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

Comparison of Intensive Care Unit Stay and Relapse Among Diabetic Ketoacidosis Patients Maintained Basal Bolus Insulin Administration in Combination With Continuous Intravenous Insulin Infusion VS Non Maintaining Basal Insulin Patients

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.

Study Overview

• Status: Completed
• Conditions: Insulin; Diabetic Ketoacidosis; Intensive Care Unit Stay
• Intervention / Treatment: Drug: insulin infusion without basal insulin; Drug: insulin infusion with basal insulin; Drug: Insulin infusion with basal insulin and bolus

Detailed Description

Diabetic ketoacidosis is one of the common, potentially serious, and avoidable acute complications of diabetes mellitus. Diabetic ketoacidosis is caused by a decrease in effective circulating insulin associated with elevations in counter-regulatory hormones . This potentially life-threatening complication of type 1.

diabetes mellitus is frequently mismanaged, leading to morbidity and increased length of stay. Advances in near-patient testing technology have improved patient care, by facilitating rapid diagnosis and closer monitoring of treatment response.

Diabetic ketoacidosis most often occurs in people with type 1 diabetes, but can also occur in patients with poorly controlled type 2 diabetes under stressful conditions .

Management of Diabetic ketoacidosis requires reversing metabolic derangements by correcting volume depletion and electrolyte imbalances and administering insulin to correct acidosis while concurrently treating the precipitating illness .

Diabetic ketoacidosis is traditionally managed using intravenous regular insulin infusion in intensive care unit /high dependency unit.

Fixed rate intravenous insulin infusion not only reduces blood glucose levels, but just as importantly, suppresses further ketogenesis, as well as correcting the electrolyte.

Basal insulin combination with Intervenors insulin infusion in acute management of Diabetic ketoacidosis could be protective against relapse with Diabetic ketoacidosis when abrupt interruption of insulin infusion is needed as in case of development of hypoglycemia during course of treatment or as in case of development of hypokalemia but this theory should be evaluated clinically. In our work, we are going to evaluate the effect of basal insulin continuation in acute management of Diabetic ketoacidosis to test the hypothesis that basal insulin continuation in acute management of Diabetic ketoacidosis could protect against relapse of ketoacidosis, hence shorten intensive care unit stay period of patient.

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; Patients treated with insulin infusion without basal insulin.	Drug: insulin infusion without basal insulin; Group I : treated with insulin infusion without basal insulin.
Experimental: Group II; Patients treated with insulin infusion with basal insulin.	Drug: insulin infusion with basal insulin; Group II : treated with insulin infusion with basal insulin.
Experimental: Group III; Patients treated with insulin infusion with basal insulin and bolus.	Drug: Insulin infusion with basal insulin and bolus; Group III : treated with insulin infusion with basal insulin and bolus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Random blood sugar assessment	every 2 hours till 4 days

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Diabetic Ketoacidosis; Basal Bolus Insulin; Intravenous Insulin Infusion
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Complications; Hyperinsulinism; Acid-Base Imbalance; Acidosis; Nutritional and Metabolic Diseases; Ketosis; Insulin Resistance; Diabetic Ketoacidosis
• Other Study ID Numbers: 36264MS408/11/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data will be obtained if it needed
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No