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NCT Number: NCT07423559

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

insulin infusion without basal insulin

Drug

Group I : treated with insulin infusion without basal insulin.

insulin infusion with basal insulin

Drug

Group II : treated with insulin infusion with basal insulin.

Insulin infusion with basal insulin and bolus

Drug

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

Primary outcomes

  1. Resolution of diabetic ketoacidosis

    Time frame: 4 days

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

Secondary outcomes

  1. Random blood sugar assessment

    Time frame: every 2 hours till 4 days

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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