Health Condition 1: E101- Type 1 diabetes mellitus with ketoacidosis
Conditions
Interventions
Intervention1: Glargine (long acting) insulin: Glargine Insulin supplementation (0.3U/kg) subcutaneously within 1 hour of initiation of regular insulin infusion.
Every 24 hourly till resolution of DKA
Sponsors
Postgraduate Institute of Medical Education and Research PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: All children > 1 month to < 12 years with DKA will be enrolled
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to resolution of acidosis(pH 7.3 and bicarbonate 15mmol/l), sensorium and closure of anion gapTimepoint: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactJayashree Muralidharan
PGIMER Chandigarh
Outcome results
None listed