- Design
- Randomised controlled trial, two arms
- Population
- 66 children with diabetic ketoacidosis
- Primary outcome
- Overall efficacy, time to pH normalisation, glucose target and ketone clearance, electrolytes, adverse reactions
- Effect
- Faster pH normalisation, glucose control and ketone clearance, with fewer adverse reactions, all P < 0.05 (absolute values not given in the abstract)
A single trial randomised 66 children with diabetic ketoacidosis to subcutaneous insulin infusion plus electrolyte supplementation or to intravenous insulin plus electrolyte supplementation. The authors report faster pH normalisation, faster glucose targets and quicker ketone clearance in the subcutaneous group, along with fewer adverse reactions.
The abstract gives test statistics rather than absolute times or event rates, so the clinical size of the differences cannot be judged. The sample is small, and it is not clear from the abstract how blinded or how severe the cases were.
Intravenous insulin remains the standard in guidelines for moderate and severe ketoacidosis. This is a hypothesis-raising trial, not a reason to alter a unit's protocol.
- Keep the local DKA protocol; this trial does not change intravenous insulin as standard care
- Watch potassium closely whichever route is used
- Ask for absolute times to resolution and adverse event counts before relying on the claim of safety
- Subcutaneous routes may suit units with limited intensive care capacity, but need larger confirmatory trials
Why it matters
It raises the question of whether intravenous infusion is always necessary, which matters where paediatric intensive care beds are scarce.
Don't overread it
A small single trial without reported absolute effects cannot overturn established DKA protocols.
The statistics, in plain English
The paper quotes t and chi-square values with P below 0.05 but not the actual differences. A very large t value on 66 children means the groups differed on average, but it does not say by how many hours, and many measures tested together raise the chance of a false positive.
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