Clinical trial NCT00591227: Management of Diabetes in the Emergency Room: a Randomized Trial of an Insulin Protocol.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2008-01-11
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 AST/ALT (aspartate transaminase/alanine transaminase) \> 3 times the upper range of normal
8. Patients currently treated with dialysis

Primary outcomes:
measure: Hospital Length of Stay
timeFrame: from hospital admission to hospital discharge
Secondary outcomes:
measure: Average Blood Glucose During the Hospital Admission
timeFrame: from admission to discharge
measure: Frequency of Hypoglycemia
timeFrame: from hospital admission to discharge
measure: Efficacy of Blood Glucose Lowering During the Emergency Room Stay
timeFrame: from emergency room admission to discharge
measure: Frequency of Hypoglycemia During Emergency Room Therapy With Insulin
timeFrame: from emergency room admission to discharge
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: David Baldwin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bernard JB, Munoz C, Harper J, Muriello M, Rico E, Baldwin D. Treatment of inpatient hyperglycemia beginning in the emergency department: a randomized trial using insulins aspart and detemir compared with usual care. J Hosp Med. 2011 May;6(5):279-84. doi: 10.1002/jhm.866.