Continuous Glucose Monitoring Glycemic cHAracterization During Pregnancy

NCT06357728 | Recruiting DMC

• 1 other identifier: 2024/2035
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

gestational diabetes; pregnancy; continuous glucose monitoring

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  During OGTT procedure at 20-35 weeks gestation

Secondary Outcomes (8)

• Maternal obstetric outcomes - Pre-eclampsia

  At the end of pregnancy at 40-42 weeks

• Maternal obstetric outcomes- Pregnancy-induced hypertension

  At the end of pregnancy at 40-42 weeks

• Maternal obstetric outcomes - C-section

  At the end of pregnancy at 40-42 weeks

• Neonatal outcomes- Large-for-gestational-age

  At the end of pregnancy at 40-42 weeks

• Neonatal outcomes-Birth weigh

  At the end of pregnancy at 40-42 weeks

Other Outcomes (1)

• Types of treatment received for gestational diabetes diagnosis

  At the end of pregnancy at 40-42 weeks

Study Arms (1)

Continuous glucose monitoring arm

EXPERIMENTAL

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.

Device: Continuous glucose monitoring

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.

Continuous glucose monitoring arm

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational; Glucose Metabolism Disorders; Metabolic Diseases

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Phaik Ling, Elaine Quah, PhD

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phaik Ling, Elaine Quah, PhD

CONTACT

65 97732543; quah.phaik.ling@kkh.com.sg

Kok Hian Tan, MD

CONTACT

65 63941099; tan.kok.hian@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: All participants will be given a continuous glucose monitoring device to wear for 10 days before during and after the oral glucose tolerance test.

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 10, 2024
• Study Start: July 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 10, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)