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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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
Oral hypoglycemics (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors) at subjects' regularly prescribed doses; glucometer
Northwestern University
Chicago, Illinois, United States
Center for Connected Health, Partners Healthcare
Boston, Massachusetts, United States
Self-efficacy
As measured by the 13-item self-efficacy expectancies and outcomes expectancies sub-scale of the Multidimensional Diabetes Questionnaire
Time frame: 3 months
Perceived effectiveness of caregiver support
As measured by the 12-item positive reinforcing behaviors and misguided support sub-scale of the Multidimensional Diabetes Questionnaire
Time frame: 3 months
Diabetes-related distress
As measured by the 20-item Problem Areas In Diabetes scale
Time frame: 3 months
At-home measurements of fasting glucose
Weekly average for each time point
Time frame: 1, 6, 12 weeks
In-clinic measurements of fasting glucose
Discrete lab measurement
Time frame: 0, 6, 12 weeks
Usability
Time frame: 3 months
Device-related and -unrelated adverse events
Time frame: Up to 4 months
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