Della Manna 2005.

Methods	Parallel randomised controlled trial Randomisation ratio: 1:1 Superiority design
Participants	Inclusion criteria: DKA, blood glucose > 300 mg/dL, pH < 7.3, and/or bicarbonate < 15 mmol/L, and > ++ ketonuria Exclusion criteria: surgery, use of glucocorticoid or immunosuppressive agents Diagnostic criteria: ADA criteria for DKA Causes of DKA (n) ‐ (subcutaneous insulin/intravenous insulin): Excessive food intake: 13/13 Infection: 8/4 Missed injection: 10/5 New onset diabetes: 6/5 Unidentified: 1/4
Interventions	Number of study centres: 1 Treatment before study: not stated Group 1: s.c. insulin lispro. 0.15 IU/kg every 2 h until blood glucose < 250 mg/dL, then every 4 h for the next 24 h (n = 30) Group 2: i.v. regular insulin. 0.1 IU/kg/h, continuous infusion until blood glucose < 250 mg/dL, and then 0.15 IU/kg subcutaneously every 4 h for 24 h (n = 30)
Outcomes	Composite outcome measures reported: no
Study details	Run‐in period: no Study terminated before regular end (for benefit/because of adverse events): no
Publication details	Language of publication: English Non‐commercial funding: Fundacao de Amparo à Pesquisa do Estado de Sao Paulo grant (FAPESP 00/09682‐7) Publication status: peer‐reviewed journal
Stated aim for study	Quote from publication: "... to compare the efficacy of a subcutaneous fast‐acting analog (lispro) with continuous intravenous regular insulin (CIRI) in the treatment of pediatric DKA"
Notes	Study authors randomised episodes of DKA, not participants
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote from publication: "Of the 60 DKA episodes, 30 were randomised to treatment with a subcutaneous fast‐acting insulin analog (lispro) and the other 30 were randomised to treatment with CIRI" Comment: no detailed information
Allocation concealment (selection bias)	Unclear risk	Comment: no detailed information
Blinding of participants and personnel (performance bias) Time to resolution of diabetic ketoacidosis	High risk	Comment: participants and personnel were probably unblinded
Blinding of participants and personnel (performance bias) All‐cause mortality	Low risk	Comment: study personnel/participants probably not blinded, but outcome measurement unlikely to be influenced by the lack of blinding
Blinding of participants and personnel (performance bias) Hypoglycaemic episodes	Unclear risk	Comment: study personnel/participants probably not blinded
Blinding of participants and personnel (performance bias) Morbidity	Low risk	Comment: study personnel/participants probably not blinded, but outcome measurement unlikely to be influenced by the lack of blinding
Blinding of outcome assessment (detection bias) Time to resolution of diabetic ketoacidosis	Unclear risk	Comment: no detailed information
Blinding of outcome assessment (detection bias) All‐cause mortality	Low risk	Comment: no detailed information, but outcome measurement unlikely to be influenced by the lack of blinding
Blinding of outcome assessment (detection bias) Morbidity	Low risk	Comment: no detailed information, but outcome measurement unlikely to be influenced by the lack of blinding
Blinding of outcome assessment (detection bias) Hypoglycaemic episodes	Unclear risk	Comment: no detailed information
Incomplete outcome data (attrition bias) Time to resolution of diabetic ketoacidosis	Low risk	Comment: reasons for dropouts explained
Incomplete outcome data (attrition bias) All‐cause mortality	Unclear risk	Comment: DKA occurrences randomised, not participants (unclear which participants had only 1 DKA)
Incomplete outcome data (attrition bias) Hypoglycaemic episodes	Unclear risk	Comment: DKA occurrences randomised, not participants (unclear which participants had only 1 DKA)
Incomplete outcome data (attrition bias) Morbidity	Unclear risk	Comment: DKA occurrences randomised, not participants (unclear which participants had only 1 DKA)
Selective reporting (reporting bias)	Unclear risk	Comment: possible outcome reporting bias for time to resolution of DKA (see Appendix 6)
Other bias	Low risk	Comment: none detected