COVID And Diabetes Assessment
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 24-002088
About this study
The purpose of this study is to take advantage of robust existing infrastructure to rapidly identify, recruit, and retain diverse cohorts of English and Spanish speaking pediatric and adult patients with recently diagnosed T1D or T2D.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Diagnosis of T1D or T2D in the past 90 days made by a clinician (per medical record of new elevated A1C, diabetes specific medications and/or new diagnosis of diabetes).
- Diabetes not related to ongoing steroid use, or pancreatic insufficiency from cancer, cystic fibrosis, or other infiltrating disease (per patient report).
- COVID+ defined as a documented case of SARS-CoV-2 infection (with positive SARS-CoV-2 by PCR or rapid antigen, including home tests or prescriptions/dispensing for paxlovid, remdesivir, molnupiravir, or a monoclonal antibody used for treatment) in 365 days prior to diagnosis (ideally within 180 days) of diabetes diagnosis OR COVIDdefined as no known history of COVID-19 and no use of a COVID-19 treatment in the past 365 days).
- Willing to participate for 2 years.
- English or Spanish speaking.
- Age 11 years and older.
(Patients who report COVID- status will also have SARS-CoV-2 nucleocapsid antibody tests performed at enrollment and results will be batched and analyzed as part of the study).
Exclusion Criteria
- Life expectancy less than 2 years.
- Insulinoma.
- Active pregnancy at enrollment or within 6 months of enrollment.
- Sickle cell anemia or other hemoglobinopathy.
- Dialysis dependence (for Extensive Level engagement).
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 2/08/2024. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Ramona Dejesus, M.D. |
Open for enrollment |
|
More information
Publications
Publications are currently not available