Continuous Glucose Monitoring Glycemic cHAracterization During Pregnancy

ConditionsGestational Diabetes Glucose Metabolism Disorders Metabolic Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age21-45

SponsorKK Women's and Children's Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Pregnant women of only Chinese or Indian ethnicity

Pregnant women between age 21--45 years old

Oral glucose tolerance test (OGTT) to be scheduled between 20-35 weeks gestational age

OGTT to be done at KK Women's and Children's Hospital

Disqualifiers

Women with serious skin conditions (e.g. eczema) that precludes wearing the sensor for 10 days

Exclusion criteria were pre-existing Type 1 or Type 2 diabetes, mental illness precluding informed consent and women who were diagnosed early (1st or early 2nd trimester for GDM).

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

60 Participants

are divided into 1 treatment group

Group A: Continuous glucose monitoring armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 0-hour (mmol/L)

Three-point OGTT (fasting, 1-hour and 2-hour) will be performed at 20-35 weeks gestation

Time frame

During OGTT procedure at 20-35 weeks gestation

Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 1-hour (mmol/L)

Three-point OGTT (fasting, 1-hour and 2-hour) will be performed at 20-35 weeks gestation

Time frame

During OGTT procedure at 20-35 weeks gestation

Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 2-hour (mmol/L)

Three-point OGTT (fasting, 1-hour and 2-hour) will be performed at 20-35 weeks gestation

Time frame

During OGTT procedure at 20-35 weeks gestation