(757) Insulin Glargine Supplementation in Early Management Phase of Pediatric DKA: A Double-Blinded RCT

Introduction: Insulin Therapy in Diabetic Ketoacidosis (DKA) Has Evolved Over the Years. The Addition of Glargine Insulin (GI) to the Standard Regimen Is One Such Facet That Is Being Explored Owing to Its Constant Dose Free of Peaks That Might Lead To Smoother Metabolic Correction in DKA. Emerging Evidence From Adult Studies is, however, Conflicting for the Effectiveness of GI in the Accelerated Resolution of DKA. The Evidence in Paediatric DKA is Limited to a Single Retrospective Cohort Study.

Methods: This Single-Centre, Double-Blinded, Placebo-Controlled Trial Explored the Effectiveness and Safety of Glargine Insulin Along With Standard Therapy in the Management of Paediatric DKA. In the Study Group, GI was Administered at 0.3 U/KG Subcutaneously Within 1 Hour of Initiation of Regular Insulin Infusion, as Against the Control Group that Received a Volume-Matched Saline Placebo. The Primary Outcome was Time to DKA Resolution. The Secondary Outcomes Included Rate of Blood Glucose Fall, Incidence of Hypoglycemia, Hypokalemia, Rebound Hyperglycemia and Treatment Failure, Total Dose of Regular Infusion, Length of Emergency/ Intensive Care Unit and Hospital Stay. The Outcomes were Adjusted for the Severity of DKA Episodes.

Results: A Total of 82 Patients Were Enrolled. The Baseline Characteristics in Both Groups Were Matched Except for a Higher Proportion of Severe Cases in the Control Group. The Median (IQR) Time to Resolution of DKA Was 8 (8, 15) Hours in the Glargine and 12 (8, 16) Hours in the Placebo Group. [Adjusted Hazard Ratio 1.05 95% CI 0.65-1.69, p=0.840]. Rebound Hyperglycemia Was Significantly Lower in the Glargine Group (34.1% vs 61.5%, P- 0.014). The Two Groups Did Not Differ With Respect to the Mean Rate of Glucose Fall, Incidence of Hypoglycemia, Hypokalemia, Treatment Failure and Total Dose of Regular Infusion, Length of Emergency/ Intensive Care Unit and Hospital Stay.

Conclusions: The Addition of Glargine Insulin to the Standard Regimen During Early DKA Management Was Not Associated With Accelerated Resolution of Ketoacidosis. However, It Resulted in Better Glycaemic Control Post-DKA Resolution by Reducing Rebound Hyperglycaemia Episodes. Administration of Glargine Was Safe and Feasible and Not Associated With an Increased Risk of Hypoglycaemia or Hypokalaemia.