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

Petrovski 2011

Methods Randomised, parallel‐group, open‐label, 2‐armed, active controlled trial.
Period of study: not mentioned.
Participants Number randomised: 25.
Eligible were type 1 diabetes mellitus (IDDM) pregnant patients attending the University Clinic of Endocrinology, Diabetes and Metabolic Disorders in Skopje during the period of study.
Inclusion criteria:

  1. On continuous subcutaneous insulin infusion (CSII) for at least 3 months before conception.

  2. Singleton pregnancy.


Exclusion criteria:

  1. Not mentioned.
Interventions Intervention:
Constant CGM ‐ 24 hours/day (n = 12).
Control:
Intermittent CGM ‐ 14 days per month (n = 13), measured blood glucose at least 6 times a day every second week (when not using the CGM).
Outcomes Outcomes used in this review:
1) Maternal glycaemic control (HbA1c, mean blood glucose).
2) Severe hypoglycaemia (maternal).
3) Caesarean section rates.
4) Preterm birth.
5) Neonatal hypoglycaemia.
Outcomes not used in this review:
1) Birthweight greater than 4 kg ‐ not used as macrosomia is defined as birthweight > 4.5k g.
2) Insulin dosage.
3) Weight gain.
4) Diabetic ketoacidosis.
Notes Setting: University Clinic of Endocrinology, Diabetes and Metabolic Disorders in Skopje.
Country: Macedonia.
Funding: Macedonion Ministry of Health and the Health Care Fund of Macedonia.
Comments:

  1. No sample size estimation reported.

  2. No type 2 DM pregnant patients included.

  3. All patients were followed 1‐3 weeks by a diabetologist and obstetrician.

  4. The device could alert increased or decreased glucose levels, insulin pump was automatically suspend insulin delivery if necessary.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote ‐ "Patients were randomised into 2 groups".
Comment ‐ Method not mentioned.
Allocation concealment (selection bias) Unclear risk 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 Intention‐to‐treat analysis.
Selective reporting (reporting bias) Unclear risk Not mentioned.
Other bias Low risk No obvious risk to other bias.