MedTrace Logo

Proteus Sustained Behavior Change Study

NCT01503008 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2013-03-05

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Proteus Digital Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Kamal Jethwani, MD · Center for Connected Health, Partners Healthcare

  • Michael J Coons, PhD · Northwestern University

  • Bonnie Spring, PhD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01503008 on ClinicalTrials.gov