Effect of long acting insulin in addition to standard treatment in management of diabetic ketoacidosis
Not Applicable
- Conditions
- Health Condition 1: E101- Type 1 diabetes mellitus with ketoacidosis
- Registration Number
- CTRI/2022/06/043076
- Lead Sponsor
- Postgraduate Institute of Medical Education and Research PGIMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All children > 1 month to < 12 years with DKA will be enrolled
Exclusion Criteria
1.Children with underlying liver disorders
2.Children with preexisting/ established renal disease
3.Children with symptomatic cerebral edema
4.Children with diagnosed or suspected inborn error of metabolism
5.Children who received glargine or long-acting insulin in past 24 hours
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to resolution of acidosis(pH 7.3 and bicarbonate 15mmol/l), sensorium and closure of anion gapTimepoint: 28 days
- Secondary Outcome Measures
Name Time Method Cost analysis of interventionTimepoint: Up to 28 days of enrollment;Incidence of hypokalemia and hypoglycemiaTimepoint: Till resolution of acidosis(pH 7.3 and bicarbonate 15mmol/l), sensorium and closure of anion gap;Incidence of rebound hyperglycemiaTimepoint: Up to 12 h after transition to subcutaneous short acting insulin;Length of PICU / hospital stayTimepoint: Up to 28 days of enrollment;Mean rate of blood glucose decreaseTimepoint: Till blood glucose falls to 250mg/dl;Proportion of in hospital all-cause mortalityTimepoint: Up to 28 days of enrollment;Total dose of regular insulinTimepoint: Till resolution of acidosis(pH 7.3 and bicarbonate 15mmol/l), sensorium and closure of anion gap