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).