Specimen and Data Collection in South Carolina Medicaid-Enrolled Patients With Type 2 Diabetes (T2D) and Metabolically Healthy Controls

Official title

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)

Overview

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.

Detailed description

Diabetes, and in particular Type 2 Diabetes which accounts for roughly 90-95% of Diabetes patients, affects tens of millions of Americans. The state of South Carolina has one of the highest rates of diabetes patients affecting every 1 in 7 adults. In addition, diabetes patients have a very high risk of developing further complications like chronic kidney disease or cardiovascular disease, which besides further threatening the lives of these patients, is very expensive to manage and treat. South Carolina also has one of the highest population growth percentage rate across the US, but the growth of the healthcare workforce particularly in the rural areas of the state is not able to keep up.

To help mitigate this, the SC Department of Health and Human Services has developed a "Rural Health Initiative" to better meet underserved communities' medical needs. Spartanburg Regional Healthcare System and Guardian Research Network have been funded by SCDHHS to serve the first study in this Initiative targeting Type 2 Diabetes (T2D).

This study aims to collect multiple types of data from SC Medicaid-enrolled type 2 diabetes (T2D) patients and healthy patients, including data from biospecimens, questionnaires, cognitive "brain" games, clinical assessments, electronic health records, wearable devices and lifestyle/behavioral data to identify elements that may be related to Chronic Kidney Disease (CKD) diagnosis or T2D progression. The primary goal is for researchers and physicians to analyze the multi-dimensional data to significantly improve the prediction of and strategies to prevent disease progression in T2D patients.

Patients between ages 40 to 70 diagnosed with T2D and enrolled in SC Medicaid may be eligible, as well as a smaller healthy (control) cohort also enrolled in SC Medicaid. Patients will be asked to provide a blood, saliva and stool sample, answer questionnaires, complete online cognitive assessments ("brain games"), and wear a study-provided Fitbit device. Type 2 Diabetes participants will also have access to a Certified Diabetes Educator to assist with disease management and potential suggested lifestyle changes to help improve health.

Interventions

• Other Not applicable- observational study
  Non-interventional biospecimen and data collection study.

Primary outcome measures

• Identify data elements or combinations of data elements with strong positive or negative correlation to Chronic Kidney Disease diagnosis and/or progression in Type 2 Diabetes patients [Time frame: Up to 24 months after enrollment]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• Pregnancy at time of enrollment (by self-report of pregnancy status)
• Lack of fluency in spoken and written English
• Type 1 diabetes or any other type of diabetes besides Type 2 diabetes
• Active cancer diagnosis or cancer that achieved complete remission within three (3) years prior to enrollment, other than non-melanoma skin cancer (e.g. malignant basal cell neoplasm of skin and/or squamous cell carcinoma of skin)
• Major Adverse Cardiovascular Events within two (2) years prior to enrollment
• Chronic Obstructive Pulmonary Disease
• Cognitive impairment or neurodegenerative diseases (e.g., Alzheimer's disease, dementia, multiple sclerosis, Parkinson's disease, etc.)
• Pancreatitis or other diseases of the pancreas (besides diabetes)
• The participant is, in the opinion of the investigator, unlikely to be able to complete all study requirements

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Case-control

Study locations

United States · 2 centers

• Clemson Health Clinic at Orangeburg — Orangeburg
• Clemson Health Clinic at Walhalla — Walhalla

Identifiers

NCT: NCT07731399 · BRISK-T2D-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗