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Cited by 194Gestational Diabetes Research and ManagementDiabetes Management and ResearchPregnancy and Medication Impact

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

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Farrar, Diane, Tuffnell, Derek J, West, Jane, West, Helen M·2016·Cochrane Database of Systematic Reviews
DOI 10.1002/14651858.cd005542.pub3PMC PMC8563847
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Abstract

BACKGROUND: Diabetes results in a rise in blood glucose above normal physiological levels; if untreated this may cause damage to many systems including the cardiovascular and renal systems. Pregnancy increases resistance to insulin action; for those women who have pre-gestational diabetes, this results in an increasing insulin requirement. There are several methods of administering insulin. Conventionally, insulin has been administered subcutaneously, formally referred to as intensive conventional treatment, but now more usually referred to as multiple daily injections (MDI). An alternative method of insulin administration is the continuous subcutaneous insulin infusion pump (CSII). OBJECTIVES: To compare CSII with MDI of insulin for pregnant women with pre-existing and gestational diabetes. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2016) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised trials comparing CSII with MDI for pregnant women with diabetes. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed studies and two review authors extracted data. Disagreements were resolved through discussion with the third author. We assessed the quality of the evidence using the GRADE approach. MAIN RESULTS: We included five single-centre trials (undertaken in Italy) with 153 women and 154 pregnancies in this review.There were no clear differences in the primary outcomes reported between CSII and MDI in the included trials: caesarean section (risk ratio (RR) 1.09, 95% confidence interval (CI) 0.66 to 1.77; three trials, 71 women, evidence graded very low), large-for-gestational age (RR 4.15, 95% CI 0.49 to 34.95; three trials, 73 infants; evidence graded very low), and perinatal mortality (RR 2.33, 95% CI 0.38 to 14.32; four trials, 83 infants, evidence graded very low). Other primary outcomes were not reported in these trials (hypertensive disorders of pregnancy, development of type 2 diabetes, composite outcome of serious neonatal outcomes, and neurosensory disability).There was no clear evidence of differences in the maternal secondary outcomes: maternal weight gain during pregnancy, 24 hour mean blood glucose in each trimester, mean maternal HbA1c in each trimester, maternal hypoglycaemia, and maternal hyperglycaemia. The included studies did not report several GRADE outcomes: perineal trauma, return to pre-pregnancy weight, postnatal depression, induction of labour. Many maternal secondary outcomes were also not reported.In two trials, including a total of 61 infants, CSII was associated with an increase in mean birthweight compared with MDI (mean difference (MD) 220.56 g, 95% CI -2.09 g to 443.20 g; P = 0.05). However, the large CI including anything from a small reduction to an increase in mean birthweight and the lack of a difference in macrosomia rate (RR 3.20, CI 0.14 to 72.62; two trials, 61 infants) suggests uncertainty. Large-for-gestational age (see above), andsmall-for-gestational age also suggests uncertainty of effect. No significant differences were found in: gestation at delivery, preterm birth < 37 weeks' gestation, preterm birth < 32 weeks' gestation, neonatal hypoglycaemia (evidence graded very low), respiratory distress syndrome, neonatal hyperbilirubinaemia, and fetal anomaly. There were no data reported on many important infant outcomes, including the GRADE outcomes adiposity and diabetes. There was no follow-up of infants in childhood or adulthood, so longer-term outcomes were not reported.The only outcome reported for use of health service resources wasmaternal days hospitalised, which did not show a difference between groups in the small number of women included (MD 9.40, CI -6.04 to 24.84; one trial, 10 women).The methods used by the trials were poorly reported, for example although blinding of participants and clinicians regarding intervention allocation is impossible, it is possible to blind assessors and this along with other aspects of trial methods was not reported, which means that the trials are at an unclear or high risk of bias. We do not know if the women who participated were representative, and therefore if the results can be generalised. Most GRADE outcomes were not reported. For the GRADE outcomes that were reported, our assessment was that the evidence is very low quality (caesarean section, large-for-gestational age, perinatal mortality, andneonatal hypoglycaemia). This was due to design limitations in the included trials, small sample sizes in the trials contributing data, wide CIs crossing both the line of no effect and the line of appreciable benefit and/or harm, and often few events. We are therefore uncertain whether CSII or MDI improves outcomes for pregnant women with diabetes and their infants, and the results of further studies may differ substantially from those presented in this review. AUTHORS' CONCLUSIONS: There is no evidence to support the use of one particula

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  • Neither multiple daily insulin injections nor continuous subcutaneous insulin infusion has been shown to be superior to the other during pregnancy.

    “Both multiple daily insulin injections and continuous subcutaneous insulin infusion are reasonable delivery strategies, and neither has been shown to be superior to the other during pregnancy (97).”

    From 15. Management of Diabetes in Pregnancy: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [97]

  • None of the currently available human insulin preparations have been demonstrated to cross the placenta.

    “None of the currently available human insulin preparations have been demonstrated to cross the placenta (93-98).”

    From 15. Management of Diabetes in Pregnancy: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [97]

    The Background (page unavailable) discusses glucose transfer across the placenta and insulin requirements during pregnancy, but not whether insulin preparations cross the placenta. A further search for placental transfer of insulin or insulin analogues found no passage addressing that claim. (LLM, conf=0.74)

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Research works printed but not linked: 12

  1. 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. [PubMed] [Google Scholar]
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Authors
Farrar, D., Tuffnell, D. J., West, J., & West, H. M.
Affiliations
  • Bradford Royal Infirmary (GB)
  • Bradford Teaching Hospitals NHS Foundation Trust (GB)
  • University of Liverpool (GB)
ORCID
Venue
Cochrane Database of Systematic Reviews
Publisher
Wiley
Published
2016-06-07
Volume
2016
Issue
6
Pages
CD005542-CD005542
ISSN
  • 1361-6137 (ISSN-L)
  • 1465-1858
DOI
10.1002/14651858.cd005542.pub3
PMC
PMC8563847
OpenAlex
W2125505470
Cited by
194
References
71
Citations by year
2026: 1 · 2025: 5 · 2024: 14 · 2023: 19 · 2022: 10 · 2021: 17 · 2020: 18 · 2019: 20 · 2018: 21 · 2017: 8 · 2016: 7 · 2015: 4 · 2014: 5 · 2013: 10 · 2012: 9
FWCI
3.29
Type
journal article
Language
en
Open access
Locations
  • Cochrane Database of Systematic Reviews (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • National Institute for Health and Care Research (13/89/05)
  • Medical Research Council (MR/K021656/1)
Topics
  • Health Sciences › Medicine › Obstetrics and Gynecology › Gestational Diabetes Research and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
Keywords
insulin pump therapy, multiple daily insulin injections, gestational diabetes mellitus, pregestational diabetes, cesarean section, large for gestational age, perinatal mortality, maternal hyperglycemia, HbA1c, neonatal outcomes, gestational weight gain
MeSH terms
Birth Weight, Diabetes Mellitus, Type 1, Female, Humans, Hypoglycemic Agents, Injections, Subcutaneous, Insulin, Insulin Infusion Systems, Pregnancy, Pregnancy in Diabetics, Randomized Controlled Trials as Topic

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