| Methods |
A total of 110 people with type 2 diabetes (55 with no retinopathy‐primary prevention cohort and 55 with simple retinopathy‐secondary intervention cohort) were randomly assigned to multiple insulin injection therapy (3 or more daily injections) or to conventional insulin therapy (1 to 2 daily injections) |
| Participants |
Participants with type 2 diabetes with 1 to 2 daily injection of insulin (outpatient clinic). Had no retinopathy or simple retinopathy, UER < 300, creatinine < 1.5, no somatic or autonomic neuropathy severe enough to require treatment, < 70, otherwise healthy, no history of DKA, negative islet cell Ab, and a C peptide > 20. |
| Interventions |
Multiple insulin injection therapy (MIT) (3 or more daily injections) or to conventional insulin therapy (CIT) (1 to 2 daily injections) |
| Outcomes |
Peripheral nerve functions were evaluated by median nerve conduction velocity and by vibration threshold on the radial styloid process of the arm and the medial malleolus of the leg on both sides |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomly assigned, otherwise not stated in methods |
| Allocation concealment (selection bias) |
Unclear risk |
Randomly assigned, otherwise not stated in methods |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Methods not stated for blinding outcome assessor |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
5 died (2 intense versus 3 conventional), 4 moved (2 versus 2) and 2 conventional changed to intense group |
| Selective reporting (reporting bias) |
Low risk |
They report all outcomes including median motor and sensory CV and VPT |
| Other bias |
Low risk |
None |
