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. 2017 Jun 8;2017(6):CD010137. doi: 10.1002/14651858.CD010137.pub2

OSLO Study 1986.

Methods
  • Study design: parallel RCT

  • Study duration (recruitment): not reported

  • Follow‐up period: 45 months

Participants
  • Country: Norway

  • Setting: multicentre

  • Patients aged 18 to 45 years with diagnosis of diabetes before 30 years and CKD stage 1; no signs of nephropathy or systemic hypertension; not pregnant; no proliferative retinopathy; no medication other than insulin

  • Number: treatment group 1 (15); treatment group 2 (15); control group (15)

  • Mean age, range (years): treatment group 1 (26, 18 to 32); treatment group 2 (26, 19 to 42); control group (26, 18 to 36)

  • Sex (M/F): treatment group 1 (7/8); treatment group 2 (7/8); control group (7/8)

  • Exclusion criteria: not reported

Interventions Treatment group 1
  • Continuous SC insulin infusion


Treatment group 2
  • Multiple injections


Control group
  • Two daily insulin injections

Outcomes
  • Diabetic control

  • Retinopathy

  • Nerve function

  • Kidney function

Notes
  • Funding source: government

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Block randomisation
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not centrally determined outcome measurements
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Selective reporting (reporting bias) High risk Data could not be meta‐analysed
Other bias Unclear risk Study appears free of other bias