Enhancing Diabetes Care: Exposome &Amp; Sensors

NCT ID: NCT06989008

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-25
• Study Completion Date: 2026-01-31

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.

Conditions

Type 2 Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Type 2 Diabetes

The study will include adults with Type 2 Diabetes living in an urban setting characterized by poor health outcomes.

Observational Study: Relationships Among Glucose, Physical Activity and Environmental Influences

Intervention Type: OTHER

This is a single group observational study with no interventions.

Interventions

Observational Study: Relationships Among Glucose, Physical Activity and Environmental Influences

This is a single group observational study with no interventions.

Intervention Type: OTHER

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)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andy Boyd, MD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois Chicago

Locations

University of Illinois - Chicago

Chicago, Illinois, United States

Site Status: RECRUITING

University of Illinois College of Nursing

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Laurie Quinn, PhD

Role: CONTACT

lquinn1@uic.edu

312 771 6497

Sulaimon Balogun, PhD Student

Role: CONTACT

sbalog6@uic.edu

773-971-0503

Facility Contacts

Laurie Quinn, PhD RN

Role: primary

lquinn1@uic.edu

312-996-7906

Laurie Quinn Clinical Professor, PhD

Role: primary

lquinn1@uic.edu

312-771-6497

Andy Boyd, MD

Role: backup

boyda@uic.edu

312-996-8339

References

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Reference Type: BACKGROUND

PMID: 33778771 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 25249787 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

2024-0372

Identifier Type: -

Identifier Source: org_study_id