Type 2 Diabetes MellitusNCT01503008
Proteus Sustained Behavior Change Study
A study testing Proteus Sustained Behavior Change system and Regularly prescribed diabetes medicines (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors) in people with Type 2 Diabetes Mellitus, run by Proteus Digital Health, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Proteus Sustained Behavior Change system and Regularly prescribed diabetes medicines (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2012to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Connected Health, Partners Healthcare
Boston, Massachusetts, 02114
Northwestern University
Chicago, Illinois, 60611
About this study
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Proteus Sustained Behavior Change system, Regularly prescribed diabetes medicines (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proteus Sustained Behavior Change systemDevice
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
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
| Study group | Role | What they receive |
|---|---|---|
| Sustained Behavior Change system support | Experimental | Not described Receives: Device: Proteus Sustained Behavior Change system |
| Control | Active comparator | Not described Receives: Drug: Regularly prescribed diabetes medicines (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy
As measured by the 13-item self-efficacy expectancies and outcomes expectancies sub-scale of the Multidimensional Diabetes Questionnaire
Measured: 3 months
Secondary outcomes (6)
Perceived effectiveness of caregiver support
As measured by the 12-item positive reinforcing behaviors and misguided support sub-scale of the Multidimensional Diabetes Questionnaire
Measured: 3 months
Diabetes-related distress
As measured by the 20-item Problem Areas In Diabetes scale
Measured: 3 months
At-home measurements of fasting glucose
Weekly average for each time point
Measured: 1, 6, 12 weeks
In-clinic measurements of fasting glucose
Discrete lab measurement
Measured: 0, 6, 12 weeks
Usability
Measured: 3 months
Device-related and -unrelated adverse events
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Proteus Digital Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kamal Jethwani, MD, Principal investigator, Center for Connected Health, Partners HealthcareMichael J Coons, PhD, Principal investigator, Northwestern UniversityBonnie Spring, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503008
- Sponsor's protocol ID
- PB-SBCT2DM
- Status last verified
- Mar 2013
- First submitted
- 28 Dec 2011
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteus Sustained Behavior Change Study
- ClinicalTrials.gov ID
- NCT01503008
- Acronym / sponsor ID
- PB-SBCT2DM
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Proteus Digital Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 2 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sustained Behavior Change system support | Experimental | Device: Proteus Sustained Behavior Change system |
| Control | Active comparator | Drug: Regularly prescribed diabetes medicines (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proteus Sustained Behavior Change systemThe 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 | Device | Sustained Behavior Change system support |
| Regularly 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 | Drug | Control |
Primary outcome
Self-efficacy
Time frame: 3 months
As measured by the 13-item self-efficacy expectancies and outcomes expectancies sub-scale of the Multidimensional Diabetes Questionnaire
6 secondary outcomes
Perceived effectiveness of caregiver support
Time frame: 3 months
Diabetes-related distress
Time frame: 3 months
At-home measurements of fasting glucose
Time frame: 1, 6, 12 weeks
In-clinic measurements of fasting glucose
Time frame: 0, 6, 12 weeks
Usability
Time frame: 3 months
Device-related and -unrelated adverse events
Time frame: Up to 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
Related trials for Type 2 Diabetes Mellitus
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Closed Loop and Education for Hypoglycemia Awareness Restoration
Diabetes Mellitus, Type 1
Not yet recruiting
Peer Support and Remote Patient Monitoring for Black Adults With Type 2 Diabetes
Type 2 Diabetes
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamal Jethwani, MD principal investigator
Center for Connected Health, Partners Healthcare
Michael J Coons, PhD principal investigator
Northwestern University
Bonnie Spring, PhD principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proteus Sustained Behavior Change system and Regularly prescribed diabetes medicines (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors) in people with Type 2 Diabetes Mellitus, run by Proteus Digital Health, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-efficacy (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2013; AzTrials last refreshed its copy on 2 Nov 2026.