Methods | Randomised, parallel‐group, open‐label, 2‐armed, active controlled trial. Period of study: not mentioned. |
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Participants |
Number randomised: 13. Eligible were type 1 (IDDM) diabetes mellitus pregnant patients attending King College's Hospital. Inclusion criteria:
Exclusion criteria:
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Interventions | Intervention: 1) Glucometer group (n = 7) measured blood glucose at home ‐ 7 times a day, twice weekly (before and after each main meal and before bedtime). Control: Non‐meter group (n = 6) ‐ checked urine glucose 4 times daily, random blood glucose measured at the fortnightly clinic visits. |
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Outcomes |
Outcomes used in this review: 1) Maternal glycaemic control (post‐prandial blood glucose). 2) Birthweight. Outcomes not used in this review: 1) Blood metabolite (lactate, alanine, glycerol, 3‐hydroxybutyrate). |
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Notes |
Setting: King's College hospital. Country: UK. Funding: Medical Research Council Project Grant and the British Diabetic Association. Comments:
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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. However, all outcomes were objectively measured. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment ‐ intention‐to‐treat. |
Selective reporting (reporting bias) | Unclear risk | Not mentioned. |
Other bias | Low risk | No obvious risk to other bias. |