| 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. |
