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

• Length of Stay in the Hospital [ Time Frame: from hospital admission to hospital discharge ] [ Designated as safety issue: No ]
• Hospital Length of Stay [ Time Frame: days ] [ Designated as safety issue: No ]
  hospital length of stay in days

• Average Blood Glucose During the Hospital Admission [ Time Frame: from admission to discharge ] [ Designated as safety issue: No ]
• Frequency of Hypoglycemia [ Time Frame: from hospital admission to discharge ] [ Designated as safety issue: Yes ]
• Efficacy of Blood Glucose Lowering During the Emergency Room Stay [ Time Frame: from emergency room admission to discharge ] [ Designated as safety issue: No ]
• Frequency of Hypoglycemia During Emergency Room Therapy With Insulin [ Time Frame: from emergency room admission to discharge ] [ Designated as safety issue: Yes ]

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.

• Active Comparator: 1-aspart detemir
  these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
  Intervention: Drug: insulins aspart and detemir
• No Intervention: 2 usual care
  these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.

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