Clinical trial NCT06989008: Enhancing Diabetes Care: Exposome &Amp; Sensors
Official title: Leveraging the Exposome and Patient Sensor Data to Enhance Personalized Diabetes Care Across Diverse Communities
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes
Keywords: physical activity
continuous glucose monitoring
Environmental
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study aims to enroll participants with type 2 diabetes who reside in an urban area that is associated with poor health outcomes as characterized by vulnerable zip codes.

Brief summary: The study aims to integrate various data types, such as electronic health records, wearable device data, and environmental data, to create a comprehensive, personalized diabetes care model. The study will focus on people with type 2 diabetes living in specified vulnerable zip codes.

Detailed description: The study procedures will commence with an initial screening to confirm participants' eligibility based on the inclusion criteria, followed by the signing of Informed Consent forms. Baseline data including medical records and quality of life questionnaires will be collected. A continuous glucose monitoring (CGM - Dexcom 7) will be inserted; a sport wristband (Fitbit Sense 2) will be provided; and environmental sensor for home data collection, will be distributed and set up in the home setting by the participant. The study will require two CGMs (10 days for each CGM). The 1st CGM will be inserted during the initial visit to the clinic. After 10 days, participants will return to the clinic, and the 2nd CGM will be inserted. The investigators will also send text reminders two days before the scheduled 2nd CGM insertion. Communication with participants will be maintained via text messages, and for those who request it, virtual meetings can be arranged (via HIPAA-protected Zoom). The subjects will be provided with a mailing envelope with postage to return the 2nd CGM, Fitbit Sense 2 and environmental sensors. If the subject is returning to clinic within the next week, they can instead return the devices during their visit, and a member of the study team will meet them in the clinic.

Throughout the study, there will be integration of real-time data from various sources, including electronic health records, wearables, and environmental sensor. The environmental sensor is a climate sensor called Airthings. The Airthings View Plus is an advanced indoor air quality monitor that tracks various environmental parameters to ensure healthy indoor air conditions. It features sensors for radon, particulate matter (PM2.5), carbon dioxide (CO2), volatile organic compounds (VOCs), humidity, temperature, and air pressure. This monitor is connected to Wi-Fi, allowing real-time access to air quality data via a smartphone app. The device is designed for ease of use with an eInk display for clear visibility of air quality readings and simple setup instructions. The Airthings View Plus is battery-operated with an option for USB power, providing flexibility in how and where the device can be used within a home.

Eligibility criteria: Inclusion Criteria

* People with diabetes in the 18-65 years of age range
* Diagnosed with type 2 diabetes
* Resides in the specified high social vulnerability zip codes - 60619, 60620, 60621, 60636, 60644, 60624, 60609, 60612, 60617, 60623, 60628, 60629, 60639, 60645, 60649, 60651, 60652, 60653
* Speak and understand the English language
* Willing to wear various devices (CGM and sports wristband)
* Own a smartphone Exclusion Criteria
* Subjects will be excluded from the study for the following reasons:
* Any concern of not understanding informed consent
* Unable to understand or unwilling to follow research protocol

Primary outcomes:
measure: The primary outcome is to collect and analyze continuous interstitial glucose measurements in 20 individuals with type 2 diabetes over a period of 20 days using a DEXCOM G7 continuous glucose monitor (CGM).
timeFrame: 20 days
Secondary outcomes:
measure: The subject's perception of their "Quality of Life" will be measured at the start of the study.
timeFrame: 1 time
measure: The subject's physical activity and sleep will be measured continuously throughout the study.
timeFrame: 20 days
measure: The subject's air quality will be measured continuously throughout the study.
timeFrame: 20 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois - Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Illinois College of Nursing
state: Illinois
Study officials:
affiliation: University of Illinois Chicago
name: Andy Boyd, MD
role: PRINCIPAL_INVESTIGATOR
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