Specimen and Data Collection for Type 2 Diabetes Study
Specimen and Data Collection in South Carolina Medicaid-Enrolled Patients With Type 2 Diabetes (T2D) and Metabolically Healthy Controls
Recruiting
Observational Study
Type 2 DiabetesHealthy (Controls)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 70
Sex
Any
Study type
Observational
Participants needed
1,200 (estimated)
Sponsor
Guardian Research Network, Inc. · Other
Who this trial is looking for
This trial is looking for South Carolina Medicaid patients aged 40 to 70 with type 2 diabetes and those who are healthy. Participants will provide health data, blood samples, and will receive support from a diabetes educator while also potentially keeping a Fitbit device.
Are You a Good Fit for This Trial?
Rules you outType 1 diabetesCognitive impairmentChronic Obstructive Pulmonary DiseasePancreatitis
You may be able to join if
I am between 40 and 70 years old
I am enrolled as a Medicaid recipient
I can give informed consent
I can provide a blood sample of up to 70 mL
I have type 2 diabetes or my hemoglobin A1c is at least 6.5%
I have a blood level of hemoglobin A1c less than or equal to 5.6%
You may not be able to join if
I am pregnant
I do not speak or write in English
I have type 1 diabetes or any diabetes other than type 2
I have been diagnosed with cancer in the last 3 years
I have had major heart problems in the past 2 years
I have chronic obstructive pulmonary disease
I have cognitive impairment or neurodegenerative diseases
I have pancreatitis or other diseases of the pancreas
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 thi…
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.
Trial Locations
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Status
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…
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
Contacts
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