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.
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.
Study Type
OBSERVATIONAL
Enrollment
20
This is a single group observational study with no interventions.
University of Illinois - Chicago
Chicago, Illinois, United States
RECRUITINGUniversity of Illinois College of Nursing
Chicago, Illinois, United States
RECRUITINGThe 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).
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: 20 days
The subject's perception of their "Quality of Life" will be measured at the start of the study.
Quality of Life will be measured by scores on the Diabetes Quality of Life (DQOL) questionnaire.
Time frame: 1 time
The subject's physical activity and sleep will be measured continuously throughout the study.
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 subject's air quality will be measured continuously throughout the study.
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.
Time frame: 20 days
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