Di Biase 1997

Methods	Randomised, parallel‐group, open‐label, 2‐armed, active controlled trial. Period of study: not mentioned.
Participants	Number randomised: 20. Eligible were type 1 diabetes mellitus (IDDM) pregnant patients attending the Diabetes Unit specialising in the treatment of diabetes in pregnancy during the period of study. Inclusion criteria: Type 1 DM pregnant patients. Exclusion criteria: Not mentioned in text.
Interventions	Intervention: DIANET system ‐ continuous automated monitoring system using a telemedicine system ‐ patient unit, diabetes workstation and the communication link (n = 10). Control: Conventional monitoring ‐ performed 3 or more tests of blood glucose per day using BM20‐800 strips (n = 10).
Outcomes	Outcomes used in this review: 1) Mean blood glucose. 2) Occurence (weekly) of hypoglycaemic reactions. Outcomes not used in this review: 1) Insulin requirement.
Notes	Setting: Diabetes Unit specialising in the treatment of diabetes in pregnancy. Country: Italy. Funding: not mentioned. Comments: No sample size estimation reported. No type 2 DM pregnant patients included. Patients enrolled at 9.5 + 10 weeks, study ended at 37.6 + 0.4 weeks. Hypoglycaemic episodes were graded in categories of 1 (mild) to 4 (severe). Trial not registered ?? Therapeutic adjustment by the Diabetes Unit was performed every week by a visit to the control group. The experimental group had their data stored in DIANET system transmitted to the team weekly. This allowed feedback to both patients and clinicians. Clinic visit for experimental group is once every 15‐30 days as they stayed at a longer distance from the clinics than the control group.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote from report ‐ "Patients were consecutively chosen by 1 of the investigators. Stratified block randomisation was used to divide patients into 2 groups at baseline." The patients were randomly assigned to a control of DIANET group. Comment ‐ Methods of sequence allocation not stated.
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. However, all outcomes were objectively measured.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment ‐ Reported results of all participants (n = 20).
Selective reporting (reporting bias)	Low risk	As reported in the article all outcomes listed have been mentioned.
Other bias	Low risk	No obvious risk to other bias.