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

Davidson 2005.

Study characteristics
Methods The effect of self monitoring of blood glucose concentrations on glycated hemoglobin levels in diabetic patients not taking insulin: a blinded, randomized trial
RCT (NA clusters and NA providers), conducted in 1) Study was carried out in a Diabetes Managed Care Program (DMCP) at a community clinic associated with King‐Drew Medical Center. 2) Intervention carried out by trained nurses and dieticians. In United States of America.
2 arms: 1. Control (nurse management) (control arm) and 2. Intervention (SMBG and nurse management) (intervention arm)
Participants Control arm N: 45
Intervention arm N: 44, NA, NA
Diabetes type: 2
Mean age: 50.34 ± NR
% Male: 26.14
Longest follow‐up: 6 months
Interventions Control arm: (nurse management)
1) Case management
2) Team change
3) Patient education
Intervention arm: (SMBG and nurse management)
1) Case management
2) Team change
3) Patient education
4) Promotion of self‐management
Outcomes Glycated haemoglobin
Funding source This study was supported by grants from Eli Lilly and Company and the NIH (DK 54047)
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported. All 89 patients consented and were randomised.
Allocation concealment (selection bias) Unclear risk Not reported.
Patient's baseline characteristics (selection bias) Low risk Table 1. *There are no significant differences between the 2 groups (for baseline characteristics). There were no differences in the baseline characteristics of the patients randomised to the monitoring group and those who were randomised to the control group (Table 1).
Patient's baseline outcomes (selection bias) Low risk Table 1. There are no significant differences between the 2 groups (for baseline characteristics: HbA1c and medications). There were no differences in the baseline characteristics of the patients randomised to the monitoring group and those who were randomised to the control group (Table 1).
Incomplete outcome data (attrition bias) High risk One patient out of 89 was excluded after randomisation. A final A1C level was measured at the end of the study in all of the 78 patients remaining on oral antidiabetes drugs without insulin. HbA1c data for 87.6% (78/89) of patients at the end of intervention (12.4% loss). Numbers of loss in each arm not reported.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Objective outcome (HbA1c). The nurse was unaware of whether the patient was randomised to the monitoring group or not.
Selective reporting (reporting bias) Unclear risk No registered protocol or previously published protocol. A1C levels were measured at entry into the study and every 2 months. The authors only report HbA1c data at 6 months.
Risk of contamination (other bias) High risk Both groups received education and counselling from nurse and dietician. Both groups met the dietitian 5 times. All patients were followed by the same specially trained nurse. All patients were part of the Diabetes Managed Care Program (DMCP) intervention. Quote: "These negative findings occurred in a practice in which intensive follow‐up and treatment are the norm, indicating that monitoring does not improve A1C levels in this setting."
Other bias Low risk None