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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sustained Behavior Change system support | Experimental |
| |
| Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proteus Sustained Behavior Change system | Device | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamal Jethwani, MD | Center for Connected Health, Partners Healthcare | Principal Investigator |
| Michael J Coons, PhD | Northwestern University | Principal Investigator |
| Bonnie Spring, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| Center for Connected Health, Partners Healthcare |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D013453 | Sulfonylurea Compounds |
| D045162 | Thiazolidinediones |
| D054873 | Dipeptidyl-Peptidase IV Inhibitors |
| D065089 | Glycoside Hydrolase Inhibitors |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D014508 |
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|
| Regularly prescribed diabetes medicines (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors) | Drug | Oral hypoglycemics (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors) at subjects' regularly prescribed doses; glucometer |
|
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 |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| D004700 | Endocrine System Diseases |
| Urea |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
| D045505 | Physiological Effects of Drugs |