Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management

• Status: Terminated
• Trial end date: 2021-08-27
• Target enrollment: 0
• Participant gender: All

Summary

The transition from IV Insulin Infusion (IVII) to Subcutaneous Long-acting insulin injections in Diabetic Ketoacidosis (DKA) management frequently results in rebound hyperglycemia, particularly if there are high insulin requirements that can adversely affect the DKA recovery, increase Length Of Stay (LOS), morbidity, and mortality. Investigators propose a prospective, open-label, intervention, non-randomized, controlled study to test the hypothesis that an insulin glargine dose of 0.4 Units/kg early administered (within four hours) of IVII initiation in DKA management in adult would be effective and safe in shortening the time to anion gap closure comparing to the standard practice.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: Insulin Glargine

Criteria

Inclusion Criteria:

• Age ≥ 18 years old

• Meet DKA definition (BG ≥ 250 mg/dl, Anion Gap > 12 mEq/L, and positive Ketones in serum or urine)

• Having the capacity to sign Informed consent

Exclusion Criteria:

• IV insulin infusion was initiated for more than 4 hours.

• Persistent hypotension (SBP<80 mmHg despite receiving 1000cc normal saline).

• Require Vasopressor

• Acute Coronary Syndrome

• Pregnant

• End-stage renal disease

• Unwilling to consent to participate in the trial

• Currently under police custody

• Transferred from another hospital

• Require emergent surgery