Study population and eligibility criteria
Eligible participants suitable for recruitment in this I-PROFILE study
included pregnant women in their first trimester of pregnancy between
December 2018 and November 2022. Participants were randomly divided into
two groups of a 1:1 ratio: The unblinded group received the Freestyle
Libre CGM sensor (Abbott Diabetes Care, Alameda, California, USA), and
the blinded study group received the Freestyle Libre Pro CGM sensor
(Abbott Diabetes Care, Alameda, California, USA). Inclusion criteria for
the study included: women of Chinese, Malay or Indian descent, aged 21
and above with singleton pregnancies. Exclusion criteria included:
patients with skin conditions such as, eczema which could potentially
affect compliance or those with pre-existing chronic diseases including,
kidney disease and pre-gestational diabetes.
Between December 2018 and November 2022, 931 patients were screened for
eligibility and 712 had to be excluded because of the following reasons:
1) did not meet the study inclusion criteria (n = 225) 2) declined study
participation (n = 469) 3) dropped out of the study before the
randomization (n = 8) 4) had a miscarriage and was no longer eligible to
participate (n = 10). Out of the n=219 participants who were randomized
into the two study arms, n=206 have completed the study (Figure 1).