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

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00591227
First received: December 27, 2007
Last updated: April 8, 2011
Last verified: April 2011
Results First Received: April 8, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Intervention: Drug: insulins aspart and detemir

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    1-aspart Detemir     2 Usual Care  
STARTED     89     87  
COMPLETED     89     87  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
    1-aspart Detemir     2 Usual Care     Total  
Number of Participants  
[units: participants]
  89     87     176  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     68     68     136  
>=65 years     21     19     40  
Age  
[units: years]
Mean ± Standard Deviation
  55  ± 15     55  ± 15     55  ± 15  
Gender  
[units: participants]
     
Female     46     53     99  
Male     43     34     77  
Region of Enrollment  
[units: participants]
     
United States     89     87     176  



  Outcome Measures

1.  Primary:   Hospital Length of Stay   [ Time Frame: days ]

2.  Primary:   Length of Stay in the Hospital   [ Time Frame: from hospital admission to hospital discharge ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Average Blood Glucose During the Hospital Admission   [ Time Frame: from admission to discharge ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Frequency of Hypoglycemia   [ Time Frame: from hospital admission to discharge ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Efficacy of Blood Glucose Lowering During the Emergency Room Stay   [ Time Frame: from emergency room admission to discharge ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Frequency of Hypoglycemia During Emergency Room Therapy With Insulin   [ Time Frame: from emergency room admission to discharge ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: David Baldwin MD
Organization: Rush University Medical Center
phone: 312-942-6163
e-mail: david_baldwin@rush.edu


No publications provided by Rush University Medical Center

Publications automatically indexed to this study:

Responsible Party: David Baldwin MD Director of Section of Endocrinology, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00591227     History of Changes
Other Study ID Numbers: 07070902
Study First Received: December 27, 2007
Results First Received: April 8, 2011
Last Updated: April 8, 2011
Health Authority: United States: Institutional Review Board