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. 2019 May 23;2019(5):CD009613. doi: 10.1002/14651858.CD009613.pub4

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. Caesarean section rates.

  2. Weight gain during pregnancy.

  3. Maternal glycaemic control (HbA1c, mean blood glucose).

  4. Severe hypoglycaemia (maternal).

  5. Diabetic ketoacidosis.

  6. Preterm birth < 37 weeks.

  7. Macrosomia.

  8. Neonatal hypoglycaemia.
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.
Declarations of interest: the authors declared that they had no competing financial interests.
Comments

  1. No sample size estimation reported.

  2. No type 2 DM pregnant patients included.

  3. All patients were followed for 1 to 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) Low risk All expected outcomes reported.
Other bias Low risk No obvious risk to other bias.