Continuous Glucose Monitoring Feedback in the Subsequent Development of Gestational Diabetes: A Pilot, Randomized, Controlled Trial in Pregnant Women

Phaik Ling Quah; Lay Kok Tan; Ngee Lek; Shephali Tagore; Bernard Su Min Chern; Seng Bin Ang; Ann Wright; Serene Pei Ting Thain; Kok Hian Tan

doi:10.1055/s-0043-1778664

Continuous Glucose Monitoring Feedback in the Subsequent Development of Gestational Diabetes: A Pilot, Randomized, Controlled Trial in Pregnant Women

Am J Perinatol. 2024 Jan 19. doi: 10.1055/s-0043-1778664. Online ahead of print.

Authors

Phaik Ling Quah¹, Lay Kok Tan², Ngee Lek^{3

4}, Shephali Tagore², Bernard Su Min Chern⁵, Seng Bin Ang⁶, Ann Wright², Serene Pei Ting Thain², Kok Hian Tan^{1

4}

Affiliations

¹ Division of Obstetrics and Gynaecology, Department of Obstetrics and Gynaecology, KK Women's and Children's Hospital, Singapore.
² Department of Maternal Fetal Medicine, KK Women's and Children's Hospital, Singapore.
³ Department of Pediatrics, KK Women's and Children's Hospital, Singapore.
⁴ Duke-NUS Medical School, Singapore.
⁵ Minimally Invasive Surgery Unit, KK Women's and Children's Hospital, Singapore.
⁶ Family Medicine Service/Menopause Unit, KK Women's and Children's Hospital, Singapore.

PMID: 38242163
DOI: 10.1055/s-0043-1778664

Abstract

Objective: This study evaluated the effects of receiving glucose feedback from continuous glucose monitoring (CGM) by intermittent scanning (unblinded group), and CGM with masked feedback (blinded group) in the subsequent development of gestational diabetes mellitus (GDM).

Study design: This was a prospective, single-center, pilot, randomized controlled trial including n = 206 pregnant women in the first trimester of pregnancy with no prior diagnosis of type 1 or type 2 diabetes. The participants were randomized into the unblinded group or blinded group and wore the CGM in the first trimester of pregnancy (9-13 weeks), the second trimester of pregnancy (18-23 weeks), and late-second to early-third trimester (24-31 weeks). The primary outcome was GDM rate as diagnosed by the 75-g oral glucose tolerance test (OGTT) at 24 to 28 weeks.

Results: Over 47 months, 206 pregnant women were enrolled at 9 to 13 weeks. The unblinded group had a higher prevalence of women who developed GDM (21.5 vs. 14.9%; p > 0.05), compared to the blinded group. In the unblinded group compared to the blinded group, plasma glucose values were higher at 1 hour (median 7.7 [interquartile range {IQR}: 6.3-9.2] vs. 7.5 [6.3-8.7]) and 2 hours (6.3 [5.8-7.7] vs. 6.2 [5.3-7.2]), but lower at 0 hour (4.2 [4.0-4.5] vs. 4.3 [4.1-4.6]; p > 0.05). All these differences were not statistically significant.

Conclusion: Glucose feedback from CGM wear in the first to the third trimester of pregnancy without personalized patient education failed to alter GDM rate.

Key points: · Continuous glucose monitoring (CGM) is feasible for use in pregnant women.. · No significant difference in gestational diabetes rates with or without CGM feedback.. · Future clinical trials should incorporate CGM education and personalized guidance to enhance study outcomes..

The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).