| Methods |
30 people with insulin dependent diabetes mellitus (IDDM) who had advanced background retinopathy were randomized to unchanged conventional treatment (UCT) or to continuous subcutaneous insulin infusion (CSII). They were prospectively followed for 2 years. |
| Participants |
Background retinopathy, postprandial C peptide < 0.2, Cr < 150, age 18 to 51, diabetes onset before 30, diabetes duration < 35 years. 40 consecutive patients fulfilling the above mentioned criteria were identified. |
| Interventions |
Unchanged conventional treatment (UCT) or to continuous subcutaneous insulin infusion (CSII) |
| Outcomes |
Vibration sense at the first phalanges of hands and feet plus the medial malleolus of the legs was measured by biothesiometer |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
32 participants were randomly assigned |
| Allocation concealment (selection bias) |
Unclear risk |
Not stated in the methods |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Unclear if assessors were blinded |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1 participant with emigration issues (UCT), 1 participant excluded based on baseline retinal photos (SCII). 1 participant in UCT switched to SCII group (excluded). |
| Selective reporting (reporting bias) |
High risk |
Did not report values for vibration perception threshold |
| Other bias |
Unclear risk |
Methods section is limited in detail. There is not enough information to determine if the baseline characteristics between the groups are equal. |
