Skip to content

Comparison of two different regimen of insulin in children with diabetic ketoacidosis

Standard dose insulin versus low dose insulin in pediatric diabetic ketoacidosis - A Randomised Control trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025638
Enrollment
50
Registered
2020-06-05
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: E101- Type 1 diabetes mellitus with ketoacidosis

Interventions

Intervention1: Low dose insulin 0.05U/kg/hr: 1.Capillary or venous blood glucose will be checked every hour or more frequently depending on clinical need. (On call Plus glucometer, ACON laboratories.

Sponsors

Institute of Child Health and Hospital for Children
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children between 1 month to 12 years diagnosed as DKA - defined as blood glucose more than 200mg/dl with acidosis pH less than 7.3 or bicarbonate less than 15mEq/l and ketonuria(urine dipstick result more than or equal to 2+/ketonemia >3mmol/L)

Exclusion criteria

Exclusion criteria: All children diagnosed as DKA and started on insulin in other hospital

Design outcomes

Primary

MeasureTime frame
1.To measure the rate of decrease in blood glucose until the level reaches 200mg/dl or less 2) to assess the time taken for resolution of acidosis- normalisation of anion gapTimepoint: 1.enrollment will be done within one hour of admission 2.intervention will start at the time of enrollment 3. As per ISPAD guidelines, patient will be assessed every hour for measuring the rate of decrease of blood glucose and every 4 hours for resolution of acidosis

Secondary

MeasureTime frame
To assess the incidences of complications like hypokalemia, hypoglycaemia and cerebral edemaTimepoint: 1.enrollment will be done within one hour of admission 2.intervention will start at the time of enrollment 3.As per ISPAD guidelines, patient will be assessed every hour for hypoglycemia and for cerebral edema 4. patient will be assessed every fourth hour for hypokalemia

Countries

India

Contacts

Public ContactProf Dr V Poovazhagi

Institute of child health and hospital for children, Madras Medical College

drdurai09@gmail.com9381014773

Outcome results

None listed

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