Collecting health data from South Carolina Medicaid patients with type 2 diabetes
Gathers health data and samples from adults with type 2 diabetes and healthy controls.
Key facts
- Who runs it
- Guardian Research Network, Inc.
- Where
- Orangeburg and Walhalla, United StatesSee the 2 sites
- Trial code
- Registry title
- Specimen and Data Collection in South Carolina Medicaid-Enrolled Patients With Type 2 Diabetes (T2D) and Metabolically Healthy Controls
- Status
- Recruiting
- People taking part
- 1,200 people, planned
- Started
- Aug 2026
- Expected to end
- Oct 2029
- Type of study
- Observational, 2 groups
- Treatments tested
- Not applicable- observational study
- Record updated
- 18 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for South Carolina Medicaid members aged 40 to 70 with type 2 diabetes, plus a smaller group of people without diabetes as controls.
- Age
- 40 to 70 years (inclusive)
- Sex
- All sexes
- Disease stage
- Diabetes group: a current type 2 diabetes diagnosis, or a hemoglobin A1c of 6.5% (48 mmol/mol) or higher at any time in the past 12 months. Control group: hemoglobin A1c of 5.6% (38 mmol/mol) or lower and no type 2 diabetes.
- Biomarker or test result
- Hemoglobin A1c of 6.5% (48 mmol/mol) or higher (diabetes group) or 5.6% (38 mmol/mol) or lower (control group).
Main reasons for not taking part
- Pregnant at enrollment
- Type 1 diabetes or any other type of diabetes besides type 2
- Active cancer, or cancer in complete remission within 3 years (non-melanoma skin cancer is allowed)
- Major cardiovascular event within 2 years before enrollment
- Chronic obstructive pulmonary disease, cognitive impairment or neurodegenerative disease, or pancreatitis
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Type 1 diabetes or any other type of diabetes besides Type 2 diabetes
- 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)
- Pregnancy at time of enrollment (by self-report of pregnancy status)
- Lack of fluency in spoken and written English
- The participant is, in the opinion of the investigator, unlikely to be able to complete all study requirements
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 70 years old?
Where in United States
- Clemson Health Clinic at OrangeburgOrangeburg, United StatesContact: Katie PoplinTaking people
- Clemson Health Clinic at WalhallaWalhalla, United StatesContact: Katie PoplinTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Type 2 Diabetes
SC Medicaid-enrolled Type 2 Diabetes Patients
Treatment: Not applicable- observational study
- Healthy Controls
SC Medicaid-enrolled non-T2D Patients
Treatment: Not applicable- observational study
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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)
- Plain-language title
- Collecting health data from South Carolina Medicaid patients with type 2 diabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07731399, who can take part
- Record updated
- 18 August 2026