Use of a Flexible Catheter for the Administration of Subcutaneous Insulin in Diabetic Ketoacidosis: A Feasibility Controlled Clinical Trial

Abstract

Background: Although intravenous insulin administration is the standard of care in diabetic ketoacidosis (DKA), subcutaneous insulin administration could be a suitable alternative in resource-limited settings, but pain caused by hourly insulin applications are limiting factors for using it, especially in children. We aimed to assess whether the use of a flexible subcutaneous catheter improves comfort in patients with DKA compared with the usual hourly injections' treatment. We also compared the evolution of metabolic variables in patients with DKA using both insulin administration systems.

Methods: Randomized feasibility controlled open trial, comparing 2 ways (flexible catheter and steel needle) for the initial insulin administration in children with DKA, who were randomly selected to receive subcutaneous insulin by a flexible catheter or using standard needles. The main outcome was pain, assessed hourly and secondary outcome time to achieve ketoacidosis resolution.

Results: Twenty subjects were included (10 by group). There were no differences between groups in baseline lab values (glycemia, urea, sodium, bicarbonate and pH). Pain assessment at first insulin administration was significantly lower in the intervention group (4.5 vs 0 points; P = 0.001). Similar differences between both treatment arms were observed in every pain assessment. There were no differences between groups regarding the time elapsed to achieve ketoacidosis resolution. (11.4±4.3 vs 16±8.4; P = 0.12). No adverse events or DKA complications were observed.

Conclusions: The use of a flexible catheter reduced the pain associated with subcutaneous insulin administration in nonsevere DKA. The flexible subcutaneous catheter could be a safe alternative for the treatment of uncomplicated DKA in resource-limited settings.

Trial registration: ClinicalTrials.gov NCT03182569.