Proteus Sustained Behavior Change Study
Status: | Completed |
---|---|
Conditions: | Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | Any |
Updated: | 2/4/2013 |
Start Date: | February 2012 |
End Date: | August 2012 |
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.
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
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