Murphy 2008

Methods	Randomised, parallel‐group, open‐label, 2‐armed, active controlled trial. Period of study: September 2003‐2006.
Participants	Number randomised: 71. Eligible were type 1 (IDDM) and type 2 (NIDDM) diabetes mellitus pregnant patients attending 2 secondary care diabetic antenatal clinics in the UK during the period of study. Inclusion criteria: Type 1 and type 2 DM pregnant women at 16 weeks' gestation. Provided written informed consent. Willing to wear a continuous glucose monitor. Exclusion criteria: Women with severe medical or psychological comorbidity.
Interventions	Intervention: Continuous glucose monitor which measured glucose in subcutaneous tissues every 10 seconds and an average value is stored every 5 minutes, providing up to 288 measurements per day (n = 38). The participants were required to wear the CGMS for 7 days at intervals of 4‐6 weeks. They were also advised to measure blood glucose at least 7 times a day. Control: Intermittent self‐monitoring of glucose levels (n = 33), at least 7 times a day (standard care).
Outcomes	Outcomes used in this review: 1) Maternal glycaemic control (HbA1c). 2) Birthweight. 3) Gestational age. 4) Frequency of maternal hypoglycaemia. 5) Caesarean section rates. 6) Frequency of neonatal hypoglycaemia. 7) Preterm birth. 8) Death of baby (stillbirth/neonatal death). 9) Neonatal intensive care admissions. Outcomes not used in this review: 1) Number of women with pre‐eclampsia. 2) Number of terminations. 3) Small‐for‐gestational age. 4) Macrosomia (more than 90th centile) ‐ definition differ from the review.
Notes	Setting: secondary care diabetic antenatal clinics. Country: UK. Funding: this was an investigator initiated study funded by the Ipswich Diabetes Centre Charity Research Fund. HRM also received salary support from Diabetes UK. The study equipment (6 x CGMS Gold monitors and 300 sensors) was donated free of charge by Medtronic UK. The research was sponsored by Ipswich Hospital NHS Trust and was independent of all the study funders. Comments: Sample size estimation was reported. Both type 1 and type 2 DM pregnant patients were included. The women were predominantly white European. The continuous glucose monitor (CGM) to be worn up to 7 days at intervals of 4‐6 weeks between 8 and 32 weeks' gestation. In addition to the CGM, intermittent self‐monitoring of glucose levels was implemented in the intervention group. Therapeutic adjustments to diet, exercise, and insulin regimens were discussed with the obstetric diabetes team, based on the combined intermittent capillary glucose and continuous glucose data for women allocated to CGM or the intermittent capillary glucose data alone for women allocated to standard antenatal care. The women were advised to measure blood glucose levels at least 7 times a day and were provided with several targets: 3.5 mmol/L to 5.5 mmol/L before meals, < 7.8 mmol/L 1 hour after meals, and < 6.7 mmol/L 2 hours after meals. The women were seen every 2‐4 weeks for up to 28 weeks, fortnightly until 32 weeks, and weekly thereafter, with assessments of fetal growth at 28, 32, and 36 weeks. Short‐acting insulin analogues were used before meals with intermediate acting insulin, long‐acting analogues, or pump therapy. The women with type 2 diabetes were treated with insulin before pregnancy or as soon as pregnancy was confirmed. Majority (90%) of women were White European, with the rest being Asian and others.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote ‐ "The study statistician used computer generated randomised numbers in blocks of 20".
Allocation concealment (selection bias)	Low risk	Quote ‐ "Concealed in sealed envelopes. Research nurses trained in accordance with good clinical practice guidelines provided the women with their group allocation".
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. However, all outcomes were objectively measured.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment ‐ Intention‐to‐treat analysis was applied.
Selective reporting (reporting bias)	Unclear risk	Unclear.
Other bias	Low risk	No obvious risk to other bias.