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Comparing a lower dose of insulin with the standard dose of insulin for the treatment of children presenting with acute severe diabetes (Diabetic ketoacidosis)

A RANDOMIZED CONTROLLED TRIAL OF LOW DOSE (0.05 U/KG/HR) VERSUS STANDARD DOSE (0.1 U/KG/HR) INTRAVENOUS INSULIN INFUSION FOR THE TREATMENT OF DIABETIC KETOACIDOSIS IN CHILDREN

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/04/002548
Enrollment
44
Registered
2012-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Health Condition 1: null- Diabetic ketoacidosis

Interventions

Intervention1: Regular Insulin: Continuous intravenous insulin infusion (0.05 U/kg/hr) till the resolution of acidosis (pH 7.3
HCO3 15) Control Intervention1: Regular insulin: Continuous intravenous insulin infusion(0.1U/kg/hr) till the resolution of acidosis (pH 7.3
HCO3 15)

Sponsors

Postgraduate Institute of Medical Education and Research PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: all children aged 12 years and below presenting with diabetic ketoacidosis are enrolled

Exclusion criteria

Exclusion criteria: 1.Features of cerebral edema at presentation 2.Received insulin infusion before admission 3.Features of sepsis at presentation 4.Anuria for more than 6 hours

Design outcomes

Primary

MeasureTime frame
Rate of fall in blood glucoseTimepoint: till blood glucose falls to 250mg/dl—

Secondary

MeasureTime frame
Incidence of cerebral edemaTimepoint: till the end point of study;incidence of hypoglycemiaTimepoint: till the end point of study;incidence of hypokalemiaTimepoint: till the end point of study;Rate of resolution of acidosisTimepoint: Till the end point of study—

Countries

India

Contacts

Public ContactJayashree

PGIMER

mjshree@hotmail.com9815594343

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 7, 2026