Outcome of Glargine Insulin in Renal Impairment Patients With Diabetic Ketoacidosis

Ain Shams University

Status: Enrolling

Conditions: Chronic Kidney Diseases

Treatments: Drug: Glargine; Other: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05219942

R 103/ 2020

Details and patient eligibility

About

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

Full 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 .

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 2 patient groups, including a placebo group

low dose insulin infusion +Subcutaneous saline

Placebo Comparator group

Description:

low dose insulin infusion +Subcutaneous saline

Treatment:

Other: normal saline

low dose insulin infusion +subcutaneous Glargine insulin

Active Comparator group

Description:

low dose insulin infusion +subcutaneous Glargine insulin

Treatment:

Drug: Glargine