Ersöz 2006.
| Methods |
Parallel randomised controlled trial Randomisation ratio: 1:1 Superiority design |
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| Participants |
Inclusion criteria: DKA (mild or moderate only), serum blood glucose > 250 mg/dL, arterial pH < 7.3, bicarbonate < 15 mmol/L, beta‐hydroxybutyrate > 1.6 mmol/L, ketonuria Exclusion criteria: plasma glucose > 600 mg/dL, pH < 7.0, bicarbonate < 10 mmol/L, persistent hypotension, hypothermia, severe concomitant illness Diagnostic criteria: ADA criteria for DKA Causes of DKA: new onset diabetes (3 subcutaneous insulin lispro/2 intravenous regular insulin) |
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| Interventions |
Number of study centres: 1 Treatment before study: not stated |
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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: no Publication status: peer‐reviewed journal |
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| Stated aim for study | Quote from publication: "... to evaluate the efficacy and safety of hourly SC insulin lispro administration in the treatment of DKA in comparison with standard IV regular insulin treatment" | |
| Notes | ‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote from publication: "The patients were randomly assigned into two groups" 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 not blinded |
| 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, outcome measurement not defined |
| 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) Hypoglycaemic episodes | Low risk | Comment: no detailed information, but outcome measurement unlikely to be influenced by the lack of blinding |
| 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 |
| 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 |