University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
NCT Number: NCT06848361
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.
Interested in participating?
Request Info25 year–75 year
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15213, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The MPowerHub app allows participants to visualize combined trends from a continuous glucose monitor (CGM) and activity monitor as well as daily self-reports in a display that the participant can customize to overlay the behavioral data they would like to compare to intraday and daily glucose data. Summary data will be displayed over time to allow users to identify potential associations between activity, sleep, stress, diet, and medication adherence and time-in-range and blood glucose variability. Participants receive daily prompts to complete five brief questions about daily health behaviors and two weekly goals/action plans and reflections based on motivational interviewing principles.
A CGM is a wearable device that collects frequent data on glucose levels. It includes an integrated sensor that is inserted under the skin and is connected to a small transmitter that automatically sends information to a smart device, allowing the user to track changes in glucose levels.
A wearable activity monitor will be used to track activity (e.g., steps) and sleep levels. Data can be viewed on the activity monitor or a smart device.
Time frame: Pre-baseline
Percent of individuals contacted and found eligible who enroll in the study. The goal benchmark is >/=60%.
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%.
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%.
Time frame: Pre-baseline
Percent among all individuals approached/contacted who enroll in the study. The goal benchmark is >/=20%.
Time frame: From 0 to 4 months
Percent of days self-report data is collected from participants in MPowerHub study arm. The goal benchmark is >/=75%.
Time frame: From 0 to 4 months
Percent of weeks participants in MPowerHub study arm respond to goal-setting prompts. The goal benchmark is >/=65%.
Time frame: 4 months
Study specific Likert-scaled survey item will be used to assess overall intervention satisfaction by participants. Response options range from 1=highly unsatisfied to 5=highly satisfied. Satisfaction will be defined as a rating of 4=satisfied or 5=highly satisfied. The goal benchmark is >/=80% satisfaction for the MPowerHub arm. The results for MPowerHub arm will also be compared to the two other arms.
Time frame: Baseline vs 4-6 Months
Hemoglobin A1c (HbA1c) data will be obtained from participant's electronic health record. The most recent HbA1c value recorded within 0-6 months prior to enrollment will be used for the baseline measure, and the most recent value recorded at 4-6 months post-enrollment will be used for the outcome measure. If no results from routine HbA1c have been recorded during the relevant time period, the outcome HbA1c data will be collected with a National Glycohemoglobin Standardization Program-certified point of care instrument.
Time frame: From baseline to 4-6 months
Prescribed diabetes medications will be obtained from the participant's electronic health record. A change in diabetes medication regimen assessed by calculating the change in diabetes medication class, e.g., adding or subtracting a class or classes. The range could be negative to positive (e.g., -2, -1, 0, +1, +2) depending on if and how many classes changes occurred.
Time frame: From baseline to 4-6 months
Prescribed insulin during the course of the intervention will be obtained from the participant's electronic health record and documented as yes/no.
Time frame: Baseline vs. 4 Months
Medication adherence will be assessed using the self-report Domains of Subjective Extent of Nonadherence (DOSE-Nonadherence) scale, which is comprised of 3 items assessing the extent to which participants missed, skipped, or did not take their medication as prescribed during the past 7 days. Possible scores range from 1=none of the time to 5=every time with a lower score indicating a greater degree of adherence. Items are summed and scores are averaged. The higher the score, the greater the nonadherence.
Time frame: Baseline vs 4 Months
Healthy eating will be assessed using the "overall health eating" Summary of Diabetes Self-Care Activities (SDSCA) scale. Participants will be asked how many of the last 7 days have they followed a healthy eating plan (0=no days and 7=all the days). The higher the score, the healthier the eating plan.
Time frame: Baseline vs 4 months
Change in fruit and vegetable intake will be assessed using the 6-item Behavioral Risk Factor Surveillance System (BRFSS) 2017 Fruit and Vegetable Module. Change in daily frequency of fruit and vegetable intake will be calculated using the BRFSS scoring algorithm.
Time frame: Baseline vs 4 Months
Change in physical activity will be assessed using the International Activity Questionnaire - Short Form (IPAQ-SF). The IPAQ-SF asks respondents to report their frequency and duration of walking, moderate-intensity activity, and vigorous-intensity activity in minutes or hours per day. Our study will score results within each domain separately. Responses will be converted into metabolic equivalent of task (MET) minutes; the higher the MET minutes, the higher the degree of physical activity.
Time frame: Baseline vs 4 months
Change in goal setting will be assessed using the Patient Assessment of Chronic Illness Care (PACIC) survey. The PACIC includes three questions about thoughts and actions around setting diabetes goals with 5-point Likert scales (almost never to almost always). Scores will be summed from 3 (all almost never) to 15 (all almost always) and averaged with higher scores reflecting better goal setting.
Time frame: Baseline vs 4 months
Change in intrinsic motivation will be assessed using the Treatment Self-Regulation Questionnaire (TSRQ) Concerning Diabetes Scale A. The scale includes 3 questions related to autonomous regulation questions measured through a 7-point Likert scale, where 1 is "not at all true", 4 is "somewhat true", and 7 is "very true". Scores will be summed and divided by the total number of items. The higher the score, the higher the level of autonomous regulation.
Time frame: Baseline vs 4 months
Change in extrinsic motivation will be assessed using the Treatment Self-Regulation Questionnaire (TSRQ) Concerning Diabetes Scale A. The scale includes 5 questions related to controlled regulation questions measured through a 7-point Likert scale, where 1 is "not at all true", 4 is "somewhat true", and 7 is "very true". Scores will be summed and divided by the total number of items. The higher the score, the higher the level of controlled regulation.
Time frame: Baseline vs 4 months
Change in empowerment will be assessed using the Diabetes Empowerment Scale-Short Form (DES-SF). Participants will be asked to respond to 8 questions measured through a 5-point Likert scale (strongly disagree to strongly agree). Scores will be summed and divided by the total number of items. The higher the score indicates a higher level of empowerment.
Time frame: Baseline vs 4 months
Change in overall diabetes distress will be assessed using the Diabetes Distress Scale - 17 (DDS17), which yields a total diabetes distress score. To score, participant's responses to the appropriate items are summed and divided by the number of items in the scale (possible range 1-6). The higher the score indicates a higher level of distress.
Time frame: Baseline vs 4 months
Change in emotional burden will be assessed using the Diabetes Distress Scale - 17 (DDS17), which yields a subscale score addressing emotional burden. To score, participant's responses to the appropriate items are summed and divided by the number of items in the emotional burden subscale, possible range 1-6). The higher the score indicates a higher level of distress.
Time frame: Baseline vs 4 months
Change in regimen distress will be assessed using the Diabetes Distress Scale - 17 (DDS17), which yields a subscale score addressing regimen distress. To score, participant's responses to the appropriate items are summed and divided by the number of items in the regimen distress subscale, possible range 1-6). The higher the score indicates a higher level of distress.
Time frame: 4 months
Intervention usability will be assessed using the System Usability Scale. Participants will be asked to respond to 10 questions measured through a 5-point Likert scale (strongly disagree to strongly agree). To score, values are converted to 0 to 4 by subtracting one from odd item scale positions and subtracting the scale position from five for even-numbered items. Converted responses are summed and the total is multiplied by 2.5; the converted range of possible values is from 0 to 100 (with 100 being the most positive response).
Time frame: 4 months
Perceptions about the benefits of continuous glucose monitoring (CGM) systems will be assessed using the Perceived Benefits of CGM (BenCGM) scale. Participants in the MPowerHub and CGM study arms will be asked 8 questions measured with a 5-point Likert scale (strongly disagree to strongly agree). Item scores are summed and range from 8 (all strongly disagree) to 40 (all strongly agree).
Time frame: 4 months
Perceptions about the barriers of continuous glucose monitoring (CGM) systems will be assessed using the Perceived Barriers of CGM (BurCGM) scale. Participants in the MPowerHub and CGM study arms will be asked 8 questions measured with a 5-point Likert scale (strongly disagree to strongly agree). Item scores are summed and range from 8 (all strongly disagree) to 40 (all strongly agree).
Ann-Marie Rosland
Other
Empowering Adults With Diabetes: Achieving Self-management Success Through Data-Driven Behavior Change, Pilot Randomized Control Trial
Acronym: MPowerHub
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07197775
Diabetes, Diabetes Mellitus
Quincy, Massachusetts, United States
View Trial DetailsNCT07387393
Body Weight, CARDIOMETABOLIC CONDITIONS
Fayetteville, Arkansas, United States
View Trial DetailsNCT06906653
Diabetes Mellitus, Diabetes Mellitus, Type 2
Pleasanton, California, United States
View Trial DetailsNCT07463209
Autoimmune Diseases, Diabetes (DM)
Chapel Hill, North Carolina, United States
View Trial Details