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

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Referencias

Referencias de los estudios incluidos en esta revisión

Botta 1986 {published data only}

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 1986 {published data only}

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.

Mello 2005 {published data only}

Mello G, Parretti E, Tondi F, Riviello C, Borri P, Scarselli G. Impact of two treatment regimens with insulin lispro in post‐prandial glucose excursion patterns and fetal fat mass growth in type 1 diabetic pregnant women [abstract]. American Journal of Obstetrics and Gynecology 2005;193(6 Suppl):S36.

Nosari 1993 {published data only}

Nosari I, Maglio ML, Lepore G, Cortinovis F, Pagani G. Is continuous subcutaneous insulin infusion more effective than intensive conventional insulin therapy in the treatment of pregnant diabetic women?. Diabetes, Nutrition & Metabolism ‐ Clinical & Experimental 1993;6:33‐7.

Trossarelli 1984 {published data only}

Trossarelli GF, Cavallo‐Perin P, Meriggi E, Menato G, Dolfin G, Carta Q, et al. Metabolic and obstetrical results in Type 1 (insulin‐dependent) diabetic pregnancy: pump versus optimized conventional insulin therapy [abstract]. Diabetologia 1984;27(2):340A.

Referencias de los estudios excluidos de esta revisión

Burkart 1988 {published data only}

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.

Collaborative 1993 {published data only}

Collaborative. The effect of intensive treatment of diabetes on the development and progression of long‐term complications in insulin‐dependent diabetes mellitus. New England Journal of Medicine 1993;329:977‐86.

Coustan 1986 {published data only}

Coustan DR, Reece A, Sherwin RS, Rudolf MCJ, Bates SE, Sockin SM, et al. A randomised clinical trial of the insulin pump vs intensive conventional therapy in diabetic pregnancy. JAMA 1986;255:631‐6.

Ignatova 2007 {published data only}

Ignatova N, Arbatskaya N, Melnikova E. Continuous subcutaneous insulin infusion (CSII) reduces the rate of hypoglycaemic episodes throughout pregnancy. Diabetologia 2007;50(Suppl 1):S383‐4.

Laatikainen 1987 {published data only}

Laatikainen L, Teramo K, Hieta‐Heikuraninen H, Koivisto V, Pelkonen R. A controlled study of the influence of continuous subcutaneous insulin infusion treatment on diabetic retinopathy during pregnancy. Acta Medica Scandinavica 1987;221:367‐76.

Zoupas 1991 {published data only}

Zoupas C. Insulin infusion pumps in pregnancy. Personal communication1991.

Referencias adicionales

Alwan 2009

Alwan N, Tuffnell DJ, West J. Treatments for gestational diabetes. Cochrane Database of Systematic Reviews 2009, Issue 3. [DOI: 10.1002/14651858.CD003395]

Anderson 1997

Anderson JH, Brundelle RL, Koivisto VA. Reduction of postprandial hyperglycaemia and frequency of hypoglycaemia in IDDM patients on insulin analog treatment. Multicentre insulin lispro study group. Diabetes 1997;46:265‐70.

Brink 1986

Brink SJ, Stewart C. Insulin pump treatment in insulin‐dependent diabetes mellitus. JAMA 1986;255(5):617‐21.

Buhling 2004

Buhling KJ, Kurzidim B, Wolhlfarth K, Mahmoudi M, Wascher C, Siebert G, et al. Introductory experience with the continuous glucose monitoring system (CGMS; Medtronic Minimed) in detecting hyperglycaemia by comparing the self monitoring of blood glucose (SMBG) in non‐pregnant women and pregnant women with impaired glucose tolerance and gestational diabetes. Experimental and Clinical Endocrinology & Diabetes 2004;112(10):556‐60.

Casson 1997

Casson IF, Clarke CA, Howard CV, McKendrick O, Pennycook S, Pharoah POD, et al. Outcomes of pregnancy in insulin dependent diabetic women: results of a five year population cohort study. BMJ 1997;315:275‐8.

CEMACH 2004

CEMACH‐Royal College of Obstetricians and Gynaecologists. Maternity services in 2002 for women with type 1 and type 2 diabetes. London: CEMACH, 2004.

CEMACH 2005

CEMACH. Pregnancy in women with type 1 and type 2 diabetes 2002‐2003. London: CEMACH, 2005.

Colquitt 2004

Colquitt JL, Green C, Sidhu MK, Hartwell D, Waugh N. Clinical and cost effectiveness of continuous subcutaneous insulin infusion for diabetes. Health Technology Assessment Programme 2004;8(9):43.

DoH 2002

Department of Health. Current and future research on diabetes: a review for the DOH and MRC. www.doh.gov.uk/nsf/diabetes/research(accessed 2002).

Egger 1997

Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta‐analysis detected by a simple, graphical test. BMJ 1997;315(7109):629‐34.

Gonzalez 2002

Gonzalez JL. Management of diabetes in pregnancy. Clinical Obstetrics and Gynecology 2002;45(1):165‐9.

Hadden 1996

Hadden DR. The management of diabetes in pregnancy. Postgraduate Medical Journal 1996;72:525‐31.

HAPO 2008

HAPO study cooperative research group. Hyperglycemia and adverse pregnancy outcomes. New England Journal of Medicine 2008;358:1991‐2002.

Harbord 2006

Harbord RM, Egger M, Sterne JA. A modified test for small‐study effects in meta‐analyses of controlled trials with binary endpoints. Statistics in Medicine 2006;25(20):3443‐57.

Hawthorne 1997

Hawthorne G, Robson S, Ryall EA, Sen D, Roberts SH, Ward Platt MP. Prospective population based survey of outcome of pregnancy in diabetic women: results of the Northern diabetic pregnancy audit, 1997. BMJ 1997;315:279‐81.

Hawthorne 2002

Hawthorne G, Modder J. Maternity services for women with diabetes in the UK. BMJ 2002;19(Suppl 4):50‐5.

Higgins 2005

Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions 4.2.5 [updated May 2005]. In: The Cochrane Library, Issue 3, 2005. Chichester, UK: John Wiley & Sons, Ltd.

Higgins 2009

Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.2 [updated September 2009]. The Cochrane Collaboration, 2009. Available from www.cochrane‐handbook.org.

Hirsch 2005

Hirsch IB, Bode BW, Garg S, Lane WS, Sussman A, Hu P, et al. Continuous subcutaneous insulin infusion (CSII) of insulin aspart versus multiple daily injection of insulin aspart/insulin glargine in type 1 diabetic patients previously treated with CSII. Diabetes Care 2005;28(3):533‐8.

Johansson 2000

Johansson UB, Adamson UC, Lins PE, Wredling RA. Improved blood glucose variability, HbA1C insuman infusat and less insulin requirement in IDDM patients using insulin lispro in CSII. The Swedish Multicentre Lispro Insulin Study. Diabetes and Metabolism 2000;26:192‐6.

John 1997

John WG. Glycated haemoglobin analysis. Annals of Clinical Biochemistry 1997;34:17‐31.

Kerssen 2004

Kerssen A, De‐Valk HW, Visser GHA. The continuous monitoring system during pregnancy of women with type 1 diabetes mellitus: accuracy assessment. Diabetes Technology & Therapeutics 2004;6(5):645‐51.

Kilpatrick 1997

Kilpatrick ES. Problems in the assessment of glycaemic control in diabetes mellitus. Diabetic Medicine 1997;14:819‐31.

Kilpatrick 1998

Kilpatrick ES, Maylor PW, Keevil BG. Biological variation of glycated haemoglobin. Diabetes Care 1998;21(2):261‐4.

Knight 1985

Knight G, Jennings AM, Boulton AJM, Tomlinson S, Ward JD. Severe hyperkalaemia and ketoacidosis during routine treatment with an insulin pump. BMJ 1985;291:371‐2.

Maresh 2001

Maresh M. Diabetes in pregnancy. Current Opinion in Obstetrics and Gynecology 2001;13:103‐7.

Marshall 2000

Marshall SM, Barth JH. Standardization of HbA1c measurements‐a consensus statement. Diabetic Medicine 2000;17:5‐6.

Mecklenburg 1984

Mecklenburg RS, Benson EA, Benson JW, Fredlund PN, Guinn T, Metz RJ, et al. Acute complications associated with insulin infusion pump therapy. Report of experience with 161 patients. JAMA 1984;252(23):3265‐9.

Mukhopadhyay 2007

Mukhopadhyay A, Farrell T, Fraser RB, Ola B. Continuous subcutaneous insulin infusion vs intensive conventional insulin therapy in pregnant diabetic women: a systematic review and metaanalysis of randomized, controlled trials. American Journal of Obstetrics and Gynecology 2007;197:447‐56.

Pickup 2002

Pickup J, Mattock M, Kerry S. Glycaemic control with continuous subcutaneous insulin infusion compared with intensive insulin injections in patients with type 1 diabetes: meta‐analysis of randomised controlled trials. BMJ 2002;324:705‐8.

Porter 2004

Porter H, Belfort MA. Evaluation of a new real‐time continuous glucose monitoring system in pregnant women without gestational diabetes: a pilot study. Journal of Perinatal and Neonatal Nursing 2004;18(2):93‐102.

RevMan 2003 [Computer program]

The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 4.2 for Windows. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2003.

RevMan 2008 [Computer program]

The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.0. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2008.

Rowan 2008

Rowan JA, Hague WM, Gao W, Battin MR, Moore MP. Metformin versus insulin for the treatment of gestational diabetes. New England Journal of Medicine 2008;358:2003‐15.

Siebenhofer 2004

Siebenhofer A, Plank J, Berghold A, Horvath K, Sawicki PT, Beck P, et al. Meta‐analysis of short‐acting insulin analogues in adult patients with type 1 diabetes: continuous subcutaneous insulin infusion versus injection therapy. Diabetologia 2004;47:1895‐905.

Siebenhofer 2006

Siebenhofer A, Plank J, Berghold A, Jeitler K, Horvath K, Narath M, et al. Short acting insulin analogues versus regular human insulin in patients with diabetes mellitus. Cochrane Database of Systematic Reviews 2006, Issue 2. [DOI: 10.1002/14651858.CD003287.pub4]

Simmons 2011

Simmons D. Diabetes and obesity in pregnancy. Best Practice & Research Clinical Obstetrics & Gynaecology 2011;25:25‐36.

Tieu 2010

Tieu J, Coat S, Hague W, Middleton P. Oral anti‐diabetic agents for women with pre‐existing diabetes mellitus/impaired glucose tolerance or previous gestational diabetes mellitus. Cochrane Database of Systematic Reviews 2010, Issue 10. [DOI: 10.1002/14651858.CD007724.pub2]

Verheijen 2005

Verheijen ECJ, Critchley JA, Whitelaw DC, Tuffnell DJ. Outcomes of pregnancies in women with pre‐existing type 1 or type 2 diabetes, in an ethnically mixed population. BJOG: an international journal of obstetrics and gynaecology 2005;112:1500‐3.

Walkinshaw 2006

Walkinshaw SA. Very tight versus tight control for diabetes in pregnancy. Cochrane Database of Systematic Reviews 2006, Issue 2. [DOI: 10.1002/14651858.CD000226.pub2]

Williams 2003

Williams J. Overview of the care of pregnant women with pre‐existing diabetes. Journal of Diabetes Nursing 2003;7:12‐6.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Botta 1986

Methods

"Randomly divided".

Participants

10 women recruited from 8 weeks to 'term'.

Interventions

CSII versus MDI.

Outcomes

Mean gestational age at birth, rate of instrumental delivery.

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 (performance bias and detection bias)
All outcomes

Unclear risk

Blinding of assessors not reported.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Pre‐specified outcomes not reported.

Selective reporting (reporting bias)

Unclear risk

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, fetal anomaly and hypoglycaemia, mean 24‐hour BG, mean HbA1c, mean gestational age at birth, mean birthweight, 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 (performance bias and detection bias)
All outcomes

Unclear risk

Blinding of assessors not reported.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Pre‐specified outcomes not reported.

Selective reporting (reporting bias)

Unclear risk

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 (performance bias and detection bias)
All outcomes

Unclear risk

Blinding of assessors not reported.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Pre‐specified outcomes not reported.

Selective reporting (reporting bias)

Unclear risk

Not reported.

Other bias

Unclear risk

Single centre trial in Italy, small trial group, limited reporting of methods.

Nosari 1993

Methods

"Randomly allocated", no other information reported .

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, fetal anomaly and hypoglycaemia, mean 24‐hour BG, mean HbA1c, mean gestational age at birth, mean birthweight, instrumental delivery rate.

Notes

No losses to follow up.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Sealed envelopes.

Allocation concealment (selection bias)

Unclear risk

Not reported.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

Blinding of assessors not reported.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Pre‐specified outcomes not reported.

Selective reporting (reporting bias)

Unclear risk

No information provided.

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

Mean blood glucose, pregnancy weight gain.

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 (performance bias and detection bias)
All outcomes

Unclear risk

Blinding of assessors not reported.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Pre‐specified outcomes not reported.

Selective reporting (reporting bias)

Unclear risk

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]

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.

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

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 Rate of caesarean section Show forest plot

3

71

Risk Ratio (M‐H, Fixed, 95% CI)

1.09 [0.66, 1.77]

Analysis 1.1

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 1 Rate of caesarean section.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 1 Rate of caesarean section.

2 Perinatal mortality Show forest plot

3

71

Risk Ratio (M‐H, Fixed, 95% CI)

2.33 [0.38, 14.32]

Analysis 1.2

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 2 Perinatal mortality.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 2 Perinatal mortality.

3 Fetal anomaly Show forest plot

2

61

Risk Ratio (M‐H, Fixed, 95% CI)

1.07 [0.07, 15.54]

Analysis 1.3

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 3 Fetal anomaly.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 3 Fetal anomaly.

4 Maternal hypoglycaemia Show forest plot

2

61

Risk Ratio (M‐H, Fixed, 95% CI)

3.0 [0.35, 25.87]

Analysis 1.4

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 4 Maternal hypoglycaemia.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 4 Maternal hypoglycaemia.

5 Maternal hyperglycaemia Show forest plot

2

61

Risk Ratio (M‐H, Fixed, 95% CI)

7.0 [0.39, 125.44]

Analysis 1.5

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 5 Maternal hyperglycaemia.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 5 Maternal hyperglycaemia.

6 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]

Analysis 1.6

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 6 Maternal 24 hour mean blood glucose (mg/dl) first trimester.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 6 Maternal 24 hour mean blood glucose (mg/dl) first trimester.

7 Macrosomia Show forest plot

2

61

Risk Ratio (M‐H, Fixed, 95% CI)

3.2 [0.14, 72.62]

Analysis 1.7

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 7 Macrosomia.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 7 Macrosomia.

8 Gestation at delivery Show forest plot

3

71

Mean Difference (IV, Fixed, 95% CI)

‐1.18 [‐2.92, 0.57]

Analysis 1.8

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 8 Gestation at delivery.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 8 Gestation at delivery.

9 Neonatal hypoglycaemia Show forest plot

1

32

Risk Ratio (M‐H, Fixed, 95% CI)

1.0 [0.07, 14.64]

Analysis 1.9

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 9 Neonatal hypoglycaemia.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 9 Neonatal hypoglycaemia.

10 Small‐for‐gestational age Show forest plot

2

61

Risk Ratio (M‐H, Random, 95% CI)

1.40 [0.10, 18.71]

Analysis 1.10

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 10 Small‐for‐gestational age.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 10 Small‐for‐gestational age.

11 Mean HbA1c first trimester Show forest plot

1

32

Mean Difference (IV, Fixed, 95% CI)

‐0.20 [‐2.13, 1.73]

Analysis 1.11

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 11 Mean HbA1c first trimester.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 11 Mean HbA1c first trimester.

12 Mean HbA1c second trimester Show forest plot

1

32

Mean Difference (IV, Fixed, 95% CI)

0.70 [‐2.29, 3.69]

Analysis 1.12

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 12 Mean HbA1c second trimester.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 12 Mean HbA1c second trimester.

13 Mean HbA1c third trimester Show forest plot

1

32

Mean Difference (IV, Fixed, 95% CI)

0.10 [‐2.38, 2.58]

Analysis 1.13

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 13 Mean HbA1c third trimester.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 13 Mean HbA1c third trimester.

14 Mean birthweight Show forest plot

2

61

Mean Difference (IV, Fixed, 95% CI)

220.56 [‐2.09, 443.20]

Analysis 1.14

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 14 Mean birthweight.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 14 Mean birthweight.

15 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]

Analysis 1.15

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 15 Maternal 24 hour mean blood glucose (mg/dl) second trimester.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 15 Maternal 24 hour mean blood glucose (mg/dl) second trimester.

16 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]

Analysis 1.16

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 16 Maternal 24 hour mean blood glucose (mg/dl) third trimester.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 16 Maternal 24 hour mean blood glucose (mg/dl) third trimester.

17 days hospitalised Show forest plot

1

10

Mean Difference (IV, Fixed, 95% CI)

9.40 [‐6.04, 24.84]

Analysis 1.17

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 17 days hospitalised.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 17 days hospitalised.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 1 Rate of caesarean section.
Figuras y tablas -
Analysis 1.1

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 1 Rate of caesarean section.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 2 Perinatal mortality.
Figuras y tablas -
Analysis 1.2

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 2 Perinatal mortality.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 3 Fetal anomaly.
Figuras y tablas -
Analysis 1.3

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 3 Fetal anomaly.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 4 Maternal hypoglycaemia.
Figuras y tablas -
Analysis 1.4

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 4 Maternal hypoglycaemia.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 5 Maternal hyperglycaemia.
Figuras y tablas -
Analysis 1.5

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 5 Maternal hyperglycaemia.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 6 Maternal 24 hour mean blood glucose (mg/dl) first trimester.
Figuras y tablas -
Analysis 1.6

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 6 Maternal 24 hour mean blood glucose (mg/dl) first trimester.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 7 Macrosomia.
Figuras y tablas -
Analysis 1.7

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 7 Macrosomia.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 8 Gestation at delivery.
Figuras y tablas -
Analysis 1.8

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 8 Gestation at delivery.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 9 Neonatal hypoglycaemia.
Figuras y tablas -
Analysis 1.9

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 9 Neonatal hypoglycaemia.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 10 Small‐for‐gestational age.
Figuras y tablas -
Analysis 1.10

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 10 Small‐for‐gestational age.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 11 Mean HbA1c first trimester.
Figuras y tablas -
Analysis 1.11

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 11 Mean HbA1c first trimester.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 12 Mean HbA1c second trimester.
Figuras y tablas -
Analysis 1.12

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 12 Mean HbA1c second trimester.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 13 Mean HbA1c third trimester.
Figuras y tablas -
Analysis 1.13

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 13 Mean HbA1c third trimester.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 14 Mean birthweight.
Figuras y tablas -
Analysis 1.14

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 14 Mean birthweight.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 15 Maternal 24 hour mean blood glucose (mg/dl) second trimester.
Figuras y tablas -
Analysis 1.15

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 15 Maternal 24 hour mean blood glucose (mg/dl) second trimester.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 16 Maternal 24 hour mean blood glucose (mg/dl) third trimester.
Figuras y tablas -
Analysis 1.16

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 16 Maternal 24 hour mean blood glucose (mg/dl) third trimester.

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 17 days hospitalised.
Figuras y tablas -
Analysis 1.17

Comparison 1 Continuous subcutaneous insulin infusion versus multiple daily injections, Outcome 17 days hospitalised.

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 Rate of caesarean section Show forest plot

3

71

Risk Ratio (M‐H, Fixed, 95% CI)

1.09 [0.66, 1.77]

2 Perinatal mortality Show forest plot

3

71

Risk Ratio (M‐H, Fixed, 95% CI)

2.33 [0.38, 14.32]

3 Fetal anomaly Show forest plot

2

61

Risk Ratio (M‐H, Fixed, 95% CI)

1.07 [0.07, 15.54]

4 Maternal hypoglycaemia Show forest plot

2

61

Risk Ratio (M‐H, Fixed, 95% CI)

3.0 [0.35, 25.87]

5 Maternal hyperglycaemia Show forest plot

2

61

Risk Ratio (M‐H, Fixed, 95% CI)

7.0 [0.39, 125.44]

6 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]

7 Macrosomia Show forest plot

2

61

Risk Ratio (M‐H, Fixed, 95% CI)

3.2 [0.14, 72.62]

8 Gestation at delivery Show forest plot

3

71

Mean Difference (IV, Fixed, 95% CI)

‐1.18 [‐2.92, 0.57]

9 Neonatal hypoglycaemia Show forest plot

1

32

Risk Ratio (M‐H, Fixed, 95% CI)

1.0 [0.07, 14.64]

10 Small‐for‐gestational age Show forest plot

2

61

Risk Ratio (M‐H, Random, 95% CI)

1.40 [0.10, 18.71]

11 Mean HbA1c first trimester Show forest plot

1

32

Mean Difference (IV, Fixed, 95% CI)

‐0.20 [‐2.13, 1.73]

12 Mean HbA1c second trimester Show forest plot

1

32

Mean Difference (IV, Fixed, 95% CI)

0.70 [‐2.29, 3.69]

13 Mean HbA1c third trimester Show forest plot

1

32

Mean Difference (IV, Fixed, 95% CI)

0.10 [‐2.38, 2.58]

14 Mean birthweight Show forest plot

2

61

Mean Difference (IV, Fixed, 95% CI)

220.56 [‐2.09, 443.20]

15 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]

16 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]

17 days hospitalised Show forest plot

1

10

Mean Difference (IV, Fixed, 95% CI)

9.40 [‐6.04, 24.84]

Figuras y tablas -
Comparison 1. Continuous subcutaneous insulin infusion versus multiple daily injections