By InvitationNot Applicable

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

United States80 participantsStarted 2025-04-28

Plain-language 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.

Who can participate

Age range25 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percent of eligible individuals who enroll in the study

Timeframe: Pre-baseline

Percent of days wearable device data is collected

Timeframe: From 0 to 4 months

Percent participants retained in study to the 4-month outcome assessment

Timeframe: From 0 to 4 months

Trial details

NCT IDNCT06848361

SponsorAnn-Marie Rosland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12