Relapse Among Diabetic Ketoacidosis Patients Maintained Basal Bolus Insulin Administration in Combination With Continuous Intravenous Insulin Infusion VS Non Maintaining Basal Insulin Patients

NCT07423559 | Completed

• 1 other identifier: 36264MS408/11/23
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to assess intensive care unit stay and relapse among patients of Diabetic ketoacidosis (type 1 diabetes mellitus) maintained basal bolus insulin and patients non maintaining along with intervenors insulin infusion.

Conditions

Diabetic Ketoacidosis; Insulin; Intensive Care Unit Stay

Keywords

Intensive Care Unit; Diabetic Ketoacidosis; Basal Bolus Insulin; Intravenous Insulin Infusion

Outcome Measures

Primary Outcomes (1)

• Resolution of diabetic ketoacidosis

  Criteria of resolution of Diabetic Ketoacidosis The anion gap (AG) \<12 mEq/L. Venous pH \>7.3. Serum bicarbonate ≥15 mEq/L

  4 days

Secondary Outcomes (1)

• Random blood sugar assessment

  every 2 hours till 4 days

Study Arms (3)

Group I

EXPERIMENTAL

Patients treated with insulin infusion without basal insulin.

Drug: insulin infusion without basal insulin

Group II

EXPERIMENTAL

Patients treated with insulin infusion with basal insulin.

Drug: insulin infusion with basal insulin

Group III

EXPERIMENTAL

Patients treated with insulin infusion with basal insulin and bolus.

Drug: Insulin infusion with basal insulin and bolus

Interventions

insulin infusion without basal insulin DRUG

Group I : treated with insulin infusion without basal insulin.

Group I

insulin infusion with basal insulin DRUG

Group II : treated with insulin infusion with basal insulin.

Group II

Insulin infusion with basal insulin and bolus DRUG

Group III : treated with insulin infusion with basal insulin and bolus

Group III

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients aged 21y or more
• who are known to have type 1 diabetes on known basal bolus insulin regimen - presented with diabetic ketoacidosis.

You may not qualify if:

• Patients with type 2 diabetes mellitus.
• If hemodynamically unstable patients.
• Patients with other metabolic problems (hepatic coma, renal failure, disturbed conscious level .

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Egypt

Location

MeSH Terms

Conditions

Diabetic Ketoacidosis; Insulin Resistance

Condition Hierarchy (Ancestors)

Ketosis; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 20, 2026
• Study Start: November 30, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG (1)