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

被引:13
作者
Di Filippo, Daria [1 ]
Henry, Amanda [1 ,2 ]
Bell, Chloe [1 ]
Haynes, Sarah [1 ]
Chang, Melissa Han Yiin [1 ]
Darling, Justine [3 ]
Welsh, Alec [1 ,4 ]
机构
[1] Univ New South Wales Sydney, Sch Clin Med, Discipline Womens Hlth, Locked Bag 2000,Barker St, Randwick, NSW 2031, Australia
[2] St George Hosp, Dept Womens & Childrens Hlth, Gray St, Kogarah, NSW 2217, Australia
[3] Diabet Clin Royal Hosp Women, Barker St Randwick, Randwick, NSW 2031, Australia
[4] Royal Hosp Women, Dept Maternal Fetal Med, Barker St Randwick, Randwick, NSW 2031, Australia
关键词
Gestational diabetes mellitus; Oral glucose tolerance test; Diagnosis; Continuous glucose monitoring;
D O I
10.1186/s12884-023-05496-7
中图分类号
R71 [妇产科学];
学科分类号
100211 ;
摘要
BackgroundGestational 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.MethodsWomen 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.ResultsOf 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.ConclusionsCGM 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.
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页数:10
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