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. 2012 Jun 13;2012(6):CD007543. doi: 10.1002/14651858.CD007543.pub2

Service 1983.

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