Review
Obstetrics
Continuous subcutaneous insulin infusion vs intensive conventional insulin therapy in pregnant diabetic women: a systematic review and metaanalysis of randomized, controlled trials

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The objective of the study was to study the effects of continuous subcutaneous insulin infusion (CSII) vs multiple-dose insulin (MDI) therapy on glycemic control and pregnancy outcome in diabetic women. Randomized, controlled trials comparing CSII vs MDI in pregnant diabetic women were included after an electronic database search. Studies were rated for quality independently by 2 reviewers in accordance with the Quality of Reporting of Metaanalyses statement. Summary weighted mean difference and odds ratio were estimated for insulin dose, birthweight, gestational age, mode of delivery, hypoglycemic/ketotic episodes, worsening retinopathy, neonatal hypoglycemia, and rates of intrauterine fetal death. Six randomized clinical trials met the inclusion criteria. Pregnancy outcomes and glycemic control were not significantly different among treatment groups. Higher number of ketoacidotic episodes and diabetic retinopathy found in the CSII group did not reach statistical significance. This systematic review does not show any advantage or disadvantage of using CSII over MDI in pregnant diabetic women. Large multicenter, randomized, controlled trials addressing the quality of life/cost effectiveness are required.

Section snippets

Materials and Methods

A protocol with explicitly defined objectives, criteria for study selection, approaches to assessment of study quality, primary and secondary outcomes, and statistical methods was developed. We also followed the guidelines for metaanalyses and systematic reviews of randomized, controlled trials outlined by the Quality of Reporting of Metaanalyses (QUOROM) conference.18 Because of the nature of this review, local research ethics committee approval was not required.

Results

The search strategy used in this review resulted in the identification of 68 studies, 59 of which did not satisfy the inclusion criteria. Typically, studies were excluded because they were observational studies or addressing different outcomes. Nine studies required closer review of which only 6 primary studies,19, 20, 21, 22, 23, 24 comprising 213 study subjects, met all inclusion criteria as shown in Figure 1 and Table 1. The characteristics of 3 excluded studies and reasons for exclusion are

Comment

Six randomized, clinical trials involving 213 patients were included in this review. No significant differences were found in pregnancy outcomes and glycemic control between treatment groups.

CSII has been associated with tighter glycemic control and better control of hypoglycemic episodes and Dawn phenomenon.27, 28 An insulin pump leads to rapid normalization of blood glucose levels. This pattern was shown in the study by Coustan et al,19 in which insulin requirements were lower in the pump

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