Study design
The Integrating the Use of
Calibration-Free Continuous Monitoring for Pregnancy Glucose Profiling
(I-PROFILE) study was a prospective, single-center, randomized
controlled trial conducted at the Department of Obstetrics and
Gynaecology, KK Women’s and Children’s Hospital, a major public hospital
in Singapore. The study was approved by the Sing Health Centralised
Institutional Review Board (reference number 2018/2128). All
participants gave written informed consent in accordance with the
Declaration of Helsinki. Protocol details are available at
ClinicalTrial.gov (clinical trial reg. no. NCT05123248) and summarized
below. The data that support the findings from this study are available
from the corresponding author upon request. CONSORT reporting guidelines
were used in the reporting of the study findings 17.