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Protocol

Continuous Glucose Monitoring Time-in-Range and HbA1c Targets in Pregnant Women with Type 1 Diabetes

  • Diana Tundidor 1
  • Claire L. Meek 2
  • Jennifer Yamamoto 3
  • Cecilia Martínez-Bru 4
  • Ignasi Gich 5
  • Denice S. Feig 6
  • Helen R. Murphy 7
  • Rosa Corcoy 1
  • 1 - Department of Medicine - Universitat Autònoma de Barcelona - Barcelona Spain
  • 2 - Cambridge Universities NHS Foundation Trust - Cambridge United Kingdom
  • 3 - Department of Medicine - Cumming School of Medicine - University of Calgary - Calgary Canada
  • 4 - Laboratory Department - Hospital de la Santa Creu i Sant Pau - Barcelona Spain
  • 5 - Department of Clinic Epidemiology and Public Health - Hospital de la Santa Creu i Sant Pau - Barcelona Spain
  • 6 - Mount Sinai Hospital - Sinai Health System - Department of Medicine - University of Toronto - Lunenfeld-Tanenbaum Research Institute - Toronto Canada
  • 7 - School of Life Course Sciences - King's College London - London United Kingdom

Abstract

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.


 


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