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Flash glucose monitoring in gestational diabetes mellitus: study protocol for a randomised controlled trial

INTRODUCTION: Gestational diabetes mellitus (GDM) is a glucose intolerance occurring in 3%–10% of pregnant women and being a risk factor for multiple maternal and fetal complications. The risk of perinatal complications is proportional to the level of maternal hyperglycaemia. Proper glycaemic contro...

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Autores principales: Majewska, Agata, Stanirowski, Paweł, Wielgoś, Mirosław, Bomba-Opoń, Dorota
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7929891/
https://www.ncbi.nlm.nih.gov/pubmed/33653744
http://dx.doi.org/10.1136/bmjopen-2020-041486
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author Majewska, Agata
Stanirowski, Paweł
Wielgoś, Mirosław
Bomba-Opoń, Dorota
author_facet Majewska, Agata
Stanirowski, Paweł
Wielgoś, Mirosław
Bomba-Opoń, Dorota
author_sort Majewska, Agata
collection PubMed
description INTRODUCTION: Gestational diabetes mellitus (GDM) is a glucose intolerance occurring in 3%–10% of pregnant women and being a risk factor for multiple maternal and fetal complications. The risk of perinatal complications is proportional to the level of maternal hyperglycaemia. Proper glycaemic control is therefore one of the key elements of GDM therapy. Until recently, determination of blood glucose concentration was performed using glucose meters, which involved multiple fingerpricks. Nowadays, due to the flash glucose monitoring (FGM) availability, it is possible to collect measurements at any time without routine puncturing. The aim of the presented study is to assess the impact of FGM on the efficacy of treatment in population of patients diagnosed with GDM. METHODS AND ANALYSIS: This is a prospective, randomised study, that will recruit 100 women at 24–28 weeks of gestation at the 1st Department of Obstetrics and Gynecology, Medical University of Warsaw, Poland. Women diagnosed with GDM, who will meet the inclusion criteria, will be individually randomised to the FGM or self-monitoring of blood glucose groups. Further on, clinical and laboratory results of the mother and their newborns will be collected for analysis during the course of pregnancy. Primary outcome is mean glycaemia result in each group after 1 month analysis and percentage of results in the target glycaemic range. The secondary objectives will be to compare the two groups for maternal and neonatal outcomes in conjunction with long-term glycaemic control using blood glycated haemoglobin and fructosamine serum concentrations. ETHICS AND DISSEMINATION: The study is exempt from regional ethics review due to its nature of quality improvement in patient care. The study has been approved by the Bioethics Committee at the Medical University of Warsaw and the patient privacy protection boards governing over the recruitment sites. Results of the study will be presented in peer-reviewed journals and at conferences. TRIAL REGISTRATION NUMBER: NCT04422821.
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spelling pubmed-79298912021-03-19 Flash glucose monitoring in gestational diabetes mellitus: study protocol for a randomised controlled trial Majewska, Agata Stanirowski, Paweł Wielgoś, Mirosław Bomba-Opoń, Dorota BMJ Open Obstetrics and Gynaecology INTRODUCTION: Gestational diabetes mellitus (GDM) is a glucose intolerance occurring in 3%–10% of pregnant women and being a risk factor for multiple maternal and fetal complications. The risk of perinatal complications is proportional to the level of maternal hyperglycaemia. Proper glycaemic control is therefore one of the key elements of GDM therapy. Until recently, determination of blood glucose concentration was performed using glucose meters, which involved multiple fingerpricks. Nowadays, due to the flash glucose monitoring (FGM) availability, it is possible to collect measurements at any time without routine puncturing. The aim of the presented study is to assess the impact of FGM on the efficacy of treatment in population of patients diagnosed with GDM. METHODS AND ANALYSIS: This is a prospective, randomised study, that will recruit 100 women at 24–28 weeks of gestation at the 1st Department of Obstetrics and Gynecology, Medical University of Warsaw, Poland. Women diagnosed with GDM, who will meet the inclusion criteria, will be individually randomised to the FGM or self-monitoring of blood glucose groups. Further on, clinical and laboratory results of the mother and their newborns will be collected for analysis during the course of pregnancy. Primary outcome is mean glycaemia result in each group after 1 month analysis and percentage of results in the target glycaemic range. The secondary objectives will be to compare the two groups for maternal and neonatal outcomes in conjunction with long-term glycaemic control using blood glycated haemoglobin and fructosamine serum concentrations. ETHICS AND DISSEMINATION: The study is exempt from regional ethics review due to its nature of quality improvement in patient care. The study has been approved by the Bioethics Committee at the Medical University of Warsaw and the patient privacy protection boards governing over the recruitment sites. Results of the study will be presented in peer-reviewed journals and at conferences. TRIAL REGISTRATION NUMBER: NCT04422821. BMJ Publishing Group 2021-03-02 /pmc/articles/PMC7929891/ /pubmed/33653744 http://dx.doi.org/10.1136/bmjopen-2020-041486 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Obstetrics and Gynaecology
Majewska, Agata
Stanirowski, Paweł
Wielgoś, Mirosław
Bomba-Opoń, Dorota
Flash glucose monitoring in gestational diabetes mellitus: study protocol for a randomised controlled trial
title Flash glucose monitoring in gestational diabetes mellitus: study protocol for a randomised controlled trial
title_full Flash glucose monitoring in gestational diabetes mellitus: study protocol for a randomised controlled trial
title_fullStr Flash glucose monitoring in gestational diabetes mellitus: study protocol for a randomised controlled trial
title_full_unstemmed Flash glucose monitoring in gestational diabetes mellitus: study protocol for a randomised controlled trial
title_short Flash glucose monitoring in gestational diabetes mellitus: study protocol for a randomised controlled trial
title_sort flash glucose monitoring in gestational diabetes mellitus: study protocol for a randomised controlled trial
topic Obstetrics and Gynaecology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7929891/
https://www.ncbi.nlm.nih.gov/pubmed/33653744
http://dx.doi.org/10.1136/bmjopen-2020-041486
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