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Impact of a Diabetes Transitions Tool Kit on Post-Hospitalization Glycemic Control (DTTK)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01495975
First Posted: December 20, 2011
Last Update Posted: October 25, 2016
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.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Deborah Wexler, MD, Massachusetts General Hospital
Results First Submitted: April 6, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Intervention: Other: Diabetes Transitions Tool Kit

  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
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Reporting Groups
  Description
Usual Care Usual care for diabetes in the 1 month after discharge.
Diabetes Transitions Tool Kit

Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.

Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge.


Participant Flow:   Overall Study
    Usual Care   Diabetes Transitions Tool Kit
STARTED   15   14 
COMPLETED   14   14 
NOT COMPLETED   1   0 
Lost to Follow-up                1                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
Usual Care Usual care for diabetes in the 1 month after discharge.
Diabetes Transitions Tool Kit

Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.

Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge.

Total Total of all reporting groups

Baseline Measures
   Usual Care   Diabetes Transitions Tool Kit   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   14   28 
Age, Customized 
[Units: Years]
Mean (Standard Deviation)
     
Age   52  (14)   54  (16)   53  (15) 
Gender 
[Units: Participants]
     
Female   3   5   8 
Male   11   9   20 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   8   8   16 
Hispanic   1   3   4 
Other   5   3   8 
Region of Enrollment 
[Units: Participants]
     
United States   14   14   28 
Average HbA1c 
[Units: %]
Mean (Standard Deviation)
 10.2  (2.4)   10.5  (1.9)   10.3  (2.2) 
Average glycated albumin 
[Units: %]
Mean (Standard Deviation)
 30  (10)   26  (7)   28  (8.7) 


  Outcome Measures

1.  Primary:   Glycemic Control   [ Time Frame: 1 month from discharge ]

2.  Secondary:   Diabetes Distress   [ Time Frame: 1 month from discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Diabetes Self-Management   [ Time Frame: 1 month from discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Unplanned Readmission or ED Visit   [ Time Frame: 1 month after discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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:  
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: Nancy Wei, MD
Organization: MGH Diabetes Center
phone: 617-724-7597
e-mail: ncwei@mgh.partners.org



Responsible Party: Deborah Wexler, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01495975     History of Changes
Other Study ID Numbers: 2011p-001573
5K23DK080228-05 ( U.S. NIH Grant/Contract )
First Submitted: December 14, 2011
First Posted: December 20, 2011
Results First Submitted: April 6, 2015
Results First Posted: April 16, 2015
Last Update Posted: October 25, 2016