Continuous subcutaneous insulin infusion versus multiple daily injections of insulin for pregnant women with diabetes

Diane Farrar; Derek J Tuffnell; Jane West; Helen M West

doi:10.1002/14651858.CD005542.pub3

Infusión continua de insulina subcutánea versus inyecciones diarias múltiples de insulina para embarazadas con diabetes

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Referencias

Referencias de los estudios incluidos en esta revisión

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Botta RM, Sinarga D, Angelico MC, Bomplani GD. Intensified conventional insulin therapy as compared to micropump therapy in pregnant women affected by type 1 diabetes mellitus [Confronto fra terapia insulinica tradizionale ottimizzata e con microinfusore in gravide affette da diabete mellito di tipo1]. Minerva Medica 1986;77:657‐61.

Carta Q, Meriggi E, Trossarelli GF, Catella G, Dal Molin V, Menato G, et al. Continuous subcutaneous insulin infusion versus intensive conventional insulin therapy in type I and type II diabetic pregnancy [Etude comparee de la perfusion sous‐cutanee continue d'insuline et de l'insulinotherapie intensive classique chez des femmes diabetiques de type I ou II enceintes]. Diabete et Metabolisme 1986;12:121‐9.

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Referencias de los estudios excluidos de esta revisión

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Burkart W, Hanker JP, Schneider HPG. Complications and fetal outcome in diabetic pregnancy ‐ Intensified conventional verses insulin pump therapy. Gynecologic and Obstetric Investigation 1988;26:104‐12.

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Referencias de los estudios en curso

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Stewart Z. Evaluation of the feasibility, utility, safety and efficacy of overnight closed‐loop insulin delivery at home in women with type 1 diabetes during pregnancy. Acronym: CLIP_03. ISRCTN Registry (http://www.isrctn.com/) [accessed 2 November 2015]2014.

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Referencias de otras versiones publicadas de esta revisión

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Farrar D, Tuffnell DJ, West J. Continuous subcutaneous insulin infusion versus multiple daily injections of insulin for pregnant women with diabetes. Cochrane Database of Systematic Reviews 2007, Issue 3. [DOI: 10.1002/14651858.CD005542.pub2]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

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Botta 1986

Methods	"Randomly divided".
Participants	10 women recruited from 8 weeks to 'term'.
Interventions	CSII versus MDI.
Outcomes	Gestational age at birth, caesarean section, weight gain during pregnancy, preterm birth, hyperbilirubinaemia, and maternal days hospitalised.
Notes	Single‐centre trial in Italy.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported.
Allocation concealment (selection bias)	Unclear risk	Not reported.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding of the type of intervention from clinician and participant for the trials was not possible because of the nature of the study.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Blinding of assessors not reported.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not reported.
Selective reporting (reporting bias)	Unclear risk	Pre‐specified outcomes not reported.
Other bias	Unclear risk	Small trial group, limited reporting.

Carta 1986

Methods	"Randomly assigned" no other information reported.
Participants	15 women with type 1 diabetes (13 on conventional insulin therapy, 2 on continuous insulin therapy) and 14 women with type 2 diabetes (4 were on oral hypoglycaemics, 10 diet‐controlled). Recruitment occurred in the first trimester, 2 women allocated to CSII had already been using a CSII pump pre‐conceptually.
Interventions	CSII versus MDI. Participants were hospitalised initially in order to achieve optimal glycaemic control, diet was prescribed according to individual needs. A Microject MC 20 portable syringe pump was used with porcine insulin (Actrapid MC) 40 U/mL, adjustments were made to the dosage in order to obtain strict glycaemic control (fasting BG < 80 + 10 mg/dL, postprandial BG < 120 mg/dL). Participants randomised to the MDI dose were given Actrapid MC split into 4 boluses.
Outcomes	Maternal and neonatal mortality, large‐for‐gestational age, fetal anomaly and hypoglycaemia, weight gain during pregnancy, mean 24‐hour BG, mean HbA1c, gestational age at delivery, preterm birth, birthweight and rate of instrumental delivery.
Notes	Single‐centre trial in Italy. Participants and their neonates were followed up at delivery and for the first 2 days postnatally.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported.
Allocation concealment (selection bias)	Unclear risk	Not reported.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding of the type of intervention from clinician and participant for the trials was not possible because of the nature of the study.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Blinding of assessors not reported.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	The numbers of women included in analysis across pregnancy comparing maternal 24‐hour mean glucose and mean HbA1c varied from 13 to 15 in the CSII group and from 8 to 14 in the MDI group.
Selective reporting (reporting bias)	Unclear risk	Pre‐specified outcomes not reported.
Other bias	Unclear risk	Small trial group, limited reporting of methods.

Mello 2005

Methods	"Randomly assigned".
Participants	71 women with type 1 diabetes.
Interventions	MDI versus CSII.
Outcomes	Daily glucose levels, 24‐hour glycaemic profiles, infant abdominal fat deposition.
Notes	Raw and mean data not reported, therefore could not be included in the analysis.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported.
Allocation concealment (selection bias)	Unclear risk	Not reported.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding of the type of intervention from clinician and participant for the trials was not possible because of the nature of the study.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Blinding of assessors not reported.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not reported.
Selective reporting (reporting bias)	Unclear risk	Pre‐specified outcomes not reported.
Other bias	Unclear risk	Single‐centre trial in Italy, small trial group, limited reporting of methods.

Nosari 1993

Methods	"Randomly allocated", using sealed envelopes.
Participants	31 women with type 1 insulin‐dependent diabetes included undergoing 32 pregnancies, 1 woman included twice for separate pregnancies. 4 women were recruited in the pre‐conception period, 28 women recruited during their first trimester. The women were described as highly motivated and referred to their centre for intensive therapy.
Interventions	Allocated either CSII or MDI. Microject MC 20 and Daedi B.V. portable battery‐powered syringe infusion pumps, participants receiving MDI had 4 daily insulin injections (regular insulin at each meal and intermediate acting insulin at night, type of insulin used was not stated).
Outcomes	Maternal and neonatal mortality, large‐for‐gestational age, fetal anomaly and hypoglycaemia, mean 24‐hour BG, mean HbA1c, gestational age at delivery, preterm birth, Apgar score < 7 at 5 minutes, respiratory distress syndrome, birthweight and rate of instrumental delivery.
Notes	No losses to follow‐up.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported.
Allocation concealment (selection bias)	Low risk	Used sealed envelopes to conceal allocation of their participants.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding of the type of intervention from clinician and participant for the trials was not possible because of the nature of the study.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Blinding of assessors not reported.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No information provided.
Selective reporting (reporting bias)	Unclear risk	Pre‐specified outcomes not reported.
Other bias	High risk	Small trial group, described as "highly motivated". Single‐centre trial in Italy, limited reporting of methods.

Trossarelli 1984

Methods	"Randomly assigned".
Participants	12 women with type 1 diabetes.
Interventions	MDI versus CSII.
Outcomes	Perinatal mortality, large‐for‐gestational age, maternal weight gain during pregnancy, mean 24‐hour BG in each trimester, and respiratory distress syndrome.
Notes	Several data outcomes described as comparable rather than reported as statistics.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported.
Allocation concealment (selection bias)	Unclear risk	Not reported.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding of the type of intervention from clinician and participant for the trials was not possible because of the nature of the study.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Blinding of assessors not reported.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not reported.
Selective reporting (reporting bias)	Unclear risk	Pre‐specified outcomes not reported.
Other bias	Unclear risk	Not reported.

BG: blood glucose
CSII: continuous subcutaneous insulin infusion
HbA1c: glycated haemoglobin
MDI: multiple daily injection

Characteristics of excluded studies [ordered by study ID]

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Study	Reason for exclusion
Burkart 1988	Exclusion of MDI group participants from analysis if normoglycaemia not achieved (number not reported).
Collaborative 1993	Wrong intervention: conventional versus intensive therapy, rather than CSII versus MDI. Women using CSII and MDI therapy included in the intensive therapy group.
Coustan 1986	21 women randomised antenatally (1 randomised twice for separate pregnancies), gestation at randomisation not stated, therefore length of treatment may be inconsistent. 7 women randomised in the pre‐conceptual period, conceiving between 2 weeks and 1 year. The differences in time to conceive and treatment length is likely to lead to inconsistency of treatment effects.
Ignatova 2007	Probably not a randomised study: 41 women were "divided" into 2 groups. Number of women included in the study and by study group inconsistently reported (41 women included and 21 in each of the 2 groups).
Laatikainen 1987	30 women randomised, 9 declined CSII, so did not receive the allocated intervention and were reported as a separate group, thus potentially confounding the results.
Murphy 2011	Wrong intervention: 2‐arm cross‐over trial comparing closed‐loop versus conventional CSII.
Zoupas 1991	No methods or data provided by trial authors, therefore assessment of the trial is not possible.

CSII: continuous subcutaneous insulin infusion
MDI: multiple daily injection

Characteristics of ongoing studies [ordered by study ID]

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Stewart 2014

Trial name or title	CLIP‐03.
Methods	2‐arm cross‐over trial comparing closed‐loop CSII overnight with not closed‐loop (continuous glucose monitor and insulin pump but not closed‐loop) CSII overnight.
Participants	Pregnant women with type 1 diabetes, 8‐24 weeks GA. Setting: UK.
Interventions	Closed‐loop CSII overnight versus continuous glucose monitor and insulin pump but not closed‐loop.
Outcomes	Overnight time spent in the target glucose range (3.5‐7.8 mmol/L), number of episodes of nocturnal hypoglycaemia, duration and outcome of events. Frequency and duration of use of the closed‐loop system, users’ responses (lifestyle change and diabetes self‐management). Overnight time above and below target range, metabolic control, trends in CGM data.
Starting date	01/04/2014.
Contact information	Dr Zoe Stewart.
Notes	This study may not be eligible for inclusion, because it does not compare CSII with MDI.

Thompson 2014

Trial name or title
Methods	2‐arm randomised trial, comparing insulin pump with multiple daily insulin injection. Single‐blind (outcome assessor). The information indicates that allocation is “randomized”, there is no description of the method.
Participants	Pregnant women with type 1 or type 2 diabetes prior to pregnancy. First trimester, singleton pregnancy, receiving intensive insulin therapy of less than 100 unit of insulin per day. Setting: Canada.
Interventions	Insulin pump versus multiple daily insulin injections.
Outcomes	Composite obstetric/perinatal morbidity or mortality, mean maternal HbA1c during pregnancy, number of episodes of severe hypoglycaemia.
Starting date	April 2014.
Contact information	Dr David Thompson [email protected]
Notes

CGM: continuous glucose monitor
CSII: continuous subcutaneous insulin infusion
GA: gestational age
HbA1c: glycated haemoglobin
MDI: multiple daily injection

Data and analyses

Open in table viewer

Comparison 1. Continuous subcutaneous insulin infusion versus multiple daily injections

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Hypertensive disorders of pregnancy (including pre‐eclampsia, pregnancy‐induced hypertension, eclampsia)	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Caesarean section Show forest plot	3	71	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.66, 1.77]
Open in figure viewer Analysis 1.2 Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 2 Caesarean section.
3 Development of type 2 diabetes	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Large‐for‐gestational age Show forest plot	3	73	Risk Ratio (M‐H, Fixed, 95% CI)	4.15 [0.49, 34.95]
Open in figure viewer Analysis 1.4 Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 4 Large‐for‐gestational age.
5 Perinatal mortality Show forest plot	4	83	Risk Ratio (M‐H, Fixed, 95% CI)	2.33 [0.38, 14.32]
Open in figure viewer Analysis 1.5 Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 5 Perinatal mortality.
6 Mortality or morbidity composite	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7 Neurosensory disability	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
8 Induction of labour	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
9 Perineal trauma	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
10 Weight gain during pregnancy Show forest plot	3	51	Mean Difference (IV, Fixed, 95% CI)	0.52 [‐1.12, 2.17]
Open in figure viewer Analysis 1.10 Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 10 Weight gain during pregnancy.
11 Maternal 24‐hour mean blood glucose (mg/dL) first trimester Show forest plot	3	67	Mean Difference (IV, Fixed, 95% CI)	0.12 [‐7.19, 7.43]
Open in figure viewer Analysis 1.11 Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 11 Maternal 24‐hour mean blood glucose (mg/dL) first trimester.
12 Maternal 24‐hour mean blood glucose (mg/dL) second trimester Show forest plot	3	73	Mean Difference (IV, Fixed, 95% CI)	1.77 [‐5.02, 8.56]
Open in figure viewer Analysis 1.12 Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 12 Maternal 24‐hour mean blood glucose (mg/dL) second trimester.
13 Maternal 24‐hour mean blood glucose (mg/dL) third trimester Show forest plot	3	69	Mean Difference (IV, Fixed, 95% CI)	0.08 [‐5.57, 5.72]
Open in figure viewer Analysis 1.13 Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 13 Maternal 24‐hour mean blood glucose (mg/dL) third trimester.
14 Mean HbA1c first trimester Show forest plot	1	32	Mean Difference (IV, Fixed, 95% CI)	‐0.20 [‐2.13, 1.73]
Open in figure viewer Analysis 1.14 Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 14 Mean HbA1c first trimester.
15 Mean HbA1c second trimester Show forest plot	1	32	Mean Difference (IV, Fixed, 95% CI)	0.70 [‐2.29, 3.69]
Open in figure viewer Analysis 1.15 Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 15 Mean HbA1c second trimester.
16 Mean HbA1c third trimester Show forest plot	1	32	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐2.38, 2.58]
Open in figure viewer Analysis 1.16 Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 16 Mean HbA1c third trimester.
17 Maternal hypoglycaemia Show forest plot	2	61	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.35, 25.87]
Open in figure viewer Analysis 1.17 Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 17 Maternal hypoglycaemia.
18 Maternal hyperglycaemia Show forest plot	2	61	Risk Ratio (M‐H, Fixed, 95% CI)	7.0 [0.39, 125.44]
Open in figure viewer Analysis 1.18 Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 18 Maternal hyperglycaemia.
19 Postnatal depression	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
20 Postnatal weight retention or return to pre‐pregnancy weight	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
21 Gestational age at birth Show forest plot	3	71	Mean Difference (IV, Fixed, 95% CI)	‐1.18 [‐2.92, 0.57]
Open in figure viewer Analysis 1.21 Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 21 Gestational age at birth.
22 Preterm birth < 37 weeks' gestation Show forest plot	3	71	Risk Ratio (M‐H, Fixed, 95% CI)	0.77 [0.18, 3.24]
Open in figure viewer Analysis 1.22 Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 22 Preterm birth < 37 weeks' gestation.
23 Preterm birth < 32 weeks' gestation Show forest plot	3	71	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 7.62]
Open in figure viewer Analysis 1.23 Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 23 Preterm birth < 32 weeks' gestation.
24 Apgar score < 7 at 5 minutes Show forest plot	1	32	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
Open in figure viewer Analysis 1.24 Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 24 Apgar score < 7 at 5 minutes.
25 Macrosomia Show forest plot	2	61	Risk Ratio (M‐H, Fixed, 95% CI)	3.2 [0.14, 72.62]
Open in figure viewer Analysis 1.25 Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 25 Macrosomia.
26 Small‐for‐gestational age Show forest plot	2	61	Risk Ratio (M‐H, Random, 95% CI)	1.40 [0.10, 18.71]
Open in figure viewer Analysis 1.26 Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 26 Small‐for‐gestational age.
27 Mean birthweight grams Show forest plot	2	61	Mean Difference (IV, Fixed, 95% CI)	220.56 [‐2.09, 443.20]
Open in figure viewer Analysis 1.27 Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 27 Mean birthweight grams.
28 Adiposity (infant)	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
29 Respiratory distress syndrome Show forest plot	2	44	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.13, 68.57]
Open in figure viewer Analysis 1.29 Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 29 Respiratory distress syndrome.
30 Neonatal hypoglycaemia Show forest plot	1	32	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.07, 14.64]
Open in figure viewer Analysis 1.30 Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 30 Neonatal hypoglycaemia.
31 Neonatal hyperbilirubinaemia Show forest plot	1	10	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.02, 6.65]
Open in figure viewer Analysis 1.31 Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 31 Neonatal hyperbilirubinaemia.
32 Fetal anomaly Show forest plot	2	61	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.07, 15.54]
Open in figure viewer Analysis 1.32 Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 32 Fetal anomaly.
33 Diabetes (infant)	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
34 Length of postnatal stay (mother) Show forest plot	1	10	Mean Difference (IV, Fixed, 95% CI)	9.40 [‐6.04, 24.84]
Open in figure viewer Analysis 1.34 Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 34 Length of postnatal stay (mother).

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 1.2

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 2 Caesarean section.

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Analysis 1.4

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 4 Large‐for‐gestational age.

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Analysis 1.5

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 5 Perinatal mortality.

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Analysis 1.10

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 10 Weight gain during pregnancy.

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Analysis 1.11

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 11 Maternal 24‐hour mean blood glucose (mg/dL) first trimester.

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Analysis 1.12

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 12 Maternal 24‐hour mean blood glucose (mg/dL) second trimester.

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Analysis 1.13

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 13 Maternal 24‐hour mean blood glucose (mg/dL) third trimester.

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Analysis 1.14

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 14 Mean HbA1c first trimester.

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Analysis 1.15

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 15 Mean HbA1c second trimester.

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Analysis 1.16

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 16 Mean HbA1c third trimester.

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Analysis 1.17

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 17 Maternal hypoglycaemia.

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Analysis 1.18

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 18 Maternal hyperglycaemia.

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Analysis 1.21

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 21 Gestational age at birth.

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Analysis 1.22

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 22 Preterm birth < 37 weeks' gestation.

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Analysis 1.23

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 23 Preterm birth < 32 weeks' gestation.

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Analysis 1.24

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 24 Apgar score < 7 at 5 minutes.

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Analysis 1.25

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 25 Macrosomia.

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Analysis 1.26

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 26 Small‐for‐gestational age.

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Analysis 1.27

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 27 Mean birthweight grams.

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Analysis 1.29

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 29 Respiratory distress syndrome.

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Analysis 1.30

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 30 Neonatal hypoglycaemia.

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Analysis 1.31

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 31 Neonatal hyperbilirubinaemia.

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Analysis 1.32

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 32 Fetal anomaly.

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Analysis 1.34

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 34 Length of postnatal stay (mother).

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Summary of findings for the main comparison. CSII versus MDI: maternal outcomes

Continuous subcutaneous insulin infusion (CSII) versus multiple daily injections (MDI) of insulin for pregnant women with diabetes
Patient or population: pregnant women with diabetes Setting: 3 studies in Italy Intervention: CSII Comparison: MDI
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with MDI	Risk with GRADE CSII
Hypertensive disorders of pregnancy (including pre‐eclampsia, pregnancy‐induced hypertension, eclampsia)				(0 studies)	outcome not reported
Caesarean section	Study population		RR 1.09 (0.66 to 1.77)	71 (3 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 2}
	444 per 1000	484 per 1000 (293 to 787)
	Moderate
	438 per 1000	477 per 1000 (289 to 774)
Development of Type 2 diabetes				(0 studies)	outcome not reported
Perineal trauma				(0 studies)	outcome not reported
Return to pre‐pregnancy weight				(0 studies)	outcome not reported
Postnatal depression				(0 studies)	outcome not reported
Induction of labour				(0 studies)	outcome 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 All studies contributing data had design limitations. ² Wide confidence interval crossing the line of no effect, and small sample size.

Summary of findings for the main comparison. CSII versus MDI: maternal outcomes

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Summary of findings 2. CSII versus MDI: infant outcomes

Continuous subcutaneous insulin infusion (CSII) versus multiple daily injections (MDI) of insulin for pregnant women with diabetes
Patient or population: infants of pregnant women with diabetes Setting: 4 studies in Italy Intervention: GRADE CSII Comparison: MDI
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with MDI	Risk with GRADE CSII
Large‐for‐gestational age	Study population		RR 4.15 (0.49 to 34.95)	73 (3 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 2}	Study population and moderate risks were not calculated, due to the small sample size, few events, and no events in the MDI group.
	0 per 1000	0 per 1000 (0 to 0)
Perinatal mortality (stillbirth and neonatal mortality)	Study population		RR 2.33 (0.38 to 14.32)	83 (4 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 2}	Moderate risks were not calculated, due to the small sample size and few events.
	24 per 1000	55 per 1000 (9 to 341)
Mortality or morbidity composite				(0 studies)	outcome not reported
Neonatal hypoglycaemia	Study population		RR 1.00 (0.07 to 14.64)	32 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{2 3}
	63 per 1000	63 per 1000 (4 to 915)
Adiposity (infant)				(0 studies)	outcome not reported
Type 1 and type 2 diabetes (infant)				(0 studies)	outcome not reported
Neurosensory disability				(0 studies)	outcome 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 All studies contributing data had design limitations. ² Wide confidence interval crossing the line of no effect, small sample size and few events. ³ One study with design limitations.

Summary of findings 2. CSII versus MDI: infant outcomes

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Comparison 1. Continuous subcutaneous insulin infusion versus multiple daily injections

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Hypertensive disorders of pregnancy (including pre‐eclampsia, pregnancy‐induced hypertension, eclampsia)	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Caesarean section Show forest plot	3	71	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.66, 1.77]

3 Development of type 2 diabetes	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Large‐for‐gestational age Show forest plot	3	73	Risk Ratio (M‐H, Fixed, 95% CI)	4.15 [0.49, 34.95]

5 Perinatal mortality Show forest plot	4	83	Risk Ratio (M‐H, Fixed, 95% CI)	2.33 [0.38, 14.32]

6 Mortality or morbidity composite	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7 Neurosensory disability	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
8 Induction of labour	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
9 Perineal trauma	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
10 Weight gain during pregnancy Show forest plot	3	51	Mean Difference (IV, Fixed, 95% CI)	0.52 [‐1.12, 2.17]

11 Maternal 24‐hour mean blood glucose (mg/dL) first trimester Show forest plot	3	67	Mean Difference (IV, Fixed, 95% CI)	0.12 [‐7.19, 7.43]

12 Maternal 24‐hour mean blood glucose (mg/dL) second trimester Show forest plot	3	73	Mean Difference (IV, Fixed, 95% CI)	1.77 [‐5.02, 8.56]

13 Maternal 24‐hour mean blood glucose (mg/dL) third trimester Show forest plot	3	69	Mean Difference (IV, Fixed, 95% CI)	0.08 [‐5.57, 5.72]

14 Mean HbA1c first trimester Show forest plot	1	32	Mean Difference (IV, Fixed, 95% CI)	‐0.20 [‐2.13, 1.73]

15 Mean HbA1c second trimester Show forest plot	1	32	Mean Difference (IV, Fixed, 95% CI)	0.70 [‐2.29, 3.69]

16 Mean HbA1c third trimester Show forest plot	1	32	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐2.38, 2.58]

17 Maternal hypoglycaemia Show forest plot	2	61	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.35, 25.87]

18 Maternal hyperglycaemia Show forest plot	2	61	Risk Ratio (M‐H, Fixed, 95% CI)	7.0 [0.39, 125.44]

19 Postnatal depression	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
20 Postnatal weight retention or return to pre‐pregnancy weight	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
21 Gestational age at birth Show forest plot	3	71	Mean Difference (IV, Fixed, 95% CI)	‐1.18 [‐2.92, 0.57]

22 Preterm birth < 37 weeks' gestation Show forest plot	3	71	Risk Ratio (M‐H, Fixed, 95% CI)	0.77 [0.18, 3.24]

23 Preterm birth < 32 weeks' gestation Show forest plot	3	71	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 7.62]

24 Apgar score < 7 at 5 minutes Show forest plot	1	32	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

25 Macrosomia Show forest plot	2	61	Risk Ratio (M‐H, Fixed, 95% CI)	3.2 [0.14, 72.62]

26 Small‐for‐gestational age Show forest plot	2	61	Risk Ratio (M‐H, Random, 95% CI)	1.40 [0.10, 18.71]

27 Mean birthweight grams Show forest plot	2	61	Mean Difference (IV, Fixed, 95% CI)	220.56 [‐2.09, 443.20]

28 Adiposity (infant)	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
29 Respiratory distress syndrome Show forest plot	2	44	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.13, 68.57]

30 Neonatal hypoglycaemia Show forest plot	1	32	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.07, 14.64]

31 Neonatal hyperbilirubinaemia Show forest plot	1	10	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.02, 6.65]

32 Fetal anomaly Show forest plot	2	61	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.07, 15.54]

33 Diabetes (infant)	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
34 Length of postnatal stay (mother) Show forest plot	1	10	Mean Difference (IV, Fixed, 95% CI)	9.40 [‐6.04, 24.84]

Comparison 1. Continuous subcutaneous insulin infusion versus multiple daily injections

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Referencias

Referencias de los estudios incluidos en esta revisión

Botta 1986 {published data only}

Carta 1986 {published data only}

Mello 2005 {published data only}

Nosari 1993 {published data only}

Trossarelli 1984 {published data only}

Referencias de los estudios excluidos de esta revisión

Burkart 1988 {published data only}

Collaborative 1993 {published data only}

Coustan 1986 {published data only}

Ignatova 2007 {published data only}

Laatikainen 1987 {published data only}

Murphy 2011 {published data only}

Zoupas 1991 {published data only}

Referencias de los estudios en curso

Stewart 2014 {published data only}

Thompson 2014 {published data only}

Referencias adicionales

Alwan 2009

Anderson 1997

Brink 1986

Brown 2015

Brown 2015a

Brown 2016

Buhling 2004

Catalano 2012

CEMACH 2005

CMACE 2010

Colquitt 2004

Farrar 2015

Gonzalez 2002

Hadden 1996

HAPO 2008

HAPO 2010

Hawthorne 1997

Hawthorne 2002

Higgins 2011

Hirsch 2005

Johansson 2000

John 1997

Kerssen 2004

Kilpatrick 1997

Kilpatrick 1998

Knight 1985

Knight 2014

Maresh 2001

Marshall 2000

Martis 2016

Mecklenburg 1984

Melamed 2009

Middleton 2016

Mukhopadhyay 2007

Penney 2003

Porter 2004

Pozzilli 2016

RevMan 2014 [Computer program]

Rowan 2008

Siebenhofer 2004

Siebenhofer 2006

Thabit 2012

Tieu 2010

Williams 2003

Zaccardi 2016

Referencias de otras versiones publicadas de esta revisión

Farrar 2007

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Characteristics of excluded studies [ordered by study ID]

Characteristics of ongoing studies [ordered by study ID]

Data and analyses

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Instituciones a las que se accedió previamente

Usuarios institucionales

Instituciones a las que se accedió previamente

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