AIMS: To determine the effectiveness and safety of early combination therapy with insulin degludec and intravenous insulin infusion (IVII) compared with IVII alone in diabetic ketoacidosis (DKA) management.

MATERIALS AND METHODS: This prospective, open-label, randomised controlled trial included 80 adults (=18 years) with DKA. Participants were randomised to either the intervention group, which received early subcutaneous (SC) insulin degludec (0.3 units/kg SC within 3 h of diagnosis) plus standard IVII, or the control group, which received standard IVII alone. The primary outcome was time to DKA resolution. Secondary outcomes included rebound hyperglycaemia, rebound DKA, hypoglycaemia, hypokalaemia, length of hospital stay (LOS), and in-hospital mortality.

RESULTS: Eighty patients were enrolled; 67.5% of participants had type 2 diabetes. Baseline characteristics were comparable between groups. DKA resolution was significantly faster in the early degludec group by 3.25 h (7.75 h, IQR 6.00-9.00 h vs. 11.00 h, IQR 6.25-15.00; p = 0.039). At 72 h after transition to SC insulin, mean capillary blood glucose (CBG) was significantly lower with early degludec (213.9 ± 25.8 mg/dL vs. 240.1 ± 42.0 mg/dL; p = 0.012). Rates of rebound hyperglycaemia at 12 h after bridging, mean CBG levels at 12, 24, and 48 h among those with rebound hyperglycaemia, as well as rates of rebound DKA, hypoglycaemia, hypokalaemia, LOS, and in-hospital mortality, were not significantly different between groups.

CONCLUSIONS: Early administration of SC insulin degludec in combination with IVII accelerated DKA resolution and improved blood glucose levels at 72 h in patients with rebound hyperglycaemia after discontinuation of IVII, without increasing the risk of hypoglycaemia or hypokalaemia.

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