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• W1972596319 abstract "Recently, a randomised controlled trial on the effectiveness of continuous glucose monitoring (CGMS) in pregnant women with diabetes was published.1 The study was accompanied by both a commentary2 and an editorial.3 Why was this study considered important and does it have any implications for current clinical practice? To understand the context of this study it is probably best to refer to the recent National Institute for Health and Clinical Excellence (NICE) guideline ‘Diabetes in pregnancy’.4 The guideline group reviewed all the evidence surrounding target ranges for blood glucose levels in pregnancy. The problem of fetal macrosomia was highlighted and the relationship between birth weight and blood glucose control during pregnancy was examined. It was concluded that HbA1c is not a reliable indicator of glycaemic control in the second and third trimester of pregnancy and that it should not be used for assessing glycaemic control. Women should aim to keep fasting blood glucose between 3.5–5.9mmol/L and the one-hour post-prandial glucose below 7.8mmol/L, although it was accepted that targets must be individualised to avoid the risk of hypoglycaemia. The evidence that informed this recommendation was derived from studies in which intensively-treated pregnant women used self-glucose monitoring testing up to seven times per day pre-prandial and either one hour or two hour post-prandial. Post-prandial blood glucose levels were more strongly associated with macrosomia. NICE has recommended that current clinical practice should change by advising women to monitor fasting blood glucose levels daily and blood glucose levels one hour after every meal during pregnancy. Women with insulin-treated diabetes should also be advised to test blood glucose levels before going to bed at night. Obviously, this is onerous for pregnant diabetic women and technology that could support this intensity of self-glucose monitoring is to be welcomed. So can ambulatory CGMS help to optimise glycaemic control and reduce the burden of self-monitoring? The CGMS is a device that measures glucose levels through electro-chemical detection in the extracellular fluid of the abdominal subcutaneous tissue and stores values in a range of 2.2–22.2mmol/L every five minutes for a maximum of three to seven days. The system is calibrated by four paired sensor glucose/meter readings per 24 hours using finger stick blood glucose levels. It is a new tool and up to now the few studies which have used this technology in diabetic pregnancy have been observational and have used small numbers of patients.5-7 The studies have focused on unravelling the relationship between macrosomia and glycaemic control in women with type 1 or type 2 diabetes. These studies have highlighted that conventional methods of monitoring glycaemic control during pregnancy are inadequate at detecting both hypo- and hyperglycaemia. Intermittent measurement of glycaemic control does not capture the diurnal glucose profile.8,9 So what have Murphy et al.1 contributed to our understanding of diabetic pregnancy management? To recap, their study was a prospective, open-label, randomised controlled trial with 71 diabetic women with type 1 or type 2 diabetes. They used CGMS at intervals of four to six weeks as an educational tool to inform shared decision making and to adjust insulin therapy. The outcome measured was HbA1c every four weeks during the second and third trimester. Women who had the CGMS intervention had lower HbA1c values from 32–36 weeks' gestation compared to women who received standard care, and they had a reduced risk of macrosomia in their off-spring. Importantly, the CGMS monitor was well tolerated and only two of the 38 women in the intervention arm withdrew. The study was carried out in two centres with considerable experience both in the management of diabetic pregnancy and in the use of CGMS. Standard care, in line with NICE guidance, was women self-monitoring seven times a day and aiming for targets of 3.5–5.5mmol/L before meals and one hour post-meal of <7.8mmol/L. The addition of CGMS improved maternal glycaemic control consistently throughout pregnancy, although this only became statistically significant from 32 weeks' gestation. This study has important limitations; the sample is small and the researchers were not blinded. The Hawthorne effect is powerful,10 and it is possible that what has been described in this paper is merely a manifestation of this well-known effect. However, the logic of optimising and normalising glycaemic control in pregnancy is compelling, and another multicentre clinical trial in adults with type 1 diabetes has also shown an improvement in glycaemic control by the use of CGMS.11 The incidence of macrosomia remains high12 and its persistence, despite near optimal glycaemic control during early pregnancy,13 highlights the deficiencies of current treatment strategies. Before there is a move to widespread adoption of CGMS in diabetic pregnancy it is important to understand fully the role of this technology. As yet, this has not been appraised by NICE. Continuous monitors provide multiple glucose levels of reasonable accuracy and are useful in studying glucose trends.14 They generate a lot of data which need interpretation to be useful, but these can provide information on all aspects of fluctuations of blood glucose levels and help prevent both hypo- and hyperglycaemia. The CGMS used by Murphy et al. did not provide ‘real time’ readings, which meant that neither the patient nor the health care professional had access to the information until the end of the three- to seven-day recording when the data were downloaded and interpreted. As the CGMS monitors glucose levels in the interstitial fluid, there is a lag between blood glucose values and those readings from the interstitial fluids – with the readings from the interstitial fluid being lower than blood glucose levels. If ‘real time’ monitors become available, patients will have to be taught that the results are not accurate and to check by finger stick blood glucose measurement. Continuous glucose monitors cost around £2000 and each sensor costs around £50.15 It is clear that if this method of measuring glycaemic control during pregnancy were to be routinely adopted for all diabetic pregnancies, including women with gestational diabetes, there would be a considerable additional cost. It is not clear if this would be cost effective especially if neonatal outcomes related to macroso-mia remain high – as suggested by Murphy et al. Our view is that it is timely for a large multicentre randomised controlled trial to include in the standard care group an additional educational intervention comparable to that in a CGMS group. It is certain that CGMS has a role in the management of diabetic pregnancy, but at the moment it is best placed in the research setting, supported by clinical expertise." @default.
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• W1972596319 date "2009-04-01" @default.
• W1972596319 modified "2023-10-14" @default.
• W1972596319 title "The role of CGMS in the management of pregnant women with diabetes" @default.
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• W1972596319 doi "https://doi.org/10.1002/pdi.1341" @default.
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