## Protocol Section
### Identification Module
**NCT ID:** NCT06436326

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 202311035RINC
#### Organization
**Class:** OTHER
**Full Name:** National Taiwan University Hospital
### Status Module
#### Completion Date
**Date:** 2026-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** National Taiwan University Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Gestational Diabetes Mellitus

- Continuous Glucose Monitoring

**Keywords:**

- Gestational Diabetes Mellitus

- Continuous Glucose Monitoring

- Health Interventions

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: Blood glucose meters (BGM)

**Label:** Controlled group-Blood glucose meters (BGM) group

**Type:** OTHER

#### Arm Group 2

**Description:** 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)".

**Intervention Names:**

- Device: Continuous glucose monitor

**Label:** Experimental group1-Continuous glucose monitoring (CGM) group

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** 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.

**Intervention Names:**

- Device: Continuous glucose monitor

- Behavioral: Perinatal nursing care for gestational diabetes

**Label:** Experimental group2-Continuous glucose monitoring (CGM) with nursing care group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental group1-Continuous glucose monitoring (CGM) group

- Experimental group2-Continuous glucose monitoring (CGM) with nursing care group

**Description:** 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), we 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.

**Name:** Continuous glucose monitor

**Other Names:**

- Abbott FreeStyle Libre 2 (CGM)

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Experimental group2-Continuous glucose monitoring (CGM) with nursing care group

**Description:** Individual nursing care and consultation for pregnant women with gestational diabetes mellitus, including glucose monitor suggestions, dietary suggestions, emotional support, breastfeeding support.

**Name:** Perinatal nursing care for gestational diabetes

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- Controlled group-Blood glucose meters (BGM) group

**Description:** 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.

**Name:** Blood glucose meters (BGM)

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Oral glucose tolerance test (OGTT) including fasting, 1-hour, and 2-hour glucose levels.

**Measure:** Maternal Oral glucose tolerance test

**Time Frame:** 24-32 weeks of pregnancy, 4-12 weeks postpartum

**Description:** glycated albumin

**Measure:** Maternal glycated albumin

**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

**Description:** albumin

**Measure:** Maternal albumin

**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

**Description:** fasting plasma glucose

**Measure:** Maternal fasting plasma glucose

**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

**Description:** insulin

**Measure:** Maternal insulin

**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

**Description:** total cholesterol

**Measure:** Total cholesterol

**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

**Description:** triglycerides

**Measure:** Triglycerides

**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

**Description:** high-density lipoprotein

**Measure:** High-density lipoprotein

**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

**Description:** low-density lipoprotein

**Measure:** Low-density lipoprotein

**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

**Description:** Fetal macrosomia is defined as a birth weight ≥4,000 g.

**Measure:** Fetal macrosomia

**Time Frame:** 4-12 weeks postpartum

#### Secondary Outcomes

**Description:** Gestational weight gain will be based on pre-pregnancy Body Mass Index (BMI) and classified according to the Institute of Medicine (IOM) recommendations.

**Measure:** Gestational weight gain

**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery

**Description:** Edinburgh Postnatal Depression Scale (EPDS)

**Measure:** Depression

**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

**Description:** infant growth curve

**Measure:** Infant growth curve

**Time Frame:** 4-12 weeks postpartum

**Description:** average fasting plasma glucose

**Measure:** Maternal average fasting plasma glucose

**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

**Description:** average plasma glucose, Post-cibum

**Measure:** Maternal average plasma glucose, Post-cibum

**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

**Description:** the weight change from pre-pregnancy to a period postpartum

**Measure:** Postpartum weight retention

**Time Frame:** 4-12 weeks postpartum

**Description:** dosage and insulin form

**Measure:** Insulin medications

**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

**Description:** preeclampsia-eclampsia, gestational hypertension

**Measure:** Hypertensive disorders in pregnancy

**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery

**Description:** Cesarean Section

**Measure:** Cesarean Section

**Time Frame:** 4-12 weeks postpartum

**Description:** Physical Activity Questionnaire

**Measure:** Physical Activity

**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

**Description:** Likert scale based on Transtheoretical model, including self-monitoring of glucose level, diet and physical activity.

**Measure:** Health behavior change of glycemic control

**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

**Description:** Likert scale based on Health belief Model

**Measure:** Health Belief of glycemic control

**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

**Description:** WHOQOL-BREF

**Measure:** Quality of life assessment

**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

**Description:** Satisfaction using continuous glucose monitoring (CGM) or blood glucose meters (BGM) access by Likert scale.

**Measure:** Glucose monitoring satisfaction

**Time Frame:** 33 weeks of pregnancy to before delivery

**Description:** Benefit of CGM (BenCGM) and Burdens of CGM (BurCGM) Questionnaires

**Measure:** Perceived benefits and barriers of CGM

**Time Frame:** 33 weeks of pregnancy to before delivery

### Eligibility Module

**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

**Gender Based:** True

**Gender Description:** The participants of this study are pregnant women with gestational diabetes mellitus.

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hunghuichen@ntu.edu.tw

**Name:** HUNG-HUI CHEN, PhD

**Phone:** 886-2-2394-7109

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hsinchu

**Contacts:**

***Contact 1:***

- **Email:** hunghuichen@ntu.edu.tw

- **Name:** HUNG-HUI CHEN

- **Phone:** +886-2-23947109

- **Role:** CONTACT

**Country:** Taiwan

**Facility:** National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital

**Zip:** 302058

#### Overall Officials

**Official 1:**

**Affiliation:** National Taiwan University Hostiptal

**Name:** HUNG-HUI CHEN, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M19012

- Name: Diabetes, Gestational

- Relevance: HIGH

- As Found: Gestational Diabetes

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes Mellitus

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016640

- Term: Diabetes, Gestational

- ID: D000003920

- Term: Diabetes Mellitus

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10365

- Name: Insulin

- Relevance: LOW

- As Found: Unknown

- ID: M173166

- Name: Insulin, Globin Zinc

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
