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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07423559
Enrollment
100
Registered
2026-02-20
Start date
2023-11-30
Completion date
2024-12-30
Last updated
2026-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Ketoacidosis, Insulin, Intensive Care Unit Stay

Keywords

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

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.

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.

Interventions

DRUGinsulin infusion without basal insulin

Group I : treated with insulin infusion without basal insulin.

DRUGinsulin infusion with basal insulin

Group II : treated with insulin infusion with basal insulin.

DRUGInsulin infusion with basal insulin and bolus

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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No

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 .

Design outcomes

Primary

MeasureTime frameDescription
Resolution of diabetic ketoacidosis4 daysCriteria of resolution of Diabetic Ketoacidosis The anion gap (AG) \<12 mEq/L. Venous pH \>7.3. Serum bicarbonate ≥15 mEq/L

Secondary

MeasureTime frame
Random blood sugar assessmentevery 2 hours till 4 days

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026