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Abstract
This review includes 12 trials involving 863 women with pre-existing diabetes during pregnancy.
- Continuous glucose monitoring (CGM) may reduce hypertensive disorders of pregnancy, but this result should be viewed with caution as it did not lead to a clear reduction in pre-eclampsia.
- No significant differences were observed in the rates of caesarean sections or large-for-gestational age infants when comparing CGM to intermittent glucose monitoring.
- Evidence regarding perinatal mortality and neonatal morbidity was insufficient, being based on single studies of low quality.
- Other monitoring techniques showed very low-quality evidence, making it uncertain whether they impact maternal and infant outcomes.
- The need for large, well-designed randomized trials is highlighted to better understand the effectiveness of different blood glucose monitoring techniques.
Simplified
BACKGROUND: There are a number of ways of monitoring blood glucose in women with diabetes during pregnancy, with self-monitoring of blood glucose (SMBG) recommended as a key component of the management plan. No existing systematic reviews consider the benefits/effectiveness of different techniques of blood glucose monitoring on maternal and infant outcomes among pregnant women with pre-existing diabetes. The effectiveness of the various monitoring techniques is unclear. This review is an update of a review that was first published in 2014 and subsequently updated in 2017.
OBJECTIVES: To compare techniques of blood glucose monitoring and their impact on maternal and infant outcomes among pregnant women with pre-existing diabetes.
SEARCH METHODS: For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (1 November 2018), and reference lists of retrieved studies.
SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-RCTs comparing techniques of blood glucose monitoring including SMBG, continuous glucose monitoring (CGM), automated telemedicine monitoring or clinic monitoring among pregnant women with pre-existing diabetes mellitus (type 1 or type 2). Trials investigating timing and frequency of monitoring were also eligible for inclusion. RCTs using a cluster-randomised design were eligible for inclusion but none were identified.
DATA COLLECTION AND ANALYSIS: Two review authors independently assessed study eligibility, extracted data and assessed the risk of bias of included studies. Data were checked for accuracy. The quality of the evidence was assessed using the GRADE approach.
MAIN RESULTS: This review update includes a total of 12 trials (863) women (792 women with type 1 diabetes and 152 women with type 2 diabetes). The trials took place in Europe, the USA and Canada. Three of the 12 included studies are at low risk of bias, eight studies are at moderate risk of bias, and one study is at high risk of bias. Four trials reported that they were provided with the continuous glucose monitors free of charge or at a reduced cost by the manufacturer.Continuous glucose monitoring (CGM) versus intermittent glucose monitoring, (four studies, 609 women)CGM may reduce hypertensive disorders of pregnancy (pre-eclampsia and pregnancy-induced hypertension) (risk ratio (RR) 0.58, 95% confidence interval (CI) 0.39 to 0.85; 2 studies, 384 women; low-quality evidence), although it should be noted that only two of the four relevant studies reported data for this composite outcome. Conversely, this did not translate into a clear reduction for pre-eclampsia (RR 0.65, 95% CI 0.39 to 1.08; 4 studies, 609 women, moderate-quality evidence). There was also no clear reduction in caesarean section (average RR 0.94, 95% CI 0.75 to 1.18; 3 studies, 427 women; I= 41%; moderate-quality evidence) or large-for-gestational age (average RR 0.84, 95% CI 0.57 to 1.26; 3 studies, 421 women; I= 70%; low-quality evidence) with CGM. There was not enough evidence to assess perinatal mortality (RR 0.82, 95% CI 0.05 to 12.61, 71 infants, 1 study; low-quality evidence), or mortality or morbidity composite (RR 0.80, 95% CI 0.61 to 1.06; 1 study, 200 women) as the evidence was based on single studies of low quality. CGM appears to reduce neonatal hypoglycaemia (RR 0.66, 95% CI 0.48 to 0.93; 3 studies, 428 infants). Neurosensory disability was not reported.Other methods of glucose monitoringFor the following five comparisons, self-monitoring versus a different type of self-monitoring (two studies, 43 women); self-monitoring at home versus hospitalisation (one study, 100 women), pre-prandial versus post-prandial glucose monitoring (one study, 61 women), automated telemedicine monitoring versus conventional system (three studies, 84 women), and constant CGM versus intermittent CGM (one study, 25 women), it is uncertain whether any of the interventions has any impact on any of our GRADE outcomes (hypertensive disorders of pregnancy, caesarean section, large-for-gestational age) because the quality of the evidence was found to be very low. This was due to evidence largely being derived from single trials, with design limitations and limitations with imprecision (wide CIs, small sample sizes, and few events). There was not enough evidence to assess perinatal mortality and neonatal mortality and morbidity composite. Other important outcomes, such as neurosensory disability, were not reported in any of these comparisons. 2 2
AUTHORS' CONCLUSIONS: Two new studies (406 women) have been incorporated to one of the comparisons for this update. Although the evidence suggests that CGM in comparison to intermittent glucose monitoring may reduce hypertensive disorders of pregnancy, this did not translate into a clear reduction for pre-eclampsia, and so this result should be viewed with caution. No differences were observed for other primary outcomes for this comparison. The evidence base for the effectiveness of other monitoring techniques analysed in the other five comparisons is weak and based on mainly single studies with very low-quality evidence. Additional evidence from large well-designed randomised trials is required to inform choices of other glucose monitoring techniques and to confirm the effectiveness of CGM.