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. 2023 May 31;2023(5):CD014513. doi: 10.1002/14651858.CD014513

Wojcicki 2001.

Study characteristics
Methods What we can really expect from telemedicine in intensive diabetes treatment: results from 3‐year study on type 1 pregnant diabetic women
RCT (NA clusters and NA providers), conducted in 1) 15 pregnant diabetic women treated in the Clinic of Gastroenterology and Metabolic Diseases of the Medical Academy in Warsaw, Poland. 2) All the patients were treated by the same diabetologist in Poland
2 arms: 1. Control (clinical exam only) (control arm) and 2. Intervention (Telematic system) (intervention arm)
Participants Control arm N: 15
Intervention arm N: 15, NA, NA
Diabetes type: 1
Mean age: 26.05 ± 12.6
% Male: 0
Longest follow‐up: 36 months
Interventions Control arm: (clinical exam only)
1) Patient education
Intervention arm: (Telematic system)
1) Case management
2) Electronic patient registry
3) Facilitated relay of clinical information
4) Patient education
5) Promotion of self‐management
Outcomes Glycated haemoglobin
Harms
Funding source This study was supported by grants from the Polish State Committee for Scientific Research, the Bayer Diagnostic Division Warsaw, and the Polish Cellular Telephony Centertel
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported.
Allocation concealment (selection bias) Unclear risk Not reported.
Patient's baseline characteristics (selection bias) Low risk See Table 1. P values > 0.05.
Patient's baseline outcomes (selection bias) Low risk See Table 1. P values > 0.05.
Incomplete outcome data (attrition bias) Low risk 2 patients with comorbidities were not included in intervention group.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Objective measure for HbA1c, harms.
Selective reporting (reporting bias) Unclear risk No protocol registered. Methods match outcomes.
Risk of contamination (other bias) High risk All the patients were treated by the same diabetologist.
Other bias Unclear risk Control participants were evaluated frequently. So much so that it must have affected PSM. Small sample size.