Continuous glucose monitoring during diabetic pregnancy (GlucoMOMS): A multicentre randomized controlled trial
Voormolen, Daphne N.; DeVries, J. Hans; Sanson, Rieneke M.E.; Heringa, Martijn P.; de Valk, Harold W.; Kok, Marjolein; van Loon, Aren J.; Hoogenberg, Klaas; Bekedam, Dick J.; Brouwer, Teri C.B.; Porath, Martina; Erdtsieck, Ronald J.; NijBijvank, Bas; Kip, Huib; van der Heijden, Olivier W.H.; Elving, Lammy D.; Hermsen, Brenda B.; Potter van Loon, B. J.; Rijnders, Robert J.P.; Jansen, Henry J.; Langenveld, Josje; Akerboom, Bettina M.C.; Kiewiet, Rosalie M.; Naaktgeboren, Christiana A.; Mol, Ben W.J.; Franx, Arie; Evers, Inge M.
(2018) Diabetes, Obesity & Metabolism, volume 20, issue 8, pp. 1894 - 1902
(Article)
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
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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.
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Keywords: CGM, diabetes, macrosomia, pregnancy, Internal Medicine, Endocrinology, Diabetes and Metabolism, Endocrinology
ISSN: 1462-8902
Publisher: Wiley-Blackwell
Note: Funding Information: I. M. has received a research grant from ZonMW (the Netherlands Organization for Health Research and Development) and J. D. V. has received research grants from Abbott, Dexcom, Medtronic and Senso-nics, and has received personal fees from Roche Diabetes Care and Sensonics. B. M. W. is supported by an NHMRC Practitioner Fellowship (GNT1082548). B. M. W. reports consultancy for ObsEVa, Merck and Guerbet. All other authors declare no support from any organization or conflict of interest. Funding Information: The study was funded by ZonMw, the Dutch Organization for Health Research and Development, project number 80-82310-97-11157. The funder had no role in study design, data collection, data analysis, data interpretation, or writing of the report. Continuous Glucose Monitors were purchased at a discount price (Medtronic®, Heerlen, The Netherlands). Medtronic had no role in study design, data collection, data analysis, data interpretation, or writing of the report. Publisher Copyright: © 2018 John Wiley & Sons Ltd
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