Observational Study: Relationships Among Glucose, Physical Activity and Environmental Influences
OtherThis is a single group observational study with no interventions.
NCT Number: NCT06989008
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Observational
University of Illinois - Chicago, Chicago, Illinois, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
This is a single group observational study with no interventions.
Time frame: 20 days
The primary outcomes will include the following CGM metrics: mean glucose "Glucose Management Indicator" which is an estimate of A1C (%); Coefficient of Variation which is an estimate of glycemic variability; Very High Time Above Range which is the percent of time above range including the % of readings and time > 250 mg/dl; High Time Above Range which is the percent of time above range including the % of readings and time 181-250 mg/dl; Time in Range which is the % of readings and time 70-180 mg/dl; Low Time Below Range which is the percent of time below range including the % of readings and time 54 - 69 mg/dl; and Very Low Time Below Range which is the percent of time below range including the % of readings and time < 54 mg/dl.
Time frame: 1 time
Quality of Life will be measured by scores on the Diabetes Quality of Life (DQOL) questionnaire.
Time frame: 20 days
The subjects activity and sleep will be measured continuously throughout the study using a FitbitSense 2 Smartwatch. Physical activity will be quantified as time spent in sedentary, low, moderate and vigorous activity; sleep will be quantified by time spent awake, light sleep, deep sleep, and REM sleep.
Time frame: 20 days
The air quality will be measured by an environmental sensor called an Airthing's View Plus that will monitor radon, particulate matter (PM2.5), carbon dioxide (CO2), volatile organic compounds (VOCs), humidity, temperature, and air pressure.
Contact information is provided by the study sponsor or research team.
Laurie Quinn, PhD
CONTACT
Sulaimon Balogun, PhD Student
CONTACT
University of Illinois at Chicago
Other
Leveraging the Exposome and Patient Sensor Data to Enhance Personalized Diabetes Care Across Diverse Communities
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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