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

SDIS Study 1988.

Methods
  • Study design: parallel RCT

  • Study duration (recruitment): not reported

  • Follow‐up period: 90 months

Participants
  • Country: Sweden

  • Setting: single centre

  • Patients with type 1 diabetes and CKD stage 1; non proliferative retinopathy; normal SCr; high blood glucose concentrations

  • Number: treatment group (48); control group (54)

  • Mean age ± SD (years): treatment group (30 ± 8); control group (32 ± 7)

  • Sex (M/F): treatment group (26/22); control group (28/26)

  • Exclusion criteria: not reported

Interventions Treatment group
  • Education + 3 insulin injections daily


Control group
  • Standard treatment

Outcomes
  • Diabetic control

  • Retinopathy

  • Kidney function

  • Death

Notes
  • Funding source: Novo‐Nordisk, Boehringer‐Mannheim Scandinavia and the Swedish Medical Research Council (06615)

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
Allocation concealment (selection bias) Low risk Closed identical envelopes
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 Low risk 6/102 lost to follow‐up (6%)
Selective reporting (reporting bias) Low risk All outcome data reported
Other bias High risk Funded by Novo‐Nordisk, Boehringer‐Mannheim Scandinavia