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. 2017 Jun 11;2017(6):CD009613. doi: 10.1002/14651858.CD009613.pub3

Stubbs 1980

Methods Randomised, parallel‐group, open‐label, 2‐armed, active controlled trial.
Period of study: not mentioned.
Participants Number randomised: 13.
Eligible were type 1 (IDDM) diabetes mellitus pregnant patients attending King College's Hospital.
Inclusion criteria:

  1. Type 1 DM pregnant women at 30‐31 weeks' gestation.


Exclusion criteria:

  1. Not mentioned.
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.
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).
Notes Setting: King's College hospital.
Country: UK.
Funding: Medical Research Council Project Grant and the British Diabetic Association.
Comments:

  1. Sample size estimation was not reported.

  2. Type 2 DM pregnant patients were not included.

  3. A third group (normal women, n = 8) was included for comparison.

  4. The women were at 30‐31 weeks' gestation at the beginning of study.

  5. Women in the intervention group had their diet and insulin dosage adjusted by telephone or clinic consultation.
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.