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

Secher 2013

Methods Randomised, parallel‐group, open‐label, 2‐armed, active controlled trial.
Period of study: 15 February 2009 to 15 February 2011.
Participants Number randomised: 154.
Eligible were 123 type 1 (IDDM) and 31 type 2 (NIDDM) pregnant patients referred to the Centre for Pregnant Women with Diabetes, Rigshospitalet, before 14 completed gestational weeks.
Inclusion criteria:

  1. Type 1 and type 2 DM pregnant women before 14 completed weeks of gestation.

  2. Provided written informed consent.

  3. Willing to wear a CGM.


Exclusion criteria:

  1. Present use of real‐time CGM.

  2. Severe mental or psychiatric barriers.

  3. Diabetic nephropathy.

  4. Severe concurrent comorbidity (e.g. severe psoriasis, previous gastric bypass surgery).
Interventions Intervention:
Real time CGM for 6 days at pregnancy visits during 8, 12, 21, 27 and 33 weeks, in addition to routine pregnancy care.
Control:
Routine pregnancy care with self‐monitored plasma glucose measurements of 7 times daily.
Outcomes Outcomes used in this review:
1) Gycemic control (HbA1c, plasma glucose).
2) Live births.
3) Miscarriage.
4) Caeserean section.
5) Gestational age at birth.
6) Preterm delivery.
7) Birthweight.
8) Neonatal hypoglycaemia.
Outcomes not used in this review:
1) Weight gain in pregnancy.
2) Pre‐eclampsia.
3) Large‐for‐gestational age infant.
Notes Setting: Centre for Pregnant women with Diabetes, Rigshospitalet.
Country: Denmark.
Funding: the real‐time CGM monitors and links were supplied, and glucose sensors were offered at a reduced price by Medtronic.
Comments:
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote ‐ "a computer generated randomization program was used".
Allocation concealment (selection bias) Low risk Quote ‐ "..treatment allocation was properly concealed using automated telephone allocation service (Paravox) provided by an independent organization".
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 Quote ‐ "Intention‐to‐treat analysis was carried out".
Selective reporting (reporting bias) Unclear risk Not mentioned.
Other bias Low risk No obvious risk to other bias.