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Continuous Glucose Monitoring Glycemic cHAracterization During Pregnancy

NCT06357728 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-10

No results posted yet for this study

Summary

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.

Conditions

  • Gestational Diabetes
  • Glucose Metabolism Disorders
  • Metabolic Disease

Interventions

DEVICE

Continuous glucose monitoring

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.

Sponsors & Collaborators

  • KK Women's and Children's Hospital

    lead OTHER_GOV

Principal Investigators

  • Phaik Ling, Elaine Quah, PhD · KK Women's and Children's Hospital

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-04-01
Completion
2025-12-01

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06357728 on ClinicalTrials.gov