Different insulin types and regimens for pregnant women with pre‐existing diabetes

Sinéad M O'Neill; Louise C Kenny; Ali S Khashan; Helen M West; Rebecca MD Smyth; Patricia M Kearney

doi:10.1002/14651858.CD011880.pub2

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Analysis 1.1

Comparison 1 Lispro versus regular insulin (Different insulin types within similar insulin regimens), Outcome 1 Perinatal death.

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Analysis 1.2

Comparison 1 Lispro versus regular insulin (Different insulin types within similar insulin regimens), Outcome 2 Caesarean section.

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Analysis 1.3

Comparison 1 Lispro versus regular insulin (Different insulin types within similar insulin regimens), Outcome 3 Pregnancy‐induced hypertension and pre‐eclampsia.

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Analysis 1.4

Comparison 1 Lispro versus regular insulin (Different insulin types within similar insulin regimens), Outcome 4 Fetal anomaly.

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$Comparison 1 Lispro versus regular insulin (Different insulin types within similar insulin regimens), Outcome 5 Birth trauma, including shoulder dystocia, nerve palsy, and fracture.$

Analysis 1.5

Comparison 1 Lispro versus regular insulin (Different insulin types within similar insulin regimens), Outcome 5 Birth trauma, including shoulder dystocia, nerve palsy, and fracture.

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Analysis 1.6

Comparison 1 Lispro versus regular insulin (Different insulin types within similar insulin regimens), Outcome 6 Vaginal delivery (spontaneous, ventouse, forceps).

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Analysis 1.7

Comparison 1 Lispro versus regular insulin (Different insulin types within similar insulin regimens), Outcome 7 Blood glucose (mmol/L) week 14 (after lunch).

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Analysis 1.8

Comparison 1 Lispro versus regular insulin (Different insulin types within similar insulin regimens), Outcome 8 Blood glucose (mmol/L) weeks 21, 28, and 34 combined (after lunch).

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Analysis 1.9

Comparison 1 Lispro versus regular insulin (Different insulin types within similar insulin regimens), Outcome 9 Postprandial increase of blood glucose (mmol/L) before week 14 (lunch).

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Analysis 1.10

Comparison 1 Lispro versus regular insulin (Different insulin types within similar insulin regimens), Outcome 10 Postprandial increase of blood glucose (mmol/L) during weeks 21, 28, and 34 combined (lunch).

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Analysis 1.11

Comparison 1 Lispro versus regular insulin (Different insulin types within similar insulin regimens), Outcome 11 Maternal hypoglycaemia and hyperglycaemia episodes requiring intervention.

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Analysis 1.12

Comparison 1 Lispro versus regular insulin (Different insulin types within similar insulin regimens), Outcome 12 Retinopathy.

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Analysis 1.13

Comparison 1 Lispro versus regular insulin (Different insulin types within similar insulin regimens), Outcome 13 Ventouse delivery.

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Analysis 2.1

Comparison 2 Human insulin (recombinant deoxyribonucleic acid ‐ Humulin) versus animal insulin (Different insulin types within similar insulin regimens), Outcome 1 Small‐for‐gestational age at delivery.

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Analysis 2.2

Comparison 2 Human insulin (recombinant deoxyribonucleic acid ‐ Humulin) versus animal insulin (Different insulin types within similar insulin regimens), Outcome 2 Preterm birth (< 37 weeks).

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Analysis 2.3

Comparison 2 Human insulin (recombinant deoxyribonucleic acid ‐ Humulin) versus animal insulin (Different insulin types within similar insulin regimens), Outcome 3 Birthweight centile (%).

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Analysis 2.4

Comparison 2 Human insulin (recombinant deoxyribonucleic acid ‐ Humulin) versus animal insulin (Different insulin types within similar insulin regimens), Outcome 4 Infant length (cm).

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Analysis 2.5

Comparison 2 Human insulin (recombinant deoxyribonucleic acid ‐ Humulin) versus animal insulin (Different insulin types within similar insulin regimens), Outcome 5 Skinfold thickness (mm).

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Analysis 2.6

Comparison 2 Human insulin (recombinant deoxyribonucleic acid ‐ Humulin) versus animal insulin (Different insulin types within similar insulin regimens), Outcome 6 Body weight percentile (%).

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Analysis 2.7

Comparison 2 Human insulin (recombinant deoxyribonucleic acid ‐ Humulin) versus animal insulin (Different insulin types within similar insulin regimens), Outcome 7 Head circumference (cm).

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Analysis 2.8

Comparison 2 Human insulin (recombinant deoxyribonucleic acid ‐ Humulin) versus animal insulin (Different insulin types within similar insulin regimens), Outcome 8 Macrosomia.

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Analysis 2.9

Comparison 2 Human insulin (recombinant deoxyribonucleic acid ‐ Humulin) versus animal insulin (Different insulin types within similar insulin regimens), Outcome 9 Insulin requirement during pregnancy (U/kg/24 hour).

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Analysis 2.10

Comparison 2 Human insulin (recombinant deoxyribonucleic acid ‐ Humulin) versus animal insulin (Different insulin types within similar insulin regimens), Outcome 10 Birthweight (g).

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Analysis 2.11

Comparison 2 Human insulin (recombinant deoxyribonucleic acid ‐ Humulin) versus animal insulin (Different insulin types within similar insulin regimens), Outcome 11 Infant fasting C‐peptide level at 3 months (pmol/mL).

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Analysis 2.12

Comparison 2 Human insulin (recombinant deoxyribonucleic acid ‐ Humulin) versus animal insulin (Different insulin types within similar insulin regimens), Outcome 12 Infant C‐peptide level 1 hour after glucose‐amino acid challenge at 3 months (pmol/mL).

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Analysis 2.13

Comparison 2 Human insulin (recombinant deoxyribonucleic acid ‐ Humulin) versus animal insulin (Different insulin types within similar insulin regimens), Outcome 13 Infant glucose fasting level at 3 months (pmol/mL).

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Analysis 2.14

Comparison 2 Human insulin (recombinant deoxyribonucleic acid ‐ Humulin) versus animal insulin (Different insulin types within similar insulin regimens), Outcome 14 Infant glucose level 1 hour after glucose‐amino acid challenge at 3 months (pmol/mL).

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Analysis 2.15

Comparison 2 Human insulin (recombinant deoxyribonucleic acid ‐ Humulin) versus animal insulin (Different insulin types within similar insulin regimens), Outcome 15 Gestational age at delivery (weeks).

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Analysis 2.16

Comparison 2 Human insulin (recombinant deoxyribonucleic acid ‐ Humulin) versus animal insulin (Different insulin types within similar insulin regimens), Outcome 16 Maternal ketonuria.

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Analysis 3.1

Comparison 3 Pre‐mixed insulin (70 NPH/30 REG) versus self‐mixed split dose insulin (Different insulin regimens with similar insulin types used within the regimen), Outcome 1 Macrosomia.

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Analysis 3.2

Comparison 3 Pre‐mixed insulin (70 NPH/30 REG) versus self‐mixed split dose insulin (Different insulin regimens with similar insulin types used within the regimen), Outcome 2 Caesarean section.

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Analysis 3.3

Comparison 3 Pre‐mixed insulin (70 NPH/30 REG) versus self‐mixed split dose insulin (Different insulin regimens with similar insulin types used within the regimen), Outcome 3 Antepartum capillary glucose measurement (mg/dL), 2 hours postprandial (after lunch).

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Analysis 3.4

Comparison 3 Pre‐mixed insulin (70 NPH/30 REG) versus self‐mixed split dose insulin (Different insulin regimens with similar insulin types used within the regimen), Outcome 4 Postpartum infection: endometritis.

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Analysis 3.5

Comparison 3 Pre‐mixed insulin (70 NPH/30 REG) versus self‐mixed split dose insulin (Different insulin regimens with similar insulin types used within the regimen), Outcome 5 Use of healthcare resources (maternal hospital days).

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Analysis 3.6

Comparison 3 Pre‐mixed insulin (70 NPH/30 REG) versus self‐mixed split dose insulin (Different insulin regimens with similar insulin types used within the regimen), Outcome 6 Birthweight (g).

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Analysis 3.7

Comparison 3 Pre‐mixed insulin (70 NPH/30 REG) versus self‐mixed split dose insulin (Different insulin regimens with similar insulin types used within the regimen), Outcome 7 Compliance score.

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Analysis 4.1

Comparison 4 Insulin injected with a Novolin pen versus insulin injected with a needle (syringe) (Different insulin regimens with similar insulin types used within the regimen), Outcome 1 Macrosomia.

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Analysis 4.2

Comparison 4 Insulin injected with a Novolin pen versus insulin injected with a needle (syringe) (Different insulin regimens with similar insulin types used within the regimen), Outcome 2 Caesarean section.

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Analysis 4.3

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Analysis 4.4

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Analysis 4.5

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Analysis 4.6

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Analysis 4.7

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Analysis 5.1

Comparison 5 Insulin Aspart + NPH insulin versus Human insulin + NPH insulin (Different insulin types within similar insulin regimens), Outcome 1 A1c (%) third trimester visit.

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Analysis 5.2

Comparison 5 Insulin Aspart + NPH insulin versus Human insulin + NPH insulin (Different insulin types within similar insulin regimens), Outcome 2 Average plasma glucose (mmol/L) third trimester visit.

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Analysis 5.3

Comparison 5 Insulin Aspart + NPH insulin versus Human insulin + NPH insulin (Different insulin types within similar insulin regimens), Outcome 3 Maternal hypoglycaemic episodes.

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Analysis 6.1

Comparison 6 Insulin Detemir + prandial insulin Aspart versus NPH insulin + prandial insulin Aspart (Different insulin types within similar insulin regimens), Outcome 1 Major congenital malformation.

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Analysis 6.2

Comparison 6 Insulin Detemir + prandial insulin Aspart versus NPH insulin + prandial insulin Aspart (Different insulin types within similar insulin regimens), Outcome 2 Major congenital malformation.

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Analysis 6.3

Comparison 6 Insulin Detemir + prandial insulin Aspart versus NPH insulin + prandial insulin Aspart (Different insulin types within similar insulin regimens), Outcome 3 Minor congenital malformation.

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Analysis 6.4

Comparison 6 Insulin Detemir + prandial insulin Aspart versus NPH insulin + prandial insulin Aspart (Different insulin types within similar insulin regimens), Outcome 4 Minor congenital malformation.

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Summary of findings for the main comparison. Lispro versus regular insulin (Different insulin types within similar insulin regimens)

Lispro versus regular insulin (Different insulin types within similar insulin regimens)
Patient or population: pregnant women with pre‐existing diabetes Setting: four centres in Sweden. The Departments of Obstetrics and Gynaecology in Huddinge Hospital, Karolinska Hospital, Södersjukhuset in Stockholm, and Örebro Regional Hospital Intervention: Lispro Comparison: regular insulin
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with regular insulin	Risk with Lispro
Macrosomia				(0 studies)	Not reported
Perinatal death	Study population		not estimable	33 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1, 2, 3}
	0 per 1000	0 per 1000 (0 to 0)
Pre‐eclampsia	Study population		RR 0.68 (0.35 to 1.30)	33 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1, 3, 4, 5}
	647 per 1000	440 per 1000 (226 to 841)
Caesarean section	Study population		RR 0.59 (0.25 to 1.39)	33 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1, 3, 4, 5}
	529 per 1000	312 per 1000 (132 to 736)
Fetal anomaly	Study population		RR 0.35 (0.02 to 8.08)	33 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1, 3, 4, 5}
	59 per 1000	21 per 1000 (1 to 475)
Birth trauma, including shoulder dystocia, nerve palsy, and fracture	Study population		Not estimable	33 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1, 2, 3}
	0 per 1000	0 per 1000 (0 to 0)
Composite outcome measure of neonatal morbidity				(0 studies)	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 High or unclear risk of bias for allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, selective outcome reporting, and other biases ² Small sample size and no events ³ One study with design limitations ⁴ Very wide 95% confidence intervals crossing the line of no effect ⁵ Small sample size with few events

Summary of findings for the main comparison. Lispro versus regular insulin (Different insulin types within similar insulin regimens)

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Summary of findings 2. Human insulin versus animal insulin (Different insulin types within similar insulin regimens)

Human insulin versus animal insulin (Different insulin types within similar insulin regimens)
Patient or population: pregnant women with pre‐existing diabetes Setting: The Children's Hospital of San Francisco and Cornell University Medical College, New York Intervention: human insulin (recombinant deoxyribonucleic acid ‐ Humulin) Comparison: animal insulin
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Outcomes	Risk with animal insulin	Risk with human insulin (Humulin)	Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Macrosomia	Study population		RR 0.22 (0.01 to 4.30)	42 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2 3 4}
Macrosomia	91 per 1000	20 per 1000 (1 to 391)	RR 0.22 (0.01 to 4.30)	42 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2 3 4}
Perinatal death				(0 studies)	Not reported
Pre‐eclampsia				(0 studies)	Not reported
Caesarean section				(0 studies)	Not reported
Fetal anomaly				(0 studies)	Not reported
Birth trauma including shoulder dystocia, nerve palsy, and fracture				(0 studies)	Not reported
Composite outcome measure of neonatal morbidity				(0 studies)	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 Risk of bias was high or unclear for random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, and selective outcome reporting ² One study with serious design limitations including lack of blinding for allocation concealment ³ Very wide 95% confidence intervals crossing the line of no effect ⁴ Small sample size and few events

Summary of findings 2. Human insulin versus animal insulin (Different insulin types within similar insulin regimens)

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Summary of findings 3. Pre‐mixed insulin (70 NPH/30 REG) versus self‐mixed split dose insulin (Different insulin regimens with similar insulin types used within the regimen)

Pre‐mixed insulin (70 NPH/30 REG) versus self‐mixed split dose insulin (Different insulin regimens with similar insulin types used within the regimen)
Patient or population: pregnant women with pre‐existing diabetes Setting: University of Mississippi Medical Centre, USA Intervention: pre‐mixed insulin (70 NPH/30 REG) Comparison: self‐mixed split dose insulin
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with self‐mixed split dose insulin	Risk with pre‐mixed insulin (70 NPH/30 REG)
Macrosomia	Study population		RR 0.49 (0.09 to 2.54)	93 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1, 2, 3}
	87 per 1000	43 per 1000 (8 to 221)
Perinatal death				(0 studies)	Not reported
Pre‐eclampsia				(0 studies)	Not reported
Caesarean section ⁴	Study population		RR 0.57 (0.25 to 1.32)	93 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2 3}
	261 per 1000	149 per 1000 (65 to 344)
Fetal anomaly				(0 studies)	Not reported
Birth trauma including shoulder dystocia, nerve palsy, or fracture				(0 studies)	Not reported
Composite outcome measure of neonatal morbidity				(0 studies)	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 Very wide 95% confidence intervals crossing the line of no effect ² Small sample size and few events ³ One study with serious design limitations ⁴ Caesarean section for cephalo‐pelvic disproportion

Summary of findings 3. Pre‐mixed insulin (70 NPH/30 REG) versus self‐mixed split dose insulin (Different insulin regimens with similar insulin types used within the regimen)

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Summary of findings 4. Insulin injected with a Novolin pen versus insulin injected with a needle or syringe (Different insulin regimens with similar insulin types used within the regimen)

Insulin injected with a Novolin pen versus insulin injected with a needle or syringe (Different insulin regimens with similar insulin types used within the regimen)
Patient or population: pregnant women with pre‐existing diabetes Setting: University of Mississippi Medical Centre, USA Intervention: insulin injected with a Novolin pen Comparison: insulin injected with a needle or syringe
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with insulin injected with a needle or syringe	Risk with insulin injected with a Novolin pen
Macrosomia	Study population		RR 0.21 (0.03 to 1.76)	93 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1, 2 ,3}
	104 per 1000	22 per 1000 (3 to 183)
Perinatal death				(0 studies)	Not reported
Pre‐eclampsia				(0 studies)	Not reported
Caesarean section ⁴	Study population		RR 0.38 (0.15 to 0.97)	93 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1, 2, 3}
	292 per 1000	111 per 1000 (44 to 283)
Fetal anomaly				(0 studies)	Not reported
Birth trauma including shoulder dystocia, nerve palsy, or fracture				(0 studies)	Not reported
Composite outcome measure of neonatal morbidity				(0 studies)	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 Very wide 95% confidence intervals crossing the line of no effect ² Small sample size with few events ³ One study with serious design limitations ⁴ Caesarean section for cephalo‐pelvic disproportion

Summary of findings 4. Insulin injected with a Novolin pen versus insulin injected with a needle or syringe (Different insulin regimens with similar insulin types used within the regimen)

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Summary of findings 5. Insulin Aspart (+ NPH) compared to human insulin (+ NPH insulin) for pregnant women with pre‐existing diabetes (Different insulin types within similar insulin regimens)

Insulin Aspart (+ NPH) compared to human insulin (+ NPH) for pregnant women with pre‐existing diabetes (Different insulin types within similar insulin regimens)
Patient or population: pregnant women with pre‐existing diabetes Setting: 63 different sites in 18 countries Intervention: insulin Aspart (+ NPH insulin) Comparison: human insulin (+ NPH insulin)
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Outcomes	Risk with human insulin (+ NPH)	Risk with insulin Aspart (+ NPH)	Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Macrosomia	‐	‐	‐	‐	‐	Not reported
Perinatal death	‐	‐	‐	‐	‐	Not reported
Pre‐eclampsia	‐	‐	‐	‐	‐	Not reported
Caesarean section	‐	‐	‐	‐	‐	Not reported
Fetal anomaly	‐	‐	‐	‐	‐	Not reported
Birth trauma including shoulder dystocia, nerve palsy and fracture	‐	‐	‐	‐	‐	Not reported
Composite outcome measure of neonatal morbidity	‐	‐	‐	‐	‐	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

Summary of findings 5. Insulin Aspart (+ NPH) compared to human insulin (+ NPH insulin) for pregnant women with pre‐existing diabetes (Different insulin types within similar insulin regimens)

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Summary of findings 6. Insulin Detemir + prandial insulin Aspart versus NPH insulin + prandial insulin Aspart (Different insulin types within similar insulin regimens)

Insulin Detemir + prandial insulin Aspart versus NPH insulin + prandial insulin Aspart (Different insulin types within similar insulin regimens)
Patient or population: pregnant women with pre‐existing diabetes Setting: 79 sites in 17 countries, mainly within Europe Intervention: insulin Detemir (+ Aspart) Comparison: NPH (+ Aspart)
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Outcomes	Risk with NPH (+ Aspart)	Risk with insulin Detemir (+ Aspart)	Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Macrosomia				(0 studies)	Not reported
Perinatal death				(0 studies)	Not reported
Pre‐eclampsia				(0 studies)	Not reported
Caesarean section				(0 studies)	Not reported
Fetal anomaly (major) ¹	Study population		RR 3.15 (0.33 to 29.67)	162 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{2, 3, 4, 5}
Fetal anomaly (major) ¹	12 per 1000	38 per 1000 (4 to 357)	RR 3.15 (0.33 to 29.67)	162 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{2, 3, 4, 5}
Birth trauma including shoulder dystocia, nerve palsy, or fracture				(0 studies)	Not reported
Composite outcome measure of neonatal morbidity				(0 studies)	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 Assessed by an expert who was blinded to the outcome ² One study with design limitations ³ Very wide 95% confidence intervals crossing the line of no effect ⁴ Large effect estimate ⁵ Small sample size with few events

Summary of findings 6. Insulin Detemir + prandial insulin Aspart versus NPH insulin + prandial insulin Aspart (Different insulin types within similar insulin regimens)

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Comparison 1. Lispro versus regular insulin (Different insulin types within similar insulin regimens)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Perinatal death Show forest plot	1	33	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

2 Caesarean section Show forest plot	1	33	Risk Ratio (M‐H, Fixed, 95% CI)	0.59 [0.25, 1.39]

3 Pregnancy‐induced hypertension and pre‐eclampsia Show forest plot	1	33	Risk Ratio (M‐H, Fixed, 95% CI)	0.68 [0.35, 1.30]

4 Fetal anomaly Show forest plot	1	33	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.02, 8.08]

5 Birth trauma, including shoulder dystocia, nerve palsy, and fracture Show forest plot	1	33	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

6 Vaginal delivery (spontaneous, ventouse, forceps) Show forest plot	1	33	Risk Ratio (M‐H, Fixed, 95% CI)	1.46 [0.80, 2.67]

7 Blood glucose (mmol/L) week 14 (after lunch) Show forest plot	1	33	Mean Difference (IV, Fixed, 95% CI)	‐1.09 [‐3.60, 1.42]

8 Blood glucose (mmol/L) weeks 21, 28, and 34 combined (after lunch) Show forest plot	1	33	Mean Difference (IV, Fixed, 95% CI)	‐0.04 [‐2.10, 2.02]

9 Postprandial increase of blood glucose (mmol/L) before week 14 (lunch) Show forest plot	1	33	Mean Difference (IV, Fixed, 95% CI)	1.0 [‐1.52, 3.52]

10 Postprandial increase of blood glucose (mmol/L) during weeks 21, 28, and 34 combined (lunch) Show forest plot	1	33	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐2.12, 2.32]

11 Maternal hypoglycaemia and hyperglycaemia episodes requiring intervention Show forest plot	1	33	Risk Ratio (M‐H, Fixed, 95% CI)	0.21 [0.01, 4.10]

12 Retinopathy Show forest plot	1	33	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.17, 6.67]

13 Ventouse delivery Show forest plot	1	33	Risk Ratio (M‐H, Fixed, 95% CI)	3.19 [0.37, 27.58]

Comparison 1. Lispro versus regular insulin (Different insulin types within similar insulin regimens)

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Comparison 2. Human insulin (recombinant deoxyribonucleic acid ‐ Humulin) versus animal insulin (Different insulin types within similar insulin regimens)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Small‐for‐gestational age at delivery Show forest plot	1	42	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

2 Preterm birth (< 37 weeks) Show forest plot	1	42	Risk Ratio (M‐H, Fixed, 95% CI)	7.67 [0.42, 139.83]

3 Birthweight centile (%) Show forest plot	1	42	Mean Difference (IV, Fixed, 95% CI)	‐6.70 [‐23.64, 10.24]

4 Infant length (cm) Show forest plot	1	42	Mean Difference (IV, Fixed, 95% CI)	‐3.30 [‐6.74, 0.14]

5 Skinfold thickness (mm) Show forest plot	1	42	Mean Difference (IV, Fixed, 95% CI)	‐4.10 [‐13.28, 5.08]

6 Body weight percentile (%) Show forest plot	1	42	Mean Difference (IV, Fixed, 95% CI)	‐6.70 [‐23.74, 10.34]

7 Head circumference (cm) Show forest plot	1	42	Mean Difference (IV, Fixed, 95% CI)	‐5.10 [‐9.52, ‐0.68]

8 Macrosomia Show forest plot	1	42	Risk Ratio (M‐H, Fixed, 95% CI)	0.22 [0.01, 4.30]

9 Insulin requirement during pregnancy (U/kg/24 hour) Show forest plot	1	42	Mean Difference (IV, Fixed, 95% CI)	‐0.33 [‐0.45, ‐0.21]

10 Birthweight (g) Show forest plot	1	42	Mean Difference (IV, Fixed, 95% CI)	‐591.0 [‐1066.27, ‐115.73]

11 Infant fasting C‐peptide level at 3 months (pmol/mL) Show forest plot	1	42	Mean Difference (IV, Fixed, 95% CI)	‐0.07 [‐0.13, ‐0.01]

12 Infant C‐peptide level 1 hour after glucose‐amino acid challenge at 3 months (pmol/mL) Show forest plot	1	42	Mean Difference (IV, Fixed, 95% CI)	‐0.11 [‐0.19, ‐0.03]

13 Infant glucose fasting level at 3 months (pmol/mL) Show forest plot	1	42	Mean Difference (IV, Fixed, 95% CI)	‐0.20 [‐0.62, 0.22]

14 Infant glucose level 1 hour after glucose‐amino acid challenge at 3 months (pmol/mL) Show forest plot	1	42	Mean Difference (IV, Fixed, 95% CI)	0.5 [‐0.04, 1.04]

15 Gestational age at delivery (weeks) Show forest plot	1	42	Mean Difference (IV, Fixed, 95% CI)	0.5 [‐3.70, 4.70]

16 Maternal ketonuria Show forest plot	1	42	Risk Ratio (M‐H, Fixed, 95% CI)	0.37 [0.08, 1.61]

Comparison 2. Human insulin (recombinant deoxyribonucleic acid ‐ Humulin) versus animal insulin (Different insulin types within similar insulin regimens)

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Comparison 3. Pre‐mixed insulin (70 NPH/30 REG) versus self‐mixed split dose insulin (Different insulin regimens with similar insulin types used within the regimen)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Macrosomia Show forest plot	1	93	Risk Ratio (M‐H, Fixed, 95% CI)	0.49 [0.09, 2.54]

2 Caesarean section Show forest plot	1	93	Risk Ratio (M‐H, Fixed, 95% CI)	0.57 [0.25, 1.32]

3 Antepartum capillary glucose measurement (mg/dL), 2 hours postprandial (after lunch) Show forest plot	1	10218	Mean Difference (IV, Fixed, 95% CI)	‐11.25 [‐12.55, ‐9.95]

4 Postpartum infection: endometritis Show forest plot	1	93	Risk Ratio (M‐H, Fixed, 95% CI)	0.52 [0.26, 1.04]

5 Use of healthcare resources (maternal hospital days) Show forest plot	1	94	Mean Difference (IV, Fixed, 95% CI)	‐0.50 [‐1.40, 0.41]

6 Birthweight (g) Show forest plot	1	93	Mean Difference (IV, Fixed, 95% CI)	‐116.56 [‐391.81, 158.69]

7 Compliance score Show forest plot	1	49	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐0.87, 0.87]

Comparison 3. Pre‐mixed insulin (70 NPH/30 REG) versus self‐mixed split dose insulin (Different insulin regimens with similar insulin types used within the regimen)

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Comparison 4. Insulin injected with a Novolin pen versus insulin injected with a needle (syringe) (Different insulin regimens with similar insulin types used within the regimen)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Macrosomia Show forest plot	1	93	Risk Ratio (M‐H, Fixed, 95% CI)	0.21 [0.03, 1.76]

2 Caesarean section Show forest plot	1	93	Risk Ratio (M‐H, Fixed, 95% CI)	0.38 [0.15, 0.97]

3 Antepartum capillary glucose measurement (mg/dL) 2 hours postprandial (after lunch) Show forest plot	1	10218	Mean Difference (IV, Fixed, 95% CI)	‐7.23 [‐8.51, ‐5.95]

4 Postpartum infection: endometritis Show forest plot	1	93	Risk Ratio (M‐H, Fixed, 95% CI)	0.56 [0.28, 1.14]

5 Use of healthcare resources (maternal hospital days) Show forest plot	1	93	Mean Difference (IV, Fixed, 95% CI)	‐0.56 [‐1.45, 0.33]

6 Birthweight (g) Show forest plot	1	93	Mean Difference (IV, Fixed, 95% CI)	‐162.36 [‐438.25, 113.53]

7 Compliance score Show forest plot	1	93	Mean Difference (IV, Fixed, 95% CI)	‐0.21 [‐0.83, 0.41]

Comparison 4. Insulin injected with a Novolin pen versus insulin injected with a needle (syringe) (Different insulin regimens with similar insulin types used within the regimen)

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Comparison 5. Insulin Aspart + NPH insulin versus Human insulin + NPH insulin (Different insulin types within similar insulin regimens)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 A1c (%) third trimester visit Show forest plot	1	223	Mean Difference (IV, Fixed, 95% CI)	‐0.10 [‐0.28, 0.08]

2 Average plasma glucose (mmol/L) third trimester visit Show forest plot	1	223	Mean Difference (IV, Fixed, 95% CI)	‐0.20 [‐0.53, 0.13]

3 Maternal hypoglycaemic episodes Show forest plot	1	223	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.99, 1.14]

Comparison 5. Insulin Aspart + NPH insulin versus Human insulin + NPH insulin (Different insulin types within similar insulin regimens)

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Comparison 6. Insulin Detemir + prandial insulin Aspart versus NPH insulin + prandial insulin Aspart (Different insulin types within similar insulin regimens)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Major congenital malformation Show forest plot	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	3.15 [0.33, 29.67]

2 Major congenital malformation Show forest plot	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	2.10 [0.19, 22.72]

3 Minor congenital malformation Show forest plot	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.01, 8.47]

4 Minor congenital malformation Show forest plot	1	162	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.22, 5.05]

Comparison 6. Insulin Detemir + prandial insulin Aspart versus NPH insulin + prandial insulin Aspart (Different insulin types within similar insulin regimens)

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