Phase 4
N=176
Management of Diabetes in the Emergency Room: a Randomized Trial of an Insulin Protocol.
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT00591227 ↗Enrolled (actual)
176
Serious AEs
0.0%
Results posted
May 2011
Primary outcome: Primary: Hospital Length of Stay — 2.7; 3.1 days — p=0.58
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- insulin aspart (Drug); insulin detemir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rush University Medical Center
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hospital Length of Stay |
2.7; 3.1 | 0.58 |
| SECONDARY Average Blood Glucose During the Hospital Admission |
— | — |
| SECONDARY Frequency of Hypoglycemia |
— | — |
| SECONDARY Efficacy of Blood Glucose Lowering During the Emergency Room Stay |
— | — |
| SECONDARY Frequency of Hypoglycemia During Emergency Room Therapy With Insulin |
— | — |
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
- 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
Data sourced from ClinicalTrials.gov (NCT00591227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.