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

NACompletedINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

October 16, 2018

Primary Completion Date

August 31, 2024

Study Completion Date

August 31, 2024

Conditions
Gestational DiabetesPregnancy
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.

Trial Locations (1)

229899

KK Women's and Children's Hospital, Singapore

All Listed Sponsors
lead

KK Women's and Children's Hospital

OTHER_GOV

NCT05123248 - Integrating the Use of Calibration-Free Continuous Monitoring for Pregnancy Glucose Profiling: I-Profile Study | Biotech Hunter | Biotech Hunter