Overview

Management of Diabetes in the Emergency Room: a Randomized Trial of an Insulin Protocol.

Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
0
Participant gender:
All
Summary
This study will examine two questions: 1. Whether insulin treatment of high blood sugar in patients with diabetes while they are in the emergency room will improve how quickly they recover from illness if they need to be hospitalized. 2. Whether immediately beginning long lasting insulin detemir in patients with diabetes when they are admitted to hospital from the emergency room will improve how quickly they recover from the illness which necessitated hospitalization.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Rush University Medical Center
Collaborator:
Novo Nordisk A/S
Treatments:
Insulin
Insulin Aspart
Insulin degludec, insulin aspart drug combination
Insulin Detemir
Insulin, Globin Zinc
Insulin, Long-Acting
Criteria
Inclusion Criteria:

1. Age 18-80 years

2. History of type 2 diabetes mellitus for at least 3 months

3. Prior therapy with dietary management, oral agents, or insulin

4. Non child-bearing potential or a negative urine pregnancy test

5. Initial blood glucose in ER > 200 mg/dl

Exclusion Criteria:

1. Subsequent finding of diabetic ketoacidosis or hyperosmolar non-ketotic syndrome after
initial evaluation.

2. Patients with critical illness suspected to require intensive care unit admission or
direct surgical intervention.

3. History of current drug or alcohol abuse.

4. History of current mental illness

5. Inability to give informed consent

6. Female patients who are pregnant or are breast feeding

7. Patients who have clinically significant liver disease with ALT/AST > 3 times the
upper range of normal

8. Patients currently treated with dialysis