 weeks postpartum
measure: Exercise Frequency
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
measure: Health behavior change of glycemic control Scale
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
measure: Health Belief of glycemic control Scale
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
measure: Quality of life assessment
timeFrame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
measure: Glucose monitoring satisfaction Scale
timeFrame: 33 weeks of pregnancy to before delivery
measure: Perceived benefits and barriers of CGM
timeFrame: 33 weeks of pregnancy to before delivery
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital
Study officials:
affiliation: National Taiwan University Hostiptal
name: HUNG-HUI CHEN, PhD
role: PRINCIPAL_INVESTIGATOR
References: