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. 2018 Sep 24;2018(9):CD011798. doi: 10.1002/14651858.CD011798.pub2

Baldwin 2012.

Methods
  • Study design: parallel RCT

  • Study time frame: June 2009 to June 2011

  • Duration of follow‐up: 6 days

Participants
  • Country: USA

  • Setting: multicentre (3 sites)

  • Inclusion criteria: patients with type 2 DM > 1 year of duration; > 18 years; eGFR ≤ 45 mL/min/1.73 m2; at least one hospital blood glucose level > 10 mmol/L; if on insulin, outpatient dose ≥ 0.5 U/kg

  • Number: treatment group (57); control group (50)

  • Mean age ± SD (years): treatment group (63.7 ± 13.0); control group (65.3 ± 10.6)

  • Sex (M/F): treatment group (28/29); control group (20/30)

  • Exclusion criteria: type 1 DM; pregnancy; chronic dialysis; solid‐organ transplant within the past 12 months; steroid therapy > 7.5 mg/d of prednisolone or equivalent medication; known hypopituitarism or adrenal insufficiency; known hypoglycaemia unawareness; length of stay < 48 h; severe liver disease

Interventions Both groups
  • All oral antidiabetic agents were stopped on hospital admission


Treatment group
  • SC insulin: 0.25 U/kg, half the dose given as glargine and half the dose as glulisine 3 times/d equally


Control group
  • SC insulin: 0.5 U/Kg, half the dose glargine and half the dose as glulisine 3 times/d equally

Outcomes
  • Percentage of BGL within the range of 5.6 to 10 mmol/L, and the percentage of subjects experiencing a hypoglycaemic event defined as a blood glucose < 3.9 mmol/L

  • Hypoglycaemic events were further separated into moderate hypoglycaemia (2.8 to 3.8 mmol/L) and severe hypoglycaemia (< 2.8 mmol/L)

Notes
  • Funding source: "This study was sponsored by an investigator‐initiated grant from sanofi‐aventis."

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The method of random sequence generation was not reported. All the paper reports was: “Eligible patients gave informed consent and were randomised 1:1 into two protocol groups by a research pharmacist”.
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 Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Low risk There were no drop‐outs in each group, and all subjects were analysed in the groups to which they were randomised
Selective reporting (reporting bias) Low risk The prespecified outcomes were available on a clinical trials database and all outcomes were reported
Other bias Low risk No conflicts of interest were reported