Early Administration of Insulin Glargine in Patients With Diabetic Ketoacidosis

X1935200

Diabetic ketoacidosis (DKA) is a medical emergency that is associated with significant morbidity and mortality for both patients with type I and type II diabetes. By correcting hyperglycemia and inhibiting the release of free fatty acids, insulin administration leads to decreased ketone formation and resolution of acidosis. Short-acting intravenous insulin is often preferred to subcutaneous administration for initial management due to its short half-life and ease of titration, but patients will eventually need to transition to subcutaneous insulin prior to discharge. The timing of initiation or resumption of home long-acting subcutaneous insulin is controversial in the treatment of DKA. It is currently unknown if resuming a portion or all of the patient's home basal regimen during the initial treatment phase of DKA will provide an impact on patient care. The purpose of this study is to evaluate the impact of early glargine administration if the patient was not previously on basal insulin or resuming the patient's home basal insulin regimen within two hours after the start of the intravenous insulin infusion in addition to usual care will improve patient outcomes.

2022-05-31

2023-02-28

2023-02-28

Terminated

Early phase I

8

Inclusion Criteria: 1. Presented to Regions Hospital ED for chief complaint of DKA, nausea, vomiting, abdominal pain, hyperglycemia, or similar 2. Meets all below diagnostic criteria for DKA per the American Diabetes Association: * Arterial or venous pH \</= 7.3 * Serum Bicarbonate \</= 18 mEq/L * Ketonuria or ketonemia * Anion Gap \> 10 * Blood sugar \> 250 mg/dL 3. Receiving IV insulin infusion 4. It is feasible to provide insulin glargine within 2 hours (+/- 30 minutes) of IV infusion start 5. Will be admitted to the ICU for DKA, or already admitted to the ICU for DKA 6. Ability to provide informed consent Exclusion Criteria: 1. Age \< 18 2. End stage renal disease or hepatic disease 3. Hypotension requiring IV vasopressors or inotropes at any point during admission (i.e. norepinephrine, dobutamine, vasopressin, etc.) 4. Need for emergent surgery 5. Pregnant patients 6. Prisoners 7. Indication for insulin therapy other than DKA (hypertriglyceridemia, beta-blocker overdose, hyperglycemia without DKA) 8. Patients receiving prior to admission insulin pump therapy 9. Patients receiving prior to admission combination insulin products (i.e. Novolin® 70/30, Novolog® 70/30, Humalog® 75/25, etc.) 10. Did not consent to study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This will be a two arm, prospective, randomized, open label trial in patients presenting with DKA. Block randomization will be used to ensure equal group sizes.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 8, 'type': 'ACTUAL'}}

2024-01-25