| Methods |
A randomized, prospective study was undertaken to determine the glycemic threshold in 50 people treated with insulin who were showing an early stage of diabetic microangiopathies and who had been treated with once or twice daily intermediate‐acting insulin injection for an average period of 6.3 years. These were divided randomly into 2 groups. |
| Participants |
People with non‐insulin dependent diabetes who had been taking once to twice daily intermediate acting insulin for an average duration of 6.3 years |
| Interventions |
22 participants, maintained on intermediate‐acting insulin (once daily injection) therapy, were used as the control group (CIT). The other 28 participants were given multiple insulin injection therapy (MIT). In the latter group, all participants were treated with multiple insulin injections, receiving either short‐, intermediate‐, or long‐acting insulin. During the experimental period, in both groups, insulin doses were frequent adjusted to accomplish as strict glycemic control as possible. |
| Outcomes |
Median nerve motor conduction velocity |
| Notes |
Report lacks many details |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
"Divided randomly into two groups” but method not stated |
| Allocation concealment (selection bias) |
Unclear risk |
Method not stated |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
The different frequencies of injections made blinding participants and treating physicians impossible. No mention is made of blinding the neurophysiologist measuring the nerve conduction velocity. |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
It is not said that all participants were followed up but no dropouts are mentioned |
| Selective reporting (reporting bias) |
Unclear risk |
The report is not sufficiently detailed to allow a judgment |
| Other bias |
Unclear risk |
The report is not sufficiently detailed to allow a judgment. There is not enough information to determine if baseline characteristics were equal between groups. |
