NCT05123248: I-Profile

Integrating the Use of Calibration-Free Continuous Monitoring for Pregnancy Glucose Profiling: I-Profile Study

Completed NA Last updated 10 October 2024

What this trial tests

NA trial testing Blinded Group in Gestational Diabetes in 240 participants. Completed in 31 August 2024.

Timeline

16 October 2018

Primary endpoint
31 August 2024

31 August 2024

Quick facts

Lead sponsor	KK Women's and Children's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	240
Start date	16 October 2018
Primary completion	31 August 2024
Estimated completion	31 August 2024
Sites	1 location across Singapore

Drugs / interventions tested

• Blinded Group
• Unblinded group

Conditions studied

• Gestational Diabetes — all drugs for Gestational Diabetes →
• Pregnancy — all drugs for Pregnancy →

Sponsor

KK Women's and Children's Hospital

Who can join

Adults 21 to 65, female only, with Gestational Diabetes or Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to test the following hypotheses in a longitudinal, observational study in pregnant women who will be randomized to received either a Blinded or Unblinded CGM sensor and followed-up 6-12 weeks after delivery:

1. CF-CGM device is well tolerable and accurate for glucose level monitoring in women with a normal pregnancy.
2. CF-CGM device is well tolerable and acceptable in women with GDM who are required intensive glucose monitoring on a daily basis during pregnancy and even after delivery.
3. There are trimester-specific glucose profiles observed in the whole pregnancy.
4. Pregnancies complicated with GDM would show a specific glucose profile that is different from non-GDM pregnancies (e.g. greater daily fluctuations, more episodes and longer duration of glucose spikes after meal).
5. There is a good correlation between one-day glucose profile and OGTT test at 24-31 weeks gestation GDM screening.
6. Pre-GDM screening glucose profiles is predictive of GDM diagnosis at 24-31 weeks gestation.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Glycemic Variability in Early Pregnancy May Predict a Subsequent Diagnosis of Gestational Diabetes.
   Quah PL, Tan LK, Lek N, Thain S, et al · · 2022 · cited 9× · PMID 36597491 · DOI 10.2147/dmso.s379616
2. First Trimester Mean Glucose Level on Continuous Glucose Monitoring Is Associated with Infant Birth Weight.
   Quah PL, Tan LK, Thain SPT, Lek N, et al · · 2025 · cited 1× · PMID 40452210 · DOI 10.4093/dmj.2024.0700