A new continuous glucose monitor for the diagnosis of gestational diabetes mellitus: a pilot study

Daria Di Filippo; Amanda Henry; Chloe Bell; Sarah Haynes; Melissa Han Yiin Chang; Justine Darling; Alec Welsh

doi:10.1186/s12884-023-05496-7

A new continuous glucose monitor for the diagnosis of gestational diabetes mellitus: a pilot study

BMC Pregnancy Childbirth. 2023 Mar 18;23(1):186. doi: 10.1186/s12884-023-05496-7.

Authors

Daria Di Filippo¹, Amanda Henry^{1

2}, Chloe Bell¹, Sarah Haynes¹, Melissa Han Yiin Chang¹, Justine Darling³, Alec Welsh^{4

5}

Affiliations

¹ Discipline of Women's Health, School of Clinical Medicine, University of New South Wales Sydney, Locked Bag 2000, Barker Street, Randwick, NSW, 2031, Australia.
² Department of Women's and Children's Health, St George Hospital, Gray St, Kogarah, NSW, 2217, Australia.
³ Diabetes Clinic Royal Hospital for Women, Barker Street - Randwick, Randwick, NSW, 2031, Australia.
⁴ Discipline of Women's Health, School of Clinical Medicine, University of New South Wales Sydney, Locked Bag 2000, Barker Street, Randwick, NSW, 2031, Australia. alec.welsh@unsw.edu.au.
⁵ Department of Maternal-Fetal Medicine, Royal Hospital for Women, Barker Street - Randwick, Randwick, NSW, 2031, Australia. alec.welsh@unsw.edu.au.

Abstract

Background: Gestational Diabetes Mellitus (GDM) incidence and adverse outcomes have increased globally. The validity of the oral glucose tolerance test (OGTT) for GDM diagnosis has long been questioned, with no suitable substitute reported yet. Continuous Glucose Monitoring (CGM) is potentially a more acceptable and comprehensive test. The aim of this study was to assess the Freestyle Libre Pro 2 acceptability as a diagnostic test for GDM, then triangulating its results with OGTT results as well as risk factors and sonographic features of GDM.

Methods: Women wore the CGM device for 7 days at 24-28 weeks, undergoing the OGTT before CGM removal. CGM/OGTT acceptability as well as GDM risk factors evaluation occurred via three online surveys. CGM distribution/variability/time in range parameters, combined in a CGM Score of Variability (CGMSV), were triangulated with OGTT results and a risk-factor-based Total Risk Score (TRS). In a subgroup, GDM ultrasound features (as modified Ultrasound Gestational Diabetes Score - m-UGDS) were also incorporated.

Results: Of 107 women recruited, 87 (81%) were included: 74 (85%) with negative OGTT (NGT) and 13 (15%) positive (GDM). No significant difference was found between NGT and GDM in terms of demographics (apart from family history of diabetes mellitus), CGM parameters and perinatal outcomes. Women considered CGM significantly more acceptable than OGTT (81% versus 27% rating 5/5, p < 0.001). Of the 55 NGT with triangulation data, 28 were considered 'true negative' (TRS concordant with OGTT and CGMSV): of these 4/5 evaluated at ultrasound had m-UGDS below the cut-off. Five women were considered 'false negative' (negative OGTT with both TRS and CGMSV above the respective cut-offs). Triangulation identified also six 'false positive' women (positive OGTT but TRS and CGM both below the cut-offs). Only one woman for each of the last two categories had m-UGDS evaluated, with discordant results.

Conclusions: CGM represents a more acceptable alternative for GDM diagnosis to the OGTT. CGM triangulation analysis suggests OGTT screening may result in both false positives and negatives. Further research including larger cohorts of patients, and additional triangulation elements (such as GDM biomarkers/outcomes and expanded m-UGDS) is needed to explore CGM potential for GDM diagnosis.

Keywords: Continuous glucose monitoring; Diagnosis; Gestational diabetes mellitus; Oral glucose tolerance test.

MeSH terms

Blood Glucose
Blood Glucose Self-Monitoring
Diabetes, Gestational* / diagnosis
Diabetes, Gestational* / epidemiology
Female
Glucose Tolerance Test
Humans
Pilot Projects
Pregnancy

Substances

Blood Glucose