Clinical trial NCT01503008: Proteus Sustained Behavior Change Study
Official title: Proteus Sustained Behavior Change Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Proteus Digital Health, Inc.
Sponsor class: INDUSTRY
First posted: 2012-01-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Self-efficacy
timeFrame: 3 months
Secondary outcomes:
measure: Perceived effectiveness of caregiver support
timeFrame: 3 months
measure: Diabetes-related distress
timeFrame: 3 months
measure: At-home measurements of fasting glucose
timeFrame: 1, 6, 12 weeks
measure: In-clinic measurements of fasting glucose
timeFrame: 0, 6, 12 weeks
measure: Usability
timeFrame: 3 months
measure: Device-related and -unrelated adverse events
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Center for Connected Health, Partners Healthcare
state: Massachusetts
Study officials:
affiliation: Center for Connected Health, Partners Healthcare
name: Kamal Jethwani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Michael J Coons, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Bonnie Spring, PhD
role: PRINCIPAL_INVESTIGATOR
References: