COMPARING TWO DOSES OF INSULIN THERAPY USED IN PEDIATRIC DIABETIC KETOACIDOSIS- A RANDOMIZED CONTROLLED TRIAL

LOW-DOSE VS STANDARD-DOSE INSULIN IN PEDIATRIC DIABETIC KETOACIDOSIS- A RANDOMIZED CONTROLLED TRIAL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/05/014040

Enrollment

Registered

2018-05-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- PEDIATRIC DIABETIC KETOACIDOSIS Health Condition 2: E101- Type 1 diabetes mellitus with ketoacidosis

Interventions

Intervention1: STANDARD DOSE INSULIN THERAPY: STANDARD DOSE INTRAVENOUS REGULAR INSULIN THERAPY GIVEN AT 0.1 Units/Kg/hour. Control Intervention1: LOW DOSE INSULIN THERAPY: LOW DOSE INTRAVENOUS REGULA

Eligibility

Inclusion criteria

Inclusion criteria: NEW DIABETIC OR KNOWN DIABETIC. MEETING BIOCHEMICAL CRITERIA OF DIABETIC KETOACIDOSIS: 1) HYPERGLYCEMIA (BLOOD GLUCOSE >200mg/dL); 2) ACIDOSIS (VENOUS pH <7.3 or BICARBONATE <15 mEq/L); 3) KETONURIA (URINE DIPSTICK MORE THAN OR EQUAL TO 2+)

Exclusion criteria

Exclusion criteria: CHILDREN WITH SYMPTOMATIC CEREBRAL EDEMA. CHILDREN WITH SEPTIC SHOCK AT PRESENTATION. CHILDREN WITH ANURIA FOR LONGER THAN 6 HOURS. CHILDREN WHO RECEIVED INSULIN TREATMENT (s.c. or i.v.) BEFORE ADMISSION.

Design outcomes

Primary

Measure	Time frame
RATE OF FALL OF GLUCOSE AND RESOLUTION OF ACIDOSISTimepoint: RATE OF FALL OF GLUCOSE AND RESOLUTION OF ACIDOSIS (MONITORING EVERY 4 HOURLY)	—

Secondary

Measure	Time frame
INCIDENCE OF COMPLICATIONSTimepoint: MONITORING EVERY 4 HOURLY	—

Countries

India

Contacts

Public ContactDr GURMEET KAUR

GGSMC&H, FARIDKOT

gkaur0702@gmail.com

Outcome results

None listed

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