Outcome of Glargine Insulin in Renal Impairment Patients With Diabetic Ketoacidosis

Not Applicable

• Conditions: Chronic Kidney Diseases
• Interventions: Other: normal saline; Drug: Glargine

• Registration Number: NCT05219942
• Lead Sponsor: Ain Shams University

Brief Summary

The study aims to compare between the use of continuous low dose insulin infusion versus co-administration of low dose continuous insulin infusion and early subcutaneous insulin glargine in diabetic ketoacidosis patients with chronic renal impairment. aim to investigate the effect of using the long acting insulin analogue glargine on the resolution time of diabetic ketoacidosis in renal impairment patients who have altered insulin pharmacokinetics and pharmacodynamics and the rate of adverse effects of this approach

Detailed Description

Diabetic ketoacidosis (DKA) is one of the most common and grave acute complications of diabetes and is a significant cause of morbidity and mortality.

The current available guidelines state that the most effective means of insulin delivery during DKA is a continuous low dose infusion of regular insulin. The patients must be admitted to the ICU for frequent and close monitoring .In addition to insulin infusion, correction of dehydration, and electrolyte and acid base disorders is achieved together with identification and treatment of co-morbid precipitating factors .

"The Joint British Diabetes Societies guideline for the management of diabetic ketoacidosis" recommends continuation of a long-acting insulin analogue such as insulin glargine during the initial management of DKA because it provides background insulin when the intravenous insulin is discontinue.

Administering basal insulin concomitantly with regular insulin infusion was found to be well tolerated, associated with faster resolution of acidosis without any adverse effects; patients required a shorter duration of intravenous insulin infusion and had a lower total dose of intravenous insulin and significantly decreased hyperglycemia after discontinuation of the intravenous insulin .

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2022-01-09
• Study First Submitted QC: 2022-01-21
• Study First Posted: 2022-02-02
• Status Verified: 2022-06
• Primary Completion: 2022-06
• Last Update Submitted: 2022-06-06
• Last Update Posted: 2022-06-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Male and female patients.
• Type I and type II diabetes mellitus.
• Patients on insulin and/or oral hypoglycemic therapy.
• Duration of diabetes more than 5 years.
• Medical and surgical patients.

Read More

Exclusion Criteria

• Severe persistent hypotension (SBP <80 inspite of receiving 1000ml of normal saline).
• Acute myocardial infarction.
• Progressive renal failure or end stage renal disease defined as eGFR < 15ml/min.
• Liver cell failure.
• Pregnancy.
• Need for emergency surgery

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low dose insulin infusion +Subcutaneous saline	normal saline	low dose insulin infusion +Subcutaneous saline
low dose insulin infusion +subcutaneous Glargine insulin	Glargine	low dose insulin infusion +subcutaneous Glargine insulin

Primary Outcome Measures

Name	Time	Method
Mean time to reversal of diabetic ketoacidosis	48 hours	Resolution of DKA is defined as blood sugar \<200mg/dl plus any two of serum bicarbonate ≥15,pH\>7.3, and anion gap less than or equal to 12
Total crystalline insulin consumption	48 hours	Total number of units of insulin infusion consumed for diabetic ketocidosis to resolve

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt