Different intensities of glycaemic control for pregnant women with pre‐existing diabetes

Philippa Middleton; Caroline A Crowther; Lucy Simmonds

doi:10.1002/14651858.CD008540.pub4

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Figure 1

Study flow diagram.

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Figure 2

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

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Figure 3

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

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Analysis 1.1

Comparison 1 Very tight versus tight‐moderate glycaemic control, Outcome 1 Caesarean section.

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Analysis 1.2

Comparison 1 Very tight versus tight‐moderate glycaemic control, Outcome 2 Perinatal mortality.

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Analysis 1.3

Comparison 1 Very tight versus tight‐moderate glycaemic control, Outcome 3 Serious perinatal morbidity.

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Analysis 1.4

Comparison 1 Very tight versus tight‐moderate glycaemic control, Outcome 4 Congenital fetal anomaly.

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Analysis 1.5

Comparison 1 Very tight versus tight‐moderate glycaemic control, Outcome 5 Pregnancy‐induced hypertension.

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Analysis 1.6

Comparison 1 Very tight versus tight‐moderate glycaemic control, Outcome 6 Chronic hypertension: not prespecified.

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Analysis 1.7

Comparison 1 Very tight versus tight‐moderate glycaemic control, Outcome 7 Glycaemic control ‐ Self‐monitored blood glucose (mean, mmol/L).

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Analysis 1.8

Comparison 1 Very tight versus tight‐moderate glycaemic control, Outcome 8 Glycaemic control ‐ Self‐monitored blood glucose tests/day.

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Analysis 1.9

Comparison 1 Very tight versus tight‐moderate glycaemic control, Outcome 9 Glycaemic control ‐ HbA1c (%): first trimester.

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Analysis 1.10

Comparison 1 Very tight versus tight‐moderate glycaemic control, Outcome 10 Glycaemic control ‐ HbA1c (%): second trimester.

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Analysis 1.11

Comparison 1 Very tight versus tight‐moderate glycaemic control, Outcome 11 Glycaemic control ‐ HbA1c (%): third trimester.

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Analysis 1.12

Comparison 1 Very tight versus tight‐moderate glycaemic control, Outcome 12 Glycaemic control ‐ Mean preprandial glucose (mmol/L).

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Analysis 1.13

Comparison 1 Very tight versus tight‐moderate glycaemic control, Outcome 13 Glycaemic control ‐ Mean postprandial glucose (mmol/L).

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Analysis 1.14

Comparison 1 Very tight versus tight‐moderate glycaemic control, Outcome 14 Glycaemic control ‐ Below FBG threshold (% days).

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Analysis 1.15

Comparison 1 Very tight versus tight‐moderate glycaemic control, Outcome 15 Hypoglycaemic episodes ‐ > 1 subjective (% of days): not prespecified.

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Analysis 1.16

Comparison 1 Very tight versus tight‐moderate glycaemic control, Outcome 16 Gestational weight gain (kg/week).

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Analysis 1.17

Comparison 1 Very tight versus tight‐moderate glycaemic control, Outcome 17 Fetal distress: not prespecified.

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Analysis 1.18

Comparison 1 Very tight versus tight‐moderate glycaemic control, Outcome 18 Gestational age at birth (weeks).

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Analysis 1.19

Comparison 1 Very tight versus tight‐moderate glycaemic control, Outcome 19 Birthweight (g).

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Analysis 1.20

Comparison 1 Very tight versus tight‐moderate glycaemic control, Outcome 20 Apgar score.

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Analysis 1.21

Comparison 1 Very tight versus tight‐moderate glycaemic control, Outcome 21 Asphyxia: not prespecified.

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Analysis 1.22

Comparison 1 Very tight versus tight‐moderate glycaemic control, Outcome 22 Neonatal hypocalcaemia.

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Analysis 1.23

Comparison 1 Very tight versus tight‐moderate glycaemic control, Outcome 23 Neonatal hypomagnesaemia: not prespecified.

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Analysis 1.24

Comparison 1 Very tight versus tight‐moderate glycaemic control, Outcome 24 Maternal hospitalisation (days).

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Analysis 2.1

Comparison 2 Tight versus moderate glycaemic control, Outcome 1 Pre‐eclampsia.

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Analysis 2.2

Comparison 2 Tight versus moderate glycaemic control, Outcome 2 Caesarean section.

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Analysis 2.3

Comparison 2 Tight versus moderate glycaemic control, Outcome 3 Perinatal mortality.

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Analysis 2.4

Comparison 2 Tight versus moderate glycaemic control, Outcome 4 Transient maternal hypertension.

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Analysis 2.5

Comparison 2 Tight versus moderate glycaemic control, Outcome 5 Hypoglycaemic epispodes ‐ first half of pregnancy: not prespecified.

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Analysis 2.6

Comparison 2 Tight versus moderate glycaemic control, Outcome 6 Large‐for‐gestational age (birthweight > 90th centile).

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Analysis 2.7

Comparison 2 Tight versus moderate glycaemic control, Outcome 7 Respiratory distress syndrome.

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Analysis 3.1

Comparison 3 Tight‐moderate versus loose glycaemic control, Outcome 1 Pre‐eclampsia.

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Analysis 3.2

Comparison 3 Tight‐moderate versus loose glycaemic control, Outcome 2 Caesarean section.

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Analysis 3.3

Comparison 3 Tight‐moderate versus loose glycaemic control, Outcome 3 Perinatal mortality.

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Analysis 3.4

Comparison 3 Tight‐moderate versus loose glycaemic control, Outcome 4 Transient maternal hypertension.

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Analysis 3.5

Comparison 3 Tight‐moderate versus loose glycaemic control, Outcome 5 Hypoglycaemic episodes ‐ in first half of pregnancy: not prespecified.

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Analysis 3.6

Comparison 3 Tight‐moderate versus loose glycaemic control, Outcome 6 Large‐for‐gestational age (birthweight > 90th centile).

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Analysis 3.7

Comparison 3 Tight‐moderate versus loose glycaemic control, Outcome 7 Respiratory distress syndrome.

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Summary of findings for the main comparison. Very tight versus tight‐moderate glycaemic control (maternal outcomes)

Very tight versus tight‐moderate glycaemic control (FBG target 3.33 to 5.0 versus 5.27 to 6.38 mmol/L)
Patient or population: pregnant women with pre‐existing type 1 diabetes Setting: one study, USA Intervention: very tight Comparison: tight‐moderate glycaemic control
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
Outcomes	Risk with tight‐moderate glycaemic control	Risk with very tight glycaemic control	Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
Pre‐eclampsia				not reported
Caesarean section	Study population		RR 0.92 (0.49 to 1.73)	22 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2}	FBG target 3.3 to 5.0 versus 5.27 to 6.38 mmol/L
Caesarean section	667 per 1000	613 per 1000 (327 to 1000)	RR 0.92 (0.49 to 1.73)	22 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2}	FBG target 3.3 to 5.0 versus 5.27 to 6.38 mmol/L
Perineal trauma				not reported
Gestational weight gain	The mean difference in gestational weight gain (kg/week) was 0	The mean difference in gestational weight gain (kg/week) was 0.02 kg/week more (0.23 fewer to 0.27 more)		22 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2}	FBG target 3.3 to 5.0 versus 5.27 to 6.38 mmol/L
Postnatal depression				not reported
Induction of labour				not reported
Later development of cardiovascular disease				not reported
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ One study with design limitations. ² Wide confidence interval crossing the line of no effect, and small sample size.

Summary of findings for the main comparison. Very tight versus tight‐moderate glycaemic control (maternal outcomes)

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Summary of findings 2. Very tight versus tight‐moderate glycaemic control (infant outcomes)

Very tight versus tight‐moderate glycaemic control (FBG target 3.33 to 5.0 versus 5.27 to 6.38 mmol/L or FBG target < 4.44 versus < 5.55 mmol/L)
Patient or population: pregnant women with pre‐existing type 1 diabetes Setting: 2 studies, both USA Intervention: very tight Comparison: tight‐moderate glycaemic control
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with tight‐moderate glycaemic control	Risk with very tight glycaemic control
Large‐for‐gestational age				not reported
Perinatal mortality	Study population		not estimable	22 (1 RCT)	⊕⊕⊝⊝ LOW ^{1 2}	FBG target 3.33 to 5.0 versus 5.27 to 6.38 mmol/L
	0 per 1000	0 per 1000 (0 to 0)
Serious perinatal morbidity	Study population		not estimable	22 (1 RCT)	⊕⊕⊝⊝ LOW ^{1 2}	FBG target 3.33 to 5.0 versus 5.27 to 6.38 mmol/L
	0 per 1000	0 per 1000 (0 to 0)
Neonatal hypoglycaemia				not reported
Childhood/adulthood adiposity				not reported
Childhood/adulthood diabetes				not reported
Childhood/adulthood neurosensory disability				not reported
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ One study with design limitations. ² Small sample size, no events.

Summary of findings 2. Very tight versus tight‐moderate glycaemic control (infant outcomes)

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Summary of findings 3. Tight versus moderate glycaemic control (maternal outcomes)

Tight versus moderate glycaemic control (FBG target ≤ 5.6 mmol/L versus 5.6 to 6.7 mmol/L) ‐ Maternal outcomes
Patient or population: pregnant women with pre‐existing type 1 diabetes Setting: 1 study, Saudi Arabia Intervention: tight Comparison: moderate glycaemic control
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with moderate glycaemic control	Risk with tight glycaemic control
Pre‐eclampsia	Study population		RR 5.29 (0.23 to 122.91)	45 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2}	FBG target ≤ 5.6 versus 5.6 to 6.7 mmol/L Moderate: 0 out of 29 women, Tight: 1 out of 16 women.
	not estimable	not estimable
Caesarean section	Study population		RR 1.21 (0.22 to 6.50)	45 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2}	FBG target ≤ 5.6 versus 5.6 to 6.7 mmol/L
	103 per 1000	125 per 1000 (23 to 672)
Perineal trauma				not reported
Gestational weight gain				not reported
Postnatal depression				not reported
Induction of labour				not reported
Later development of cardiovascular disease				not reported
¹ One study with design limitations. ² Wide confidence interval crossing the line of no effect, few events and small sample size.

Summary of findings 3. Tight versus moderate glycaemic control (maternal outcomes)

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Summary of findings 4. Tight versus moderate glycaemic control (infant outcomes)

Tight versus moderate glycaemic control (FBG target ≤ 5.6 mmol/L versus 5.6 to 6.7 mmol/L) ‐ Infant outcomes
Patient or population: pregnant women with pre‐existing type 1 diabetes Setting: 1 study, Saudi Arabia Intervention: tight Comparison: moderate glycaemic control
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with moderate glycaemic control	Risk with tight glycaemic control
Large‐for‐gestational age (birthweight > 90th centile)	Study population		not estimable	45 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2}	FBG target ≤ 5.6 versus 5.6 to 6.7 mmol/L
	0 per 1000	0 per 1000 (0 to 0)
Perinatal mortality	Study population		not estimable	45 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2}	FBG target ≤ 5.6 versus 5.6 to 6.7 mmol/L
	0 per 1000	0 per 1000 (0 to 0)
Serious perinatal morbidity				not reported
Neonatal hypoglycaemia				not reported
Childhood/adulthood adiposity				not reported
Childhood/adulthood diabetes				not reported
Childhood/adulthood neurosensory disability				not reported
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ One study with design limitations. ² No events & small sample size.

Summary of findings 4. Tight versus moderate glycaemic control (infant outcomes)

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Summary of findings 5. Tight‐moderate versus loose glycaemic control (maternal outcomes)

Tight‐moderate versus loose glycaemic control (FBG ≤ 6.7 mmol/L versus 6.7 to 8.9 mmol/L) ‐ Maternal outcomes
Patient or population: pregnant women with pre‐existing type 1 diabetes Setting: 1 study, Saudi Arabia Intervention: tight‐moderate Comparison: loose glycaemic control (mother)
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with loose glycaemic control (mother)	Risk with Tight‐moderate
Pre‐eclampsia	Study population		RR 0.11 (0.01 to 0.99)	60 (1 RCT)	⊕⊕⊝⊝ LOW ^{1 2}	FBG target ≤ 6.7 mmol/L versus 6.7 to 8.9 mmol/L
	200 per 1000	22 per 1000 (2 to 198)
Caesarean section	Study population		RR 0.28 (0.10 to 0.78)	60 (1 RCT)	⊕⊕⊝⊝ LOW ^{1 3}	FBG target ≤ 6.7 versus 6.7 to 8.9 mmol/L
	400 per 1000	112 per 1000 (40 to 312)
Perineal trauma				not reported
Gestational weight gain				not reported
Postnatal depression				not reported
Induction of labour				not reported
Later development of cardiovascular disease				not reported
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio;
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ One study with design limitations. ² Few events and small sample size. ³ Small sample size.

Summary of findings 5. Tight‐moderate versus loose glycaemic control (maternal outcomes)

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Summary of findings 6. Tight‐moderate versus loose glycaemic control (infant outcomes)

Tight‐moderate versus loose glycaemic control (FBG ≤ 6.7 mmol/L versus 6.7 to 8.9 mmol/L) ‐ Infant outcomes
Patient or population: pregnant women with pre‐existing type 1 diabetes Setting: 1 study, Saudi Arabia Intervention: tight‐moderate Comparison: loose glycaemic control
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with loose glycaemic control	Risk with tight‐moderate glycaemic control
Large‐for‐gestational age (birthweight > 90th centile)	Study population		RR 0.01 (0.00 to 0.20)	60 (1 RCT)	⊕⊕⊝⊝ LOW ^{1 2}	FBG target ≤ 6.7 versus 6.7 to 8.9 mmol/L
	867 per 1000	9 per 1000 (0 to 173)
Perinatal mortality	Study population		RR 0.07 (0.00 to 1.37)	60 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 3}	FBG target ≤ 6.7 versus 6.7 to 8.9 mmol/L
	133 per 1000	9 per 1000 (0 to 183)
Serious perinatal morbidity				not reported
Neonatal hypoglycaemia				not reported
Childhood/adulthood adiposity				not reported
Childhood/adulthood diabetes				not reported
Childhood/adulthood neurosensory disability				not reported
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ One study with design limitations. ² Small sample size. ³ Wide confidence interval crossing the line of no effect, few events and small sample size.

Summary of findings 6. Tight‐moderate versus loose glycaemic control (infant outcomes)

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Comparison 1. Very tight versus tight‐moderate glycaemic control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Caesarean section Show forest plot	1	22	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.49, 1.73]

1.1 FBG target 3.33 to 5.0 vs 5.27 to 6.38 mmol/L	1	22	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.49, 1.73]
2 Perinatal mortality Show forest plot	1	22	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

2.1 FBG target 3.33 to 5.0 vs 5.27 to 6.38 mmol/L	1	22	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Serious perinatal morbidity Show forest plot	1	22	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

3.1 FBG target 3.33 to 5.0 vs 5.27 to 6.38 mmol/L	1	22	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Congenital fetal anomaly Show forest plot	1	22	Risk Ratio (M‐H, Fixed, 95% CI)	3.57 [0.19, 66.61]

4.1 FBG target 3.33 to 5.0 vs 5.27 to 6.38 mmol/L	1	22	Risk Ratio (M‐H, Fixed, 95% CI)	3.57 [0.19, 66.61]
5 Pregnancy‐induced hypertension Show forest plot	1	137	Risk Ratio (M‐H, Fixed, 95% CI)	1.40 [0.60, 3.25]

5.1 FBG target < 4.44 vs < 5.55 mmol/L	1	137	Risk Ratio (M‐H, Fixed, 95% CI)	1.40 [0.60, 3.25]
6 Chronic hypertension: not prespecified Show forest plot	1	22	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

6.1 FBG target 3.33 to 5.0 mmol/L vs 5.27 to 6.38 mmol/L	1	22	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7 Glycaemic control ‐ Self‐monitored blood glucose (mean, mmol/L) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

7.1 FBG target 3.33 to 5.0 vs 5.27 to 6.38 mmol/L: first trimester	1	22	Mean Difference (IV, Fixed, 95% CI)	‐1.23 [‐2.19, ‐0.27]
7.2 FBG target 3.33 to 5.0 vs 5.27 to 6.38 mmol/L: second trimester	1	22	Mean Difference (IV, Fixed, 95% CI)	‐0.99 [‐1.64, ‐0.34]
7.3 FBG target 3.33 to 5.0 vs 5.27 to 6.38 mmol/L: third trimester	1	22	Mean Difference (IV, Fixed, 95% CI)	‐0.66 [‐1.60, 0.28]
8 Glycaemic control ‐ Self‐monitored blood glucose tests/day Show forest plot	1	22	Mean Difference (IV, Fixed, 95% CI)	1.60 [‐0.15, 3.35]

8.1 FBG target 3.33 to 5.0 vs 5.27 to 6.39 mmol/L	1	22	Mean Difference (IV, Fixed, 95% CI)	1.60 [‐0.15, 3.35]
9 Glycaemic control ‐ HbA1c (%): first trimester Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

9.1 FBG target 3.33 to 5.0 vs 5.27 to 6.38 mmol/L	1	22	Mean Difference (IV, Fixed, 95% CI)	‐1.20 [‐2.25, ‐0.15]
9.2 FBG target < 4.44 vs < 5.55 mmol/L	1	137	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐0.62, 0.62]
10 Glycaemic control ‐ HbA1c (%): second trimester Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

10.1 FBG target 3.33 to 5.0 vs 5.27 to 6.38 mmol/L	1	22	Mean Difference (IV, Fixed, 95% CI)	‐0.5 [‐1.09, 0.09]
10.2 FBG target < 4.44 vs < 5.55 mmol/L	1	137	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐0.37, 0.57]
11 Glycaemic control ‐ HbA1c (%): third trimester Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

11.1 FBG target 3.33 to 5.0 vs 5.27 to 6.38 mmol/L	1	22	Mean Difference (IV, Fixed, 95% CI)	‐0.30 [‐0.92, 0.32]
11.2 FBG target < 4.44 vs < 5.55 mmol/L	1	137	Mean Difference (IV, Fixed, 95% CI)	‐0.10 [‐0.49, 0.29]
12 Glycaemic control ‐ Mean preprandial glucose (mmol/L) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

12.1 FBG target < 4.44 vs < 5.55 mmol/L: first trimester	1	137	Mean Difference (IV, Fixed, 95% CI)	‐0.39 [‐1.33, 0.55]
12.2 FBG target < 4.44 vs < 5.55 mmol/L: second trimester	1	137	Mean Difference (IV, Fixed, 95% CI)	‐0.27 [‐1.19, 0.65]
12.3 FBG target < 4.44 vs < 5.55 mmol/L: third trimester	1	137	Mean Difference (IV, Fixed, 95% CI)	‐0.34 [‐1.40, 0.72]
13 Glycaemic control ‐ Mean postprandial glucose (mmol/L) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

13.1 FBG target < 4.44 vs < 5.55 mmol/L: first trimester	1	137	Mean Difference (IV, Fixed, 95% CI)	‐0.94 [‐2.05, 0.17]
13.2 FBG target < 4.44 vs < 5.55 mmol/L: second trimester	1	137	Mean Difference (IV, Fixed, 95% CI)	‐0.56 [‐1.38, 0.26]
13.3 FBG target < 4.44 vs < 5.55 mmol/L: third trimester	1	137	Mean Difference (IV, Fixed, 95% CI)	‐0.11 [‐1.26, 1.04]
14 Glycaemic control ‐ Below FBG threshold (% days) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

14.1 < 3.33 mmol/L	1	22	Mean Difference (IV, Fixed, 95% CI)	20.0 [7.00, 33.00]
14.2 < 2.78 mmol/L	1	22	Mean Difference (IV, Fixed, 95% CI)	17.0 [4.04, 29.96]
14.3 < 2.22 mmol/L	1	22	Mean Difference (IV, Fixed, 95% CI)	8.0 [‐3.56, 19.56]
15 Hypoglycaemic episodes ‐ > 1 subjective (% of days): not prespecified Show forest plot	1	22	Mean Difference (IV, Fixed, 95% CI)	22.0 [11.07, 32.93]

15.1 FBG target 3.33 to 5.0 vs 5.27 to 6.38 mmol/L	1	22	Mean Difference (IV, Fixed, 95% CI)	22.0 [11.07, 32.93]
16 Gestational weight gain (kg/week) Show forest plot	1	22	Mean Difference (IV, Fixed, 95% CI)	0.02 [‐0.23, 0.27]

16.1 FBG target 3.3 to 5.0 vs 5.27 to 6.38 mmol/L	1	22	Mean Difference (IV, Fixed, 95% CI)	0.02 [‐0.23, 0.27]
17 Fetal distress: not prespecified Show forest plot	1	137	Risk Ratio (M‐H, Fixed, 95% CI)	1.15 [0.63, 2.11]

17.1 FBG target < 4.44 vs < 5.55 mmol/L	1	137	Risk Ratio (M‐H, Fixed, 95% CI)	1.15 [0.63, 2.11]
18 Gestational age at birth (weeks) Show forest plot	2	159	Mean Difference (IV, Fixed, 95% CI)	0.43 [‐0.23, 1.08]

18.1 FBG target 3.33 to 5.0 vs 5.27 to 6.38 mmol/L	1	22	Mean Difference (IV, Fixed, 95% CI)	‐0.30 [‐2.44, 1.84]
18.2 FBG target < 4.44 vs < 5.55 mmol/L	1	137	Mean Difference (IV, Fixed, 95% CI)	0.5 [‐0.19, 1.19]
19 Birthweight (g) Show forest plot	2	159	Mean Difference (IV, Fixed, 95% CI)	‐2.62 [‐179.83, 174.59]

19.1 FBG target 3.33 to 5.0 vs 5.27 to 6.38 mmol/L	1	22	Mean Difference (IV, Fixed, 95% CI)	‐272.0 [‐803.99, 259.99]
19.2 FBG target < 4.44 vs < 5.55 mmol/L	1	137	Mean Difference (IV, Fixed, 95% CI)	31.0 [‐156.95, 218.95]
20 Apgar score Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

20.1 < 7 at 1 minute: FBG target < 4.44 vs < 5.55 mmol/L	1	137	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.40, 2.55]
20.2 < 7 at 5 minutes: FBG target < 4.44 vs < 5.55 mmol/L	1	137	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
21 Asphyxia: not prespecified Show forest plot	1	137	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.58, 1.78]

21.1 FBG target < 4.44 vs < 5.55 mmol/L	1	137	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.58, 1.78]
22 Neonatal hypocalcaemia Show forest plot	1	137	Risk Ratio (M‐H, Fixed, 95% CI)	0.55 [0.30, 1.03]

22.1 FBG target < 4.44 vs < 5.55 mmol/L	1	137	Risk Ratio (M‐H, Fixed, 95% CI)	0.55 [0.30, 1.03]
23 Neonatal hypomagnesaemia: not prespecified Show forest plot	1	127	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.25, 1.68]

23.1 FBG target < 4.44 vs < 5.55 mmol/L	1	127	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.25, 1.68]
24 Maternal hospitalisation (days) Show forest plot	1	137	Mean Difference (IV, Fixed, 95% CI)	10.60 [9.53, 11.67]

24.1 FBG target < 4.44 vs < 5.55 mmol/L	1	137	Mean Difference (IV, Fixed, 95% CI)	10.60 [9.53, 11.67]

Comparison 1. Very tight versus tight‐moderate glycaemic control

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Comparison 2. Tight versus moderate glycaemic control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pre‐eclampsia Show forest plot	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	5.29 [0.23, 122.91]

1.1 FBG target ≤ 5.6 mmol/L vs 5.6 to 6.7 mmol/L	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	5.29 [0.23, 122.91]
2 Caesarean section Show forest plot	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	1.21 [0.22, 6.50]

2.1 FBG target ≤ 5.6 vs 5.6 to 6.7 mmol/L	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	1.21 [0.22, 6.50]
3 Perinatal mortality Show forest plot	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

3.1 FBG target ≤ 5.6 vs 5.6 to 6.7 mmol/L	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Transient maternal hypertension Show forest plot	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	0.59 [0.03, 13.66]

4.1 FBG target ≤ 5.6 vs 5.6 to 6.7 mmol/L	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	0.59 [0.03, 13.66]
5 Hypoglycaemic epispodes ‐ first half of pregnancy: not prespecified Show forest plot	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	26.47 [1.61, 435.38]

5.1 FBG target ≤ 5.6 vs 5.6 to 6.7 mmol/L	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	26.47 [1.61, 435.38]
6 Large‐for‐gestational age (birthweight > 90th centile) Show forest plot	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

6.1 FBG target ≤ 5.6 vs 5.6 to 6.7 mmol/L	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7 Respiratory distress syndrome Show forest plot	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.09, 9.24]

7.1 FBG target ≤ 5.6 v 5.6 to 6.7 mmol/L	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.09, 9.24]

Comparison 2. Tight versus moderate glycaemic control

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Comparison 3. Tight‐moderate versus loose glycaemic control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pre‐eclampsia Show forest plot	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.11 [0.01, 0.99]

1.1 FBG ≤ 6.7 mmol/L vs 6.7 to 8.9 mmol/L	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.11 [0.01, 0.99]
2 Caesarean section Show forest plot	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.28 [0.10, 0.78]

2.1 FBG target ≤ 6.7 vs 6.7 to 8.9 mmol/L	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.28 [0.10, 0.78]
3 Perinatal mortality Show forest plot	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.07 [0.00, 1.37]

3.1 FBG target ≤ 6.7 vs 6.7 to 8.9 mmol/L	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.07 [0.00, 1.37]
4 Transient maternal hypertension Show forest plot	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	1.81 [0.12, 27.07]

4.1 FBG target ≤ 6.7 vs 6.7 to 8.9 mmol/L	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	1.81 [0.12, 27.07]
5 Hypoglycaemic episodes ‐ in first half of pregnancy: not prespecified Show forest plot	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	5.22 [0.32, 86.28]

5.1 FBG target ≤ 6.7 vs 6.7 to 8.9 mmol/L	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	5.22 [0.32, 86.28]
6 Large‐for‐gestational age (birthweight > 90th centile) Show forest plot	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.01 [0.00, 0.20]

6.1 FBG target ≤ 6.7 vs 6.7 to 8.9 mmol/L	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.01 [0.00, 0.20]
7 Respiratory distress syndrome Show forest plot	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.17 [0.05, 0.59]

7.1 FBG target ≤ 6.7 vs 6.7 to 8.9 mmol/L	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.17 [0.05, 0.59]

Comparison 3. Tight‐moderate versus loose glycaemic control

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