No effect of the FitFor2 exercise programme on blood glucose, insulin sensitivity, and birthweight in pregnant women who were overweight and at risk for gestational diabetes: results of a randomised controlled trial

IntroductionReal-time continuous glucose monitoring (rt-CGM) informs users about current interstitial glucose levels and allows early detection of glycaemic excursions and timely adaptation by behavioural change or pharmacological intervention. Randomised controlled studies adequately powered to evaluate the impact of long-term application of rt-CGM systems on the reduction of adverse obstetric outcomes in women with gestational diabetes (GDM) are missing. We aim to assess differences in the proportion of large for gestational age newborns in women using rt-CGM as compared with women with self-monitored blood glucose (primary outcome). Rates of neonatal hypoglycaemia, caesarean section and shoulder dystocia are secondary outcomes. A comparison of glucose metabolism and quality of life during and after pregnancy completes the scope of this study.Methods and analysisOpen-label multicentre randomised controlled trial with two parallel groups including 372 female patients with a recent diagnosis of GDM (between 24+0 until 31+6 weeks of gestation): 186 with rt-CGM (Dexcom G6) and 186 with self-monitored blood glucose (SMBG). Women with GDM will be consecutively recruited and randomised to rt-CGM or control (SMBG) group after a run-in period of 6–8 days. The third visit will be scheduled 8–10 days later and then every 2 weeks. At every visit, glucose measurements will be evaluated and all patients will be treated according to the standard care. The control group will receive a blinded CGM for 10 days between the second and third visit and between week 36+0 and 38+6. Cord blood will be sampled immediately after delivery. 48 hours after delivery neonatal biometry and maternal glycosylated haemoglobin A1c (HbA1c) will be assessed, and between weeks 8 and 16 after delivery all patients receive a re-examination of glucose metabolism including blinded CGM for 8–10 days.Ethics and disseminationThis study received ethical approval from the main ethic committee in Vienna. Data will be presented at international conferences and published in peer-reviewed journals.Trial registration numberNCT03981328; Pre-results.

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Subsidy programme for gestational diabetes mellitus screening and lifestyle management in rural areas of western China: a study protocol for a multicentre randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-045503 ◽

2021 ◽

Vol 11 (7) ◽

pp. e045503

Author(s):

Tingting Xu ◽

Xiaozhen Lai ◽

Kun He ◽

Liangkun Ma ◽

Hai Fang

Keyword(s):

Diabetes Mellitus ◽

Randomised Controlled Trial ◽

Gestational Diabetes ◽

Gestational Diabetes Mellitus ◽

Pregnant Women ◽

Rural China ◽

Controlled Trial ◽

Lifestyle Management ◽

Subsidy Program ◽

Randomised Controlled

IntroductionGestational diabetes mellitus (GDM) has become an increasing health problem among pregnant women in western rural China. Insufficient compliance and motivation due to economic factors is one of the major contributors to the currently low GDM screening and management rate. A subsidy program offering GDM screening and lifestyle management might be an effective way to increase pregnant women’s awareness of GDM, and further improve maternal and neonatal health in western rural China. This study had two primary purposes: (1) to examine whether the subsidy program would increase the screening and management rates of GDM and reduce adverse complications for mothers and new-born babies and (2) to evaluate whether the subsidy program is cost-effective from a societal perspective.Methods and analysisThis randomised controlled trial will include 3000 pregnant women (at 24–28 weeks of pregnancy) who will be followed up at six hospitals in the provinces of Yunnan, Sichuan and Shaanxi in China. Pregnant women without overt diabetes, with a singleton pregnancy, with telephone access and with written informed consent will be invited. The intervention group will receive subsidies and standard care, and the control group will only receive usual antenatal care. The randomisation sequence will be stratified by study sites with balanced blocks of six patients. Data will be collected using self-report questionnaires and hospital records. Data will be analysed according to the intention-to-treat principle. The primary outcomes are the maternal and neonatal complications. Secondary outcomes are the mother’s cognition scores, screening rate, number of re-examinations, weight gain during pregnancy, changes in diet and exercise, and quality of life. Group comparisons will be conducted using χ2 test for categorical variables, and t-test or the Mann-Whitney-Wilcoxon test for continuous variables where applicable. Multiple logistic regression will also be performed for the primary outcomes.Ethics and disseminationThis study was approved by the Ethics Review Committee of Peking University Health Science Center. Findings will be disseminated through publication in peer-reviewed journals, seminars and national and international conferences.Trial registration numberChiCTR1800017488.

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Prevention of Gestational Diabetes in Pregnant Women with Obesity: Protocol for a Pilot Randomised Controlled Trial

10.21203/rs.3.rs-924115/v1 ◽

2021 ◽

Author(s):

Ola Quotah ◽

Glen Nishku ◽

Jessamine Hunt ◽

Paul T Seed ◽

Carolyn Gill ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Gestational Diabetes ◽

Risk Stratification ◽

Antenatal Care ◽

Pregnant Women ◽

Controlled Trial ◽

Lifestyle Advice ◽

Targeted Intervention ◽

Pilot Randomised Controlled Trial ◽

Randomised Controlled

Abstract BackgroundObesity in pregnancy increases the risk of gestational diabetes mellitus (GDM) and associated adverse outcomes. Despite metabolic differences, all pregnant women with obesity are considered to have the same risk of developing GDM. Improved risk stratification is required to enable targeted intervention in women with obesity who would benefit the most. The aim of this study is to identify pregnant women with obesity at higher risk of developing GDM and in a pilot randomised controlled trial (RCT), show efficacy of a lifestyle intervention and/or metformin to improve glycaemic control.MethodsWomen aged 18 years or older with a singleton pregnancy and body mass index (BMI) ≥30kg/m2 will be recruited from one maternity unit in London, UK. Risk of GDM will be assessed using a multivariable GDM prediction model combining maternal age, mid-arm circumference, systolic blood pressure, serum triglycerides and whole blood HbA1c. Women identified at higher risk of developing GDM will be randomly allocated to one of two intervention groups (lifestyle advice with or without metformin) or standard antenatal care. Primary outcome; reduction in mean glucose/24hr of 0.5mmol/l as assessed by continuous glucose monitoring. A sample of 60 high risk women is required.DiscussionEarly risk stratification of GDM in pregnant women with obesity and targeted intervention using lifestyle advice with or without metformin could improve glucose tolerance compared to standard antenatal care. If successful, an adequately powered RCT will be performed to investigate whether this strategy is effective in preventing GDM in women with obesity. Ethics and trial registrationThis study has been approved by the NHS Research Ethics Committee (UK IRAS integrated research application system; reference 18/LO/1500). EudraCT Number 2018-000003-16.

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