Addition of intermittently scanned continuous glucose monitoring to standard care in a cohort of pregnant women with type 1 diabetes: effect on glycaemic control and pregnancy outcomes.

AIMS/HYPOTHESIS: The aim of this study was to assess whether the addition of intermittently scanned continuous glucose monitoring (isCGM) to standard care (self-monitoring of blood glucose [SMBG] alone) improves glycaemic control and pregnancy outcomes in women with type 1 diabetes and multiple daily injections. METHODS: This was a multicentre observational cohort study of 300 pregnant women with type 1 diabetes in Spain, including 168 women using SMBG (standard care) and 132 women using isCGM in addition to standard care. In addition to HbA1c, the time in range (TIR), time below range (TBR) and time above range (TAR) with regard to the pregnancy glucose target range (3.5-7.8 mmol/l) were also evaluated in women using isCGM. Logistic regression models were performed for adverse pregnancy outcomes adjusted for baseline maternal characteristics and centre. RESULTS: The isCGM group had a lower median HbA1c in the second trimester than the SMBG group (41.0 [IQR 35.5-46.4] vs 43.2 [IQR 37.7-47.5] mmol/mol, 5.9% [IQR 5.4-6.4%] vs 6.1% [IQR 5.6-6.5%]; p=0.034), with no differences between the groups in the other trimesters (SMBG vs isCGM: first trimester 47.5 [IQR 42.1-54.1] vs 45.9 [IQR 39.9-51.9] mmol/mol, 6.5% [IQR 6.0-7.1%] vs 6.4% [IQR 5.8-6.9%]; third trimester 43.2 [IQR 39.9-47.5] vs 43.2 [IQR 39.9-47.5] mmol/mol, 6.1% [IQR 5.8-6.5%] vs 6.1% [IQR 5.7-6.5%]). The whole cohort showed a slight increase in HbA1c from the second to the third trimester, with a significantly higher rise in the isCGM group than in the SMBG group (median difference 2.2 vs 1.1 mmol/mol [0.2% vs 0.1%]; p=0.033). Regarding neonatal outcomes, newborns of women using isCGM were more likely to have neonatal hypoglycaemia than newborns of non-sensor users (27.4% vs 19.1%; ORadjusted 2.20 [95% CI 1.14, 4.30]), whereas there were no differences between the groups in large-for-gestational-age (LGA) infants (40.6% vs 45.1%; ORadjusted 0.73 [95% CI 0.42, 1.25]), Caesarean section (57.6% vs 48.8%; ORadjusted 1.33 [95% CI 0.78, 2.27]) or prematurity (27.3% vs 24.8%; ORadjusted 1.05 [95% CI 0.55, 1.99]) in the adjusted models. A sensitivity analysis in pregnancies without LGA infants or prematurity also showed that the use of isCGM was associated with a higher risk of neonatal hypoglycaemia (non-LGA: ORadjusted 2.63 [95% CI 1.01, 6.91]; non-prematurity: ORadjusted 2.52 [95% CI 1.12, 5.67]). For isCGM users, the risk of delivering an LGA infant was associated with TIR, TAR and TBR in the second trimester in the logistic regression analysis. CONCLUSIONS/INTERPRETATION: isCGM use provided an initial improvement in glycaemic control that was not sustained. Furthermore, offspring of isCGM users were more likely to have neonatal hypoglycaemia, with similar rates of macrosomia and prematurity to those of women receiving standard care.

Application of customized birth weight curves in the assessment of perinatal outcomes in infants of diabetic mothers.

OBJECTIVE: To determine whether the use of customized curves (CC) allows better detection of large- (LGA) or small-for-gestational age (SGA) infants at risk of adverse perinatal morbidity than non-CC in women with diabetes mellitus (DM). MATERIAL AND METHODS: A model of CC was applied to all infants of diabetic mothers (IDM) who attended the Hospital Universitario Materno Infantil de Canarias between 2008 and 2011. We compared perinatal outcomes of IDM classified as LGA or SGA by non-CC versus CC. RESULTS: One of 4 LGA was appropriate for gestational age (AGA) by CC (false-positive rate: 25%) and 30% of SGA by CC were not identified by non-CC (false-negative rate). False-positive LGA and SGA showed similar perinatal outcomes to AGA infants. The rates of cesarean section, cephalopelvic disproportion, total fetal distress and shoulder dystocia were significantly higher in false-negative LGA than in AGA by CC (p < 0.004, p < 0.02, p < 0.04 and p < 0.04, respectively). Fetal distress was higher in false-negative SGA than in AGA by CC (p < 0.03). DISCUSSION: In pregnancies complicated by DM, the use of CC allowed more accurate identification of LGA and SGA infants at high risk of perinatal morbidity than non-CC.

The NDDG criteria versus the IADPSG or the ADA criteria for diagnosing early-onset gestational diabetes mellitus or abnormal glucose tolerance.

OBJECTIVE: To analyze the effects of substituting the National Diabetes Data Group (NDDG) criteria with the International Association of Diabetes and Pregnancy Study Groups (IADPSG) or American Diabetes Association (ADA) criteria for the diagnosis of early-onset gestational diabetes mellitus (Early-GDM) or first trimester abnormal glucose tolerance (1 t-AGT). METHODS: A retrospective cohort study was conducted of 3200 women: 400 with Early-GDM, 800 with GDM, and 2000 with Non-GDM, according to the NDDG criteria. Rates of women with missed and new Early-GDM according to the IADPSG or ADA criteria were calculated. Multivariate logistic regression analysis was used to compare perinatal outcomes between groups. RESULTS: Using the IADPSG criteria, 61.6% of women with Early-GDM according to the NDDG were undiagnosed (Missed-Early-GDM group), and 25.9% of women with GDM and 15.7% of women with Non-GDM were diagnosed with Early-GDM (New-Early-GDM groups). Perinatal outcomes were worse in Missed-Early-GDM than in Non-GDM and better in New-Early-GDM groups than in the Early-GDM group. According to the ADA recommendations, only 11.8% of women with Early-GDM according to the NDDG criteria were diagnosed. CONCLUSION: Replacing the NDDG recommendations for the diagnosis of Early-GDM with the IADPSG or ADA criteria would mean depriving a large number of women with AGT and higher risk of adverse perinatal outcomes from early treatment and treating others with lower risk.

Prevalence and genotype distribution of cervical human papilomavirus infection in the pre-vaccination era: a population-based study in the Canary Islands.

OBJECTIVE: National Spanish studies show that prevalence of cervical human papillomavirus (HPV) infection in the female population is increasingly frequent, with an overall estimate of 14% in women aged 18-65 years. The objective of this study is to know the prevalence and distribution of HPV types in the female population of the Canary Islands prior to the introduction of HPV vaccines and to investigate the associated clinical and sociodemographic factors. METHODS: Based on the Primary Health Care database, a sample of adult women (aged 18-65 years) of Gran Canaria (GC) and Tenerife (TF) stratified into nine age groups was carried out between 2002 and 2007. Women were contacted by postal letter and telephone call and were visited in their primary care centre. A clinical-epidemiological survey was completed and cervical samples were taken for cytological study and HPV detection. HPV prevalence and its 95% CI were estimated, and multivariate analyses were performed using logistic regression to identify factors associated with the infection. RESULTS: 6010 women participated in the study, 3847 from GC and 2163 from TF. The overall prevalence of HPV infection was 13.6% (CI 12.8%-14.5%) and 11.1% (CI 10.3%-11.9%) for high-risk types. The most frequent HPV type was 16 followed by types 51, 53, 31, 42 and 59. HPV types included in the nonavalent vaccine were detected in 54.1% of infected women. Factors associated with an increased risk of infection were: young ages (18-29 years), the number of sexual partners throughout life, not being married, being a smoker, and having had previous cervical lesions or genital warts. CONCLUSIONS: It is confirmed that prevalence of HPV infection in the female population of the Canary Islands is high, but similar to that of Spain, HPV 16 being the most frequent genotype. The determinants of infection are consistent with those of other populations.

Twin pregnancy among women with pregestational type 1 or type 2 diabetes mellitus.

OBJECTIVE: To assess the impact of twin versus singleton pregnancy on obstetric and perinatal outcomes among women with pregestational diabetes mellitus (DM). METHODS: Multicenter retrospective cohort study of women with pregestational DM and twin or singleton pregnancy, conducted in Spain during 2005-2010. Each group included 63 women (type 1 DM, n=39; type 2 DM, n=24). RESULTS: Of 269 565 deliveries, 68 (0.025%) were twins of mothers with pregestational DM, with 28/63 (44.4%) conceptions achieved with assisted reproduction technology. Among women with type 1 DM, hypertensive complications were more common among those with twins than among controls (13% versus 3%, P=0.02); the rate of preterm birth was higher (69% versus 15%, P<0.001); and the rate of admission to the neonatal intensive care unit was higher (51% versus 21%, P=0.005). Twin pregnancy was an independent risk factor for adverse perinatal outcomes regardless of the type of diabetes. CONCLUSION: Twin pregnancy in women with either type of DM dramatically increased the risk of perinatal morbidity. In mothers with type 1 DM, twin pregnancy was more often associated with hypertensive complications than singleton pregnancy. Transfer of more than one embryo should be avoided if ART is needed in a woman with DM.