An Observational Clinical Research Study Assembling and Analyzing Highly Complex, Multi-dimensional Molecular and Clinical Data With a Focus on High-risk Diabetes Patients in South Carolina, in Support of the Biomedical Research Initiative for Scientific Knowledge (BRISK)
The primary purpose of this study is to use multiomic data in combination with clinical assessments, electronic health records, cognitive and mood assessments, wearable technologies and lifestyle/behavioral data to identify data elements or combinations of data elements with strong positive or negative correlation to CKD diagnosis and/or progression in Type 2 Diabetes (T2D) patients. Achieving this aim will allow researchers and physicians to significantly improve the prediction of health trajectories of and formulate novel strategies to potentially prevent, treat or reverse T2D. South Carolina Medicaid-enrolled patients diagnosed with T2D and a smaller subset of non-T2D SC Medicaid patients may participate in this study. Participants who complete required procedures will be compensated for their time and transportation, may keep their study-provided Fitbit device to help maintain their healthcare improvement journey, and will have a personal Certified Diabetes Educator to consult and assist with managing their diabetes diagnosis.
⁃ All Participants:
• 40 to 70 years of age (inclusive) at enrollment
• Enrolled as Medicaid recipients
• Ability to provide informed consent and authorization for release of relevant protected health information or personal data
• Ability to provide a blood sample(s) of up to 70 mL and other required biospecimens, including genetic samples.
⁃ T2D Group:
⁃ • Current diagnosis of Type 2 diabetes OR a blood level of hemoglobin A1c equal to or greater than 6.5% at any time within the past 12 months
⁃ Control Group:
• Blood level of hemoglobin A1c less than or equal to 5.6% at time of enrollment
• No diagnosis of Type 2 diabetes