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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-70
SponsorGuardian Research Network, Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial population

South Carolina Medicaid-enrolled participants

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Not applicable- observational study

    Other intervention

    Non-interventional biospecimen and data collection study.

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: Type 2 Diabetes1 intervention
Group B: Healthy Controls1 intervention

Trial outcomes

Primary outcomes

1

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

Perform omics and clinical labs on blood and stool, administer surveys, and analyze medical record data

Time frame
Up to 24 months after enrollment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guardian Research Network, Inc.

Lead sponsor

South Carolina Department of Health and Human Services

Collaborator

Spartanburg Regional Healthcare System

Collaborator