Proteus Sustained Behavior Change Study

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Proteus Sustained Behavior Change Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01503008
• Other study ID #: PB-SBCT2DM
• Status: Withdrawn
• Phase: N/A
• First received: December 28, 2011
• Last updated: March 1, 2013
• Start date: February 2012
• Est. completion date: August 2012

Study information

• Verified date: March 2013
• Source: Proteus Digital Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. The SBC system uses ingestible and wearable sensing devices and mobile phones to reinforce positive behaviors around medication usage, exercise and rest.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Device:
• Proteus 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

Drug:
• 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

Locations

Country	Name	City	State
United States	Center for Connected Health, Partners Healthcare	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Proteus Digital Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-efficacy	As measured by the 13-item self-efficacy expectancies and outcomes expectancies sub-scale of the Multidimensional Diabetes Questionnaire	3 months	No
Secondary	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	No
Secondary	Diabetes-related distress	As measured by the 20-item Problem Areas In Diabetes scale	3 months	No
Secondary	At-home measurements of fasting glucose	Weekly average for each time point	1, 6, 12 weeks	No
Secondary	In-clinic measurements of fasting glucose	Discrete lab measurement	0, 6, 12 weeks	No
Secondary	Usability		3 months	No
Secondary	Device-related and -unrelated adverse events		Up to 4 months	Yes