Clinical Trial: Proteus Sustained Behavior Change Study

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Proteus Sustained Behavior Change Study

Brief Summary: The study will test whether the Proteus Sustained Behavior Change (SBC) System will help Type 2 diabetics feel more able to perform self-care activities, feel less distressed about diabetes, and reduce mean fasting blood glucose levels. The SBC system uses ingestible and wearable sensing devices and mobile phones to reinforce positive behaviors around medication usage, exercise and rest.

Detailed Summary:
Sponsor: Proteus Digital Health, Inc.

Current Primary Outcome: Self-efficacy [ Time Frame: 3 months ]

As measured by the 13-item self-efficacy expectancies and outcomes expectancies sub-scale of the Multidimensional Diabetes Questionnaire


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Perceived effectiveness of caregiver support [ Time Frame: 3 months ]
    As measured by the 12-item positive reinforcing behaviors and misguided support sub-scale of the Multidimensional Diabetes Questionnaire
  • Diabetes-related distress [ Time Frame: 3 months ]
    As measured by the 20-item Problem Areas In Diabetes scale
  • At-home measurements of fasting glucose [ Time Frame: 1, 6, 12 weeks ]
    Weekly average for each time point
  • In-clinic measurements of fasting glucose [ Time Frame: 0, 6, 12 weeks ]
    Discrete lab measurement
  • Usability [ Time Frame: 3 months ]
  • Device-related and -unrelated adverse events [ Time Frame: Up to 4 months ]


Original Secondary Outcome: Same as current

Information By: Proteus Digital Health, Inc.

Dates:
Date Received: December 28, 2011
Date Started: February 2012
Date Completion: August 2012
Last Updated: March 1, 2013
Last Verified: March 2013