Enhancing Diabetes Care: Exposome &Amp; Sensors

Официальное название

Leveraging the Exposome and Patient Sensor Data to Enhance Personalized Diabetes Care Across Diverse Communities

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Observational Study: Relationships Among Glucose, Physical Activity and Environmental Influences
  This is a single group observational study with no interventions.

Первичные конечные точки

• 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). [Срок оценки: 20 days]

Вторичные конечные точки (3)

• The subject's perception of their "Quality of Life" will be measured at the start of the study. [Срок оценки: 1 time]
• The subject's physical activity and sleep will be measured continuously throughout the study. [Срок оценки: 20 days]
• The subject's air quality will be measured continuously throughout the study. [Срок оценки: 20 days]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 2 центра

• University of Illinois - Chicago — Chicago
• University of Illinois College of Nursing — Chicago

Публикации

• Sarker IH. Machine Learning: Algorithms, Real-World Applications and Research Directions. SN Comput Sci. 2021;2(3):160. doi: 10.1007/s42979-021-00592-x. Epub 2021 Mar 22. PMID 33778771
• Wu Y, Ding Y, Tanaka Y, Zhang W. Risk factors contributing to type 2 diabetes and recent advances in the treatment and prevention. Int J Med Sci. 2014 Sep 6;11(11):1185-200. doi: 10.7150/ijms.10001. eCollection 2014. PMID 25249787
• Vrijheid M, Slama R, Robinson O, Chatzi L, Coen M, van den Hazel P, Thomsen C, Wright J, Athersuch TJ, Avellana N, Basagana X, Brochot C, Bucchini L, Bustamante M, Carracedo A, Casas M, Estivill X, Fairley L, van Gent D, Gonzalez JR, Granum B, Grazuleviciene R, Gutzkow KB, Julvez J, Keun HC, Kogevinas M, McEachan RR, Meltzer HM, Sabido E, Schwarze PE, Siroux V, Sunyer J, Want EJ, Zeman F, Nieuwenh PMID 24610234
• Sevil M, Rashid M, Maloney Z, Hajizadeh I, Samadi S, Askari MR, Hobbs N, Brandt R, Park M, Quinn L, Cinar A. Determining Physical Activity Characteristics from Wristband Data for Use in Automated Insulin Delivery Systems. IEEE Sens J. 2020 Nov;20(21):12859-12870. doi: 10.1109/jsen.2020.3000772. Epub 2020 Jun 8. PMID 33100923
• Li X, Dunn J, Salins D, Zhou G, Zhou W, Schussler-Fiorenza Rose SM, Perelman D, Colbert E, Runge R, Rego S, Sonecha R, Datta S, McLaughlin T, Snyder MP. Digital Health: Tracking Physiomes and Activity Using Wearable Biosensors Reveals Useful Health-Related Information. PLoS Biol. 2017 Jan 12;15(1):e2001402. doi: 10.1371/journal.pbio.2001402. eCollection 2017 Jan. PMID 28081144
• Sevil M, Rashid M, Hajizadeh I, Askari MR, Hobbs N, Brandt R, Park M, Quinn L, Cinar A. Discrimination of simultaneous psychological and physical stressors using wristband biosignals. Comput Methods Programs Biomed. 2021 Feb;199:105898. doi: 10.1016/j.cmpb.2020.105898. Epub 2020 Dec 17. PMID 33360529

Идентификаторы

NCT: NCT06989008 · 2024-0372

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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