Effectiveness and Safety of Early Insulin Glargine Administration in Combination with Continuous Intravenous Insulin Infusion in the Management of Diabetic Ketoacidosis: A Prospective Randomized Controlled Trial

Phase 3

Completed

• Conditions: Diabetic ketoacidosis Adult; Basal insulin; Diabetic ketoacidosis; Hypoglycemia; Hypokalemia; Rebound hyperglycemia; Type 2 diabetes mellitus

• Registration Number: TCTR20200710006
• Lead Sponsor: /A

Brief Summary

Early combination of insulin glargine with IV insulin infusion led to a faster DKA resolution and a shorter LOS, without increasing hypoglycemia and hypokalemia.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-10
• Study Completion: 2021-11-30
• Results First Posted: 2022-12-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients who age at least 18 years old and were diagnosed with DKA

Exclusion Criteria

Glargine allergy
Euglycemic DKA
Hemodynamic instability (need vasopressor to maintain hemodynamic status) Pregnant or breastfeeding women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to resolution of DKA When complete criteria of DKA resolution Time to resolution of DKA in medical record

Secondary Outcome Measures

Name	Time	Method
Rebound hyperglycemia at least 12 hours after discontinuation of IV insulin infusion Routinely checked capillary blood glucose (at least 4 times per day: before meal and bedtime) after discontinuation of IV insulin infusion