A Message from TrialNet Chair, Carla Greenbaum, M.D.

The health and safety of our TrialNet family is always our top priority. That includes our participants and research teams throughout the world. With this in mind, we have been closely monitoring the rapidly evolving situation around COVID-19. 

In addition to following recommendations from the Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO), and the National Institutes of Health (NIH), the TrialNet leadership team and our dedicated team of infectious disease specialists are in regular communication. We are also in frequent contact with clinical teams at healthcare facilities where our research is conducted. These sites are not only at the forefront of research; they are at the frontlines of providing healthcare for their local communities. All have been greatly impacted by COVID-19, including:

  • Instructing “non-essential” staff to stay at home
  • Reassigning clinical research beds and staff to clinical care
  • Limiting or prohibiting “non-critical” research visits and new enrollment for trials

We will keep this page updated with any new changes impacting TrialNet research.

Thank you for your patience as we navigate these unprecedented times. We remain committed to advancing TrialNet research while ensuring the health and well-being of the entire TrialNet family. 

Our thoughts go out to everyone impacted by COVID-19,

Carla Greenbaum, M.D., TrialNet Chair

Following are temporary changes to TrialNet studies and operations as a result of current COVID-19 precautions. These guidelines are subject to restrictions at local TrialNet clinical centers

This page will be updated as new information becomes available.

 

3/27/2020

Pathway to Prevention Screening

We are continuing to offer Type 1 Diabetes risk screening because it is vital to advancing T1D research. 

  • If you are in the United States, we encourage you to consent online and select an in-home test kit or a lab test kit.
  • If you are outside of the United States, please visit www.trialnet.org/participate to have a Study Coordinator contact you to discuss your options.
  • If you ordered a lab test kit, you will need to contact your local LabCorp or Quest lab to confirm they are open and able to conduct the test. 
  • Results are typically reported in 4-6 weeks. However, your screening results may be delayed due to lab demands/restrictions related to the coronavirus.  
  • For participants who already have a Quest/LabCorp kit and prefer an in-home test kit replacement, please email info@trialnet.org.  
     

Participants in Monitoring

  • If you have an upcoming monitoring visit, most likely your clinical center has already contacted you. If not, please call ahead to confirm your appointment and follow your clinical center’s current guidelines.
  • If your clinical center cannot accommodate your monitoring visit, they will contact you to collect information by phone or email. If needed, you will be referred to another TrialNet site or a local lab for necessary testing.
  • If you/your child experience symptoms of T1D (frequent urination, extreme thirst, weight loss, feeling very tired), contact your health care provider and alert your TrialNet site. 

Participants in LIFT

  • Study visits will not be performed at this time

Participants in Abatacept

For participants in treatment phase: 

  • Study drug infusions will not be performed at this time. 
  • If your clinical center cannot accommodate you for an in-person study visit, they will contact you to collect information by phone or email. 
  • You may need clinical lab tests in order to collect important information. They may be done at your study site or a nearby TrialNet affiliate. We can also refer you to a local clinical lab. If referred to a local clinical lab, you will need to contact the location to confirm they are open.
  • If you/your child is experiencing symptoms of T1D (frequent urination, extreme thirst, weight loss, feeling very tired), contact your health care provider and alert your TrialNet site.

For participants in follow-up phase: 

  • If possible, you will visit your clinical center for your scheduled Oral Glucose Tolerance Test (OGTT). This test provides critical study data. If your clinical center cannot do this test, they will help you find another TrialNet site or clinical lab that can do the test.
  • If we are unable to conduct an in-person study visit, study data may need to be collected by phone or email. 
  • If we are unable to collect glucose tolerance data within a 3-month visit window, we will contact you to help determine if you are having symptoms of high blood sugar. 
  • If other lab testing is needed, we will refer you to an appropriate lab. If referred to a local clinical lab, you will need to contact the location to confirm they are open.
  • If you/your child is experiencing symptoms of T1D (frequent urination, extreme thirst, weight loss, feeling very tired), contact your health care provider and alert your TrialNet site.
     

Participants in Hydroxychloroquine

You are in a clinical study testing hydroxychloroquine to see if it can delay T1D, and it is very important that you only use your study medication for that purpose at the dose prescribed. Do not share your study medication with anyone.  Although hydroxychloroquine is among the medications that researchers are testing for potential anti-virus effects, its usefulness has not been proven and it is not FDA-approved to treat, cure, or prevent coronavirus.

  • If you have an upcoming study visit, most likely your clinical center has already contacted you. If not, please call ahead to confirm your appointment and follow your clinical center’s current virus guidelines.
  • The study drug is dispensed at 3, 6, 12 months and then every 6 months. If an in-person study visit is not possible, you can remain on treatment if:
    • Staff is available to send you the study drug via FedEx. 
    • You have access to a scale and can report your current weight (dosing is weight dependent). 
    • For women of child-bearing age, you are willing to take a pregnancy test and share the results.
    • You are willing to answer questions about any reactions to the study drug and symptoms of diabetes.
    • You are able to obtain safety lab results from a clinical lab as indicated by your site. 
  • If possible, you will visit your clinical center for your scheduled lab tests. These tests provide critical safety and study data. If your clinical center cannot do these tests, they will help you find another TrialNet site or a clinical lab. 
  • If we are unable to conduct an in-person study visit, study data may need to be collected by phone or email. 
  • If it’s not possible to take your ophthalmology exam at this time, it may be postponed until later during the study. 
  • If we are unable to collect glucose tolerance data within a 3-month visit window, we will contact you to help determine if you are having symptoms of high blood sugar.
  • If at any time you/your child is experiencing symptoms of T1D (frequent urination, extreme thirst, weight loss, feeling very tired), contact your health care provider and alert your TrialNet site.

Links to additional information and guidelines related to COVID-19: 

https://www.coronavirus.gov/