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Continuous Glucose Monitoring Glycemic cHAracterization During Pregnancy

Study acronym: I-CHAP
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Apr 1, 2025 to Dec 1, 2026
    • Study completion date: Dec 1, 2025 to Dec 1, 2026
    • Site details revised
    v3
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 1, 2024 to Jul 1, 2024
    • Study sites: 0 to 1
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06357728
Lead Sponsor KK Women's and Children's Hospital
Conditions
(from sponsor)
Gestational Diabetes, Glucose Metabolism Disorders, Metabolic Disease
Related terms Diabetes, Gestational, Glucose Metabolism Disorders, Metabolic Diseases
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov