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Meta-Analysis
. 2017 Jun 11;6(6):CD009613.
doi: 10.1002/14651858.CD009613.pub3.

Techniques of monitoring blood glucose during pregnancy for women with pre-existing diabetes

Affiliations
Meta-Analysis

Techniques of monitoring blood glucose during pregnancy for women with pre-existing diabetes

Foong Ming Moy et al. Cochrane Database Syst Rev. .

Update in

Abstract

Background: Self-monitoring of blood glucose (SMBG) is recommended as a key component of the management plan for diabetes therapy during pregnancy. No existing systematic reviews consider the benefits/effectiveness of various 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.

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: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 November 2016), searched reference lists of retrieved studies and contacted trial authors.

Selection criteria: Randomised controlled trials (RCTs) and quasi-RCTs comparing techniques of blood glucose monitoring including SMBG, continuous glucose monitoring (CGM) 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 included. 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 at total of 10 trials (538) women (468 women with type 1 diabetes and 70 women with type 2 diabetes). The trials took place in Europe and the USA. Five of the 10 included studies were at moderate risk of bias, four studies were at low to moderate risk of bias, and one study was at high risk of bias. The trials are too small to show differences in important outcomes such as macrosomia, preterm birth, miscarriage or death of baby. Almost all the reported GRADE outcomes were assessed as being very low-quality evidence. This was due to design limitations in the studies, wide confidence intervals, small sample sizes, and few events. In addition, there was high heterogeneity for some outcomes.Various methods of glucose monitoring were compared in the trials. Neither pooled analyses nor individual trial analyses showed any clear advantages of one monitoring technique over another for primary and secondary outcomes. Many important outcomes were not reported.1. Self-monitoring versus standard care (two studies, 43 women): there was no clear difference for caesarean section (risk ratio (RR) 0.78, 95% confidence interval (CI) 0.40 to 1.49; one study, 28 women) or glycaemic control (both very low-quality), and not enough evidence to assess perinatal mortality and neonatal mortality and morbidity composite. Hypertensive disorders of pregnancy, large-for-gestational age, neurosensory disability, and preterm birth were not reported in either study.2. Self-monitoring versus hospitalisation (one study, 100 women): there was no clear difference for hypertensive disorders of pregnancy (pre-eclampsia and hypertension) (RR 4.26, 95% CI 0.52 to 35.16; very low-quality: RR 0.43, 95% CI 0.08 to 2.22; very low-quality). There was no clear difference in caesarean section or preterm birth less than 37 weeks' gestation (both very low quality), and the sample size was too small to assess perinatal mortality (very low-quality). Large-for-gestational age, mortality or morbidity composite, neurosensory disability and preterm birth less than 34 weeks were not reported.3. Pre-prandial versus post-prandial glucose monitoring (one study, 61 women): there was no clear difference between groups for caesarean section (RR 1.45, 95% CI 0.92 to 2.28; very low-quality), large-for-gestational age (RR 1.16, 95% CI 0.73 to 1.85; very low-quality) or glycaemic control (very low-quality). The results for hypertensive disorders of pregnancy: pre-eclampsia and perinatal mortality are not meaningful because these outcomes were too rare to show differences in a small sample (all very low-quality). The study did not report the outcomes mortality or morbidity composite, neurosensory disability or preterm birth.4. Automated telemedicine monitoring versus conventional system (three studies, 84 women): there was no clear difference for caesarean section (RR 0.96, 95% CI 0.62 to 1.48; one study, 32 women; very low-quality), and mortality or morbidity composite in the one study that reported these outcomes. There were no clear differences for glycaemic control (very low-quality). No studies reported hypertensive disorders of pregnancy, large-for-gestational age, perinatal mortality (stillbirth and neonatal mortality), neurosensory disability or preterm birth.5.CGM versus intermittent monitoring (two studies, 225 women): there was no clear difference for pre-eclampsia (RR 1.37, 95% CI 0.52 to 3.59; low-quality), caesarean section (average RR 1.00, 95% CI 0.65 to 1.54; I² = 62%; very low-quality) and large-for-gestational age (average RR 0.89, 95% CI 0.41 to 1.92; I² = 82%; very low-quality). Glycaemic control indicated by mean maternal HbA1c was lower for women in the continuous monitoring group (mean difference (MD) -0.60 %, 95% CI -0.91 to -0.29; one study, 71 women; moderate-quality). There was not enough evidence to assess perinatal mortality and there were no clear differences for preterm birth less than 37 weeks' gestation (low-quality). Mortality or morbidity composite, neurosensory disability and preterm birth less than 34 weeks were not reported.6. Constant CGM versus intermittent CGM (one study, 25 women): there was no clear difference between groups for caesarean section (RR 0.77, 95% CI 0.33 to 1.79; very low-quality), glycaemic control (mean blood glucose in the 3rd trimester) (MD -0.14 mmol/L, 95% CI -2.00 to 1.72; very low-quality) or preterm birth less than 37 weeks' gestation (RR 1.08, 95% CI 0.08 to 15.46; very low-quality). Other primary (hypertensive disorders of pregnancy, large-for-gestational age, perinatal mortality (stillbirth and neonatal mortality), mortality or morbidity composite, and neurosensory disability) or GRADE outcomes (preterm birth less than 34 weeks' gestation) were not reported.

Authors' conclusions: This review found no evidence that any glucose monitoring technique is superior to any other technique among pregnant women with pre-existing type 1 or type 2 diabetes. The evidence base for the effectiveness of monitoring techniques is weak and additional evidence from large well-designed randomised trials is required to inform choices of glucose monitoring techniques.

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Conflict of interest statement

Foong Ming Moy: none declared.

Amita Ray: none declared.

Brian Buckley: none declared.

Helen West: was paid to work on Cochrane reviews by a grant to Cochrane Pregnancy and Childbirth. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.

Figures

Figure 1
Figure 1
Study flow diagram.
Figure 2
Figure 2
Study flow diagram 2016
Figure 3
Figure 3
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Figure 4
Figure 4
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Analysis 1.1
Analysis 1.1
Comparison 1 Self‐monitoring versus standard care, Outcome 1 Caesarean section.
Analysis 1.2
Analysis 1.2
Comparison 1 Self‐monitoring versus standard care, Outcome 2 Perinatal mortality.
Analysis 1.3
Analysis 1.3
Comparison 1 Self‐monitoring versus standard care, Outcome 3 Neonatal mortality and morbidity composite.
Analysis 1.4
Analysis 1.4
Comparison 1 Self‐monitoring versus standard care, Outcome 4 Glycaemic control during/end of treatment (maternal post‐prandial blood glucose).
Analysis 1.5
Analysis 1.5
Comparison 1 Self‐monitoring versus standard care, Outcome 5 Glycaemic control during/end of treatment (maternal HbA1c).
Analysis 1.6
Analysis 1.6
Comparison 1 Self‐monitoring versus standard care, Outcome 6 Miscarriage.
Analysis 1.7
Analysis 1.7
Comparison 1 Self‐monitoring versus standard care, Outcome 7 Neonatal mortality.
Analysis 1.8
Analysis 1.8
Comparison 1 Self‐monitoring versus standard care, Outcome 8 Gestational age at birth.
Analysis 1.9
Analysis 1.9
Comparison 1 Self‐monitoring versus standard care, Outcome 9 Birthweight.
Analysis 1.10
Analysis 1.10
Comparison 1 Self‐monitoring versus standard care, Outcome 10 Respiratory distress syndrome.
Analysis 1.11
Analysis 1.11
Comparison 1 Self‐monitoring versus standard care, Outcome 11 Neonatal hypoglycaemia.
Analysis 1.12
Analysis 1.12
Comparison 1 Self‐monitoring versus standard care, Outcome 12 Neonatal jaundice (hyperbilirubinaemia).
Analysis 1.13
Analysis 1.13
Comparison 1 Self‐monitoring versus standard care, Outcome 13 Neonatal hypocalcaemia.
Analysis 1.14
Analysis 1.14
Comparison 1 Self‐monitoring versus standard care, Outcome 14 Neonatal polycythaemia.
Analysis 1.15
Analysis 1.15
Comparison 1 Self‐monitoring versus standard care, Outcome 15 Neonatal cord vein C‐peptide.
Analysis 2.1
Analysis 2.1
Comparison 2 Self‐monitoring versus hospitalisation, Outcome 1 Pre‐eclampsia.
Analysis 2.2
Analysis 2.2
Comparison 2 Self‐monitoring versus hospitalisation, Outcome 2 Hypertension in pregnancy.
Analysis 2.3
Analysis 2.3
Comparison 2 Self‐monitoring versus hospitalisation, Outcome 3 Caesarean section.
Analysis 2.4
Analysis 2.4
Comparison 2 Self‐monitoring versus hospitalisation, Outcome 4 Perinatal mortality.
Analysis 2.5
Analysis 2.5
Comparison 2 Self‐monitoring versus hospitalisation, Outcome 5 Placental abruption.
Analysis 2.6
Analysis 2.6
Comparison 2 Self‐monitoring versus hospitalisation, Outcome 6 Preterm birth < 37 weeks.
Analysis 2.7
Analysis 2.7
Comparison 2 Self‐monitoring versus hospitalisation, Outcome 7 Respiratory distress syndrome.
Analysis 2.8
Analysis 2.8
Comparison 2 Self‐monitoring versus hospitalisation, Outcome 8 Neonatal hypoglycaemia.
Analysis 2.9
Analysis 2.9
Comparison 2 Self‐monitoring versus hospitalisation, Outcome 9 Neonatal jaundice (hyperbilirubinaemia).
Analysis 2.10
Analysis 2.10
Comparison 2 Self‐monitoring versus hospitalisation, Outcome 10 Major anomalies.
Analysis 2.11
Analysis 2.11
Comparison 2 Self‐monitoring versus hospitalisation, Outcome 11 Antenatal hospital admission.
Analysis 2.12
Analysis 2.12
Comparison 2 Self‐monitoring versus hospitalisation, Outcome 12 Feeding difficulties (not pre‐specified).
Analysis 3.1
Analysis 3.1
Comparison 3 Pre‐prandial versus post‐prandial glucose monitoring, Outcome 1 Pre‐eclampsia.
Analysis 3.2
Analysis 3.2
Comparison 3 Pre‐prandial versus post‐prandial glucose monitoring, Outcome 2 Caesarean section.
Analysis 3.3
Analysis 3.3
Comparison 3 Pre‐prandial versus post‐prandial glucose monitoring, Outcome 3 Large‐for‐gestational age.
Analysis 3.4
Analysis 3.4
Comparison 3 Pre‐prandial versus post‐prandial glucose monitoring, Outcome 4 Perinatal mortality.
Analysis 3.5
Analysis 3.5
Comparison 3 Pre‐prandial versus post‐prandial glucose monitoring, Outcome 5 Weight gain during pregnancy.
Analysis 3.6
Analysis 3.6
Comparison 3 Pre‐prandial versus post‐prandial glucose monitoring, Outcome 6 Insulin dose.
Analysis 3.7
Analysis 3.7
Comparison 3 Pre‐prandial versus post‐prandial glucose monitoring, Outcome 7 Glycaemic control ‐ Insulin dose.
Analysis 3.8
Analysis 3.8
Comparison 3 Pre‐prandial versus post‐prandial glucose monitoring, Outcome 8 Glycaemic control ‐ HbA1c.
Analysis 3.9
Analysis 3.9
Comparison 3 Pre‐prandial versus post‐prandial glucose monitoring, Outcome 9 Stillbirth.
Analysis 3.10
Analysis 3.10
Comparison 3 Pre‐prandial versus post‐prandial glucose monitoring, Outcome 10 Gestational age at birth.
Analysis 3.11
Analysis 3.11
Comparison 3 Pre‐prandial versus post‐prandial glucose monitoring, Outcome 11 Preterm birth < 37 weeks.
Analysis 3.12
Analysis 3.12
Comparison 3 Pre‐prandial versus post‐prandial glucose monitoring, Outcome 12 Macrosomia.
Analysis 3.13
Analysis 3.13
Comparison 3 Pre‐prandial versus post‐prandial glucose monitoring, Outcome 13 Birthweight.
Analysis 3.14
Analysis 3.14
Comparison 3 Pre‐prandial versus post‐prandial glucose monitoring, Outcome 14 Adiposity ‐ Subscapula skinfold thickness.
Analysis 3.15
Analysis 3.15
Comparison 3 Pre‐prandial versus post‐prandial glucose monitoring, Outcome 15 Adiposity ‐ Triceps skinfold thickness.
Analysis 3.16
Analysis 3.16
Comparison 3 Pre‐prandial versus post‐prandial glucose monitoring, Outcome 16 Birth trauma (shoulder dystocia, bone fracture, nerve palsy) (not pre‐specified as a composite).
Analysis 3.17
Analysis 3.17
Comparison 3 Pre‐prandial versus post‐prandial glucose monitoring, Outcome 17 Respiratory distress syndrome.
Analysis 3.18
Analysis 3.18
Comparison 3 Pre‐prandial versus post‐prandial glucose monitoring, Outcome 18 Neonatal hypoglycaemia.
Analysis 3.19
Analysis 3.19
Comparison 3 Pre‐prandial versus post‐prandial glucose monitoring, Outcome 19 Neonatal jaundice (hyperbilirubinaemia).
Analysis 3.20
Analysis 3.20
Comparison 3 Pre‐prandial versus post‐prandial glucose monitoring, Outcome 20 Cord IGF‐1.
Analysis 3.21
Analysis 3.21
Comparison 3 Pre‐prandial versus post‐prandial glucose monitoring, Outcome 21 Neonatal glucose at age 1 hour (not pre‐specified).
Analysis 3.22
Analysis 3.22
Comparison 3 Pre‐prandial versus post‐prandial glucose monitoring, Outcome 22 Transient tachypnea (not pre‐specified).
Analysis 3.23
Analysis 3.23
Comparison 3 Pre‐prandial versus post‐prandial glucose monitoring, Outcome 23 Neonatal intensive care admissions.
Analysis 4.1
Analysis 4.1
Comparison 4 Automated telemedicine monitoring versus conventional, Outcome 1 Caesarean section.
Analysis 4.2
Analysis 4.2
Comparison 4 Automated telemedicine monitoring versus conventional, Outcome 2 Neonatal morbidity composite.
Analysis 4.3
Analysis 4.3
Comparison 4 Automated telemedicine monitoring versus conventional, Outcome 3 Weight gain during pregnancy [kg].
Analysis 4.4
Analysis 4.4
Comparison 4 Automated telemedicine monitoring versus conventional, Outcome 4 Use of additional insulin therapy.
Analysis 4.5
Analysis 4.5
Comparison 4 Automated telemedicine monitoring versus conventional, Outcome 5 Insulin requirement at end of study.
Analysis 4.6
Analysis 4.6
Comparison 4 Automated telemedicine monitoring versus conventional, Outcome 6 Glycaemic control ‐ Maternal fasting blood glucose: before breakfast.
Analysis 4.7
Analysis 4.7
Comparison 4 Automated telemedicine monitoring versus conventional, Outcome 7 Glycaemic control ‐ Maternal fasting blood glucose: before lunch.
Analysis 4.8
Analysis 4.8
Comparison 4 Automated telemedicine monitoring versus conventional, Outcome 8 Glycaemic control ‐ Maternal HbA1c.
Analysis 4.9
Analysis 4.9
Comparison 4 Automated telemedicine monitoring versus conventional, Outcome 9 Glycaemic control ‐ Maternal post‐prandial blood glucose.
Analysis 4.10
Analysis 4.10
Comparison 4 Automated telemedicine monitoring versus conventional, Outcome 10 Gestational age at birth.
Analysis 4.11
Analysis 4.11
Comparison 4 Automated telemedicine monitoring versus conventional, Outcome 11 Macrosomia.
Analysis 4.12
Analysis 4.12
Comparison 4 Automated telemedicine monitoring versus conventional, Outcome 12 Birthweight.
Analysis 5.1
Analysis 5.1
Comparison 5 Continuous glucose monitoring versus intermittent glucose monitoring, Outcome 1 Pre‐eclampsia.
Analysis 5.2
Analysis 5.2
Comparison 5 Continuous glucose monitoring versus intermittent glucose monitoring, Outcome 2 Caesarean section.
Analysis 5.3
Analysis 5.3
Comparison 5 Continuous glucose monitoring versus intermittent glucose monitoring, Outcome 3 Large‐for‐gestational age.
Analysis 5.4
Analysis 5.4
Comparison 5 Continuous glucose monitoring versus intermittent glucose monitoring, Outcome 4 Perinatal mortality.
Analysis 5.5
Analysis 5.5
Comparison 5 Continuous glucose monitoring versus intermittent glucose monitoring, Outcome 5 Glycaemic control ‐ Maternal HbA1c.
Analysis 5.6
Analysis 5.6
Comparison 5 Continuous glucose monitoring versus intermittent glucose monitoring, Outcome 6 Miscarriage.
Analysis 5.7
Analysis 5.7
Comparison 5 Continuous glucose monitoring versus intermittent glucose monitoring, Outcome 7 Neonatal mortality.
Analysis 5.8
Analysis 5.8
Comparison 5 Continuous glucose monitoring versus intermittent glucose monitoring, Outcome 8 Gestational age at birth.
Analysis 5.9
Analysis 5.9
Comparison 5 Continuous glucose monitoring versus intermittent glucose monitoring, Outcome 9 Preterm birth < 37 weeks.
Analysis 5.10
Analysis 5.10
Comparison 5 Continuous glucose monitoring versus intermittent glucose monitoring, Outcome 10 Small‐for‐gestational age.
Analysis 5.11
Analysis 5.11
Comparison 5 Continuous glucose monitoring versus intermittent glucose monitoring, Outcome 11 Birthweight.
Analysis 5.12
Analysis 5.12
Comparison 5 Continuous glucose monitoring versus intermittent glucose monitoring, Outcome 12 Neonatal hypoglycaemia.
Analysis 5.13
Analysis 5.13
Comparison 5 Continuous glucose monitoring versus intermittent glucose monitoring, Outcome 13 Major anomalies.
Analysis 5.14
Analysis 5.14
Comparison 5 Continuous glucose monitoring versus intermittent glucose monitoring, Outcome 14 Neonatal intensive care unit admissions.
Analysis 6.1
Analysis 6.1
Comparison 6 Constant CGM versus intermittent CGM, Outcome 1 Caesarean section.
Analysis 6.2
Analysis 6.2
Comparison 6 Constant CGM versus intermittent CGM, Outcome 2 Weight gain during pregnancy.
Analysis 6.3
Analysis 6.3
Comparison 6 Constant CGM versus intermittent CGM, Outcome 3 Insulin dosage, 3rd trimester (IU/kg/day).
Analysis 6.4
Analysis 6.4
Comparison 6 Constant CGM versus intermittent CGM, Outcome 4 Glycaemic control ‐ Maternal blood glucose (1st trimester).
Analysis 6.5
Analysis 6.5
Comparison 6 Constant CGM versus intermittent CGM, Outcome 5 Glycaemic control ‐ Maternal blood glucose (3rd trimester).
Analysis 6.6
Analysis 6.6
Comparison 6 Constant CGM versus intermittent CGM, Outcome 6 Glycaemic control ‐ Maternal HbA1c (1st trimester).
Analysis 6.7
Analysis 6.7
Comparison 6 Constant CGM versus intermittent CGM, Outcome 7 Glycaemic control ‐ Maternal HbA1c (3rd trimester).
Analysis 6.8
Analysis 6.8
Comparison 6 Constant CGM versus intermittent CGM, Outcome 8 Maternal hypoglycemia.
Analysis 6.9
Analysis 6.9
Comparison 6 Constant CGM versus intermittent CGM, Outcome 9 Diabetic ketoacidosis (not pre‐specified).
Analysis 6.10
Analysis 6.10
Comparison 6 Constant CGM versus intermittent CGM, Outcome 10 Preterm birth < 37 weeks.
Analysis 6.11
Analysis 6.11
Comparison 6 Constant CGM versus intermittent CGM, Outcome 11 Macrosomia.
Analysis 6.12
Analysis 6.12
Comparison 6 Constant CGM versus intermittent CGM, Outcome 12 Neonatal hypoglycaemia.

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References

References to studies included in this review

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Additional references

    1. ACOG Committee on Practice Bulletins, authors. Pregestational diabetes mellitus: ACOG Clinical Management Guidelines for Obstetrician‐Gynecologists #60. Obstetrics & Gynecology 2005;105:675‐85. - PubMed
    1. ADA. Preconception care of women with diabetes (Position Statement). Diabetes Care 2004;27:S76‐S78. - PubMed
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References to other published versions of this review

    1. Moy FM, Ray A, Buckley BS. Techniques of monitoring blood glucose during pregnancy for women with pre‐existing diabetes. Cochrane Database of Systematic Reviews 2012, Issue 2. [DOI: 10.1002/14651858.CD009613] - DOI - PubMed
    1. Moy FM, Ray A, Buckley BS. Techniques of monitoring blood glucose during pregnancy for women with pre‐existing diabetes. Cochrane Database of Systematic Reviews 2014, Issue 4. [DOI: 10.1002/14651858.CD009613.pub2] - DOI - PubMed

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