Outcome of Using Long Acting Glargine Insulin With Low Dose Regular Insulin Infusion in Diabetic Ketoacidosis Patients :A Comparative Study
Overview
- Phase
- Not Applicable
- Sponsor
- Ain Shams University
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Mean time to reversal of diabetic ketoacidosis
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
Patients of both groups know that they will receive crystalline insulin infusion.However they are not told whether they receive glargine insulin or not.
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
low dose insulin infusion +Subcutaneous saline
low dose insulin infusion +Subcutaneous saline
Intervention: normal saline (Other)
low dose insulin infusion +subcutaneous Glargine insulin
low dose insulin infusion +subcutaneous Glargine insulin
Intervention: Glargine (Drug)
Outcomes
Primary Outcomes
Mean time to reversal of diabetic ketoacidosis
Time Frame: 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
Time Frame: 48 hours
Total number of units of insulin infusion consumed for diabetic ketocidosis to resolve
Secondary Outcomes
No secondary outcomes reported
Investigators
Mona Ammar
Assistant Professor
Ain Shams University