Clinical trial NCT06848361: Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Official title: Empowering Adults With Diabetes: Achieving Self-management Success Through Data-Driven Behavior Change, Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: Type 2 Diabetes Mellitus
Adult
Glucose Monitoring
Mobile Application
Diabetes Self-Management
Activity Tracker
Continuous Glucose Monitoring
Empowerment
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: The Pittsburgh Foundation
First posted: 2025-02-27
Enrollment: 80
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of eligible individuals who enroll in the study
timeFrame: Pre-baseline
measure: Percent of weeks wearable device data is collected
timeFrame: From 0 to 4 months
measure: Percent participants retained in study to the 4-month outcome assessment
timeFrame: From 0 to 4 months
Secondary outcomes:
measure: Percent of individuals contacted who enroll in the study
timeFrame: Pre-baseline
measure: Percent of days self-report data is collected
timeFrame: From 0 to 4 months
measure: Percent of weeks participant responds to goal-setting prompts
timeFrame: From 0 to 4 months
measure: Participant satisfaction with intervention
timeFrame: 4 months
measure: Change in hemoglobin A1c
timeFrame: Baseline vs 4-6 Months
measure: Change in diabetes medication regimen
timeFrame: From baseline to 4-6 months
measure: Started on insulin
timeFrame: From baseline to 4-6 months
measure: Change in medication adherence
timeFrame: Baseline vs. 4 Months
measure: Change in healthy eating
timeFrame: Baseline vs 4 Months
measure: Change in fruit and vegetable intake per day
timeFrame: Baseline vs 4 months
measure: Change in physical activity
timeFrame: Baseline vs 4 Months
measure: Change in goal setting
timeFrame: Baseline vs 4 months
measure: Change in empowerment
timeFrame: Baseline vs 4 months
measure: Change in diabetes distress - overall
timeFrame: Baseline vs 4 months
measure: Change in diabetes distress - emotional burden
timeFrame: Baseline vs 4 months
measure: Change in diabetes distress - regimen distress
timeFrame: Baseline vs 4 months
measure: Change in diabetes distress - interpersonal distress
timeFrame: Baseline vs 4 months
measure: Change in diabetes distress - physician-related distress
timeFrame: Baseline vs 4 months
measure: Participant rating of intervention usability
timeFrame: 4 months
measure: Participant perceptions of the benefit and barriers of continuous glucose monitoring systems
timeFrame: 4 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Ann-Marie Rosland, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Carissa Low, PhD
role: PRINCIPAL_INVESTIGATOR
References: