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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

Efficacy and safety of early administration of subcutaneous long acting insulin in management of children with moderate and severe diabetic ketoacidosis: An open label randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056945
Enrollment
48
Registered
2023-08-25
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: E101- Type 1 diabetes mellitus with ketoacidosis

Interventions

Intervention1: Subcutaneous Basalog along with intravenous regular insulin infusion: The intervention group will receive subcutaneous insulin glargine at a dose of 0.3units / kilogram within 2 hours o

Sponsors

Bharati Vidyapeeth medical college
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
To compare the time taken for resolution of acidosis in between two groups. To calculate and compare the duration of insulin infusion and total IV insulin requirement in between the two groups. Timepoint: From starting of DKA protocol to time of resolution of DKA (pH more than 7.3 and HCO3 more than 18).

Secondary

MeasureTime frame
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. 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).

Countries

India

Contacts

Public ContactDr Bhakti Sarangi

Bharati Vidhyapeeth (deemed to be University) medical college

dr.bhaktisarangi@gmail.com9823746976

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026