Health Condition 1: E101- Type 1 diabetes mellitus with ketoacidosis
Conditions
Interventions
Intervention1: Lispro group: Subcutaneous (SC) rapid-acting analog-Lispro will be initiated at a dose of 0.15 U/kg every 2 hours, the first dose being administered one hour after the initiation of flu
Sponsors
JIPMER
Eligibility
Inclusion criteria
Inclusion criteria: All children aged 1 month to 12 years (completed), admitted in the department of Pediatrics, JIPMER, with the diagnosis of DKA will be included. The diagnosis of DKA will be based on Clinical Practice Consensus Guidelines 2018 by ISPAD (International Society for Pediatric and Adolescent Diabetes)
Exclusion criteria
Exclusion criteria: 1. Children with complicated DKA requiring intubation 2. Children with symptomatic cerebral edema with raised ICP requiring osmotic agents (mannitol, 3% saline) 3. Children in shock requiring vasoactive agents 4. Children with diagnosed inborn error of metabolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the time to resolution of DKA in children (1 month- 12yrs) managed with continuous intravenous regular insulin infusion (group1) versus rapid acting intermittent subcutaneous insulin (group 2)Timepoint: Resolution of DKA(Definition as per ISPAD guidelines) | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of therapy until glucose is 250 mg/dl (hours)Timepoint: Until glucose is less than 250 mg/dl;Amount of Insulin administered until glucose is less than 250 mg/dl (units)Timepoint: Until glucose is less than 250 mg/dl;Amount of Insulin administered until resolution of DKA (units)Timepoint: Until resolution of DKA;Duration of PICU stay (days)Timepoint: until discharge from PICU;Duration of hospital stay (days)Timepoint: Until discharge from hospital;Hypoglycemic episodesTimepoint: Until resolution of DKA;Adverse events other than hypoglycemic episodes (Cerebral edema, AKI, death)Timepoint: Until resolution of DKA;Proportion of all cause in hospital mortalityTimepoint: Until discharge from hospital | — |
Countries
India
Contacts
Public ContactR SANTHOSH KUMAR
JIPMER
Outcome results
None listed