Empowering Adults With Diabetes: Achieving Self-management Success Through Data-Driven Behavior Change, Pilot Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Percent of eligible individuals who enroll in the study
Study Overview
Brief Summary
Day-to-day self-management by adults with type 2 diabetes, including glucose monitoring, taking medications, and healthy habits, is essential to avoid diabetes complications, yet, despite the rapidly expanding availability of wearable glucose and activity monitors, successful self-management remains challenging for many. This research aims to develop and test an approach to help adults use their personal diabetes information from wearable devices to achieve and sustain health diabetes self-management, which will reduce diabetes complications, and improve health and quality of life for people with type 2 diabetes.
Detailed Description
MPowerHub trial protocol feasibility will be assessed by randomizing 80 adults with type 2 diabetes and glycemic levels above clinical goals to MPowerHub (MPowerHub platform + continuous glucose monitoring & activity monitoring), continuous glucose monitor alone, or activity monitor alone for four months. Mixed quantitative and qualitative assessments will examine recruitment, engagement, and retention metrics and feedback. Finally, changes in self-management behaviors (measured using semi-structured interview) and clinic glycemic levels (obtained from participants' electronic health record or finger-stick by study research staff) from pre- to post-monitoring will be compared between arms.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Received outpatient care in the participating health system in the last 12 months
- •Has a diagnosis of type 2 diabetes mellitus (ICD10 codes E08.xx, E09.xx, E11.xx, E13.xx,O24.1x , O24.3x, O24.8x, O24.9x)
- •Last Hemoglobin A1c (HbA1c) value obtained in the last 6 months was ≥7.5%
- •Currently prescribed at least one non-insulin diabetes medication
- •Able to provide informed consent
- •Able to interact with a simple smartphone application
- •Owns or has access to a smartphone that is able to access an internet website
- •Did not participate a prior study related to this protocol
Exclusion Criteria
- •Originally was diagnosed with type 2 diabetes before the age of 21 years
- •Has a diagnosis of type 1 diabetes mellitus
- •Has a diagnosis of gestational diabetes without any other diabetes diagnoses
- •Is currently prescribed insulin
- •Currently is using a CGM device
- •Has a diagnosis (active or prior) of schizophrenia or other psychotic/delusional disorder
- •Has a life-limiting severe illness (e.g., chronic obstructive pulmonary disease requiring oxygen)
- •Is pregnant or planning to become pregnant within the next 6 months
- •Has other concerns that may interfere significantly with their ability to participate in the intervention (ongoing health issues, personal events, etc.)
- •Currently is enrolled in another diabetes management intervention study
Arms & Interventions
MPowerHub
Participants will:
- Meet with a Diabetes Care and Education Specialist for an initial diabetes self-management education session that will include individualized assessment, education, and coaching on how to set personal diabetes self-management behavior goals and action plans, and follow-up education as needed.
- Be trained on how to use assigned study devices (MPowerHub, continuous glucose monitor (CGM), and activity tracker).
- Be asked to use assigned study devices (MPowerHub, CGM, and activity tracker) for 4 months.
Intervention: MPowerHub (Device)
MPowerHub
Participants will:
- Meet with a Diabetes Care and Education Specialist for an initial diabetes self-management education session that will include individualized assessment, education, and coaching on how to set personal diabetes self-management behavior goals and action plans, and follow-up education as needed.
- Be trained on how to use assigned study devices (MPowerHub, continuous glucose monitor (CGM), and activity tracker).
- Be asked to use assigned study devices (MPowerHub, CGM, and activity tracker) for 4 months.
Intervention: Continuous Glucose Monitor (CGM) (Device)
MPowerHub
Participants will:
- Meet with a Diabetes Care and Education Specialist for an initial diabetes self-management education session that will include individualized assessment, education, and coaching on how to set personal diabetes self-management behavior goals and action plans, and follow-up education as needed.
- Be trained on how to use assigned study devices (MPowerHub, continuous glucose monitor (CGM), and activity tracker).
- Be asked to use assigned study devices (MPowerHub, CGM, and activity tracker) for 4 months.
Intervention: Activity Monitor (Device)
Activity Monitor Only
Participants will:
- Meet with a Diabetes Care and Education Specialist for an initial diabetes self-management education session that will include individualized assessment, education, and coaching on how to set personal diabetes self-management behavior goals and action plans, and follow-up education as needed.
- Be trained on how to use assigned study device (activity tracker).
- Be asked to use assigned study device (activity tracker) for 4 months.
Intervention: Activity Monitor (Device)
Continuous Glucose Monitor (CGM) Only
Participants will:
- Meet with a Diabetes Care and Education Specialist for an initial diabetes self-management education session that will include individualized assessment, education, and coaching on how to set personal diabetes self-management behavior goals and action plans, and follow-up education as needed.
- Be trained on how to use assigned study device (CGM).
- Be asked to use assigned study device (CGM) for 4 months.
Intervention: Continuous Glucose Monitor (CGM) (Device)
Outcomes
Primary Outcomes
Percent of eligible individuals who enroll in the study
Time Frame: Pre-baseline
Percent of individuals contacted and found eligible who enroll in the study. The goal benchmark is \>/=60%.
Percent participants retained in study to the 4-month outcome assessment
Time Frame: From 0 to 4 months
Percent of participants retained in the study through the 4-month outcome assessment. The goal benchmark is \>/=85%.
Percent of eligible individuals who enroll in the study
Time Frame: Pre-baseline
Percent of individuals contacted and found eligible who enroll in the study. The goal benchmark is \>/=60%.
Percent of days wearable device data is collected
Time Frame: From 0 to 4 months
Percent of days adequate wearable device data is collected during the 4-month intervention. The goal benchmark is \>/=75%.
Percent participants retained in study to the 4-month outcome assessment
Time Frame: From 0 to 4 months
Percent of participants retained in the study through the 4-month outcome assessment. The goal benchmark is \>/=85%.
Secondary Outcomes
- Change in fruit and vegetable intake per day(Baseline vs 4 months)
- Percent of individuals contacted who enroll in the study(Pre-baseline)
- Percent of days self-report data is collected(From 0 to 4 months)
- Percent of weeks participant responds to goal-setting prompts(From 0 to 4 months)
- Participant satisfaction with intervention(4 months)
- Change in hemoglobin A1c(Baseline vs 4-6 Months)
- Change in diabetes medication regimen(From baseline to 4-6 months)
- Started on insulin(From baseline to 4-6 months)
- Change in physical activity(Baseline vs 4 Months)
- Change in goal setting(Baseline vs 4 months)
- Change in intrinsic motivation(Baseline vs 4 months)
- Change in extrinsic motivation(Baseline vs 4 months)
- Change in empowerment(Baseline vs 4 months)
- Change in diabetes distress - overall(Baseline vs 4 months)
- Change in diabetes distress - emotional burden(Baseline vs 4 months)
- Change in diabetes distress - regimen distress(Baseline vs 4 months)
- Change in medication adherence(Baseline vs. 4 Months)
- Change in healthy eating(Baseline vs 4 Months)
- Participant rating of intervention usability(4 months)
- Participant perceptions of the benefit of continuous glucose monitoring systems(4 months)
- Participant perceptions of the barriers of continuous glucose monitoring systems(4 months)
- Percent of individuals contacted who enroll in the study(Pre-baseline)
- Percent of days self-report data is collected(From 0 to 4 months)
- Percent of weeks participant responds to goal-setting prompts(From 0 to 4 months)
- Participant satisfaction with intervention(4 months)
- Change in hemoglobin A1c(Baseline vs 4-6 Months)
- Change in diabetes medication regimen(From baseline to 4-6 months)
- Started on insulin(From baseline to 4-6 months)
- Change in medication adherence(Baseline vs. 4 Months)
- Change in healthy eating(Baseline vs 4 Months)
- Change in fruit and vegetable intake per day(Baseline vs 4 months)
- Change in physical activity(Baseline vs 4 Months)
- Change in goal setting(Baseline vs 4 months)
- Change in intrinsic motivation(Baseline vs 4 months)
- Change in extrinsic motivation(Baseline vs 4 months)
- Change in empowerment(Baseline vs 4 months)
- Change in diabetes distress - overall(Baseline vs 4 months)
- Change in diabetes distress - emotional burden(Baseline vs 4 months)
- Change in diabetes distress - regimen distress(Baseline vs 4 months)
- Participant rating of intervention usability(4 months)
- Participant perceptions of the benefit of continuous glucose monitoring systems(4 months)
- Participant perceptions of the barriers of continuous glucose monitoring systems(4 months)
Investigators
Ann-Marie Rosland
Associate Professor of Medicine
University of Pittsburgh