Daphne N Voormolen1, J Hans DeVries2, Rieneke M E Sanson3, Martijn P Heringa1, Harold W de Valk4, Marjolein Kok5, Aren J van Loon6, Klaas Hoogenberg7, Dick J Bekedam8, Teri C B Brouwer9, Martina Porath10, Ronald J Erdtsieck11, Bas NijBijvank12, Huib Kip13, Olivier W H van der Heijden14, Lammy D Elving15, Brenda B Hermsen16, B J Potter van Loon17, Robert J P Rijnders18, Henry J Jansen19, Josje Langenveld20, Bettina M C Akerboom21, Rosalie M Kiewiet22, Christiana A Naaktgeboren23, Ben W J Mol24,25, Arie Franx1, Inge M Evers26. 1. Department of Obstetrics and Gynecology, Division of Women and Baby, University Medical Centre Utrecht, Utrecht, The Netherlands. 2. Department of Endocrinology, Academic Medical Centre, Amsterdam, The Netherlands. 3. Department of Internal Medicine, Meander Medical Centre, Amersfoort, The Netherlands. 4. Department of Endocrinology, University Medical Centre Utrecht, Utrecht, The Netherlands. 5. Department of Obstetrics and Gynecology, Academic Medical Centre, Amsterdam, The Netherlands. 6. Department of Obstetrics and Gynecology, Martini Hospital, Groningen, The Netherlands. 7. Department of Internal Medicine, Martini Hospital, Groningen, The Netherlands. 8. Department of Obstetrics and Gynecology, OLVG, Amsterdam, The Netherlands. 9. Department of Internal Medicine, OLVG, Amsterdam, The Netherlands. 10. Department of Obstetrics and Gynecology, Maxima Medical Centre, Veldhoven, The Netherlands. 11. Department of Internal Medicine, Maxima Medical Centre, Veldhoven, The Netherlands. 12. Department of Obstetrics and Gynecology, Isala Hospital, Zwolle, The Netherlands. 13. Department of Internal Medicine, Isala Hospital, Zwolle, The Netherlands. 14. Department of Obstetrics and Gynecology, University Medical Centre St Radboud, Nijmegen, The Netherlands. 15. Department of Internal Medicine, University Medical Centre St Radboud, Nijmegen, The Netherlands. 16. Department of Obstetrics and Gynecology, St Lucas Andreas Hospital, Amsterdam, The Netherlands. 17. Department of Internal Medicine, St Lucas Andreas Hospital, Amsterdam, The Netherlands. 18. Department of Obstetrics and Gynecology, Jeroen Bosch Hospital, Den Bosch, The Netherlands. 19. Department of Internal Medicine, Jeroen Bosch Hospital, Den Bosch, The Netherlands. 20. Department of Obstetrics and Gynecology, Zuyderland Medical Centre, Heerlen, The Netherlands. 21. Department of Obstetrics and Gynecology, Albert Schweitzer Hospital, Dordrecht, The Netherlands. 22. Department of Internal Medicine, Albert Schweitzer Hospital, Dordrecht, The Netherlands. 23. Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands. 24. The Robinson Research Institute, School of Medicine, University of Adelaide, Adelaide, Australia. 25. The South Australian Health and Medical Research Institute Adelaide, Adelaide, Australia. 26. Department of Obstetrics and Gynecology, Meander Medical Centre, Amersfoort, The Netherlands.
Abstract
AIM: Diabetes is associated with a high risk of adverse pregnancy outcomes. Optimal glycaemic control is fundamental and is traditionally monitored with self-measured glucose profiles and periodic HbA1c measurements. We investigated the effectiveness of additional use of retrospective continuous glucose monitoring (CGM) in diabetic pregnancies. MATERIAL AND METHODS: We performed a nationwide multicentre, open label, randomized, controlled trial to study pregnant women with type 1 or type 2 diabetes who were undergoing insulin therapy at gestational age < 16 weeks, or women who were undergoing insulin treatment for gestational diabetes at gestational age < 30 weeks. Women were randomly allocated (1:1) to intermittent use of retrospective CGM or to standard treatment. Glycaemic control was assessed by CGM for 5-7 days every 6 weeks in the CGM group, while self-monitoring of blood glucose and HbA1c measurements were applied in both groups. Primary outcome was macrosomia, defined as birth weight above the 90th percentile. Secondary outcomes were glycaemic control and maternal and neonatal complications. RESULTS:Between July 2011 and September 2015, we randomized 300 pregnant women with type 1 (n = 109), type 2 (n = 82) or with gestational (n = 109) diabetes to either CGM (n = 147) or standard treatment (n = 153). The incidence of macrosomia was 31.0% in the CGM group and 28.4% in the standard treatment group (relative risk [RR], 1.06; 95% CI, 0.83-1.37). HbA1c levels were similar between treatment groups. CONCLUSIONS: In diabetic pregnancy, use of intermittent retrospective CGM did not reduce the risk of macrosomia. CGM provides detailed information concerning glycaemic fluctuations but, as a treatment strategy, does not translate into improved pregnancy outcome.
RCT Entities:
AIM: Diabetes is associated with a high risk of adverse pregnancy outcomes. Optimal glycaemic control is fundamental and is traditionally monitored with self-measured glucose profiles and periodic HbA1c measurements. We investigated the effectiveness of additional use of retrospective continuous glucose monitoring (CGM) in diabetic pregnancies. MATERIAL AND METHODS: We performed a nationwide multicentre, open label, randomized, controlled trial to study pregnant women with type 1 or type 2 diabetes who were undergoing insulin therapy at gestational age < 16 weeks, or women who were undergoing insulin treatment for gestational diabetes at gestational age < 30 weeks. Women were randomly allocated (1:1) to intermittent use of retrospective CGM or to standard treatment. Glycaemic control was assessed by CGM for 5-7 days every 6 weeks in the CGM group, while self-monitoring of blood glucose and HbA1c measurements were applied in both groups. Primary outcome was macrosomia, defined as birth weight above the 90th percentile. Secondary outcomes were glycaemic control and maternal and neonatal complications. RESULTS: Between July 2011 and September 2015, we randomized 300 pregnant women with type 1 (n = 109), type 2 (n = 82) or with gestational (n = 109) diabetes to either CGM (n = 147) or standard treatment (n = 153). The incidence of macrosomia was 31.0% in the CGM group and 28.4% in the standard treatment group (relative risk [RR], 1.06; 95% CI, 0.83-1.37). HbA1c levels were similar between treatment groups. CONCLUSIONS: In diabetic pregnancy, use of intermittent retrospective CGM did not reduce the risk of macrosomia. CGM provides detailed information concerning glycaemic fluctuations but, as a treatment strategy, does not translate into improved pregnancy outcome.
Authors: Verónica Perea; Maria José Picón; Ana Megia; Maria Goya; Ana Maria Wägner; Begoña Vega; Nuria Seguí; Maria Dolores Montañez; Irene Vinagre Journal: Diabetologia Date: 2022-05-12 Impact factor: 10.460
Authors: Carol J Levy; Nicole C Foster; Stephanie N DuBose; Shivani Agarwal; Sarah K Lyons; Anne L Peters; Gabriel I Uwaifo; Linda A DiMeglio; Jennifer L Sherr; Sarit Polsky Journal: J Diabetes Sci Technol Date: 2020-11-20