Outcome of Glargine Insulin in Renal Impairment Patients With Diabetic Ketoacidosis

Chronic Kidney Diseases Clinical Trial

Official title:

Outcome of Using Long Acting Glargine Insulin With Low Dose Regular Insulin Infusion in Diabetic Ketoacidosis Patients :A Comparative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05219942
• Other study ID #: R 103/ 2020
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: July 2022

Study information

• Verified date: June 2022
• Source: Ain Shams University
• Contact: Eeman A Bayoumi, MD
• Phone: 0021001635744
• Email: eeman_aboubakr[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: July 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Diabetic Ketoacidosis
• Ketosis
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Glargine
regular low dose insulin infusion 0.1 IU/Kg/hour and subcutaneous Glargine insulin (made by Sanofi®) within the first 2 hours of ICU admission. The dose of insulin glargine will be adjusted according to the calculated (eGFR > 90 dose = 0.27 IU/kg/day, eGFR 60-89 dose = 0.25 IU/kg/day, eGFR <60 dose = 0.19 IU/kg/day.

Other:
• normal saline
regular low dose insulin infusion 0.1 IU/Kg/hour and subcutaneous saline instead of insulin glargine will be given in the control group.

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Barski L, Brandstaetter E, Sagy I, Jotkowitz A. Basal insulin for the management of diabetic ketoacidosis. Eur J Intern Med. 2018 Jan;47:14-16. doi: 10.1016/j.ejim.2017.08.025. Epub 2017 Aug 31. Review. — View Citation

Barski L, Kezerle L, Zeller L, Zektser M, Jotkowitz A. New approaches to the use of insulin in patients with diabetic ketoacidosis. Eur J Intern Med. 2013 Apr;24(3):213-6. doi: 10.1016/j.ejim.2013.01.014. Epub 2013 Feb 8. Review. — View Citation

Chapter 1: Definition and classification of CKD. Kidney Int Suppl (2011). 2013 Jan;3(1):19-62. — View Citation

Savage MW, Dhatariya KK, Kilvert A, Rayman G, Rees JA, Courtney CH, Hilton L, Dyer PH, Hamersley MS; Joint British Diabetes Societies. Joint British Diabetes Societies guideline for the management of diabetic ketoacidosis. Diabet Med. 2011 May;28(5):508-15. doi: 10.1111/j.1464-5491.2011.03246.x. — View Citation

Svensson M, Yu ZW, Eriksson JW. A small reduction in glomerular filtration is accompanied by insulin resistance in type I diabetes patients with diabetic nephrophathy. Eur J Clin Invest. 2002 Feb;32(2):100-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean time to reversal of diabetic ketoacidosis	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	48 hours
Primary	Total crystalline insulin consumption	Total number of units of insulin infusion consumed for diabetic ketocidosis to resolve	48 hours