Outcome of Glargine Insulin in Renal Impairment Patients With Diabetic Ketoacidosis

Study Overview
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Brief Summary
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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
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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 .

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

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Drug: Glargine
* Other: normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: low dose insulin infusion +Subcutaneous saline<br>low dose insulin infusion +Subcutaneous saline | Other: normal saline<br>* regular low dose insulin infusion 0.1 IU/Kg/hour and subcutaneous saline instead of insulin glargine will be given in the control group.<br>|
| Active Comparator: low dose insulin infusion +subcutaneous Glargine insulin<br>low dose insulin infusion +subcutaneous Glargine insulin | Drug: Glargine<br>* 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.<br>* Other names: insulin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Total crystalline insulin consumption | Total number of units of insulin infusion consumed for diabetic ketocidosis to resolve | 48 hours |