Karoli 2011.
| Methods |
Parallel randomised controlled trial Randomisation ratio: 1:1 Superiority design |
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| Participants |
Inclusion criteria: DKA (mild or moderate only, ADA criteria) Exclusion criteria: severe DKA and those requiring ICU admission, loss of consciousness, acute myocardial ischaemia, congestive heart failure, end‐stage renal disease, anasarca, pregnancy, serious comorbidities, persistent hypotension Diagnostic criteria: ADA criteria for DKA Causes of DKA (% regular intravenous insulin/subcutaneous insulin lispro)
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| Interventions | Number of study centres: 1 Treatment before study: not stated Titration period: no |
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| Outcomes | Composite outcome measures reported: no | |
| Study details |
Run‐in period: no Study terminated before regular end (for benefit/because of adverse events): no |
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| Publication details |
Language of publication: English Commercial funding/non‐commercial funding/other funding: none Publication status: peer‐reviewed journal |
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| Stated aim for study | Quote from publication: "... to compare the efficacy of insulin lispro subcutaneous 2 hourly in patients of mild to moderate DKA with standard intravenous regular insulin" | |
| Notes | ‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "The study patients were randomised in emergency department following a computer generated randomisation table in two groups" |
| 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 | Quote from publication: "In this prospective, randomised and open trial ..." Comment: participants and personnel were unblinded (open trial) |
| Blinding of participants and personnel (performance bias) All‐cause mortality | Low risk | Quote from publication: "In this prospective, randomised and open trial ..." Comment: participants and study personnel not blinded, but outcome measurement not likely to be influenced by the lack of blinding |
| Blinding of participants and personnel (performance bias) Hypoglycaemic episodes | Unclear risk | Quote from publication: "In this prospective, randomised and open trial ..." Comment: participants and personnel were unblinded (open trial) |
| Blinding of participants and personnel (performance bias) Morbidity | Unclear risk | Quote from publication: "In this prospective, randomised and open trial ..." Comment: participants and personnel were unblinded (open trial) |
| Blinding of participants and personnel (performance bias) Socioeconomic effects | Unclear risk | Quote from publication: "In this prospective, randomised and open trial ..." Comment: participants and personnel were unblinded (open trial) |
| 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, outcome not likely to be influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) Morbidity | Unclear risk | Comment: no detailed information |
| Blinding of outcome assessment (detection bias) Hypoglycaemic episodes | Unclear risk | Comment: no detailed information |
| Blinding of outcome assessment (detection bias) Socioeconomic effects | Unclear risk | Comment: no detailed information |
| Incomplete outcome data (attrition bias) Time to resolution of diabetic ketoacidosis | Low risk | Comment: all randomised participants completed the study |
| Incomplete outcome data (attrition bias) All‐cause mortality | Low risk | Comment: all randomised participants completed the study |
| Incomplete outcome data (attrition bias) Hypoglycaemic episodes | Low risk | Comment: all randomised participants completed the study |
| Incomplete outcome data (attrition bias) Morbidity | Low risk | Comment: all randomised participants completed the study |
| Incomplete outcome data (attrition bias) Socioeconomic effects | Low risk | Comment: all randomised participants completed the study |
| Selective reporting (reporting bias) | Low risk | Comment: none detected |
| Other bias | Low risk | Comment: none detected |