Manderson 2003

Methods	Randomised, parallel‐group, open‐label, 2‐armed, active controlled trial. Period of study: not mentioned.
Participants	Number randomised: 61 Eligible were type 1 diabetes mellitus (IDDM) pregnant patients attending or referred to the Regional Joint Metabolic/Antenatal Clinic at the Royal Maternity Hospital, Belfast during the period of study. Inclusion criteria: Type 1 DM pregnant women at 16 weeks' gestation. Exclusion criteria: Patients without results due to reasons like: stillbirth, abortions, major congenital abnormalities.
Interventions	Intervention: Pre‐prandial glucose monitoring (n = 31). Control: Post‐prandial glucose monitoring (n = 30).
Outcomes	Outcomes used in this review: 1) Maternal glycaemic control (HbA1c, fasting blood glucose, post‐prandial blood glucose, fructosamine).   2) Birthweight. 3) Caesarean section rates. 4) Gestational age (at birth). 5) Frequency of neonatal hypoglycaemia. 6) Neonatal intensive care admissions. 7) Stillbirth. Outcomes not used in this review: 1) Insulin dosage. 2) Pre‐eclampsia. 3) Success in glycaemic control. 4) Compliance with schedule. 5) Birth trauma. 6) Cord Insulin. 7) Cord IGF‐1. 8) Neonatal glucose at age 1 hour. 9) Triceps skinfold thickness. 10) Subscapula skinfold thickness.
Notes	Setting: Regional Joint Metabolic/Antenatal Clinic at the Royal Maternity Hospital, Belfast. Country: UK. Funding: Department of Health and Social Sevices, Northern lreland, the Northern Ireland Mother and Baby Appeal, the Metabolic Unit Research Fund, Royal Victoria Hospital, Belfast, the Royal Maternity Hospital, Royal Victoria Hospital, Belfast, and the Irish Perinatal Society. Comments: No sample size estimation reported. No type 2 DM pregnant patients included. Only white women were included. Patients were reviewed fortnightly or more frequently if clinically indicated. Insulin doses were adjusted to achieve fasting glucose values between 60 mg/dL and 90 mg/dL (3.3 mmol/L and 5.0 mmol/L), pre‐prandial values between 60 mg/dL and 105 mg/dL (3.3 mmol/L and 5.9 mmol/L), and post‐prandial values less than 140 mg/dL (7.8 mmol/L). Post‐prandial glucose monitoring may significantly reduce the incidence of pre‐eclampsia and neonatal triceps skinfold thickness compared with pre‐prandial monitoring.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote ‐ "Women were randomly assigned at 16 weeks' gestation to 1 of 2 blood glucose monitoring protocols". Comment ‐ method not mentioned.
Allocation concealment (selection bias)	Low risk	Quote ‐ "allocations were via a sealed envelope system, which the patient selected from a box at the clinic visit".
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Comment ‐ No blinding of participants and personnel.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment ‐ No blinding of outcome assessment. However, all outcomes were objectively measured.
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote ‐ "74 patients were recruited. 13 were excluded because they did not have results for analysis. This left 61 diabetic women (31 pre‐prandial and 30 post‐prandial monitoring) with results suitable for analysis".
Selective reporting (reporting bias)	Low risk	No obvious risk to selective reporting.
Other bias	Low risk	No obvious risk to other bias.