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Diabetes in the Elderly: Prospective Study (DMElderly)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier:
NCT01131052
First received: May 19, 2010
Last updated: December 18, 2014
Last verified: December 2014
Results First Received: December 18, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes
Hyperglycemia
Interventions: Drug: Insulin Glargine
Drug: Insulin
Drug: Insulin glulisine

  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
Recruitment took place at Emory University-Wesley Woods Campus between March 2011 through December 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
BASAL PLUS Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
Sliding Scale Regular Insulin (SSRI) Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed

Participant Flow:   Overall Study
    BASAL PLUS   Sliding Scale Regular Insulin (SSRI)
STARTED   75   75 
COMPLETED   75   75 
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
BASAL PLUS Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
Sliding Scale Regular Insulin (SSRI) Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
Total Total of all reporting groups

Baseline Measures
   BASAL PLUS   Sliding Scale Regular Insulin (SSRI)   Total 
Overall Participants Analyzed 
[Units: Participants]
 75   75   150 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   2   3   5 
>=65 years   73   72   145 
Gender 
[Units: Participants]
     
Female   49   47   96 
Male   26   28   54 
Region of Enrollment 
[Units: Participants]
     
United States   75   75   150 


  Outcome Measures
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1.  Primary:   Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL   [ Time Frame: 3 months ]

2.  Primary:   Percent of Participants With a Mean Blood Glucose Concentration of Less Than 40 mg/dL   [ Time Frame: 3 months ]

3.  Primary:   Mean of Weekly Fasting Blood Glucose Concentration   [ Time Frame: 3 months ]

4.  Secondary:   Mean Blood Glucose Concentration   [ Time Frame: Baseline ]

5.  Secondary:   Mean of Glycosylated Hemoglobin (hbA1c)   [ Time Frame: Baseline ]

6.  Secondary:   Mean of Daily Blood Glucose Concentration   [ Time Frame: Baseline ]

7.  Secondary:   Mean of Glycosylated Hemoglobin (hbA1c)   [ Time Frame: 3 months ]

8.  Secondary:   Mean of Glycosylated Hemoglobin (hbA1c)   [ Time Frame: 6 months ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Guillermo Umpierrez
Organization: Emory University
phone: 404-778-1665
e-mail: geumpie@emory.edu



Responsible Party: Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier: NCT01131052     History of Changes
Other Study ID Numbers: IRB00038789
Study First Received: May 19, 2010
Results First Received: December 18, 2014
Last Updated: December 18, 2014
Health Authority: United States: Institutional Review Board