Search

Background: Continuous glucose monitoring (CGM) provides far greater detail about fetal exposure to maternal glucose across the 24 hour day, but recommended summary statistics give no dynamic information about the glucose profile across 24 hours. Aim: To examine whether differences in temporal glucose control occur in women with type 1 diabetes who develop large for gestational age infants (LGA). Research Design and Methods: CGM data was available from 200 pregnant women (100 CGM intervention; 100 controls) in the CONCEPTT study, at baseline, 24 and 34 weeks gestation. All women were being treated to tight glycemic targets (mean HbA1c 6.4% at 34 weeks gestation). Functional data analysis (FDA) was applied to determine differences in temporal glucose profiles. LGA was defined as birth weight ≥90th percentile adjusted for infant sex, gestational age, maternal BMI, ethnicity and parity. Results: 122/200 women had a LGA infant (61%). FDA revealed that those women who gave birth to a LGA infant ran a significantly higher glucose (by 9-14mg/dL; 0.5-0.8 mmol/l) for 16.5 hours of the day compared to those women who did not have a LGA infant (see fig). Conclusion: Women who go on to have LGA infants have significantly higher fetal exposure to glucose across the 24 hour day, despite being treated to tight glucose targets. Disclosure: E.M. Scott: Advisory Panel; Self; Abbott. Speaker's Bureau; Self; Abbott, Eli Lilly and Company. H.R. Murphy: Advisory Panel; Self; Medtronic MiniMed, Inc. D. Feig: Advisory Panel; Self; Medtronic. Speaker's Bureau; Self; Medtronic. G. Law: None. Funding: JDRF; Canadian Clinical Trials Network; National Institute for Health Research [ABSTRACT FROM AUTHOR]

Background: The CONCEPTT randomized trial of CGM in pregnant women with type 1 diabetes showed significant improvement in pregnancy outcomes, but no difference in mean CGM glucose between those allocated to CGM vs. capillary glucose monitoring. Whilst summary statistics are recommended for the reporting of CGM data, they do not give dynamic information about the glucose profile across 24 hours. Aim: To determine, using novel functional data analysis (FDA), if differences in the temporal glucose profile occurred in women randomized to CGM. Methods: CGM data was available from 200 pregnant women (100 CGM intervention; 100 control) in the CONCEPTT study, at baseline, 24 and 34 weeks gestation. FDA was applied to the glucose data to generate functional glucose curves and multivariable statistical analysis applied. Results: Despite having the same mean CGM glucose as those on capillary glucose monitoring alone 121 vs. 126 mg/dL; 6.7 vs. 7.0 mmol/l p=0.14, FDA revealed that pregnant CGM users were in fact running a significantly lower glucose (by 9-14mg/dL; 0.5-0.8 mmol/l) for a total of 8 hours a day (08.30-12.30 and 15.00-19.00). Conclusion: Analysis of temporal glucose profiles gives key information about glucose control, missed by commonly reported CGM metrics. The women allocated to CGM ran a significantly lower glucose for 33% of the day. Disclosure: E.M. Scott: Advisory Panel; Self; Abbott. Speaker's Bureau; Self; Abbott, Eli Lilly and Company. H.R. Murphy: Advisory Panel; Self; Medtronic MiniMed, Inc. D. Feig: Advisory Panel; Self; Medtronic. Speaker's Bureau; Self; Medtronic. G. Law: None. Funding: JDRF; Canadian Clinical Trials Network; National Institute for Health Research [ABSTRACT FROM AUTHOR]

Aims: To evaluate the cost-effectiveness of continuous glucose monitoring (CGM) in type 1 diabetes (T1D) pregnancy. Methods: Decision analytical models to compare T1D antenatal care with and without use of CGM. Probabilities, maternal health state utilities and healthcare resource utilization were obtained from individual patient-trial data. Costs and neonatal health state utilities were obtained from the literature. Primary outcome of interest was neonatal quality adjusted life years (QALY). The willingness to pay threshold was £30,000/QALY. Results: Direct costs of CGM use were £2,045. From a neonatal perspective, CGM during was cost saving (- £2,613), and effective (75.43 vs. 73.77 QALYs), with an incremental cost effectiveness ratio (ICER) - 1,570.57/QALY (Figure 1). Sensitivity analyses demonstrated robustness of the model across ranges of variables including varying NICU care for preterm and term neonates, and health state utilities. From a maternal perspective, CGM was associated with additional cost (£330), but remained effective; QALYs 61.33 vs. 61.27 and ICER £5,508.00/QALY. CGM remained efficacious and the favored treatment strategy in the sensitivity analyses performed. Conclusions: CGM use during T1D pregnancy is cost saving from a neonatal perspective and associated with improved cost effectiveness for both mother and neonate. Disclosure: H.R. Murphy: Advisory Panel; Self; Medtronic MiniMed, Inc. D. Feig: Advisory Panel; Self; Medtronic. Speaker's Bureau; Self; Medtronic. N. Patel: None. Funding: JDRF (17-2011-533); JDRF Canadian Clinical Trial Network (80-2010-585) [ABSTRACT FROM AUTHOR]

Background: Maternal hyperglycaemia alone does'nt explain the incidence of large for gestational age offspring (LGA) amongst women with T1DM. Placental vascular development is regulated by angiogenic factors. Placental growth factor (PIGF) is such a factor with a PlGF >100 signifying a well-developed placenta. Co-measurement of PlGF and SFLT-1 (soluble receptor antagonist to VEGF), combined as a ratio, is predictive of maternal vascular perfusion. A low sFLT-1:PlGF (<85) is a marker of good placental health. We assessed if markers of placental function and glycemic control can explain variations in birthweight in women with T1DM. Methods: Amongst 157 women who participated in CONCEPTT; PlGF, sFLT-1:PlGF and a HbA1c< or >6.5% at randomisation and 34 weeks' gestation were assessed. Two separate linear regression models were used to test for a differential effect of placental function on mean birth weight in those with different levels of glycemic control, one using sFLT-1:PlGF and the other PlGF. Results: No significant relationship was found between birthweight and markers of placental function and glycemic control at randomisation. At 34 weeks, the relationship of birth weight to sFLT-1: PlGF differed depending upon HbA1c (p=0.007). Where HbA1c< 6.5%, birth weights were similar for a sFLT-1:PlGF <85 (3592g) and >85 (3699g). Where HbA1c > 6.5%, birthweights were higher with a sFLT-1:PlGF < 85 (3809g) vs. > 85 (3355g). A similar pattern emerged for PlGF alone, with a differential effect of a healthy placenta on birthweight dependent upon glycemic control (p=0.013). Where HbA1c<6.5%, birthweights were similar (3635±556g and 3604±602g) with low and high PlGF. Where HbA1c>6.5%, an elevated PlGF (>100) resulted in higher birth weight than in those with lower PlGF (3822g ±679 vs. 3344g ±556). Conclusion: In women with T1DM, the combination of a healthy placenta with poor glycemic control resulted in the highest birthweights. Tighter glycemic control to avoid LGA is needed in women with healthy placental function. Disclosure: S. Bacon: None. D. Burger: None. M. Tailor: None. G.A. Tomlinson: None. H.R. Murphy: Advisory Panel; Self; Medtronic MiniMed, Inc. D. Feig: Advisory Panel; Self; Medtronic. Speaker's Bureau; Self; Medtronic. [ABSTRACT FROM AUTHOR]