protocolSection identificationModule nctId: NCT06357728, orgStudyIdInfo id: 2024/2035, briefTitle: Continuous Glucose Monitoring Glycemic cHAracterization During Pregnancy, acronym: I-CHAP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: KK Women's and Children's Hospital, class: OTHER_GOV, descriptionModule briefSummary: Our study named Integrated Continuous glucose monitoring glycemic cHAracterization during Pregnancy in comparison with oral glucose tolerance test (I-CHAP) aims to establish much needed preliminary evidence in our Asian population to show the capabilities of CGM use and its wealth of data for GDM diagnosis. This study aims to test the following aims and hypotheses in a single-armed intervention pilot trial study of pregnant women undergoing the oral glucose tolerance test:Aim 1. To characterize CGM glucose values with the 3-point blood glucose measured during the OGTT procedure.The investigators hypothesize that the CGM glucose values at single time points while fasted, and after the 75-g glucose load will be positively correlated with 3-timepoint blood glucose values captured during the OGTT.Aim 2. To correlate the CGM glucose excursions and CGM-derived metrics (glycaemic variability and glycaemic control) with maternal-fetal outcomes and treatment outcomes.The investigators hypothesize that higher AUC, glycemic variability and poorer glycaemic control will better distinguish maternal-fetal outcomes and treatment outcomes, compared to the OGTT.Aim 3. To describe the acceptability of using the Dexcom G6 CGM as a diagnostic tool instead of the OGTT. The investigators hypothesize that a higher proportion of participants will report CGM to be more acceptable than the OGTT for GDM diagnosis., conditionsModule conditions: Gestational Diabetes, conditions: Glucose Metabolism Disorders, conditions: Metabolic Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: All participants will be given a continuous glucose monitoring device to wear for 10 days before during and after the oral glucose tolerance test., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Continuous glucose monitoring, outcomesModule primaryOutcomes measure: Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 0-hour (mmol/L), primaryOutcomes measure: Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 1-hour (mmol/L), primaryOutcomes measure: Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 2-hour (mmol/L), secondaryOutcomes measure: Maternal obstetric outcomes - Pre-eclampsia, secondaryOutcomes measure: Maternal obstetric outcomes- Pregnancy-induced hypertension, secondaryOutcomes measure: Maternal obstetric outcomes - C-section, secondaryOutcomes measure: Neonatal outcomes- Large-for-gestational-age, secondaryOutcomes measure: Neonatal outcomes-Birth weigh, secondaryOutcomes measure: Neonatal outcomes- Small-for-gestational-age, secondaryOutcomes measure: Neonatal outcomes-Pre-term birth, secondaryOutcomes measure: Neonatal outcomes-Neonatal hypoglycaemia, otherOutcomes measure: Types of treatment received for gestational diabetes diagnosis, eligibilityModule sex: FEMALE, minimumAge: 21 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP_ICF, hasProtocol: True, hasSap: True, hasIcf: True, label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form, date: 2024-02-20, uploadDate: 2024-03-18T04:35, filename: Prot_SAP_ICF_000.pdf, size: 218503, hasResults: False