RecruitingNot ApplicableNCT06648174

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

The Project for Managing Cardiometabolic Risk in Women Diagnosed With Gestational Diabetes Mellitus: The Development and Application of "a Lifestyle Intervention Based on Health Belief Model Supported by Mobile Health"

Sponsor

National Taiwan University Hospital

Enrollment

120 participants

Start Date

Nov 11, 2024

Study Type

INTERVENTIONAL

Conditions

Continuous Glucose Monitoring Gestational Diabetes Mellitus

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).

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Blood glucose meters (BGM), a medical device called Continuous glucose monitor, and others for people with continuous glucose monitoring and gestational diabetes mellitus. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEContinuous glucose monitor

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.

BEHAVIORALPerinatal nursing care for gestational diabetes

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.

OTHERBlood glucose meters (BGM)

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.