The Project for Managing Cardiometabolic Risk in Women Diagnosed With Gestational Diabetes Mellitus
NCT ID: NCT06648174
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2024-11-11
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Controlled group-Blood glucose meters (BGM) group
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.
Blood 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.
Experimental group1-Continuous glucose monitoring (CGM) group
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.
Continuous 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.
Experimental group2-Continuous glucose monitoring (CGM) with nursing care group
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.
Continuous 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.
Perinatal 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.
Interventions
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Continuous 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.
Perinatal 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.
Blood 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Pregnant women diagnosed with gestational diabetes mellitus
3. Willing to participate in the study
Exclusion Criteria
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
18 Years
FEMALE
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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HUNG-HUI CHEN, PhD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hostiptal
Locations
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National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital
Hsinchu, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202403080RIND
Identifier Type: -
Identifier Source: org_study_id
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