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.