A culturally tailored personaliseD nutrition intErvention in South ASIan women at risk of Gestational Diabetes Mellitus (DESI-GDM): a randomised controlled trial protocol.

INTRODUCTION: South Asians are more likely to develop gestational diabetes mellitus (GDM) than white Europeans. Diet and lifestyle modifications may prevent GDM and reduce undesirable outcomes in both the mother and offspring. Our study seeks to evaluate the effectiveness and participant acceptability of a culturally tailored, personalised nutrition intervention on the glucose area under the curve (AUC) after a 2-hour 75 g oral glucose tolerance test (OGTT) in pregnant women of South Asian ancestry with GDM risk factors. METHODS AND ANALYSIS: A total of 190 South Asian pregnant women with at least 2 of the following GDM risk factors-prepregnancy body mass index>23, age>29, poor-quality diet, family history of type 2 diabetes in a first-degree relative or GDM in a previous pregnancy will be enrolled during gestational weeks 12-18, and randomly assigned in a 1:1 ratio to: (1) usual care, plus weekly text messages to encourage walking and paper handouts or (2) a personalised nutrition plan developed and delivered by a culturally congruent dietitian and health coach; and FitBit to track steps. The intervention lasts 6-16 weeks, depending on week of recruitment. The primary outcome is the glucose AUC from a three-sample 75 g OGTT 24-28 weeks' gestation. The secondary outcome is GDM diagnosis, based on Born-in-Bradford criteria (fasting glucose>5.2 mmol/L or 2 hours post load>7.2 mmol/L). ETHICS AND DISSEMINATION: The study has been approved by the Hamilton Integrated Research Ethics Board (HiREB #10942). Findings will be disseminated among academics and policy-makers through scientific publications along with community-orientated strategies. TRIAL REGISTRATION NUMBER: NCT03607799.

Prevalence of Hyperglycemia in Pregnancy and Related Screening Practices in Rural Dehradun: The First Population-Based Study from Uttarakhand (PGDRD-1).

Aims: Phase I of the Prevalence of Gestational Diabetes Mellitus in Rural Dehradun (PGDRD) project estimates hyperglycemia in pregnancy (HIP) prevalence and identifies gaps in the utilization of community-related services in rural areas of the Dehradun district (western Uttarakhand); a state where notably no prior population-based study has ever been conducted despite being an Empowered Action Group state for more than two decades. Methods: Using a multistage random sampling technique, 1,223 pregnant women locally registered in the rural field practice area of a block were identified. Those requiring HIP screening were subjected to a 2-h 75 g oral glucose tolerance test during the house visit irrespective of their period-of-gestation and last meal timings, diagnosed using the Diabetes in Pregnancy Study Group India (DIPSI) criterion (when indicated). Data were collected by personal interviews using a pretested data collection tool. Statistical Package for Social Sciences version 20.0 was used for analysis. Results: The overall HIP prevalence recorded was 9.7% (95% CI: 8.1-11.5%); the majority (95.8%) were GDM followed by overt DIP (4.2%). Less than 1% of the subjects (0.7%) self-reported pre-GDM. Despite this burden, more than three-fourths were never screened for HIP in their pregnancy. Of those tested, the majority availed secondary healthcare facilities. Few even had to bear expenses in private with a very handful being tested free-of-cost by ANM in the community; findings that altogether sharply contrast to those recommended by national protocols. Conclusion: Despite the high HIP burden, beneficiaries are unable to utilize community-related universal screening protocols as desired.

Maternal glucose levels and future risk of developing cardiovascular disease: a systematic review and meta-analysis protocol.

INTRODUCTION: Hyperglycaemia during pregnancy has been considered as one of the risk factors for cardiovascular diseases (CVDs) among women. Although the evidence regarding the association between gestational diabetes mellitus (GDM) and subsequent CVD has been synthesised, there are no systematic reviews covering the evidence of the association among the non-GDM population. This systematic review and meta-analysis, therefore, aim to fill the gap by summarising existing evidence on the association between maternal glucose levels and the risk of future CVD in pregnant women with or without a diagnosis of GDM. METHODS AND ANALYSIS: This systematic review protocol was reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols guidelines. Comprehensive literature searches were performed in the following electronic databases: MEDLINE, EMBASE and CINAHL to identify relevant papers from inception to 31 December 2022. All observational studies (case-control studies, cohort studies and cross-sectional studies) will be included. Two reviewers will perform the abstract and full-text screening based on the eligibility criteria through Covidence. The Newcastle-Ottawa Scale will be used to assess the methodological quality of included studies. Statistical heterogeneity will be assessed by using the I2 test and Cochrane's Q test. If the included studies are found to be homogeneous, pooled estimates will be calculated and meta-analysis will be performed using Review Manager 5 (RevMan) software. Random effects will be used to determine weights for meta-analysis, if needed. Pre-specified subgroup analysis and sensitivity analysis will be performed, if needed. The study results will be presented in the sequence of main outcomes, secondary outcomes and important subgroup analysis for each type of glucose level separately. ETHICS AND DISSEMINATION: Given no original data will be collected, ethics approval is not applicable for this review. The results of this review will be disseminated by publication and conference presentation. PROSPERO REGISTRATION NUMBER: CRD42022363037.

Study protocol on risk factors for the diagnosis of gestational diabetes mellitus in different trimesters and their relation to maternal and neonatal outcomes (GDM-RIDMAN).

INTRODUCTION: Gestational diabetes mellitus (GDM) is often associated with adverse pregnancy outcomes. However, the association of risk factors with GDM diagnosis, maternal and neonatal health outcomes is less established when compared with women without GDM. We aim to examine the diagnostic accuracy of the conventional and novel risk factors for a GDM diagnosis and their impact on maternal and neonatal health outcomes. METHODS AND ANALYSIS: This retrospective cohort and nested case-control study at six public health clinics is based on medical records and questionnaire survey of women between 2 and 12 months postpartum. The estimated required sample size is 876 complete records (292 cases, 584 control, at a ratio of 1:2). Oral glucose tolerance test results will be used to identify glucose dysregulation, and maternal and neonatal outcomes include maternal weight gain, pre-eclampsia, polyhydramnios, mode of delivery, preterm or postdate birth, complications in labour, birth weight, gestational age at birth, Apgar score, congenital anomaly, congenital hypothyroidism, neonatal death or stillbirth, hypoglycaemia and hyperbilirubinaemia. Psychosocial measures include the WHO Quality of Life: brief, mother-infant bonding (14-item Postpartum Bonding Questionnaire and 19-item Maternal Postnatal Attachment Scale), anxiety (7-item Generalised Anxiety Disorder), depression (9-item Patient Health Questionnaire) and stress (Perceived Stress Scale symptoms) questionnaires. The comparative incidences of maternal and neonatal health outcomes, the comparative prevalence of the psychosocial outcomes between women with GDM and without GDM, specificity, sensitivity, positive and negative predictive values of the risk factors, separately and combined, will be reported. All GDM risk factors and outcomes will be modelled using multivariable regression analysis and the receiver operating characteristics curve will be reported. ETHICS AND DISSEMINATION: This study was approved by the Malaysia Research and Ethics Committee, Ministry of Health Malaysia. Informed consent will be obtained from all participants. Findings will be submitted for publications in scientific journals.

Benefits of the addition of continuous or flash glucose monitoring versus standard practice using self-monitored blood glucose and haemoglobin A1c in the primary care of diabetes mellitus: a systematic review protocol.

INTRODUCTION: Studies demonstrate that optimal glycaemic control reduces morbidity from diabetes mellitus but remains elusive in a significant portion of patients. Although research shows that continuous glucose monitoring (CGM) and flash glucose monitoring (FGM) improves glycaemic control in selected subsets of patients with diabetes in specialty practices, we found no systematic reviews evaluating the use of CGM/FGM in primary care, where the majority of patients with diabetes are cared for.This systematic review aims to answer the questions: 'compared with usual care of self-monitoring blood glucose and haemoglobin A1c (HbA1c), does the addition of CGM/FGM use in the primary care of patients with diabetes improve glycaemic control, decrease rates of hypoglycaemia, and improve patient and physician satisfaction?' and if so, 'what subgroups of primary care patients with diabetes are most likely to benefit?'. METHODS AND ANALYSIS: Aligning with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines, a search will be conducted in PubMed, EMBASE, Scopus, CINAHL, Cochrane Central Register of Controlled Trials and Web of Science. We will include studies investigating CGM/FGM use and reporting the primary outcome measure of HbA1c and secondary outcome measures of hypoglycaemia, time in range, time below range, time above range and patient/staff satisfaction. We will examine which patient populations appear to benefit from CGM/FGM. Three independent researchers will use the Covidence systematic review software for blinded screening and study selection. The National Heart, Lung, and Blood Institute quality assessment tool and Grading of Recommendations Assessment, Development and Evaluation will be used to assess the risk of bias and quality of evidence. ETHICS AND DISSEMINATION: The systematic review methodology does not require ethics approval due to the nature of the study design. Study findings will be publicly available to a wide readership across disciplines and will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42021229416.

Limiting the Use of Oral Glucose Tolerance Tests to Screen for Hyperglycemia in Pregnancy during Pandemics.

We aimed to evaluate each proposal of Australian-New Zealand Societies to limit the number of oral glucose tolerance tests (OGTTs) to diagnose hyperglycemia in pregnancy (HIP) during the coronavirus disease 2019 (COVID-19) pandemic. At our university hospital (2012-2016), we retrospectively applied in 4245 women who had OGTT between 22 and 30 weeks of gestation (reference standard: WHO criteria) the proposals in which OGTT is performed only in high-risk women; in all (Option 1) or high-risk (Option 1-Sel) women with fasting plasma glucose (FPG) 4.7-5.0 mmol/L; in all (Option 2) or high-risk (Option 2-Sel) women without history of HIP and with FPG 4.7-5.0 mmol/L. We also tested FPG measurement alone in all high-risk women. Measuring FPG alone had a sensitivity of 49% (95% confidence interval 45-54) applying universal screening. Option 2 appeared to have the best balance considering the needed OGTT (17.3%), sensitivity (72% (67-76)) and rates of a composite outcome (true negative cases: 10.6%, false positive cases: 24.4%; true positive cases: 19.5%; false negative cases: 10.2%). Consideration of a history of HIP and measuring first FPG can avoid more than 80% of OGTTs and identify women with the highest risk of adverse HIP-related events.