Abstract
BACKGROUND: Incidence of gestational diabetes mellitus (GDM) is increasing and is associated with adverse perinatal outcomes including macrosomia, pre-eclampsia, and pre-term delivery. Optimum glycaemic control can reduce these adverse perinatal outcomes. Continuous glucose monitoring (CGM) informs users about interstitial glucose levels allowing early detection of glycaemic excursions and pharmacological or behavioural intervention. Few adequately powered RCTs to evaluate the impact of using CGM in women with GDM on perinatal outcomes have been undertaken. We aim to establish the feasibility of a multi-site RCT to evaluate the clinical- and cost-effectiveness of an intermittently scanned continuous glucose monitor (isCGM) compared with self-monitored blood glucose (SMBG) in women with GDM for reducing fetal macrosomia and improving maternal and fetal outcomes. We will evaluate recruitment and retention rates, adherence to device requirements, adequacy of data capture and acceptability of trial design and isCGM devices.
METHODS: Open-label multicentre randomised controlled feasibility trial.
INCLUSION CRITERIA: pregnant women, singleton pregnancy, recent diagnosis of GDM (within 14 days of commencing medication, up to 34 weeks gestation) prescribed metformin and/or insulin. Women will be consecutively recruited and randomised to isCGM (FreestyleLibre2) or SMBG. At every antenatal visit, glucose measurements will be evaluated. The SMBG group will use blinded isCGM for 14 days at baseline (~ 12-32 weeks) and ~ 34-36 weeks. The primary outcome is the recruitment rate and absolute number of women participating. Clinical assessments of maternal and fetal/infant health will be undertaken at baseline, birth, up to ~ 13 weeks post-natal. Psychological, behavioural and health economic measures will be assessed at baseline and ~ 34-36 weeks gestation. Qualitative interviews will be undertaken with study decliners, participants, and professionals to explore trial acceptability, of using isCGM and SMBG.
DISCUSSION: GDM can be associated with adverse pregnancy outcomes. isCGM could offer a timely, easy-to-engage-with intervention, to improve glycaemic control, potentially reducing adverse pregnancy, birth and long-term health outcomes for mother and child. This study will determine the feasibility of conducting a large-scale multisite RCT of isCGM in women with GDM.
TRIAL REGISTRATION: This study has been registered with the ISRCTN (reference: ISRCTN42125256 , Date registered: 07/11/2022).
| Original language | English |
|---|---|
| Article number | 120 |
| Pages (from-to) | 120 |
| Journal | Pilot and Feasibility Studies |
| Volume | 9 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 11 Jul 2023 |
Bibliographical note
Funding Information:This study/project is funded by the NIHR Research for Patient Benefit award (Reference: NIHR203182). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The NIHR had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results.
Publisher Copyright:
© 2023, The Author(s).
