Comparison of continuous versus intermittent administration of insulin for the treatment of diabetic ketoacidosis in childre
Not Applicable
- Conditions
- Health Condition 1: E101- Type 1 diabetes mellitus with ketoacidosis
- Registration Number
- CTRI/2019/08/020687
- Lead Sponsor
- JIPMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Adverse events other than hypoglycemic episodes (Cerebral edema, AKI, death)Timepoint: Until resolution of DKA;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 hospital stay (days)Timepoint: Until discharge from hospital;Duration of PICU stay (days)Timepoint: until discharge from PICU;Duration of therapy until glucose is 250 mg/dl (hours)Timepoint: Until glucose is less than 250 mg/dl;Hypoglycemic episodesTimepoint: Until resolution of DKA;Proportion of all cause in hospital mortalityTimepoint: Until discharge from hospital