Protocol for a multi-site randomised controlled feasibility study investigating intermittently scanned blood continuous glucose monitoring use for gestational diabetes: the RECOGNISE study
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)...
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| Format: | Article |
| Language: | English |
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BMC
2023-07-01
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| Series: | Pilot and Feasibility Studies |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s40814-023-01341-y |
| _version_ | 1797779050419191808 |
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| author | Anna Davies Erik Lenguerrand Eleanor Scott Rebecca Kandiyali Isabelle Douek Jane Norman Abi Loose Lynn Sawyer Laura Timlin Christy Burden |
| author_facet | Anna Davies Erik Lenguerrand Eleanor Scott Rebecca Kandiyali Isabelle Douek Jane Norman Abi Loose Lynn Sawyer Laura Timlin Christy Burden |
| author_sort | Anna Davies |
| collection | DOAJ |
| description | 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). |
| first_indexed | 2024-03-12T23:25:09Z |
| format | Article |
| id | doaj.art-52f68d42dd894dadb9c01cdb2ae4dbab |
| institution | Directory Open Access Journal |
| issn | 2055-5784 |
| language | English |
| last_indexed | 2024-03-12T23:25:09Z |
| publishDate | 2023-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj.art-52f68d42dd894dadb9c01cdb2ae4dbab2023-07-16T11:09:49ZengBMCPilot and Feasibility Studies2055-57842023-07-019111410.1186/s40814-023-01341-yProtocol for a multi-site randomised controlled feasibility study investigating intermittently scanned blood continuous glucose monitoring use for gestational diabetes: the RECOGNISE studyAnna Davies0Erik Lenguerrand1Eleanor Scott2Rebecca Kandiyali3Isabelle Douek4Jane Norman5Abi Loose6Lynn Sawyer7Laura Timlin8Christy Burden9Academic Women’s Health Unit, Translational Health Sciences, University of BristolAcademic Women’s Health Unit, Translational Health Sciences, University of BristolLeeds Institute of Cardiovascular and Metabolic Medicine, University of LeedsWarwick Clinical Trials Unit, Warwick UniversitySomerset Foundation NHS TrustAcademic Women’s Health Unit, Translational Health Sciences, University of BristolNorth Bristol NHS TrustNHS England-South-WestNorth Bristol NHS TrustAcademic Women’s Health Unit, Translational Health Sciences, University of BristolAbstract 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).https://doi.org/10.1186/s40814-023-01341-yGestational diabetesContinuous glucose monitoringFeasibility studyLarge for gestational age |
| spellingShingle | Anna Davies Erik Lenguerrand Eleanor Scott Rebecca Kandiyali Isabelle Douek Jane Norman Abi Loose Lynn Sawyer Laura Timlin Christy Burden Protocol for a multi-site randomised controlled feasibility study investigating intermittently scanned blood continuous glucose monitoring use for gestational diabetes: the RECOGNISE study Pilot and Feasibility Studies Gestational diabetes Continuous glucose monitoring Feasibility study Large for gestational age |
| title | Protocol for a multi-site randomised controlled feasibility study investigating intermittently scanned blood continuous glucose monitoring use for gestational diabetes: the RECOGNISE study |
| title_full | Protocol for a multi-site randomised controlled feasibility study investigating intermittently scanned blood continuous glucose monitoring use for gestational diabetes: the RECOGNISE study |
| title_fullStr | Protocol for a multi-site randomised controlled feasibility study investigating intermittently scanned blood continuous glucose monitoring use for gestational diabetes: the RECOGNISE study |
| title_full_unstemmed | Protocol for a multi-site randomised controlled feasibility study investigating intermittently scanned blood continuous glucose monitoring use for gestational diabetes: the RECOGNISE study |
| title_short | Protocol for a multi-site randomised controlled feasibility study investigating intermittently scanned blood continuous glucose monitoring use for gestational diabetes: the RECOGNISE study |
| title_sort | protocol for a multi site randomised controlled feasibility study investigating intermittently scanned blood continuous glucose monitoring use for gestational diabetes the recognise study |
| topic | Gestational diabetes Continuous glucose monitoring Feasibility study Large for gestational age |
| url | https://doi.org/10.1186/s40814-023-01341-y |
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