Proteus Sustained Behavior Change Study

Proteus Digital Health

Status

Withdrawn

Conditions

Type 2 Diabetes Mellitus

Treatments

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

Device: Proteus Sustained Behavior Change system

Study type

Interventional

Funder types

Industry

Identifiers

NCT01503008

PB-SBCT2DM

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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