Accuracy, User Acceptability, and Safety Evaluation for the FreeStyle Libre Flash Glucose Monitoring System When Used by Pregnant Women with Diabetes.

Accuracy of the FreeStyle Libre™ Flash Glucose Monitoring System has not been evaluated in pregnant women with diabetes. The aim of this study was to determine accuracy (compared to self-monitoring of blood glucose [SMBG]), clinical safety, and acceptability of the FreeStyle Libre System when used at home by this population.Seventy-four participants, with type 1 (T1D, n = 24), type 2 (T2D, n = 11), or gestational (n = 39) diabetes, were enrolled across 13 sites (9 in United Kingdom, 4 in Austria). Average gestation was 26.6 ± 6.8 weeks (mean ± standard deviation), age was 30.5 ± 5.1 years, diabetes duration was 13.1 ± 7.3 years for T1D and 3.2 ± 2.5 years for T2D, and 49/74 (66.2%) used insulin to manage their diabetes. Sensors were worn for up to 14 days. Sensor glucose values (masked) were compared with capillary SMBG values (made at least 4 times/day).Clinical accuracy of sensor results versus SMBG results was demonstrated, with 88.1% and 99.8% of results within Zone A and Zones A and B of the Consensus Error Grid, respectively. Overall mean absolute relative difference was 11.8%. Sensor accuracy was unaffected by the type of diabetes, the stage of pregnancy, whether insulin was used, age or body mass index. User questionnaires indicated high levels of satisfaction with sensor wear, system use, and comparison to SMBG. There were no unanticipated device-related adverse events.Good agreement was demonstrated between the FreeStyle Libre System and SMBG. Accuracy of the system was unaffected by patient characteristics, indicating that the system is safe and accurate to use by pregnant women with diabetes

Risk and Recurrence of Serious Adverse Outcomes in the First and Second Pregnancies of Women With Preexisting Diabetes

OBJECTIVE: Women with preexisting (type 1 or type 2) diabetes experience an increased risk of serious adverse pregnancy outcomes. It is not known, however, how these risks change between the first and second pregnancy andwhether there is an increased risk of recurrence. This study describes the absolute risks and recurrence of serious adverse pregnancy outcomes in 220 women with preexisting diabetes. RESEARCH DESIGN AND METHODS: A total of 440 pregnancies occurring in 220 women with preexisting diabetes who delivered successive singleton pregnancies in the North of England during 1996-2008 were identified fromtheNorthern Diabetes in Pregnancy Survey (NorDIP). Predictors of serious adverse outcome were estimated by competing-risks regression. RESULTS: Sixty-seven first pregnancies (30.5%) ended in serious adverse outcome, including 14 (6.4%) with congenital anomalies and 53 (24.1%) additional fetal or infant deaths. Thirty-seven second pregnancies (16.8%) ended in serious adverse outcomedhalf the rate among first pregnancies (P = 0.0004)dincluding 21 (9.5%) with congenital anomalies and 16 (7.3%) additional fetal or infant deaths. Serious adverse outcomes in the second pregnancy occurred twice as frequently in women who experienced a previous adverse outcome than in those who did not (26.9% vs. 12.4%, P = 0.004), but previous adverse outcome was not associated with preparation for the following pregnancy. CONCLUSIONS: Serious adverse outcomes are less common in the second pregnancies of women with preexisting diabetes, although the risk is comparable in those whose first pregnancy ends in adverse outcome. Reducing the risk of recurrence may require more support in the immediate period after an adverse pregnancy outcome

Pre-existing diabetes, maternal glycated haemoglobin, and the risks of fetal and infant death: A population-based study

Aims/hypothesis: Pre-existing diabetes is associated with an increased risk of stillbirth, but few studies have excluded the effect of congenital anomalies. This study used data from a long-standing population-based survey of women with pre-existing diabetes to investigate the risks of fetal and infant death and quantify the contribution of glycaemic control. Methods: All normally formed singleton offspring of women with pre-existing diabetes (1,206 with type 1 diabetes and 342 with type 2 diabetes) in the North of England during 1996-2008 were identified from the Northern Diabetes in Pregnancy Survey. RRs of fetal death (≥20 weeks of gestation) and infant death were estimated by comparison with population data from the Northern Perinatal Morbidity and Mortality Survey. Predictors of fetal and infant death in women with pre-existing diabetes were examined by logistic regression. Results: The prevalence of fetal death in women with diabetes was over four times greater than in those without (RR 4.56 [95% CI 3.42, 6.07], p < 0.0001), and for infant death it was nearly doubled (RR 1.86 [95% CI 1.00, 3.46], p = 0.046). There was no difference in the prevalence of fetal death (p = 0.51) or infant death (p = 0.70) between women with type 1 diabetes and women with type 2 diabetes. There was no evidence that the RR of fetal and infant death had changed over time (p = 0.95). Increasing periconception HbA1c concentration above 49 mmol/mol (6.6%) (adjusted odds ratio [aOR] 1.02 [95% CI 1.00, 1.04], p = 0.01), prepregnancy retinopathy (aOR 2.05 [95% CI 1.04, 4.05], p = 0.04) and lack of prepregnancy folic acid consumption (aOR 2.52 [95% CI 1.12, 5.65], p = 0.03) were all independently associated with increased odds of fetal and infant death. Conclusions/interpretation: Pre-existing diabetes is associated with a substantially increased risk of fetal and infant death in normally formed offspring, the effect of which is largely moderated by glycaemic control