Oral glucose tolerance test and continuous glucose monitoring for gestational diabetes diagnosis: a survey study of women and health care professionals.

AIMS: The oral glucose tolerance test (OGTT), used for gestational diabetes mellitus (GDM) diagnosis for over 65 years, has poor acceptability and tolerability. Continuous glucose monitoring is being considered as potential alternative. The aim of our study was to formally assess women's and health care professionals' perception of both tests as diagnostic tools for GDM. METHODS: Participants in a pilot study on continuous glucose monitoring for GDM diagnosis were invited to fill two questionnaires, each of 6 Likert-scale and one optional open-ended question. A range of healthcare practitioners were also invited to fill a questionnaire of 13 Likert-scale and 7 optional open-ended questions. RESULTS: Sixty women completed the OGTT and 70 the continuous glucose monitoring questionnaire. OGTT was reported as poorly acceptable. Continuous glucose monitoring was described as significantly more tolerable (81% vs 27% 5/5 general acceptability rate, p < 0.001); ninety-three percent of the participants would recommend it for GDM diagnosis. Thirty health care professionals completed the survey. Most of them (73%) had confidence in OGTT as a diagnostic test for GDM with 66% raising some concerns. Doubts on continuous glucose monitoring were raised in terms of costs, accessibility and accuracy for GDM diagnosis due to "lack of evidence". CONCLUSIONS: Continuous glucose monitoring was substantially better tolerated for women than OGTT. Current lack of evidence for diagnostic accuracy for GDM underlines the need for studies on correlation between continuous glucose monitoring parameters and pregnancy outcomes to strengthen evidence for its use as diagnostic test for GDM.

Non-Invasive Glucose Sensing Technologies and Products: A Comprehensive Review for Researchers and Clinicians.

Diabetes Mellitus incidence and its negative outcomes have dramatically increased worldwide and are expected to further increase in the future due to a combination of environmental and social factors. Several methods of measuring glucose concentration in various body compartments have been described in the literature over the years. Continuous advances in technology open the road to novel measuring methods and innovative measurement sites. The aim of this comprehensive review is to report all the methods and products for non-invasive glucose measurement described in the literature over the past five years that have been tested on both human subjects/samples and tissue models. A literature review was performed in the MDPI database, with 243 articles reviewed and 124 included in a narrative summary. Different comparisons of techniques focused on the mechanism of action, measurement site, and machine learning application, outlining the main advantages and disadvantages described/expected so far. This review represents a comprehensive guide for clinicians and industrial designers to sum the most recent results in non-invasive glucose sensing techniques' research and production to aid the progress in this promising field.

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

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.

Continuous Glucose Monitoring for the Diagnosis of Gestational Diabetes Mellitus: A Pilot Study.

Background: Gestational diabetes mellitus (GDM) is diabetes first diagnosed in pregnancy. GDM, together with its short- and long-term negative outcomes, is increasing in incidence all over the world. The current diagnostic method for GDM, the oral glucose tolerance test (OGTT), is dated and has been reported as inconvenient for women as well as poorly reproducible and reliable. Aims: We aimed at assessing the acceptability, feasibility, and accuracy of continuous glucose monitoring (CGM) as a diagnostic test for GDM and explore its correlation with the OGTT and risk factors for GDM. Methods: In this prospective cohort study, pregnant women due for or having completed OGTT underwent CGM for seven days, performing daily finger-prick blood glucose levels before completing an acceptability questionnaire. Data on GDM risk factors and CGM variability were analyzed and compared with OGTT results. Results: Seventy-three women completed CGM (40 GDM, 33 normal glucose tolerances); 34 concurrently underwent OGTT. CGM was acceptable and generally well-tolerated, with skin irritation/itchiness the only adverse event (11 mild, one severe). CGM and OGTT strongly correlated for fasting glucose values (r = 0.86, p < 0.05) only. Triangulating GDM risk factors, OGTT results and CGM variability parameters with the application of machine learning highlighted the possibility of unmasking false positive (11 showed low CGM variability and demographic risks but positive OGTT) and false-negative OGTT diagnoses (1 showed high CGM variability and demographic risks but negative OGTT). Conclusions: CGM was well-tolerated, showing poorer glycaemic control in GDM, and revealing potential misdiagnosis of the OGTT when combined with GDM risk factors. Future research is needed to determine cut-off values for CGM-defined and OGTT-independent screening criteria for GDM.

Development and evaluation of an online questionnaire to identify women at high and low risk of developing gestational diabetes mellitus.

BACKGROUND: Established risk factors for Gestational Diabetes Mellitus (GDM) include age, ethnicity, family history of diabetes and previous GDM. Additional significant influences have recently been demonstrated in the literature. The oral glucose tolerance test (OGTT) used for GDM diagnosis has sub-optimal sensitivity and specificity, thus often results in GDM misdiagnoses. Comprehensive screening of risk factors may allow more targeted monitoring and more accurate diagnoses, preventing the devastating consequences of untreated or misdiagnosed GDM. We aimed to develop a comprehensive online questionnaire of GDM risk factors and triangulate it with the OGTT and continuous glucose monitoring (CGM) parameters to better evaluate GDM risk and diagnosis. METHODS: Pregnant women participating in two studies on the use of CGM for GDM were invited to complete the online questionnaire. A risk score, based on published literature, was calculated for each participant response and compared with the OGTT result. A total risk score (TRS) was then calculated as a normalised sum of all risk factors. Triangulation of OGTT, TRS and CGM score of variability (CGMSV) was analysed to expand evaluation of OGTT results. RESULTS: Fifty one women completed the questionnaire; 29 were identified as 'high-risk' for GDM. High-risk ethnic background (p < 0.01), advanced age, a family diabetic history (p < 0.05) were associated with a positive OGTT result. The triangulation analysis (n = 45) revealed six (13%) probable misdiagnoses (both TRS and CGMSV discordant with OGTT), consisting of one probable false positive and five probable false negative by OGTT results. CONCLUSIONS: This study identified pregnant women at high risk of developing GDM based on an extended evaluation of risk factors. Triangulation of TRS, OGTT and CGMSV suggested potential misdiagnoses of the OGTT. Future studies to explore the correlation between TRS, CGMSV and pregnancy outcomes as well as additional GDM pregnancy biomarkers and outcomes to efficiently evaluate OGTT results are needed.

The diagnostic indicators of gestational diabetes mellitus from second trimester to birth: a systematic review.

BACKGROUND: Gestational diabetes mellitus (GDM) is glucose intolerance first recognised during pregnancy. Both modalities and thresholds of the GDM diagnostic test, the Oral Glucose Tolerance Test (OGTT), have varied widely over time and among countries. Additionally, OGTT limitations include inconsistency, poor patient tolerability, and questionable diagnostic reliability. Many biological parameters have been reported to be modified by GDM and could potentially be used as diagnostic indicators. This study aimed to 1) systematically explore biomarkers reported in the literature as differentiating GDM from healthy pregnancies 2) screen those indicators assessed against OGTT to propose OGTT alternatives. MAIN BODY: A systematic review of GDM diagnostic indicators was performed according to PRISMA guidelines (PROSPERO registration CRD42020145499). Inclusion criteria were full-text, comprehensible English-language articles published January 2009-January 2021, where a biomarker (from blood, ultrasound, amniotic fluid, placenta) was compared between GDM and normal glucose tolerance (NGT) women from the second trimester onward to immediately postpartum. GDM diagnostic method had to be clearly specified, and the number of patients per study higher than 30 in total or 15 per group. Results were synthesised by biomarkers. RESULTS: Of 13,133 studies identified in initial screening, 174 studies (135,801 participants) were included. One hundred and twenty-nine studies described blood analytes, one amniotic fluid analytes, 27 ultrasound features, 17 post-natal features. Among the biomarkers evaluated in exploratory studies, Adiponectin, AFABP, Betatrophin, CRP, Cystatin-C, Delta-Neutrophil Index, GGT, TNF-A were those demonstrating statistically and clinically significant differences in substantial cohorts of patients (> 500). Regarding biomarkers assessed versus OGTT (i.e. potential OGTT alternatives) most promising were Leptin > 48.5 ng/ml, Ficolin3/adiponectin ratio ≥ 1.06, Chemerin/FABP > 0.71, and Ultrasound Gestational Diabetes Score > 4. These all demonstrated sensitivity and specificity > 80% in adequate sample sizes (> / = 100). CONCLUSIONS: Numerous biomarkers may differentiate GDM from normoglycaemic pregnancy. Given the limitations of the OGTT and the lack of a gold standard for GDM diagnosis, advanced phase studies are needed to triangulate the most promising biomarkers. Further studies are also recommended to assess the sensitivity and specificity of promising biomarkers not yet assessed against OGTT. TRIAL REGISTRATION: PROSPERO registration number CRD42020145499.

Fetal abdominal wall defects in an Australian tertiary setting: contemporary characteristics, ultrasound accuracy, and outcome.

PURPOSE: In this study, we aimed to comprehensively evaluate risk factors, ultrasound estimation of fetal weight, prenatal management, and pregnancy outcomes of gastroschisis and omphalocele at a metropolitan Australian hospital. MATERIAL AND METHODS: This was a retrospective single-center cohort study from 2006 to 2014 at a tertiary hospital with colocated neonatal surgical facilities. Demographic, pregnancy, ultrasound, birth and neonatal data were compared between gastroschisis and omphalocele. Correlation between routine (Hadlock 1 &2) and specific (Siemer) estimated fetal weight (EFW) estimation formulae with birth weight (BW) was made for those 50 gastroschisis cases with ≥2 third trimester scans and last scan ≤2 weeks prior to birth. RESULTS: There were 126 abdominal wall defects: 83 gastroschisis and 43 omphalocele. Consistent with international literature, the average maternal age was lower for gastroschisis and rates of smoking higher, while there were more intrauterine deaths and pregnancy terminations in omphalocele. Gastroschisis mothers were more likely living outside Sydney, had more infections in pregnancy and were followed with a larger number of antenatal visits, with a shorter period from the last visit to birth. In omphalocele pregnancies, amniocentesis was more likely performed, with more abnormal results than in gastroschisis fetuses. All EFW formulae had a good correlation between Z score for the last US and actual BW (ICC 0.693-0.815), with Hadlock 2 being the best. Siemer formula had the best correlation from first to the last scan. Gastroschisis newborns were born earlier (36.8 versus 38.2 wks p = .001), with smaller birthweight (2.52 versus 3.03 kg, p < .001), a longer request of intensive care (central line, parenteral nutrition, intubation) and second surgery, along with more multisystem complications (average 1.5 versus 0.7, p = .004) and a longer hospital stay (58.8 versus 36.8 d, p < .001). CONCLUSION: Demographic, antenatal, and pregnancy outcome data for abdominal wall defects correlated well with the international literature. Hadlock 1-2 gave the most consistent EFW estimate, with all formulae showing good correlation.

Guidelines for Pregnancy Management During the COVID-19 Pandemic: A Public Health Conundrum.

Pregnant women seem to be at risk for developing complications from COVID-19. Given the limited knowledge about the impact of COVID-19 on pregnancy, management guidelines are fundamental. Our aim was to examine the obstetrics guidelines released from December 2019 to April 2020 to compare their recommendations and to assess how useful they could be to maternal health workers. We reviewed 11 guidelines on obstetrics management, assessing four domains: (1) timeliness: the time between the declaration of pandemics by WHO and a guideline release and update; (2) accessibility: the readiness to access a guideline by searching it on a common browser; (3) completeness: the amount of foundational topics covered; and (4) consistency: the agreement among different guidelines. In terms of timeliness, the Royal College of Obstetricians and Gynaecologists (RCOG) was the first organization to release their recommendation. Only four guidelines were accessible with one click, while only 6/11 guidelines covered more than 80% of the 30 foundational topics we identified. For consistency, the study highlights the existence of 10 points of conflict among the recommendations. The present research revealed a lack of uniformity and consistency, resulting in potentially challenging decisions for healthcare providers.

Bimanual examination for clot evacuation: a retrospective cohort study of women with postpartum haemorrhage after vaginal delivery.

BACKGROUND: Bimanual clot evacuation (BCE) is a simple clinical manoeuvre that may reduce need for surgical intervention in the management of severe postpartum haemorrhage (PPH). We sought to determine whether performing BCE in cases of severe PPH after vaginal birth reduces the need for surgical intervention. METHODS: A retrospective chart review of women who delivered vaginally with a severe PPH between January 1, 2011 and December 31, 2014 in a single tertiary women's hospital in Sydney, Australia was conducted. Severe PPH was classified as a blood loss ≥1000mls. The need for surgical management (including operating theatre uterine exploration or evacuation, intrauterine balloon tamponade, repair of significant trauma, uterine or internal iliac artery ligation, B-Lynch suture insertion or hysterectomy) was the primary outcome measure, as expressed by need for operating theatre utilisation. RESULTS: From a cohort of 438, 149 women (34.0%) had BCE, of whom 29 (19.5%) required surgical management compared to 103 of 289 women with no BCE (35.6%); an odds ratio (OR) of 0.38 for BCE (confidence interval 0.20-0.72; p = 0.003). Early BCE (< 1 h of delivery) was associated with a further reduction in surgery (OR 0.24; confidence interval 0.08-0.70; p = 0.009) compared to late BCE (> 1 h of delivery). There was no reduction in estimated blood loss (p = 0.86) or blood transfusion (p = 0.71) with BCE. CONCLUSION: Our study suggests BCE reduces theatre utilisation in the context of severe PPH following vaginal delivery. Prospective trials are needed to determine whether BCE should be endorsed as a treatment modality for PPH post-vaginal delivery.