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Proteus Sustained Behavior Change Study

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01503008
First Posted: January 2, 2012
Last Update Posted: March 5, 2013
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.
Information provided by (Responsible Party):
Proteus Digital Health, Inc.
December 28, 2011
January 2, 2012
March 5, 2013
February 2012
August 2012   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01503008 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Proteus Sustained Behavior Change Study
Proteus Sustained Behavior Change Study
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Device: Proteus Sustained Behavior Change system
    The SBC system uses ingestible and wearable sensing devices and mobile phones to reinforce positive behaviors around medication usage, exercise and rest. Subjects will be taking their regularly prescribed oral hypoglycemics (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors); glucometer
  • Drug: Regularly prescribed diabetes medicines (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors)
    Oral hypoglycemics (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors) at subjects' regularly prescribed doses; glucometer
  • Experimental: Sustained Behavior Change system support
    Intervention: Device: Proteus Sustained Behavior Change system
  • Active Comparator: Control
    Intervention: Drug: Regularly prescribed diabetes medicines (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2012
August 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Self-reported diagnosis of Type 2 Diabetes Mellitus within the past 2-12 months
  • Hemoglobin A1c ≥7.5 and ≤11, obtained with the point-of-care HbA1c diagnostic device during the enrollment visit
  • Self-reported current use of metformin for Type 2 diabetes
  • Male or female ≥ 18
  • Outpatient
  • Self-reported capacity to perform "moderate" exercise, as specified by in the 2010 joint American College of Sports Medicine/American Diabetes Association guidelines
  • Designation of one caregiver to be involved in the study for its entire duration. A caregiver can be a relative, friend, or trained or untrained hired individual.
  • Self-reported mobile phone reception at home and/or at work
  • Willingness to adhere to study procedures, including troubleshooting of the Raisin System by a third-party if needed. The third party will be blinded to any personal subject identifiers.
  • Capacity to read and speak English proficiently, as judged by the investigator during the screening interview
  • Capacity to understand the instructions for the study, as judged by the investigator during the screening interview

Exclusion Criteria:

  • Self-reported treatment with metformin for less than 2 months at the time of screening
  • Self-reported adverse reaction to metformin (e.g., ongoing nausea, vomiting, bloating, diarrhea) or to other concomitant medications being administered at the time of screening
  • Self-reported use of injectable hypoglycemic agents, such as insulin, exenatide, liraglutide or pramlintide
  • Physical or medical condition that could prevent safe participation in moderate levels of physical activity, as surveyed by the Physical Activity Readiness Questionnaire (PAR-Q) and interpreted by the investigator
  • Inability to use a mobile phone (e.g., to find icons or to open and to read a SMS), or inability to operate the approved glucometer that will be provided for use in the study
  • Self-reported current (i.e., in the last 12 months) alcohol or drug abuse (including, but not limited, to use of marijuana)
  • Positive urine pregnancy test for women
  • Women of child bearing potential who are not using a medically accepted means of contraception. Accepted means of contraception include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy
  • Self-reported history of myocardial infarction within past 60 days
  • Self-reported history of cerebral vascular accident within past 60 days
  • Self-reported history of skin sensitivity to adhesive medical tape or metals
  • Self-reported history of acute or chronic dermatitis, excluding atopic dermatitis
  • Self-reported allergies that could preclude safe participation in the study
  • Current participation in another clinical study, or participation in a clinical study in the past 30 days during which an investigational device or drug was used
  • Any condition that, in the investigator's opinion, would preclude the subject's being able to meet all of the protocol requirements, or would compromise the subject's safety during participation in the study
  • Presence of cognitive impairment, as judged by the investigator during the screening interview
  • Inability to provide informed consent for any reason
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01503008
PB-SBCT2DM
No
Not Provided
Not Provided
Proteus Digital Health, Inc.
Proteus Digital Health, Inc.
Not Provided
Principal Investigator: Kamal Jethwani, MD Center for Connected Health, Partners Healthcare
Principal Investigator: Michael J Coons, PhD Northwestern University
Principal Investigator: Bonnie Spring, PhD Northwestern University
Proteus Digital Health, Inc.
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP