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

Phase 4

Completed

• Conditions: Health Condition 1: E101- Type 1 diabetes mellitus with ketoacidosis

• Registration Number: CTRI/2022/08/044760
• Lead Sponsor: Jawaharlal Institute of Postgraduate Medical Education and Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-01-25
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

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 <7.3

Urine ketones ++(dipstick)

Bicarbonates <18 Anion gap > 10

Exclusion Criteria

1.Chronic Liver Disease

2.Chronic Kidney Disease

3.Patient on Assisted mechanical ventilation

4.Hypotensive patients on inotropic support

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Resolution of DKATimepoint: RBS every 2-3 hours <br/ ><br>VBG every 4-6 hours <br/ ><br>Till resolution of DKA <br/ ><br> <br/ ><br>Patient is assessed every 4-6 hourly till DKA resolves

Secondary Outcome Measures

Name	Time	Method
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