Hanson 1984

Methods	Randomised, parallel‐group, open‐label, 2‐armed, active controlled trial. Period of study: 1 October 1979 ‐ 1 October 1982.
Participants	Number randomised: 100. Eligible were type 1 diabetes mellitus (IDDM) and type 2 diabetes mellitus (NIDDM) pregnant patients attending the from 5 hospitals in Stockholm during the period of study. Inclusion criteria: Patients with a diagnosis of diabetes, either insulin‐dependent or non‐insulin‐dependent prior to pregnancy. Exclusion criteria: Not mentioned in text.
Interventions	Intervention: Patients self‐monitored their blood glucose at home from the 32nd week until the 36th week of gestation. Weekly hospital visit from 32‐36 weeks and then hospitalised during the 37th week until delivery (n = 54). Control: Patients were hospitalised from 32nd week until delivery (n = 46).
Outcomes	Outcomes used in this review: 1) Mean blood glucose. 2) HbA1c. 3) Antenatal hospital stay (% requiring admission, length of stay). 4) Caesarean section rates. 5) Preterm birth. 6) Neonatal hypoglycaemia. 7) Perinatal death. 8) Neonatal hospital stay. Outcomes not used in this review: Maternal complications Number of pregnancies. Hypertenslon ln pregnancy. Pre‐eclampsia Placenta praevia. Abruptio placenta. Pulmonary embolism. Premature delivery (Induced, spontaneous). Neonatal outcomes Number of infants. Major congenital malformations. Respiratory distress syndrome. Transient tachypnoea. Hypoglycaemia, total. Hypoglycaemia, symptomatic. Hyperbilirubinemia. Feeding problems. Erythrocytosis.
Notes	Setting: 5 hospitals in Stockholm. Country: Sweden. Funding: Expressens Perinatal forskningsfond, AIImanna Barnbordshusets Minnesfond, Svenska Diabetesstiftelsen, Nordisk Insulinfond, Swedish Medical Research Council (Project No. 3787), and Tielman's Fund for Pediatric Research. Comments: No sample size estimation reported. Twins were included (2 pairs). If complications occurred, home monitoring situation was interrupted. The study was approved by the Regional Ethical Committee. Informed consent was obtained from all participants.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment ‐ Not mentioned.
Allocation concealment (selection bias)	Unclear risk	Comment ‐ Not mentioned.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Comment ‐ No blinding of participants and personnel. However, this may not affect the results as all outcomes were objectively measured.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment ‐ No blinding of outcome assessment. Objective measurements used.
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment ‐ 1 excluded for severe drug addiction, 8 spontaneous abortions and 1 mother died.
Selective reporting (reporting bias)	Low risk	No obvious risk to selective reporting.
Other bias	Low risk	No obvious risk to other bias.