Journal article

CONCEPTT: Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial: A multi-center, multi-national, randomized controlled trial - Study protocol

DS Feig, E Asztalos, R Corcoy, A De Leiva, L Donovan, M Hod, L Jovanovic, E Keely, C Kollman, R McManus, K Murphy, K Ruedy, JJ Sanchez, G Tomlinson, HR Murphy, B Cleave, D Donat, S Gandhi, M Strom, AI Chico Show all

BMC Pregnancy and Childbirth | BIOMED CENTRAL LTD | Published : 2016

Open access

Abstract

Background: Women with type 1 diabetes strive for optimal glycemic control before and during pregnancy to avoid adverse obstetric and perinatal outcomes. For most women, optimal glycemic control is challenging to achieve and maintain. The aim of this study is to determine whether the use of real-time continuous glucose monitoring (RT-CGM) will improve glycemic control in women with type 1 diabetes who are pregnant or planning pregnancy. Methods/design: A multi-center, open label, randomized, controlled trial of women with type 1 diabetes who are either planning pregnancy with an HbA1c of 7.0 % to ≤10.0 % (53 to ≤ 86 mmol/mol) or are in early pregnancy (<13 weeks 6 days) with an HbA1c of 6.5 ..

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University of Melbourne Researchers

Grants

Awarded by Juvenile Diabetes Research Foundation United States of America


Funding Acknowledgements

The trial is funded by JDRF grants #17-2011-533, and grants under the JDRF Canadian Clinical Trial Network (CCTN), a public-private partnership including JDRF and FedDev Ontario and supported by JDRF # 80-2010-585. HRM conducts independent research supported by the National Institute for Health Research (Career Development Fellowship, CDF-2013-06-035). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the UK Department of Health.