"Despite promising pilot evaluations of continuous glucose monitoring it is an expensive and relatively inconvenient tool, prompting the National Institute for Health and Clinical Excellence to call for randomized studies assessing its efficacy on clinically meaningful end points," write Helen R. Murphy, from Ipswich Hospital NHS Trust in Ipswich, United Kingdom, and colleagues. "Evidence of effectiveness on long term glycaemic control or diabetes related morbidity has not been established, with previous studies limited to the use of blood glucose or HbA1c [hemoglobin A1c] levels as surrogate markers of morbidity from diabetes. We evaluated the effectiveness of antenatal continuous glucose monitoring on maternal glycaemic control and pregnancy related morbidity — namely, birth weight and risk of macrosomia in the offspring of mothers with type 1 and type 2 diabetes."
At 2 secondary care, multidisciplinary, UK obstetric clinics, 71 women with type 1 diabetes (n = 46) or type 2 diabetes (n = 25) were randomly assigned to antenatal care plus continuous glucose monitoring (n = 38) or to standard antenatal care (n = 33). At intervals of 4 to 6 weeks during pregnancy, the continuous glucose monitoring group used this intervention as an educational tool to inform shared decision making and future therapeutic changes. Antenatal care was otherwise similar in both groups.
The main endpoint was maternal glycemic control during the second and third trimesters on the basis of measurements of HbA1c levels every 4 weeks. Secondary endpoints were birth weight and the risk for macrosomia on the basis of birth weight SD scores and customized birth weight centile. Analyses were by intent-to-treat.
Compared with women assigned to standard antenatal care, those assigned to continuous glucose monitoring had lower mean HbA1c levels from 32 to 36 weeks' gestation (5.8% ± 0.6% vs 6.4% ± 0.7%, respectively).
Compared with infants of mothers in the control group, those born to mothers in the continuous glucose monitoring group had decreased mean birth weight SD scores (0.9 vs 1.6; effect size, 0.7 SD; 95% confidence interval [CI], 0.0 - 1.3), decreased median customized birth weight centiles (69% vs 93%), and a lower risk for macrosomia (odds ratio, 0.36; 95% CI, 0.13 - 0.98).
"Continuous glucose monitoring during pregnancy is associated with improved glycaemic control in the third trimester, lower birth weight, and reduced risk of macrosomia," the study authors write. "If confirmed by other studies these data have important implications for the antenatal management of women with diabetes as well as the immediate and longer term health of their infants."
Limitations of this study include women predominantly of white European ethnicity, limiting generalizability; lack of blinding of health professionals; longer duration of diabetes in the intervention group; and small sample size.
In an accompanying editorial, Mario R. Festin, from the University of the Philippines, Ermita, in Manila, notes that other standard interventions such as dietary control and medications need to be continued in pregnant women with diabetes.
"This study has shown the potential benefits of continuous glucose monitoring," Dr. Festin writes. "Continuous glucose monitoring is relatively cheap compared with a clinic based monitoring system, and more widespread use may lower costs and make it affordable even in developing countries. The high prevalence and lasting effects of maternal hyperglycaemia suggest that preventive interventions such as continuous glucose monitoring should be the focus of future public health strategies."
Medtronic UK donated the study equipment. The Ipswich Diabetes Centre Charity Research Fund supported this study. The research was sponsored by Ipswich Hospital NHS Trust and was independent of all of the study funders. Dr. Murphy has received salary support from Diabetes UK. Two of the study authors have received honorariums for speaking at research symposiums sponsored by Medtronic in 2004 and 2005.
Dr. Festin has disclosed no relevant financial relationships.
BMJ. Published online September 26, 2008. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 [标签:content1][标签:content2]
作者:admin@医学,生命科学 2011-04-29 14:38