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Randomized Controlled Trial
. 2008 Sep 25:337:a1680.
doi: 10.1136/bmj.a1680.

Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial

Helen R Murphy  1 , Gerry Rayman, Karen Lewis, Susan Kelly, Balroop Johal, Katherine Duffield, Duncan Fowler, Peter J Campbell, Rosemary C Temple
Affiliations
Randomized Controlled Trial

Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial

Helen R Murphy et al. BMJ. .

Abstract

Objective: To evaluate the effectiveness of continuous glucose monitoring during pregnancy on maternal glycaemic control, infant birth weight, and risk of macrosomia in women with type 1 and type 2 diabetes.

Design: Prospective, open label randomised controlled trial.

Setting: Two secondary care multidisciplinary obstetric clinics for diabetes in the United Kingdom.

Participants: 71 women with type 1 diabetes (n=46) or type 2 diabetes (n=25) allocated to antenatal care plus continuous glucose monitoring (n=38) or to standard antenatal care (n=33).

Intervention: Continuous glucose monitoring was used as an educational tool to inform shared decision making and future therapeutic changes at intervals of 4-6 weeks during pregnancy. All other aspects of antenatal care were equal between the groups.

Main outcome measures: The primary outcome was maternal glycaemic control during the second and third trimesters from measurements of HbA(1c) levels every four weeks. Secondary outcomes were birth weight and risk of macrosomia using birthweight standard deviation scores and customised birthweight centiles. Statistical analyses were done on an intention to treat basis.

Results: Women randomised to continuous glucose monitoring had lower mean HbA(1c) levels from 32 to 36 weeks' gestation compared with women randomised to standard antenatal care: 5.8% (SD 0.6) v 6.4% (SD 0.7). Compared with infants of mothers in the control arm those of mothers in the intervention arm had decreased mean birthweight standard deviation scores (0.9 v 1.6; effect size 0.7 SD, 95% confidence interval 0.0 to 1.3), decreased median customised birthweight centiles (69% v 93%), and a reduced risk of macrosomia (odds ratio 0.36, 95% confidence interval 0.13 to 0.98).

Conclusion: Continuous glucose monitoring during pregnancy is associated with improved glycaemic control in the third trimester, lower birth weight, and reduced risk of macrosomia.

Trial registration: Current Controlled Trials ISRCTN84461581.

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Conflict of interest statement

Competing interests: HRM and GR have received honorariums for speaking at research symposiums sponsored by Medtronic in 2004 and 2005.

Figures

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Fig 1 Progression of women through trial
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Fig 2 Mean HbA1c levels every four weeks in women receiving standard antenatal care (n=33) or antenatal care plus continuous glucose monitoring (n=38). Vertical lines are standard deviation at each time point
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Fig 3 Distribution of birthweight standard deviation scores for 62 healthy living singletons of mothers in continuous glucose monitoring arm (n=32) or standard antenatal care arm (n=30). *Infants of mothers who withdrew from intervention arm (included in intention to treat analysis). Thick lines indicate medians and thin lines interquartile ranges
See this image and copyright information in PMC

Comment in

References

    1. Evers IM, de Valk HW, Mol BW, ter Braak EW, Visser GH. Macrosomia despite good glycaemic control in type I diabetic pregnancy; results of a nationwide study in the Netherlands. Diabetologia 2002;45:1484-9. - PubMed
    1. Macintosh MC, Fleming KM, Bailey JA, Doyle P, Modder J, Acolet D, et al. Perinatal mortality and congenital anomalies in babies of women with type 1 or type 2 diabetes in England, Wales, and Northern Ireland: population based study. BMJ 2006;333:177. - PMC - PubMed
    1. Jensen DM, Damm P, Moelsted-Pedersen L, Ovesen P, Westergaard JG, Moeller M, et al. Outcomes in type 1 diabetic pregnancies: a nationwide, population-based study. Diabetes Care 2004;27:2819-23. - PubMed
    1. Confidential enquiry into maternal and child health: pregnancy in women with type 1 and type 2 diabetes in 2002-03, England, Wales, and Northern Ireland. London: CEMACH, 2005.
    1. Roland JM, Murphy HR, Ball V, Northcote-Wright J, Temple RC. The pregnancies of women with type 2 diabetes: poor outcomes but opportunities for improvement. Diabet Med 2005;22:1774-7. - PubMed

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