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

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: insulin aspart; Drug: insulin detemir

• Registration Number: NCT00591227
• Lead Sponsor: Rush University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-27
• Study First Submitted QC: 2007-12-31
• Study First Posted: 2008-01-11
• Study Start: 2008-05
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Results First Submitted: 2011-04-08
• Results First Submitted QC: 2011-04-08
• Results First Posted: 2011-05-05
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aspart detemir	insulin aspart	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.
aspart detemir	insulin 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.

Primary Outcome Measures

Name	Time	Method
Hospital Length of Stay	from hospital admission to hospital discharge	hospital length of stay in days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States