Type 2 Diabetes Mellitus
Conditions
Brief summary
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.
Interventions
DEVICEProteus Sustained Behavior Change system
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
DRUGRegularly prescribed diabetes medicines (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors)
Oral hypoglycemics (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors) at subjects' regularly prescribed doses; glucometer
Sponsors
Proteus Digital Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-efficacy | 3 months | As measured by the 13-item self-efficacy expectancies and outcomes expectancies sub-scale of the Multidimensional Diabetes Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived effectiveness of caregiver support | 3 months | As measured by the 12-item positive reinforcing behaviors and misguided support sub-scale of the Multidimensional Diabetes Questionnaire |
| Diabetes-related distress | 3 months | As measured by the 20-item Problem Areas In Diabetes scale |
| At-home measurements of fasting glucose | 1, 6, 12 weeks | Weekly average for each time point |
| In-clinic measurements of fasting glucose | 0, 6, 12 weeks | Discrete lab measurement |
| Usability | 3 months | — |
| Device-related and -unrelated adverse events | Up to 4 months | — |
Countries
United States
Outcome results
None listed