Effectiveness of real-time continuous glucose monitoring to improve glycaemic control and pregnancy outcome in patients with gestational diabetes mellitus: a study protocol for a randomised controlled trial

Evelyn Annegret Huhn, Tina Linder, Daniel Eppel, Karen Weißhaupt, Christine Klapp, Karen Schellong, Wolfgang Henrich, Gülen Yerlikaya-Schatten, Ingo Rosicky, Peter Husslein, Kinga Chalubinski, Martina Mittlböck, Petra Rust, Irene Hoesli, Bettina Winzeler, Johan Jendle, T Fehm, Andrea Icks, Markus Vomhof, Gregory Gordon Greiner, Julia Szendrödi, Michael Roden, Andrea Tura, Christian S Göbl, Evelyn Annegret Huhn, Tina Linder, Daniel Eppel, Karen Weißhaupt, Christine Klapp, Karen Schellong, Wolfgang Henrich, Gülen Yerlikaya-Schatten, Ingo Rosicky, Peter Husslein, Kinga Chalubinski, Martina Mittlböck, Petra Rust, Irene Hoesli, Bettina Winzeler, Johan Jendle, T Fehm, Andrea Icks, Markus Vomhof, Gregory Gordon Greiner, Julia Szendrödi, Michael Roden, Andrea Tura, Christian S Göbl

Abstract

Introduction: Real-time continuous glucose monitoring (rt-CGM) informs users about current interstitial glucose levels and allows early detection of glycaemic excursions and timely adaptation by behavioural change or pharmacological intervention. Randomised controlled studies adequately powered to evaluate the impact of long-term application of rt-CGM systems on the reduction of adverse obstetric outcomes in women with gestational diabetes (GDM) are missing. We aim to assess differences in the proportion of large for gestational age newborns in women using rt-CGM as compared with women with self-monitored blood glucose (primary outcome). Rates of neonatal hypoglycaemia, caesarean section and shoulder dystocia are secondary outcomes. A comparison of glucose metabolism and quality of life during and after pregnancy completes the scope of this study.

Methods and analysis: Open-label multicentre randomised controlled trial with two parallel groups including 372 female patients with a recent diagnosis of GDM (between 24+0 until 31+6 weeks of gestation): 186 with rt-CGM (Dexcom G6) and 186 with self-monitored blood glucose (SMBG). Women with GDM will be consecutively recruited and randomised to rt-CGM or control (SMBG) group after a run-in period of 6-8 days. The third visit will be scheduled 8-10 days later and then every 2 weeks. At every visit, glucose measurements will be evaluated and all patients will be treated according to the standard care. The control group will receive a blinded CGM for 10 days between the second and third visit and between week 36+0 and 38+6. Cord blood will be sampled immediately after delivery. 48 hours after delivery neonatal biometry and maternal glycosylated haemoglobin A1c (HbA1c) will be assessed, and between weeks 8 and 16 after delivery all patients receive a re-examination of glucose metabolism including blinded CGM for 8-10 days.

Ethics and dissemination: This study received ethical approval from the main ethic committee in Vienna. Data will be presented at international conferences and published in peer-reviewed journals.

Trial registration number: NCT03981328; Pre-results.

Keywords: clinical trials; diabetes in pregnancy; fetal medicine; maternal medicine.

Conflict of interest statement

Competing interests: The authors declare that there are no further financial or personal relationships with other people or organisations that could inappropriately influence the work reported or the conclusions, implications or opinions stated.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Patient flow diagram. CGM, continuous glucose monitoring; FSCTT, fetal subcutanous tissue thickness; FFQ, food frequency questionnaire; GDM, gestational diabetes mellitus; IPAQ, international physical activity questionnaire; PPAQ, pregnancy physical activity questionnaire; RT-CGM, real-time CGM; SF-36, short form 36; SMBG, self-monitored bloodglucose.

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