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Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01698528
First Posted: October 3, 2012
Last Update Posted: September 14, 2017
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:
Massachusetts Institute of Technology
Information provided by (Responsible Party):
Joslin Diabetes Center
Results First Submitted: April 20, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Type II Diabetes
Intervention: Device: Tablet Computer

  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
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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
Intervention Group

The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.

Tablet Computer

Control Group The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.

Participant Flow:   Overall Study
    Intervention Group   Control Group
STARTED   20   20 
COMPLETED   19   16 
NOT COMPLETED   1   4 



  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.
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Reporting Groups
  Description
Intervention Group

The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.

Tablet Computer

Control Group The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
Total Total of all reporting groups

Baseline Measures
   Intervention Group   Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   40 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.8  (16.04)   53.3  (1.88)   53.52  (13.76) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      7  35.0%      7  35.0%      14  35.0% 
Male      13  65.0%      13  65.0%      26  65.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   20   20   40 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Glycemic Control as Determined by the Change in Absolute HbA1c Level   [ Time Frame: 3 months ]

2.  Secondary:   Number of Participants Reaching Target of HbA1c ≤ 7%   [ Time Frame: 3 months ]

3.  Secondary:   Change in Average Participation Satisfaction   [ Time Frame: 3 months ]

4.  Secondary:   Number of Participants With Hypoglycemia   [ Time Frame: 3 months ]

5.  Secondary:   Time Health Care Providers and Subjects Spend on Managing the Insulin Titration   [ Time Frame: 3 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 William Hsu
Organization: Joslin Diabetes Center
phone: 617-309-5803
e-mail: william.hsu@joslin.harvard.edu



Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT01698528     History of Changes
Other Study ID Numbers: CHS 2012-18
First Submitted: October 1, 2012
First Posted: October 3, 2012
Results First Submitted: April 20, 2017
Results First Posted: September 14, 2017
Last Update Posted: September 14, 2017