Management of Hyperglycemia in the Emergency Room: A Randomized Clinical Trial of a Subcutaneous Insulin Aspart Protocol Coupled With Rapid Initiation of Basal Bolus Insulin Prior to Hospital Admission Versus Usual Care
Overview
- Phase
- Phase 4
- Intervention
- insulin aspart
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Rush University Medical Center
- Enrollment
- 176
- Locations
- 1
- Primary Endpoint
- Hospital Length of Stay
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18-80 years
- •History of type 2 diabetes mellitus for at least 3 months
- •Prior therapy with dietary management, oral agents, or insulin
- •Non child-bearing potential or a negative urine pregnancy test
- •Initial blood glucose in ER \> 200 mg/dl
Exclusion Criteria
- •Subsequent finding of diabetic ketoacidosis or hyperosmolar non-ketotic syndrome after initial evaluation.
- •Patients with critical illness suspected to require intensive care unit admission or direct surgical intervention.
- •History of current drug or alcohol abuse.
- •History of current mental illness
- •Inability to give informed consent
- •Female patients who are pregnant or are breast feeding
- •Patients who have clinically significant liver disease with AST/ALT (aspartate transaminase/alanine transaminase) \> 3 times the upper range of normal
- •Patients currently treated with dialysis
Arms & Interventions
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: insulin aspart
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: insulin detemir
Outcomes
Primary Outcomes
Hospital Length of Stay
Time Frame: from hospital admission to hospital discharge
hospital length of stay in days
Secondary Outcomes
- Average Blood Glucose During the Hospital Admission(from admission to discharge)
- Frequency of Hypoglycemia(from hospital admission to discharge)
- Frequency of Hypoglycemia During Emergency Room Therapy With Insulin(from emergency room admission to discharge)
- Efficacy of Blood Glucose Lowering During the Emergency Room Stay(from emergency room admission to discharge)