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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00591227
• Other study ID #: 07070902
• Status: Completed
• Phase: Phase 4
• Start date: May 2008
• Est. completion date: July 2009

Study information

• Verified date: January 2022
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Emergencies
• Type 2 Diabetes Mellitus

Intervention

Drug:
• insulin aspart
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.
• insulin detemir
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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Length of Stay	hospital length of stay in days	from hospital admission to hospital discharge
Secondary	Average Blood Glucose During the Hospital Admission		from admission to discharge
Secondary	Frequency of Hypoglycemia		from hospital admission to discharge
Secondary	Efficacy of Blood Glucose Lowering During the Emergency Room Stay		from emergency room admission to discharge
Secondary	Frequency of Hypoglycemia During Emergency Room Therapy With Insulin		from emergency room admission to discharge