The effectiveness and safety of early administration of subcutaneous long acting insulin in treatment of children with moderate and severe diabetic ketoacidosis: An open label randomized controlled trial
Not Applicable
- Conditions
- Health Condition 1: - Health Condition 2: E101- Type 1 diabetes mellitus with ketoacidosis
- Registration Number
- CTRI/2023/08/056945
- Lead Sponsor
- Bharati Vidyapeeth medical college
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Children between 1 year and 18 years of age with type 1 DM who are admitted to the pediatric intensive care unit with moderate or severe diabetic ketoacidosis (DKA) as per the ISPAD 2022 guidelines.
Exclusion Criteria
-Children with mild DKA.
-Children with moderate or severe DKA who have received a dose of glargine insulin within the last 24 hours.
-Children who’s parents refuse to participate in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the time taken for resolution of acidosis in between two groups. <br/ ><br>To calculate and compare the duration of insulin infusion and total IV insulin requirement in between the two groups. <br/ ><br> <br/ ><br>Timepoint: From starting of DKA protocol to time of resolution of DKA (pH more than 7.3 and HCO3 more than 18).
- Secondary Outcome Measures
Name Time Method To assess the occurrence of rebound hyperglycemia post transition to subcutaneous insulin in between the two groups. <br/ ><br>To determine the incidence of complications including hypoglycemia and hypokalemia and compare outcomes in terms of length of PICU stay. <br/ ><br>Timepoint: From starting of DKA protocol to 6 hours after time of resolution of DKA (pH more than 7.3 and HCO3 more than 18).