| Methods |
24 participants with insulin dependent diabetes mellitus (IDDM) were allocated to either continuous subcutaneous insulin (CSII) or conventional insulin therapy (CIT) at random |
| Participants |
12 woman and 12 men with IDDM. None received any other medication. |
| Interventions |
Participants on CSII treatment used the Nordic Infusor. Highly purified crystalline U‐100 porcine insulin was infused subcutaneously in the abdominal wall. This delivered ˜50% of the total 24‐hour dose as basal continuous insulin with the remaining dose given before meals. CIT group received 2 daily subcutaneous injections of crystalline and NPH highly purified porcine insulin. |
| Outcomes |
Vibration perception threshold (VPT) was determined with a biothesiometer at the pulp of the second finger, the styloid process of the radial bone, the medial malleolus, and the pulp of the great toe |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Random, otherwise not stated |
| Allocation concealment (selection bias) |
Unclear risk |
Not stated in methods |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Not stated in methods |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
One participant in the continuous group withdrew because of problems with the pump. One participant in each group did not finish the study because of pregnancy. |
| Selective reporting (reporting bias) |
Low risk |
Reported on all 4 sites of VPT |
| Other bias |
Unclear risk |
Methods section is extremely brief and therefore other sources of bias are unclear |
