Surveillance of COVID-19 in Patients with T1D
What is the purpose of the study/registry?
To build a body of information that can support the management of people with type 1 diabetes who have confirmed suspected COVID-19 illness.
Who are the Principal Investigators for this study?
PIs for this study are Drs. Osagie Ebekozien (T1D Exchange); G. Todd Alonso (Barbara Davis Center); and Mary Pat Gallagher (NYU Langone Health).
Where does data get entered?
T1D Healthcare Providers or designated staff can submit relevant cases by using this secure survey link, here.
How long does the survey take?
Does my clinic need to have a data agreement with T1D Exchange to be a part of this study?
No. All the data is anonymous and there is no patient identifier used.
Does this study contain any PHI?
Does my clinic need to secure an internal IRB to participate?
Short answer, No. T1D Exchange has secured a central IRB waiver. As the coordinating center, we received a Non-Human Subjects Research determination from the Western Institutional Review Board for a central IRB. Other centers have also received a waiver and allowed to participate in the study. However, if your institution requires a local approval before you can participate, you are welcome to use this language in their internal IRB, if institutions require that.
Is this just surveillance or does it involve interventions?
This is simply surveillance data capture.
Does this tracking involve both T1D and T2D?
No. This is only tracking people with type 1 diabetes.
How big is this study?
Everyone’s contributions make it more relevant and helpful for diabetes policy settings related to health outcomes for people with type 1 diabetes with COVID-19.
Who should be entering the data? Should different clinicians from the same hospital enter data separately?
Please designate one person from your clinic to contribute data.
How often should we be sharing our COVID-19 data?
Please share whenever you have a confirmed or suspected case of COVID 19 in a patient with Type 1 diabetes.
Are you collecting retrospective or prospective data?
Both. Please share data from all patients with COVID-19 or COVID-19 symptoms from past months (February 2020 – present) and any new relevant case in the future.
If we have a backlog of patients with COVID-19, do we have to enter them all in separately?
Yes, we can also share with you an excel spreadsheet you can return to us securely with multiple case reports. Please email firstname.lastname@example.org if you prefer this option.
Do patients have to have an official diagnosis of COVID-19 or is it appropriate to include people suspected to have COVID-19 without a confirmed diagnosis?
Patients don’t need to have a diagnosis. We are collecting information from suspected cases presenting with COVID like illness as well.
How will this data be used?
We will also share insights and aggregate data with you regularly to inform immediate improvement and care.
Do I need to see the patient in person or can a telephone or video/telehealth visit count for tracking COVID-19?
You do not need to see the patient in person. Tracking remotely managed patients counts.
I don't see my question here.
Share your question with us at QI@T1DExchange.org and we will respond ASAP.