Management of Diabetes in the Emergency Room: a Randomized Trial of an Insulin Protocol.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00591227|
Recruitment Status : Completed
First Posted : January 11, 2008
Results First Posted : May 5, 2011
Last Update Posted : May 5, 2011
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: insulins aspart and detemir||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||176 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||May 2008|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
Active Comparator: 1-aspart 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.
Drug: insulins aspart and 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.
No Intervention: 2 usual care
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.
- Length of Stay in the Hospital [ Time Frame: from hospital admission to hospital discharge ]
- Hospital Length of Stay [ Time Frame: days ]hospital length of stay in days
- Average Blood Glucose During the Hospital Admission [ Time Frame: from admission to discharge ]
- Frequency of Hypoglycemia [ Time Frame: from hospital admission to discharge ]
- Efficacy of Blood Glucose Lowering During the Emergency Room Stay [ Time Frame: from emergency room admission to discharge ]
- Frequency of Hypoglycemia During Emergency Room Therapy With Insulin [ Time Frame: from emergency room admission to discharge ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00591227
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||David Baldwin, MD||Rush University Medical Center|