Search

The CONCEPTT trial compared real-time Continuous Glucose Monitoring (RT-CGM) to capillary glucose monitoring in pregnant women with type 1 diabetes. We analyzed CGM and glycated hemoglobin (HbA1c) measures in first (n = 221), second (n = 197), and third (n = 172) trimesters, aiming to examine target glucose attainment and associations with pregnancy outcomes. CGM targets were Time-in-range (TIR) > 70%, Time-above-range (TAR) <25%, and Time-below-range (TBR) < 4%, and HbA1c targets < 6.5% (National Institute for Health and Care Excellence [NICE]) and HbA1c < 6.0% in second and third trimesters (American Diabetes Association [ADA]). TIR/TAR/TBR targets were achieved by 7.7/14.5/30.3% participants in first, 10.2/14.2/52.8% in second, and 35.5/37.2/52.9% in third trimesters. CGM target attainment was low but increased during pregnancy and with RT-CGM use. In the adjusted analyses, achieving TBR target was associated with a higher risk of pre-eclampsia and neonatal hypoglycemia. ADA HbA1c target attainment was low and unchanged during pregnancy (23.5/27.9/23.8%) but increased with RT-CGM use. In the adjusted analyses, HbA1c target attainment was associated with a lower risk of preterm birth, large-for-gestational age and neonatal hypoglycemia. We conclude that CONCEPTT trial participants had a low rate of CGM and of HbA1c target attainment. Attainment of CGM and NICE HbA1c targets increased throughout gestation and all targets (both NICE/ADA HbA1c and CGM) were more likely to be achieved by RT-CGM users, at 34 weeks' gestation. ADA HbA1c target achievement was independently associated with better perinatal outcomes, while the independent association of TBR target achievement with increased risk warrants further study. ClinicalTrials.gov Registration Identifier NCT01788527. [ABSTRACT FROM AUTHOR]

Objective: The optimal method of monitoring glycemia in pregnant women with type 1 diabetes remains controversial. This study aimed to assess the predictive performance of HbA1c, continuous glucose monitoring (CGM) metrics, and alternative biochemical markers of glycemia to predict obstetric and neonatal outcomes.Research Design and Methods: One hundred fifty-seven women from the Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT) were included in this prespecified secondary analysis. HbA1c, CGM data, and alternative biochemical markers (glycated CD59, 1,5-anhydroglucitol, fructosamine, glycated albumin) were compared at ∼12, 24, and 34 weeks' gestation using logistic regression and receiver operating characteristic (ROC) curves to predict pregnancy complications (preeclampsia, preterm delivery, large for gestational age, neonatal hypoglycemia, admission to neonatal intensive care unit).Results: HbA1c, CGM metrics, and alternative laboratory markers were all significantly associated with obstetric and neonatal outcomes at 24 weeks' gestation. More outcomes were associated with CGM metrics during the first trimester and with laboratory markers (area under the ROC curve generally <0.7) during the third trimester. Time in range (TIR) (63-140 mg/dL [3.5-7.8 mmol/L]) and time above range (TAR) (>140 mg/dL [>7.8 mmol/L]) were the most consistently predictive CGM metrics. HbA1c was also a consistent predictor of suboptimal pregnancy outcomes. Some alternative laboratory markers showed promise, but overall, they had lower predictive ability than HbA1c.Conclusions: HbA1c is still an important biomarker for obstetric and neonatal outcomes in type 1 diabetes pregnancy. Alternative biochemical markers of glycemia and other CGM metrics did not substantially increase the prediction of pregnancy outcomes compared with widely available HbA1c and increasingly available CGM metrics (TIR and TAR). [ABSTRACT FROM AUTHOR]

Type 1 diabetes (T1D) in pregnancy is associated with increased neonatal morbidity, which improves with optimal glycemic control. Aim: To compare lab and CGM glucose summary measures as predictors of neonatal outcomes in T1D pregnancy. Methods: 225 CONCEPTT participants had 6-day CGM and blood analysis of glycemic markers in 1st trimester, 24 and 34 weeks (Average glucose; % time in target 63-140 mg/dl, coefficient of variation (CV)); HbA1c; glycated CD59 (gCD59); 1,5-anhydroglucitol (1,5AG); glycated albumin). Outcomes: large for gestational age (LGA), neonatal hypoglycemia (NH) and neonatal intensive care unit (NICU) admission. Statistics: Unadjusted logistic regression. Results: All glucose summary measures excluding CV predicted neonatal outcomes (Table). Glycemic control at all timepoints from 1st trimester was important for LGA, but emerged later for NH (24 and 34 weeks) and NICU (mainly 24 weeks). Both CGM time in target and average glucose and lab markers HbA1c, 1,5AG and gCD59 predicted all three outcomes studied. Time in target was the best CGM predictor. The best lab predictors were HbA1c, 1,5AG and gCD59. HbA1c was the strongest predictor of LGA and NH, but only predicted NICU admission late in pregnancy. Conclusions: In women with T1D, both CGM and lab glucose summary measures can predict neonatal outcomes from 1st trimester. Disclosure: C.L. Meek: None. D. Tundidor: None. H.R. Murphy: Advisory Panel; Self; Medtronic MiniMed, Inc. J.M. Yamamoto: None. E.M. Scott: Advisory Panel; Self; Abbott. Speaker's Bureau; Self; Abbott, Eli Lilly and Company. D. Ma: None. J. Halperin: Stock/Shareholder; Self; Mellitus, LLC. D. Feig: Advisory Panel; Self; Medtronic. Speaker's Bureau; Self; Medtronic. R. Corcoy: None. Funding: JDRF; Canadian Clinical Trials Network; National Institute for Health Research; European Foundation for the Study of Diabetes/Sanofi; Diabetes UK (17/0005712 to C.L.M.); Asahi Kasei Pharma Corporation; GlycoMark, Inc. [ABSTRACT FROM AUTHOR]