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.

Study Overview

• Status: Withdrawn
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Device: Proteus Sustained Behavior Change system; Drug: Regularly prescribed diabetes medicines (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Center for Connected Health, Partners HealthCare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy	As measured by the 13-item self-efficacy expectancies and outcomes expectancies sub-scale of the Multidimensional Diabetes Questionnaire	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Proteus Digital Health, Inc.
• Investigators: Principal Investigator: Kamal Jethwani, MD, Center for Connected Health, Partners HealthCare; Principal Investigator: Michael J Coons, PhD, Northwestern University

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): August 1, 2012
• Study Completion (Anticipated): August 1, 2012

Study Registration Dates

• First Submitted: December 28, 2011
• First Submitted That Met QC Criteria: December 30, 2011
• First Posted (Estimate): January 2, 2012

Study Record Updates

• Last Update Posted (Estimate): March 5, 2013
• Last Update Submitted That Met QC Criteria: March 1, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Hypoglycemic Agents; Metformin; Dipeptidyl-Peptidase IV Inhibitors; 2,4-thiazolidinedione; Glycoside Hydrolase Inhibitors
• Other Study ID Numbers: PB-SBCT2DM