METHODS
The Integrating the Use of
Calibration-Free Continuous Monitoring for Pregnancy Glucose Profiling
(I-PROFILE) study recruited 118 pregnant Singapore citizens or permanent
residents in their first trimester of pregnancy between December 2018
and April 2021. This longitudinal, observational study was conducted in
KK Women’s and Children’s Hospital which is a major public hospital in
Singapore. Inclusion criteria included women of Chinese, Malay or Indian
descent, aged 21 and above with singleton pregnancies. Persons with
serious skin conditions (e.g., eczema) that might interfere with the
compliance to the study, or those with pre-existing chronic diseases
(e.g., kidney disease, Type 1 or Type 2 diabetes) were excluded from
participation. 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.
In the first trimester and second trimester, there were 51 and 44
pregnant women with complete continuous glucose monitoring (CGM) data
and gestational diabetes mellitus (GDM) outcomes, respectively (Figure
1). A subset of n=43 with complete CGM data at both time points were
used for sensitivity analyses.