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Effectiveness of re...
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
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- Huhn, Evelyn Annegret (författare)
- Department of Obstetrics and Gynaecology, University Hospital Basel, Basel, Switzerland
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- Linder, Tina (författare)
- Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria
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- Eppel, Daniel (författare)
- Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria
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- Weißhaupt, Karen (författare)
- Clinic of Obstetrics, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
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- Klapp, Christine (författare)
- Clinic of Obstetrics, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
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- Schellong, Karen (författare)
- Clinic of Obstetrics, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
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- Henrich, Wolfgang (författare)
- Clinic of Obstetrics, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
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- Yerlikaya-Schatten, Gülen (författare)
- Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria
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- Rosicky, Ingo (författare)
- Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria
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- Husslein, Peter (författare)
- Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria
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- Chalubinski, Kinga (författare)
- Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria
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- Mittlböck, Martina (författare)
- Center of Medical Statistics, Informatics, and Intelligent Systems, Section for Clinical Biometrics, Medical University of Vienna, Vienna, Austria
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- Rust, Petra (författare)
- Department of Nutritional Sciences, University of Vienna, Vienna, Austria
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- Hoesli, Irene (författare)
- Department of Obstetrics and Gynaecology, University Hospital Basel, Basel, Switzerland
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- Winzeler, Bettina (författare)
- Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland
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- Jendle, Johan, 1963- (författare)
- Örebro universitet,Institutionen för medicinska vetenskaper
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- Fehm, T. (författare)
- Department of Obstetrics and Gynaecology, Medical Faculty, Heinrich-Heine University Düsseldorf, Dusseldorf, Germany
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- Icks, Andrea (författare)
- Institute of Health Services Research and Health Economics, Centre for Health and Society, Faculty of Medicine, Heinrich Heine University, Düsseldorf, Germany; Institute for Health Services Research and Health Economics, German Diabetes Center at Heinrich-Heine University Düsseldorf, Leibniz Institute for Diabetes Research, Düsseldorf, Germany; German Center for Diabetes Research, München-Neuherberg, Oberschleißheim, Germany
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- Vomhof, Markus (författare)
- Institute of Health Services Research and Health Economics, Centre for Health and Society, Faculty of Medicine, Heinrich Heine University, Düsseldorf, Germany; Institute for Health Services Research and Health Economics, German Diabetes Center at Heinrich-Heine University Düsseldorf, Leibniz Institute for Diabetes Research, Düsseldorf, Germany; German Center for Diabetes Research, München-Neuherberg, Oberschleißheim, Germany
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- Greiner, Gregory Gordon (författare)
- Institute of Health Services Research and Health Economics, Centre for Health and Society, Faculty of Medicine, Heinrich Heine University, Düsseldorf, Germany; Institute for Health Services Research and Health Economics, German Diabetes Center at Heinrich-Heine University Düsseldorf, Leibniz Institute for Diabetes Research, Düsseldorf, Germany; German Center for Diabetes Research, München-Neuherberg, Oberschleißheim, Germany
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- Szendrödi, Julia (författare)
- German Center for Diabetes Research, München-Neuherberg, Oberschleißheim, Germany; Division of Endocrinology and Diabetology, Medical Faculty, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany; Institute for Clinical Diabetology, German Diabetes Centre, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany
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- Roden, Michael (författare)
- German Center for Diabetes Research, München-Neuherberg, Oberschleißheim, Germany; Division of Endocrinology and Diabetology, Medical Faculty, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany; Institute for Clinical Diabetology, German Diabetes Centre, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany
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- Tura, Andrea (författare)
- Metabolic Unit, Institute of Neuroscience, National Research Council, Padova, Italy
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- Göbl, Christian S. (författare)
- Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria
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(creator_code:org_t)
- 2020-11-30
- 2020
- Engelska.
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Ingår i: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 10:11
- Relaterad länk:
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https://doi.org/10.1...
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https://bmjopen.bmj....
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Reproduktionsmedicin och gynekologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Obstetrics, Gynaecology and Reproductive Medicine (hsv//eng)
Nyckelord
- Clinical trials
- diabetes in pregnancy
- fetal medicine
- maternal medicine
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Huhn, Evelyn Ann ...
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Linder, Tina
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Eppel, Daniel
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Weißhaupt, Karen
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Klapp, Christine
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Schellong, Karen
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Henrich, Wolfgan ...
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Yerlikaya-Schatt ...
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Rosicky, Ingo
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Husslein, Peter
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Chalubinski, Kin ...
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Mittlböck, Marti ...
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Rust, Petra
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Hoesli, Irene
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Winzeler, Bettin ...
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Jendle, Johan, 1 ...
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Fehm, T.
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Icks, Andrea
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Vomhof, Markus
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Greiner, Gregory ...
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Szendrödi, Julia
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Roden, Michael
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Tura, Andrea
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Göbl, Christian ...
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