Integrated Continuous Glucose Monitoring Glycemic cHAracterization During Pregnancy in Comparison With OGTT (I-CHAP)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Maximum Age: 45
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Singapore
KK Women's and Children's Hospital
RECRUITING
Singapore
Contact Information
Primary
Phaik Ling, Elaine Quah, PhD
quah.phaik.ling@kkh.com.sg
65 97732543
Backup
Kok Hian Tan, MD
tan.kok.hian@singhealth.com.sg
65 63941099
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: KK Women's and Children's Hospital

This content was sourced from clinicaltrials.gov