NCT07423559

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Diabetic Ketoacidosis
• Insulin
• Intensive Care Unit Stay

Interventions

Type	Name	Description
DRUG	insulin infusion without basal insulin	Group I : treated with insulin infusion without basal insulin.
DRUG	insulin infusion with basal insulin	Group II : treated with insulin infusion with basal insulin.
DRUG	Insulin infusion with basal insulin and bolus	Group III : treated with insulin infusion with basal insulin and bolus

Timeline

• Start date: 2023-11-30
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2026-02-20
• Last updated: 2026-02-20

Locations

1 site across 1 country: Egypt