| Methods |
Design: three group parallel trial
Purpose: examine the effect of a blood glucose monitoring manual in adults with diabetes |
| Participants |
Patients: out‐patients with diabetes
Baseline comparability: yes |
| Interventions |
Placebo: session of diabetes education and a blood glucose meter ('attention control')
Untreated: no session
Experimental: session of diabetes education based on a blood glucose manual and a blood glucose meter
(Co‐intervention: standard diabetes care) |
| Outcomes |
Frequency of blood glucose measurements
Glycaemic control
Knowledge of HbA1c
Affect regarding blood glucoses results |
| Notes |
We have multiplied the results by negative 1 to change the direction of the effect in the analyses. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/manual) |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (not naturally positive continuous outcomes e.g. change) |
| Trial size > 49? |
Low risk |
N = 149 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out > 15% or NS and unclear allocation concealment |
