Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management (MPowerHub)

Ann-Marie Rosland

Status: Invitation-only

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Device: Activity Monitor; Device: MPowerHub; Device: Continuous Glucose Monitor (CGM)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06848361

1R01DK136788-01A1 (U.S. NIH Grant/Contract)

STUDY23080053

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 3 patient groups

MPowerHub

Experimental group

Description:

Participants will: 1. 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. 2. Be trained on how to use assigned study devices (MPowerHub, continuous glucose monitor (CGM), and activity tracker). 3. Be asked to use assigned study devices (MPowerHub, CGM, and activity tracker) for 4 months.

Treatment:

Device: Continuous Glucose Monitor (CGM)

Device: MPowerHub

Device: Activity Monitor

Continuous Glucose Monitor (CGM) Only

Active Comparator group

Description:

Participants will: 1. 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. 2. Be trained on how to use assigned study device (CGM). 3. Be asked to use assigned study device (CGM) for 4 months.

Treatment:

Device: Continuous Glucose Monitor (CGM)

Activity Monitor Only

Active Comparator group

Description:

Participants will: 1. 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. 2. Be trained on how to use assigned study device (activity tracker). 3. Be asked to use assigned study device (activity tracker) for 4 months.

Treatment:

Device: Activity Monitor