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

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ClinicalTrials.gov Identifier: NCT00591227
Recruitment Status : Completed
First Posted : January 11, 2008
Results First Posted : May 5, 2011
Last Update Posted : May 5, 2011
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
Rush University Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Intervention Drug: insulins aspart and detemir
Enrollment 176
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1-aspart Detemir 2 Usual Care
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 89 87
Completed 89 87
Not Completed 0 0
Arm/Group Title 1-aspart Detemir 2 Usual Care Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 89 87 176
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 87 participants 176 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
68
  76.4%
68
  78.2%
136
  77.3%
>=65 years
21
  23.6%
19
  21.8%
40
  22.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 89 participants 87 participants 176 participants
55  (15) 55  (15) 55  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 87 participants 176 participants
Female
46
  51.7%
53
  60.9%
99
  56.3%
Male
43
  48.3%
34
  39.1%
77
  43.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 89 participants 87 participants 176 participants
89 87 176
1.Primary Outcome
Title Length of Stay in the Hospital
Hide Description [Not Specified]
Time Frame from hospital admission to hospital discharge
Outcome Measure Data Not Reported
2.Primary Outcome
Title Hospital Length of Stay
Hide Description hospital length of stay in days
Time Frame days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1-aspart Detemir 2 Usual Care
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 89 87
Mean (95% Confidence Interval)
Unit of Measure: days
2.7
(0.7 to 4.7)
3.1
(1.2 to 5.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1-aspart Detemir, 2 Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
3.Secondary Outcome
Title Average Blood Glucose During the Hospital Admission
Hide Description [Not Specified]
Time Frame from admission to discharge
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Frequency of Hypoglycemia
Hide Description [Not Specified]
Time Frame from hospital admission to discharge
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Efficacy of Blood Glucose Lowering During the Emergency Room Stay
Hide Description [Not Specified]
Time Frame from emergency room admission to discharge
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Frequency of Hypoglycemia During Emergency Room Therapy With Insulin
Hide Description [Not Specified]
Time Frame from emergency room admission to discharge
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1-aspart Detemir 2 Usual Care
Hide Arm/Group Description 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. 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.
All-Cause Mortality
1-aspart Detemir 2 Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
1-aspart Detemir 2 Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/87 (0.00%)   0/89 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
1-aspart Detemir 2 Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/87 (0.00%)   0/89 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: David Baldwin MD
Organization: Rush University Medical Center
Phone: 312-942-6163
EMail: david_baldwin@rush.edu
Layout table for additonal information
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
First Submitted: December 27, 2007
First Posted: January 11, 2008
Results First Submitted: April 8, 2011
Results First Posted: May 5, 2011
Last Update Posted: May 5, 2011