- Design
- Randomised controlled trial, single report
- Population
- 66 children with diabetic ketoacidosis
- Primary outcome
- Overall efficacy and time to pH normalisation, glucose target and urine ketone clearance
- Effect
- Favoured subcutaneous infusion on all listed measures (all P < 0.05); effect sizes not given in the abstract
A randomised trial of 66 children with diabetic ketoacidosis compared continuous subcutaneous insulin infusion plus electrolyte supplementation with intravenous insulin plus electrolyte supplementation. The investigators reported faster pH normalisation, faster glucose targets and ketone clearance, lower inflammatory markers and fewer adverse reactions in the subcutaneous group, all at P below 0.05.
The abstract reports test statistics rather than effect sizes with intervals, so the size of the differences and the actual adverse-event rates cannot be judged from what was published. The sample is small, the setting is a single report, and the abstract does not say how severe the ketoacidosis was or how blinding and monitoring were handled.
Intravenous insulin with close monitoring remains the standard in moderate and severe DKA, and current paediatric protocols have not changed on this evidence. It is worth knowing as a signal that subcutaneous delivery may be worth testing in larger, well-reported trials, not a protocol to adopt.
- Continue to follow your institution's paediatric DKA protocol, including fluid and potassium management.
- Do not switch to subcutaneous infusion in moderate or severe DKA on the basis of this trial.
- Keep hourly glucose and regular potassium, pH and ketone checks regardless of route.
- Watch for larger multicentre trials reporting cerebral oedema and hypoglycaemia rates.
Why it matters
It reopens the question of whether pump-style delivery has a role in acute DKA, but offers no basis for changing practice.
Don't overread it
This is a single small trial with effect sizes not reported in the abstract; it does not show that subcutaneous insulin is safer than intravenous insulin.
The statistics, in plain English
The abstract gives t and chi-squared values and states P below 0.05. These show a difference was unlikely to be chance but do not say how large it was or how precisely it was measured. With 66 children, rare outcomes such as cerebral oedema could not be assessed.
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