The Project for Managing Cardiometabolic Risk in Women Diagnosed With Gestational Diabetes Mellitus

NCT06648174 | Recruiting FDA Device

• 1 other identifier: 202403080RIND
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to examine the effects of a lifestyle intervention based on a health belief model (HBM) supported by mobile health (mHealth) and the impact of continuous glucose monitoring (CGM) on maternal glycemic parameters, cardiometabolic risk, health behavior and infant's outcomes among women diagnosed with gestational diabetes mellitus (GDM).

Conditions

Gestational Diabetes Mellitus; Continuous Glucose Monitoring

Keywords

Gestational Diabetes Mellitus; Continuous Glucose Monitoring; Health Interventions

Outcome Measures

Primary Outcomes (9)

• Number of Participants with Abnormal Maternal Oral Glucose Tolerance Test Results

  This outcome measure assesses the number of participants with abnormal results from the Oral Glucose Tolerance Test (OGTT), which includes measurements of fasting, 1-hour, and 2-hour glucose levels. The data will be summarized based on the thresholds established for abnormal glucose levels, as per standard diagnostic criteria for gestational diabetes.

  24-32 weeks of pregnancy, 4-12 weeks postpartum

• HOMA-IR Value for Assessing Insulin Resistance in Participants

  This outcome measure evaluates the HOMA-IR (Homeostasis Model Assessment of Insulin Resistance) value in participants, calculated using fasting insulin and fasting glucose levels. Data will be obtained through reviews of medical records.

  24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum

• Total Cholesterol Levels in Participants

  This outcome measure assesses the total cholesterol levels in participants. Data will be obtained through reviews of medical records. The data will be summarized by reporting the mean total cholesterol level, as well as the proportion of participants classified as having high total cholesterol levels based on established clinical thresholds.

  24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum

• Triglycerides Levels in Participants

  This outcome measure assesses the triglycerides levels in participants. The data obtained through medical record reviews. The data will be summarized by reporting the mean triglycerides level, as well as the proportion of participants classified as having high triglycerides levels based on established clinical thresholds.

  24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum

• High-density Lipoprotein Levels in Participants

  This outcome measure assesses the high-density lipoprotein levels in participants. The data obtained through medical record reviews. The data will be summarized by reporting the mean high-density lipoprotein level, as well as the proportion of participants classified as having high high-density lipoprotein levels based on established clinical thresholds.

  24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum

• Low-density Lipoprotein Levels in Participants

  This outcome measure assesses the low-density lipoprotein levels in participants. The data obtained through medical record reviews. The data will be summarized by reporting the mean low-density lipoprotein level, as well as the proportion of participants classified as having high low-density lipoprotein levels based on established clinical thresholds.

  24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum

• Glycated Albumin Levels in Participants

  This outcome measure assesses the glycated albumin levels in participants. The data obtained through medical record reviews. The data will be summarized by reporting the mean glycated albumin level, as well as the proportion of participants classified as having high glycated albumin levels based on established clinical thresholds.

  24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum

• Fasting Plasma Glucose Levels in Participants

  This outcome measure assesses the fasting plasma glucose levels in participants. The data obtained through medical record reviews. The data will be summarized by reporting the mean fasting plasma glucose level, as well as the proportion of participants classified as having high fasting plasma glucose levels based on established clinical thresholds.

  24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum

• Incidence of Fetal Macrosomia as Measured by Birth Weight

  This outcome measure assesses the incidence of fetal macrosomia in participants. Data will be summarized by reporting the proportion of newborns classified as having fetal macrosomia based on the established weight threshold.

  4-12 weeks postpartum

Secondary Outcomes (13)

• Incidence of Hypertensive Disorders in Pregnancy

  24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery

• Rate of Cesarean Section Deliveries

  4-12 weeks postpartum

• Health Belief Scale for Glycemic Control

  24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery

• Glucose monitoring satisfaction Scale

  33 weeks of pregnancy to before delivery

• Perceived benefits and barriers of CGM assessed by Benefits of CGM (BenCGM) and Burdens of CGM (BurCGM) Questionnaires

  33 weeks of pregnancy to before delivery

Study Arms (3)

Controlled group-Blood glucose meters (BGM) group

OTHER

The participants will receive structured questionnaires at 24-32 weeks of pregnancy, 33 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 7-14 days of glucose monitoring at "24-32 weeks of pregnancy", glucose monitor reports will be given to the participants. After the 7-14 days of glucose monitoring at "33 weeks to before delivery ", another glucose monitor reports will be given to the participants.

Other: Blood glucose meters (BGM)

Experimental group1-Continuous glucose monitoring (CGM) group

EXPERIMENTAL

The participants will receive structured questionnaires at 24-32 weeks of pregnancy, 33 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)". After 7-14 days of glucose monitoring at "24-32 weeks of pregnancy", glucose monitor reports will be given to the participants. After the 7-14 days of glucose monitoring at "33 weeks to before delivery ", another glucose monitor reports will be given to the participants.

Device: Continuous glucose monitor

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

EXPERIMENTAL

The participants will receive structured questionnaires at 24-32 weeks of pregnancy, 33 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)". After 7-14 days of glucose monitoring at "24-32 weeks of pregnancy", glucose monitor reports will be given to the participants. After the 7-14 days of glucose monitoring at "33 weeks to before delivery ", another glucose monitor reports will be given to the participants. Participants will receive nursing care for gestational diabetes at 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, and 4-12 weeks postpartum.

Device: Continuous glucose monitor; Behavioral: Perinatal nursing care for gestational diabetes

Interventions

Continuous glucose monitor DEVICE

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 7-14 days after starting to wear), the investigators will provide glucose monitor reports. The second CGM was worn from the 33rd week of pregnancy to before delivery, and another glucose monitor reports was given approximately 7-14 days after starting to wear.

Also known as: Abbott FreeStyle Libre 2 (CGM)

Experimental group1-Continuous glucose monitoring (CGM) group; Experimental group2-Continuous glucose monitoring (CGM) with nursing care group

Perinatal nursing care for gestational diabetes BEHAVIORAL

Individual nursing care and consultation for women with gestational diabetes mellitus, including glucose monitor suggestions, dietary suggestions, emotional support, breastfeeding support at 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, and 4-12 weeks postpartum.

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

Blood glucose meters (BGM) OTHER

Participants are required to use blood glucose meters (BGM) at 24-32 weeks of pregnancy and 33 weeks to before delivery. After 7-14 days of glucose monitoring at 24-32 weeks of pregnancy, glucose monitor reports will be given to the participants. After the 7-14 days of glucose monitoring at 33 weeks to before delivery, another glucose monitor reports will be given to the participants.

Controlled group-Blood glucose meters (BGM) group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The participants of this study are pregnant women with gestational diabetes mellitus.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or above
• Pregnant women diagnosed with gestational diabetes mellitus
• Willing to participate in the study

You may not qualify if:

• Diagnosed with diabetes mellitus before pregnancy
• Allergic to materials such as tapes (e.g., redness, swelling, itching, pain, blisters, or rashes caused by breathable tapes or patches)
• Abnormal coagulation function

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital

Hsinchu, 302058, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• HUNG-HUI CHEN, PhD

  National Taiwan University Hostiptal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HUNG-HUI CHEN, PhD

CONTACT

886-2-2394-7109; hunghuichen@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: October 18, 2024
• Study Start: November 11, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)