Proteus Sustained Behavior Change Study

NCT01503008 | Withdrawn

• 1 other identifier: PB-SBCT2DM
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Self-efficacy

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

  3 months

Secondary Outcomes (6)

• Perceived effectiveness of caregiver support

  3 months

• Diabetes-related distress

  3 months

• At-home measurements of fasting glucose

  1, 6, 12 weeks

• In-clinic measurements of fasting glucose

  0, 6, 12 weeks

• Usability

  3 months

Study Arms (2)

Sustained Behavior Change system support

EXPERIMENTAL

Device: Proteus Sustained Behavior Change system

Control

ACTIVE COMPARATOR

Drug: Regularly prescribed diabetes medicines (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors)

Interventions

Proteus Sustained Behavior Change system DEVICE

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

Sustained Behavior Change system support

Regularly prescribed diabetes medicines (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors) DRUG

Oral hypoglycemics (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors) at subjects' regularly prescribed doses; glucometer

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Proteus Digital Health, Inc.: lead

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Center for Connected Health, Partners Healthcare

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; Sulfonylurea Compounds; Thiazolidinediones; Dipeptidyl-Peptidase IV Inhibitors; Glycoside Hydrolase Inhibitors

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Urea; Amides; Sulfones; Sulfur Compounds; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Officials

• Kamal Jethwani, MD

  Center for Connected Health, Partners Healthcare

  PRINCIPAL INVESTIGATOR

• Michael J Coons, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Bonnie Spring, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2011
• First Posted: January 2, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 5, 2013

Record last verified: 2013-03

Locations

US (2)