Proteus Sustained Behavior Change Study

Study Overview
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Brief Summary
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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.

Official Title
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Proteus Sustained Behavior Change Study

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Device: Proteus Sustained Behavior Change system
* Drug: Regularly prescribed diabetes medicines (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sustained Behavior Change system support<br> | Device: Proteus Sustained Behavior Change system<br>* 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<br>|
| Active Comparator: Control<br> | Drug: Regularly prescribed diabetes medicines (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors)<br>* Oral hypoglycemics (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors) at subjects' regularly prescribed doses; glucometer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-efficacy | As measured by the 13-item self-efficacy expectancies and outcomes expectancies sub-scale of the Multidimensional Diabetes Questionnaire | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived effectiveness of caregiver support | As measured by the 12-item positive reinforcing behaviors and misguided support sub-scale of the Multidimensional Diabetes Questionnaire | 3 months | 
| Diabetes-related distress | As measured by the 20-item Problem Areas In Diabetes scale | 3 months | 
| At-home measurements of fasting glucose | Weekly average for each time point | 1, 6, 12 weeks | 
| In-clinic measurements of fasting glucose | Discrete lab measurement | 0, 6, 12 weeks | 
| Usability |  | 3 months | 
| Device-related and -unrelated adverse events |  | Up to 4 months |