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Early Resolution of Acidosis with Subcutaneous insulin in addition to IV insulin in DKA

Early Neutral Protamine Hagedorn Insulin in the management of Diabetic Ketoacidosis â?? An Exploratory Study in a Low Resource Setting.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/044760
Enrollment
50
Registered
2022-08-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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: SC INSULIN: In addition to IV Regular insulin in the standard arm, patients receive an addition dose of insulin in the form NPH Insulin at a dose of 0.25 units/kg split into two doses 1

Sponsors

Jawaharlal Institute of Postgraduate Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All adults > 18 years of age with DKA. DKA is defined as a patients having all of the following RBS >250mg/dl pH Urine ketones ++(dipstick) Bicarbonates 10

Exclusion criteria

Exclusion criteria: 1.Chronic Liver Disease 2.Chronic Kidney Disease 3.Patient on Assisted mechanical ventilation 4.Hypotensive patients on inotropic support

Design outcomes

Primary

MeasureTime frame
Resolution of DKATimepoint: RBS every 2-3 hours VBG every 4-6 hours Till resolution of DKA Patient is assessed every 4-6 hourly till DKA resolves

Secondary

MeasureTime frame
To assess the duration of hospital stay in study participants.Timepoint: At the time of discharge;To determine the frequency of hypoglycemia in study participants.Timepoint: Till the Resolution of DKA;To evaluate the time to rebound hyperglycemia within 24 hours of stopping IV Insulin Infusion.Timepoint: Within 1 day of stopping insulin infusion

Countries

India

Contacts

Public ContactNaveen Baby

Jawaharlal Institute of Postgraduate Medical Education & Research

mukta.wyawahare@gmail.com8903307660

Outcome results

None listed

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