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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: insulin aspart
* Drug: insulin detemir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: aspart detemir<br>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. | Drug: insulin aspart<br>* insulin aspart: insulin aspart will be given every 2 hours dosed from 0.05 to 0.15 units per kg weight to patients with a prior history of diabetes if blood glucose is more than 200 mg/dl in the ER. If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.<br>Drug: insulin detemir<br>* insulin detemir: insulin aspart will be given every 2 hours dosed from 0.05 to 0.15 units per kg weight to patients with a prior history of diabetes if blood glucose is more than 200 mg/dl in the ER. If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.<br>|
| No Intervention: usual care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Length of Stay | hospital length of stay in days | from hospital admission to hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Blood Glucose During the Hospital Admission |  | from admission to discharge | 
| Frequency of Hypoglycemia |  | from hospital admission to discharge | 
| Efficacy of Blood Glucose Lowering During the Emergency Room Stay |  | from emergency room admission to discharge | 
| Frequency of Hypoglycemia During Emergency Room Therapy With Insulin |  | from emergency room admission to discharge |