Open Access
CC BY-NC-ND 4.0 · Am J Perinatol 2024; 41(S 01): e3374-e3382
DOI: 10.1055/s-0043-1778664
Original Article

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

Phaik Ling Quah
1   Division of Obstetrics and Gynaecology, Department of Obstetrics and Gynaecology, KK Women's and Children's Hospital, Singapore
,
Lay Kok Tan
2   Department of Maternal Fetal Medicine, KK Women's and Children's Hospital, Singapore
,
Ngee Lek
3   Department of Pediatrics, KK Women's and Children's Hospital, Singapore
4   Duke-NUS Medical School, Singapore
,
Shephali Tagore
2   Department of Maternal Fetal Medicine, KK Women's and Children's Hospital, Singapore
,
Bernard Su Min Chern
5   Minimally Invasive Surgery Unit, KK Women's and Children's Hospital, Singapore
,
Seng Bin Ang
6   Family Medicine Service/Menopause Unit, KK Women's and Children's Hospital, Singapore
,
Ann Wright
2   Department of Maternal Fetal Medicine, KK Women's and Children's Hospital, Singapore
,
Serene Pei Ting Thain
2   Department of Maternal Fetal Medicine, KK Women's and Children's Hospital, Singapore
,
Kok Hian Tan
1   Division of Obstetrics and Gynaecology, Department of Obstetrics and Gynaecology, KK Women's and Children's Hospital, Singapore
4   Duke-NUS Medical School, Singapore
› Institutsangaben
Funding This research was supported by the Integrated Platform for Research in Advancing Metabolic Health Outcomes in Women and Children (IPRAMHO)—Singapore Ministry of Health's National Medical Research Council Centre Grant NMRC/CG/C008A/2017_KKH.
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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.

Keywords

pregnancy - continuous glucose monitoring - gestational diabetes mellitus - pilot trial

Note

Date of registration: November 17, 2021


Date of initial participant enrolment: October 16, 2018


Clinical trial identification number: NCT05123248


URL of the registration site: https://clinicaltrials.gov/ct2/show/NCT05123248?term=I-Profile&draw=2&rank=1


Authors' Contributions

P.L.Q. contributed to the design of the study, the statistical analysis, and the writing of the manuscript. K.H.T., L.K.T., N. L., S.T., B.S.M.C., A.W., S.P.T.T., and S.B.A. contributed to the conceptualization of the study. K.H.T. was responsible for the funding acquisition for this study. P.L.Q., K.H.T., L.K.T., N.L., S.T., B.S.M.C., A.W., S.P.T.T., and S.B.A. were responsible for finalizing the manuscript. All authors contributed to and approved the final manuscript.


Supplementary Material



Publikationsverlauf

Eingereicht: 27. September 2023

Angenommen: 22. Oktober 2023

Artikel online veröffentlicht:
19. Januar 2024

© 2024. 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/)

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