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

National Taiwan University

Status: Enrolling

Conditions: Gestational Diabetes Mellitus; Continuous Glucose Monitoring

Treatments: Other: Blood glucose meters (BGM); Device: Continuous glucose monitor; Behavioral: Perinatal nursing care for gestational diabetes

Study type: Interventional

Funder types: Other

Identifiers

NCT06648174

202403080RIND

Details and patient eligibility

About

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).

Full description

Background: Women with gestational diabetes mellitus (GDM) are more likely to develop cardiometabolic risk (CMR). CMR refers to the risk factors that promote the chance of developing type 2 diabetes mellitus or cardiovascular events. However, using a family-centered approach, the effectiveness of continuous administration of both mobile health management and theoretical based lifestyle intervention from pregnancy to postpartum in preventing women at high risk of GDM from developing CMR has rarely been studied.

Methods: This randomized controlled trial will recruit 120 GDM pregnant women in northern Taiwan. The participants will be randomly assigned to the control group (blood glucose meters (BGM); n=40 people), intervention group 1 (continuous glucose monitoring (CGM); n=40 people), intervention group 2 (HBM-based lifestyle and mHealth intervention + CGM; n=40 people).The comparison group will receive the routine care and finger-prick test for blood glucose monitoring (BGM) during pregnancy.The intervention group 1 will receive CGM during pregnancy. The intervention group 2 will receive a HBM-based lifestyle and mHealth management program on 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum, including CGM during pregnancy.We intend to compare outcome variables among three groups. The outcomes variables will be assessed at baseline (24-32 weeks of pregnancy), 33 weeks of pregnancy to before delivery, 4 to 12 weeks after delivery. The primary outcomes were maternal glycemic parameters, cardiometabolic risk factors, and maternal health behavior. Outcomes will be assessed at baseline (24-32 weeks of pregnancy), 33 weeks of pregnancy to before delivery, 4 to 12 weeks after delivery. Generalized estimating equation (GEE) will be used to examine the trajectories and the effectiveness of the project for managing cardiometabolic risk on cardiometabolic risk and health behavior.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18 years or above
2. Pregnant women diagnosed with gestational diabetes mellitus
3. Willing to participate in the study

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Controlled group-Blood glucose meters (BGM) group

Other group

Description:

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.

Treatment:

Other: Blood glucose meters (BGM)

Experimental group1-Continuous glucose monitoring (CGM) group

Experimental group

Description:

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.

Treatment:

Device: Continuous glucose monitor

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

Experimental group

Description:

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.

Treatment:

Behavioral: Perinatal nursing care for gestational diabetes

Device: Continuous glucose monitor