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Proteus Sustained Behavior Change Study

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Proteus Digital Health, Inc.
ClinicalTrials.gov Identifier:
NCT01503008
First received: December 28, 2011
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Device: Proteus Sustained Behavior Change system
Drug: Regularly prescribed diabetes medicines (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Proteus Sustained Behavior Change Study

Resource links provided by NLM:


Further study details as provided by Proteus Digital Health, Inc.:

Primary Outcome Measures:
  • Self-efficacy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    As measured by the 13-item self-efficacy expectancies and outcomes expectancies sub-scale of the Multidimensional Diabetes Questionnaire


Secondary Outcome Measures:
  • Perceived effectiveness of caregiver support [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    As measured by the 20-item Problem Areas In Diabetes scale

  • At-home measurements of fasting glucose [ Time Frame: 1, 6, 12 weeks ] [ Designated as safety issue: No ]
    Weekly average for each time point

  • In-clinic measurements of fasting glucose [ Time Frame: 0, 6, 12 weeks ] [ Designated as safety issue: No ]
    Discrete lab measurement

  • Usability [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Device-related and -unrelated adverse events [ Time Frame: Up to 4 months ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: February 2012
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sustained Behavior Change system support 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
Active Comparator: Control 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01503008

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Massachusetts
Center for Connected Health, Partners Healthcare
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Proteus Digital Health, Inc.
Investigators
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
  More Information

No publications provided

Responsible Party: Proteus Digital Health, Inc.
ClinicalTrials.gov Identifier: NCT01503008     History of Changes
Other Study ID Numbers: PB-SBCT2DM
Study First Received: December 28, 2011
Last Updated: March 1, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
2,4-thiazolidinedione
Hypoglycemic Agents
Metformin
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014