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

Varner 1983

Methods Randomised, parallel‐group, open‐label, 2‐armed, active controlled trial.
Period of study: 1 February 1980 to 16 September 1981.
Participants Number randomised: 30.
Eligible were type 1 diabetes mellitus (IDDM) pregnant patients attending the High Risk Obstetric Clinic at the University of Iowa Hospitals and Clinics during the period of study.
Inclusion criteria:

  1. Less than 20 weeks' gestation.


Exclusion criteria:

  1. Not mentioned.
Interventions Intervention:
Daily home glucose monitoring (n = 15) ‐ fasting, 2‐hour post‐prandial morning, afternoon and evening glucose values were measured daily.
Control:
Weekly venipuncture (n = 15) ‐ fasting, 2 hours after breakfast, and 2 hours after lunch glucose levels measured on 1 day each week.
Outcomes Outcomes used in this review:
1) Maternal glycaemic control (HbA1c).
2) Birthweight.
3) Caesarean section.
4) Gestational age.
Outcomes not used in this review:
1) Cord vein C‐peptide.
Notes Setting: High Risk Obstetric Clinic at the University of Iowa Hospitals and Clinics, Iowa.
Country: USA.
Funding: Research Fellowship from the Iowa Affiliate of the American Diabetes Association.
Comments:

  1. No sample size estimation reported.

  2. No type 2 DM pregnant patients included.

  3. Patients telephoned their physicians weekly to report their blood glucose values or possible complications.

  4. Insulin was adjusted by the patients with physicians' consultation.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote ‐ "Patients were assigned to control and experimental groups using a random number sequence".
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 High risk 2 patients from each group had a first trimester spontaneous miscarriage and were excluded (2 out of 30 = 7%).
Selective reporting (reporting bias) Unclear risk Not mentioned.
Other bias Low risk No obvious risk to other bias.