Type 2 Diabetes
Conditions
Keywords
physical activity, continuous glucose monitoring, Environmental
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.
Interventions
OTHERObservational Study: Relationships Among Glucose, Physical Activity and Environmental Influences
This is a single group observational study with no interventions.
Sponsors
University of Illinois at Chicago
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The subject's perception of their Quality of Life will be measured at the start of the study. | 1 time | Quality of Life will be measured by scores on the Diabetes Quality of Life (DQOL) questionnaire. |
| The subject's physical activity and sleep will be measured continuously throughout the study. | 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. |
| The subject's air quality will be measured continuously throughout the study. | 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. |
Countries
United States
Contacts
Primary ContactLaurie Quinn, PhD
Backup ContactSulaimon Balogun, PhD Student
Outcome results
None listed