The Project for Managing Cardiometabolic Risk in Women Diagnosed With Gestational Diabetes Mellitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNational Taiwan University Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 years or above
Pregnant women diagnosed with gestational diabetes mellitus
Willing to participate in the study
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Continuous glucose monitor
DeviceParticipants 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
BehavioralIndividual 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)
Other interventionParticipants 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 groups
120 Participants
are divided into 3 treatment groupsGroup A: Controlled group-Blood glucose meters (BGM) groupOther 1 intervention
Group B: Experimental group1-Continuous glucose monitoring (CGM) groupExperimental treatment 1 intervention
Group C: Experimental group2-Continuous glucose monitoring (CGM) with nursing care groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
24-32 weeks of pregnancy, 4-12 weeks postpartum2
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.
Time frame
24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum3
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.
Time frame
24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum4
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.
Time frame
24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartumSecondary outcomes
1
Incidence of Hypertensive Disorders in Pregnancy
This outcome measure assesses the incidence of hypertensive disorders in pregnancy, including gestational hypertension, preeclampsia, and eclampsia. Data will be summarized by reporting the proportion of participants diagnosed with any hypertensive disorder during pregnancy.
Time frame
24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery2
Rate of Cesarean Section Deliveries
This outcome measure assesses the rate of cesarean section deliveries among participants.
Time frame
4-12 weeks postpartum3
Health Belief Scale for Glycemic Control
A 21-item Likert scale based on the Health Belief model includes 5 categories: perceived susceptibility, perceived severity, perceived benefits, perceived barriers and self-efficacy.
Time frame
24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery4
Glucose monitoring satisfaction Scale
Satisfaction of using continuous glucose monitoring (CGM) or blood glucose meters (BGM) access by Likert scale. A 4-item Likert scale includes 4 categories: ease of use, painful, convenience and overall satisfaction. Each item scores from 1-5. A higher score means lower satisfaction.
Time frame
33 weeks of pregnancy to before deliverySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov