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

Wojcicki 2001.

Methods Randomised, parallel‐group, open‐label, 2‐armed, active controlled trial.
Period of study: not mentioned.
Participants Number randomised: 32.
Eligible were type 1 diabetes mellitus (IDDM) pregnant patients attending the Clinic of Gastroenterology and Metabolic Diseases of the Medical Academy in Warsaw during the period of study.
Inclusion criteria

  1. Duration of pregnancy less than 16 weeks.

  2. No diseases.

  3. Acceptable intelligence level according to the modified Wechsler‐Bellevue Scale for Adults.

  4. Glycaemic control in the range of HbA1c < 9.5%.


Exclusion criteria

  1. Not mentioned.
Interventions Intervention:
Telematic Management System (Central Clinical Unit and Patients' Teletransmission Modules) (n = 15) ‐ daily transfer of glycaemic data to diabetologist, at least 6 blood glucose measurements daily.
Control:
Standard care without Telematic Management System (n = 15), 6 blood glucose measurement daily and routine clinic visit every 3 weeks.
Outcomes Outcomes used in this review

  1. Gestational age at birth.

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

  3. Hypoglycaemia (maternal).
Notes Setting: Clinic of Gastroenterology and Metabolic Diseases of the Medical Academy in Warsaw.
Country: Poland.
Funding: supported by grants from the Polish State Committee for Scientific Research, the Bayer Diagnostic Division Warsaw, and the Polish Cellular Telephony Centertel.
Declarations of interest: not reported.
Comments

  1. No sample size estimation reported.

  2. No type 2 DM pregnant patients included.

  3. 2 participants in the intervention group were excluded as they had pneumonia and Meniere's disease not diagnosed before randomisation.

  4. Intensive insulin treatment was provided with multi‐injection technique with 6 blood glucose measurements per day (before and 60 minutes after the 3 main meals).

  5. Each patient was followed up every 3 weeks by the same diabetologist.

  6. Patients from the intervention group had their blood glucose data transmitted to the diabetologist daily. Thus the diabetologist was able to examine the metabolic state and to intervene if necessary.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation stated but method of sequence generation not clear. Quote: "Before randomization written consent was taken........".
Allocation concealment (selection bias) High risk Not possible as the same diabetologist was seeing both groups and knew to which group the participant belonged (control group could access the diabetologist by phone any time).
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 participants and personnel. However, all outcomes were objectively measured.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All participants accounted for and all data reported.
Selective reporting (reporting bias) Low risk No obvious risk to selective reporting.
Other bias Low risk No obvious risk to other bias.

BMI: body mass index
 CGM: continuous glucose monitoring
 CGMS: continuous glucose monitoring system
 DM: diabetes mellitus
 GDM: gestational diabetes mellitus
 IDDM: insulin‐dependent diabetes mellitus
 IGF‐1: insulin‐like growth factor‐1
 IQR: interquartile range
 NIDDM: non insulin‐dependent diabetes mellitus