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

Skeie 2009.

Study characteristics
Methods Self‐monitoring of blood glucose in type 1 diabetes patients with insufficient metabolic control: focused self‐monitoring of blood glucose intervention can lower glycated hemoglobin A1C
Patient RCT, conducted in a diabetes outpatient clinic (Stavanger University Hospital, Stavanger, Norway), Norway
Two arms: 1. Control (control arm) and 2. Intervention (intervention arm)
Participants Control arm N: 65
Intervention arm N: 69
Diabetes type: type 1
Mean age: NR ± NR
% Male: NR
Longest follow‐up: 9 months
Interventions Control arm:
None
Intervention arm:
1) Case management
2) Facilitated relay of clinical information
3) Patient education
4) Promotion of self‐management
Outcomes 1) HbA1c, mean % (SD)
Control arm: pre 8.6 (0.1), post 8.8 (NR)
Intervention arm: pre 8.7 (0.1), post 8.2 (1.2)
Funding source Hemocue AB, Ängelholm, Sweden, provided funds to the Norwegian Quality Improvement of Laboratory Services in Primary Care for performing this study. Hemocue AB did not take part in the design of the protocol, conduct of the study, or interpretation and publication of results.
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described.
Allocation concealment (selection bias) Unclear risk Not described.
Patient's baseline characteristics (selection bias) Unclear risk Unclear in text and P values not provided in table.
Patient's baseline outcomes (selection bias) Low risk Quote: "The randomization resulted in comparable study groups with no major differences."
Incomplete outcome data (attrition bias) High risk Intention‐to‐treat analysis, but not sure if true. Reasons and numbers for lost to follow‐up provided and disproportionate; may be due to the fact that intervention group consented after trial was complete.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk HbA1c using high performance liquid chromatography.
Primary care physicians were blinded when data was collected (NB: study investigators were not blinded where visits happened for intervention). However, study participants were not blinded; possible Hawthorne effect.
Selective reporting (reporting bias) High risk Secondary outcomes in protocol not reported.
Risk of contamination (other bias) Low risk Quote: "The clinical research location and the study nurse were different and physically separated from the outpatient clinic with the outpatient clinic personnel caring for the control group and regular patients otherwise."
Other bias Low risk None.