RecruitingNot Applicable

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

Taiwan120 participantsStarted 2024-11-11

Plain-language 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).

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants with Abnormal Maternal Oral Glucose Tolerance Test Results

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

HOMA-IR Value for Assessing Insulin Resistance in Participants

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

Total Cholesterol Levels in Participants

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

Triglycerides Levels in Participants

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

High-density Lipoprotein Levels in Participants

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

Low-density Lipoprotein Levels in Participants

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

Trial details

NCT IDNCT06648174

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

HUNG-HUI CHEN, PhD

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

View on ClinicalTrials.gov More Gestational Diabetes Mellitus trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

. 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

What they're measuring

Number of Participants with Abnormal Maternal Oral Glucose Tolerance Test Results

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

HOMA-IR Value for Assessing Insulin Resistance in Participants

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

Total Cholesterol Levels in Participants

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

Triglycerides Levels in Participants

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

High-density Lipoprotein Levels in Participants

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

Low-density Lipoprotein Levels in Participants

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