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 yet recruiting

Conditions: Type 1 diabetes mellitus with ketoacidosis,

Registration Number: CTRI/2023/08/056945

Lead Sponsor: Bharati Vidyapeeth medical college

Brief Summary: Children with underlying T1DM or T2DM who present in Diabetic Ketoacidosis will form the study population. Once diagnosed, the children will be categorized into moderate and severe diabetic ketoacidosis based on ISPAD 2022. An informed and written consent will be obtained from the parents of the child while an assent will also be taken in cases where the child is more than 8 years old. The consent and assent will be administered by the primary investigator (myself) or the pediatric intensive care fellow on duty. The enrolled subjects will be randomized using block randomization with pre-formed blocks of 4 with parallel arms. The intervention group will receive subcutaneous insulin glargine at a dose of 0.3units / kilogram within 2 hours of diagnosis of DKA followed by a same dose once every 24 hours while the control group will receive the standard treatment protocol. The brand of insulin glargine used will be Basalog (100 IU/ml) by Biocon limited.Both sets of patients will otherwise be managed with replacement fluids and insulin infusion as per ISPAD 2022 recommendations and any complications will be managed as per standard therapy.The lab monitoring for both groups will consist of an hourly bedside blood glucose level, venous blood gas every 6 hours and serum electrolytes and anion gap every 12 hours. On resolution of DKA (pH > 7.3 and HCO3 > 15), children in both groups will be transitioned to subcutaneous regular insulin as per the sliding scale with continued monitoring of blood sugars and blood gas parameters additionally as indicated.An increase in BSL beyond >250mg/dl within 2 hours after stopping of insulin infusion will be considered as rebound hyperglycemia.Demographical data, clinical data and laboratory findings of patients are recorded.Criteria considered to transfer the patient out of PICU include normalized glucose levels without any rebound hyperglycemia or acidosis, after 6 hours of transition from IV insulin infusion to subcutaneous (SC) insulin injections.The outcome measures will include time taken for acidosis resolution, total insulin infusion requirement, rate in fall of blood sugar level, incidence of complications (hypoglycemia / hypokalemia), incidence of rebound hyperglycemia and length of PICU stay.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 48

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 whoâ€™s parents refuse to participate in the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To calculate and compare the duration of insulin infusion and total IV insulin requirement in between the two groups.	From starting of DKA protocol to time of resolution of DKA (pH more than 7.3 and HCO3 more than 18).
To compare the time taken for resolution of acidosis in between two groups.	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.	To determine the incidence of complications including hypoglycemia and hypokalemia and compare outcomes in terms of length of PICU stay.

Trial Locations

Locations (1): Department of Pediatrics, Bharati Vidyapeeth medical college
🇮🇳
Pune, MAHARASHTRA, India
Department of Pediatrics, Bharati Vidyapeeth medical college
🇮🇳Pune, MAHARASHTRA, India
Dr Sai Charitha Naladala
Principal investigator
7842776909
saicharitha97@gmail.com