Methods |
A prospective, stratified, randomized 3‐year clinical trial was conducted on the rigorous versus conventional glucose control on peripheral nerve function in 33 people who had diabetes treated with insulin, with a duration of diabetes of less than 2 years |
Participants |
Recent onset (< 2 years) of diabetes requiring insulin stratified by IDDM versus NIDDM by clinical characteristics and basal/postprandial C peptide values (< 1 = IDDM) |
Interventions |
Continued conventional insulin regiment which consisted of a single insulin injection in all but 3 participants versus an intensive insulin regimen in which all with IDDM received multiple injections. |
Outcomes |
At entry and every 6 months, each participant was examined by the same neurologist who was unaware of treatment group. They performed a neurologic symptom score and a neurologic disability score, and each underwent a computer‐assisted sensation examination of the detection threshold of touch‐pressure, vibration, and thermal cooling and a comprehensive evaluation of amplitude, latencies, and conduction velocities of motor and sensory fibers of multiple limb nerves. |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Randomly assigned using a book of random numbers |
Allocation concealment (selection bias) |
Unclear risk |
Methods not clearly stated |
Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Neurologist was blinded to assigned group |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
7 participants were excluded after randomization because insulin was no longer required (2), followed (1), or because of early < 6 month dropouts (4). Only 5 participants completed 3 years. 7 participants only completed 6 months. |
Selective reporting (reporting bias) |
High risk |
Only report 11 of 25 nerve conduction study variables. No reporting of neurologic symptom score. |
Other bias |
High risk |
The treatment groups had different key baseline demographics variables |