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Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management

NCT04567225 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2022-09-21

Study results available
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Summary

Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management

Conditions

Interventions

DRUG

Early Glargine

A dose of insulin glargine, 0.4 unit/kg, will be given within 4 hours from initiating the IV Insulin Infusion

DRUG

Late Glargine

A historical retrospective control group for the adult patients admitted to the same ICU with a diagnosis of DKA and received insulin glargine after anion gap closure.

OTHER

IV insulin infusion

Continuous weight based IV insulin infusion as per Cleveland Clinic DKA Protocol

OTHER

IV fluid and electrolytes replacement

The IV fluid and electrolytes replacement will be left to the treating physician's discretion. IV fluid to contain dextrose to keep Target Blood Glucose 150 - 200 mg/dl during the DKA management and 140 - 180 mg/dl after DKA resolution.

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Mohammed Al jaghbeer, MD · The Cleveland Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2021-08-27
Completion
2021-08-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04567225 on ClinicalTrials.gov