MedTrace Logo

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

NCT05123248 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2024-10-10

No results posted yet for this study

Summary

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.

Conditions

  • Gestational Diabetes
  • Pregnancy

Interventions

DEVICE

Blinded Group

Participants in the blinded group will be wearing the sensor for 14 days without a reader. Glucose levels will be recorded from the interstitial fluid every 15 minutes using intermittent/ flash glucose scanning. After 14 days, participants are required to scan the sensor themselves or with the assistance of a CRC to a designated blinded-reader.

DEVICE

Unblinded group

Participants in the non-blinded group are required to wear the CGM sensor for 14 days with an open reader. Glucose levels will be recorded from the interstitial fluid every 15 minutes using intermittent/ flash glucose scanning. The participant will be required to upload their glucose readings no longer than 8 hours by scanning the reader provided.

Sponsors & Collaborators

  • KK Women's and Children's Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • Singapore

Study Locations

More Related Trials

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 NCT05123248 on ClinicalTrials.gov