Parekh 2016.

Study characteristics
Methods	Study design: parallel randomised controlled clinical trial
Participants	Inclusion criteria: adults with a diagnosis of diabetes mellitus who were admitted for deceased donor renal transplantation Exclusion criteria: children and adult candidates enrolled in a concurrent study evaluating the effect of a medication or other intervention on graft function Diagnostic criteria: — Setting: University of California San Francisco Medical Center Age group: adults Gender distribution: females and males Country where trial was performed: USA
Interventions	Intervention(s): moderately intense glucose control: insulin infusion if blood glucose > 120 mg/dL no earlier than 4 hours before the anticipated start of the transplant. Operation: glucose goal between 80 mg/dL and 160 mg/dL. Postoperative: insulin infusion with glucose goal of 100 mg/dL to 180 mg/dL during 24 hours. Comparator(s): standard control preoperative: insulin sliding scale when serum blood glucose > 200 mg/dL. Operation: intravenous insulin if the glucose was above 200 mg/dL. Postoperative: standard sliding scale for 24 hours. Duration of intervention: pre‐ and postoperative 24 hours Duration of follow‐up: up to 1 year Run‐in period: none Number of study centres: 1 Treatment before study (medication for diabetes): I: 76.6%, C: 80%
Outcomes	Reported outcome(s) in full text of publication: the primary outcome for the trial was poor graft function defined by the need for dialysis within 7 days of transplant or a failure of the serum creatinine to drop by more than 10% for 3 consecutive days. Secondary outcomes were DGF (delayed graft function; need for dialysis within 7 days of transplant), perioperative death, stroke and seizure, as well as serum creatinine and estimated glomerular filtration rate (GFR), using the Modification of Diet in Renal Disease (MDRD) study calculation, at 30 days, 6 months and 1 year. Graft‐specific outcomes were biopsy‐proven rejection and graft loss.
Study registration	Trial identifier:NCT01643382 Trial terminated early: yes Quote: "the trial was then stopped after 60 patients or 75% of the planned total recruitment as the criterion for stopping the trial based on the primary outcome was met"
Publication details	Language of publication: English Funding: supported by the American Diabetes Association Clinical Investigator Award 7‐07‐CR‐22 Publication status: peer‐reviewed journal
Stated aim of study	Quote: "determine whether moderately intense glucose control during allograft reperfusion would reduce the incidence of poor graft function"
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “The randomization was generated per computer algorithm”
Allocation concealment (selection bias)	Low risk	Quote: “[…] the randomization scheme was hidden in an electronic file until each patient was enrolled”
Blinding of participants and personnel (performance bias) All‐cause mortality	Low risk	Comment: described as an open‐label trial; outcome measure unlikely influenced by lack of blinding
Blinding of participants and personnel (performance bias) Hypoglycaemic episodes	High risk	Comment: described as an open‐label trial; outcome measure likely influenced by lack of blinding
Blinding of participants and personnel (performance bias) Adverse events other than hypoglycaemic episodes	High risk	Comment: described as an open‐label trial; outcome measure likely influenced by lack of blinding
Blinding of participants and personnel (performance bias) Cardiovascular events	Low risk	Comment: described as an open‐label trial; outcome measure unlikely influenced by lack of blinding
Blinding of participants and personnel (performance bias) Renal failure	Low risk	Comment: described as an open‐label trial; outcome measure unlikely influenced by lack of blinding
Blinding of participants and personnel (performance bias) Length of ICU and hospital stay	High risk	Comment: described as an open‐label trial; outcome measure likely influenced by lack of blinding
Blinding of participants and personnel (performance bias) Infection events	High risk	Comment: described as an open‐label trial; outcome measure likely influenced by lack of blinding
Blinding of participants and personnel (performance bias) Mean blood glucose during intervention	High risk	Comment: described as an open‐label trial; outcome measure likely influenced by lack of blinding
Blinding of outcome assessment (detection bias) Infection events	Unclear risk	Comment: described as an open‐label trial; outcome measure likely influenced by lack of blinding
Blinding of outcome assessment (detection bias) All‐cause mortality	Low risk	Comment: described as an open‐label trial; outcome measure unlikely influenced by lack of blinding
Blinding of outcome assessment (detection bias) Hypoglycaemic episodes	Unclear risk	Comment: described as an open‐label trial; outcome measure likely influenced by lack of blinding
Blinding of outcome assessment (detection bias) Adverse events other than hypoglycaemic episodes	Unclear risk	Comment: described as an open‐label trial; outcome measure likely influenced by lack of blinding
Blinding of outcome assessment (detection bias) Cardiovascular events	Low risk	Comment: described as an open‐label trial; outcome measure unlikely influenced by lack of blinding
Blinding of outcome assessment (detection bias) Renal failure	Low risk	Comment: described as an open‐label trial; outcome measure unlikely influenced by lack of blinding
Blinding of outcome assessment (detection bias) Length of ICU and hospital stay	Unclear risk	Comment: described as an open‐label trial; outcome measure likely influenced by lack of blinding
Blinding of outcome assessment (detection bias) Mean blood glucose during intervention	Unclear risk	Comment: described as an open‐label trial; outcome measure likely influenced by lack of blinding
Incomplete outcome data (attrition bias) All‐cause mortality	Unclear risk	Comment: sample size calculation for 80 participants. The trial only randomised 60 patients according a pre‐specified rule to stop the trial as the primary outcome criterion was met, but the report only describes criteria for stopping early for safety
Incomplete outcome data (attrition bias) Hypoglycaemic episodes	Unclear risk	Comment: sample size calculation for 80 participants. The trial only randomised 60 patients according a pre‐specified rule to stop the trial as the primary outcome criterion was met, but the report only describes criteria for stopping early for safety
Incomplete outcome data (attrition bias) Adverse events other than hypoglycaemic episodes	Unclear risk	Comment: sample size calculation for 80 participants. The trial only randomised 60 patients according a pre‐specified rule to stop the trial as the primary outcome criterion was met, but the report only describes criteria for stopping early for safety
Incomplete outcome data (attrition bias) Cardiovascular events	Unclear risk	Comment: sample size calculation for 80 participants. The trial only randomised 60 patients according a pre‐specified rule to stop the trial as the primary outcome criterion was met, but the report only describes criteria for stopping early for safety
Incomplete outcome data (attrition bias) Renal failure	Unclear risk	Comment: sample size calculation for 80 participants. The trial only randomised 60 patients according a pre‐specified rule to stop the trial as the primary outcome criterion was met, but the report only describes criteria for stopping early for safety
Incomplete outcome data (attrition bias) Length of ICU and hospital stay	Unclear risk	Comment: sample size calculation for 80 participants. The trial only randomised 60 patients according a pre‐specified rule to stop the trial as the primary outcome criterion was met, but the report only describes criteria for stopping early for safety
Incomplete outcome data (attrition bias) Infection events	Unclear risk	Comment: sample size calculation for 80 participants. The trial only randomised 60 patients according a pre‐specified rule to stop the trial as the primary outcome criterion was met, but the report only describes criteria for stopping early for safety
Incomplete outcome data (attrition bias) Mean blood glucose during intervention	Unclear risk	Comment: sample size calculation for 80 participants. The trial only randomised 60 patients according a pre‐specified rule to stop the trial as the primary outcome criterion was met, but the report only describes criteria for stopping early for safety.
Selective reporting (reporting bias)	Low risk	Comment: the trial register record only disclosed the primary outcome that was reported
Other bias	Low risk	Nothing detected