SummaryBackgroundPregnant women with type 1 diabetes are a high-risk population who are recommended to strive for optimal glucose control, but neonatal outcomes attributed to maternal hyperglycaemia remain suboptimal. Our aim was to examine the effectiveness of continuous glucose monitoring (CGM) on maternal glucose control and obstetric and neonatal health outcomes.MethodsIn this multicentre, open-label, randomised controlled trial, we recruited women aged 18–40 years with type 1 diabetes for a minimum of 12 months who were receiving intensive insulin therapy. Participants were pregnant (≤13 weeks and 6 days' gestation) or planning pregnancy from 31 hospitals in Canada, England, Scotland, Spain, Italy, Ireland, and the USA. We ran two trials in parallel for pregnant participants and for participants planning pregnancy. In both trials, participants were randomly assigned to either CGM in addition to capillary glucose monitoring or capillary glucose monitoring alone. Randomisation was stratified by insulin delivery (pump or injections) and baseline glycated haemoglobin (HbA1c). The primary outcome was change in HbA1c from randomisation to 34 weeks' gestation in pregnant women and to 24 weeks or conception in women planning pregnancy, and was assessed in all randomised participants with baseline assessments. Secondary outcomes included obstetric and neonatal health outcomes, assessed with all available data without imputation. This trial is registered with ClinicalTrials.gov, number NCT01788527.FindingsBetween March 25, 2013, and March 22, 2016, we randomly assigned 325 women (215 pregnant, 110 planning pregnancy) to capillary glucose monitoring with CGM (108 pregnant and 53 planning pregnancy) or without (107 pregnant and 57 planning pregnancy). We found a small difference in HbA1c in pregnant women using CGM (mean difference −0·19%; 95% CI −0·34 to −0·03; p=0·0207). Pregnant CGM users spent more time in target (68% vs 61%; p=0·0034) and less time hyperglycaemic (27% vs 32%; p=0·0279) than did pregnant control participants, with comparable severe hypoglycaemia episodes (18 CGM and 21 control) and time spent hypoglycaemic (3% vs 4%; p=0·10). Neonatal health outcomes were significantly improved, with lower incidence of large for gestational age (odds ratio 0·51, 95% CI 0·28 to 0·90; p=0·0210), fewer neonatal intensive care admissions lasting more than 24 h (0·48; 0·26 to 0·86; p=0·0157), fewer incidences of neonatal hypoglycaemia (0·45; 0·22 to 0·89; p=0·0250), and 1-day shorter length of hospital stay (p=0·0091). We found no apparent benefit of CGM in women planning pregnancy. Adverse events occurred in 51 (48%) of CGM participants and 43 (40%) of control participants in the pregnancy trial, and in 12 (27%) of CGM participants and 21 (37%) of control participants in the planning pregnancy trial. Serious adverse events occurred in 13 (6%) participants in the pregnancy trial (eight [7%] CGM, five [5%] control) and in three (3%) participants in the planning pregnancy trial (two [4%] CGM and one [2%] control). The most...

BackgroundGestational diabetes mellitus (GDM) is an increasingly common condition of pregnancy. It is associated with adverse fetal, infant and maternal outcomes, as well as an increased risk of GDM in future pregnancies and type 2 diabetes for both mother and offspring. Previous studies have shown that GDM can result in an emotionally distressing pregnancy, but there is little research on the patient experience of GDM care, especially of a demographically diverse UK population. The aim of this research was to explore the experiences of GDM and GDM care for a group of women attending a large diabetes pregnancy unit in southeast London, UK, in order to improve care.MethodsFramework analysis was used to support an integrated analysis of data from six focus groups with 35 women and semi-structured interviews with 15 women, held in 2015. Participants were purposively sampled and were representative of the population being studied in terms of ethnicity, age, deprivation score and body mass index (BMI).ResultsWe identified seven themes: the disrupted pregnancy, projected anxiety, reproductive asceticism, women as baby machines, perceived stigma, lack of shared understanding and postpartum abandonment. These themes highlight the often distressing experience of GDM. While most women were grateful for the intensive support they received during pregnancy, the costs to their personal autonomy were high. Women described feeling valued solely as a means to produce a healthy infant, and felt chastised if they failed to adhere to the behaviours required to achieve this. This sometimes had an enduring impact to the potential detriment of women’s long-term psychological and physical health.ConclusionsThis study reveals the experiences of a demographically diverse group of patients with GDM, reflecting findings from previous studies globally and extending analysis to the context of improving care. Healthcare delivery may need to be reoriented to improve the pregnancy experience and help ensure women are engaged and attentive to their own health, particularly after birth, without compromising clinical pregnancy outcomes. Areas for consideration in GDM healthcare include: improved management of emotional responses to GDM; a more motivational approach; rethinking the medicalisation of care; and improved postpartum care.Electronic supplementary materialThe online version of this article (10.1186/s12884-018-1657-9) contains supplementary material, which is available to authorized users.

Insulin resistance and the metabolic syndrome are increased in adult patients with BBS compared with matched control subjects. Increased subclinical hypothyroidism in the BBS cohort needs further investigation.

This study identified some common drivers that may regulate the health behaviours of women following GDM, and recognized some ways to improve care to impact on this. Interventions for diabetes prevention in this population need to address factors at both the individual and systemic levels.