Continuous Glucose Monitoring Glycemic cHAracterization During Pregnancy

Sponsor
KK Women's and Children's Hospital
Study ID
NCT06357728
Status
Recruiting
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Conditions

  • Gestational Diabetes
  • Glucose Metabolism Disorders
  • Metabolic Disease

Eligibility Criteria

Sex
FEMALE
Age
21 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Continuous glucose monitoring — DEVICE
    Continuous glucose monitoring sensor: All study participants wear the sensor on the back of either right or left upper arm for up to 10 days. Glucose levels will be recorded from the interstitial fluid every 5 minutes using intermittent/ flash glucose scanning. Data will be captured using a receiver.

Study Details

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.

Key Dates

First listed
Apr 10, 2024
Start date
Jul 1, 2024
Status verified
Sep 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Continuous glucose monitoring arm
    Continuous glucose monitoring sensor: All study participants wear the sensor on the back of either right or left upper arm for up to 10 days. Glucose levels will be recorded from the interstitial fluid every 5 minutes using intermittent/ flash glucose scanning. Data will be captured using a receiver.

Primary Outcome Measure

Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 0-hour (mmol/L) [ Time Frame: During OGTT procedure at 20-35 weeks gestation ]

Central Contacts

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