Study Name: Early Markers of Disease and Response to Therapy
Principal Investigator: Carla Greenbaum, MD
What is the DREAMT Study?
We are recruiting newly diagnosed individuals for this study to help scientists predict how abatacept helps preserve insulin production.
In earlier studies, abatacept was shown to slow down beta cell destruction and preserve insulin secretion in people after diagnosis of type 1 diabetes. Abatacept seemed to work better in some people than in others. This study seeks to identify markers that predict how effective abatacept will be in individuals with type 1 diabetes.
Abatacept is approved by the U.S. Food & Drug Administration (FDA) for use in several autoimmune diseases, including rheumatoid arthritis and juvenile idiopathic arthritis, in adults and in children as young as age six.
Who can participate?
You may be eligible to participate if you:
- have been diagnosed with type 1 diabetes within the last six months,
- are 6 – 55 years of age,
- test positive for at least one diabetes-related autoantibody,
- are in good general health, and
- live in or near Seattle.
What will study participants be asked to do?
First, a researcher will have a phone conversation with you to review initial screening criteria. If you meet initial criteria, you’ll be invited to Benaroya Research Institute’s clinical research center at Virginia Mason Hospital for an approximately four-hour visit that determines eligibility to participate. If you are eligible, within three months of the screening visit, you would return for a baseline visit and begin treatment.
Treatment is by weekly subcutaneous injection, for 12 weeks. Participants self-administer the injections at home (after instruction from the study team). Participants also take weekly fingerstick blood collections.
There are five clinic visits during this period: a baseline visit and visits at 2, 4, 6 and 12 weeks. There is one follow-up visit one year after beginning treatment.
Participation in the study is 15 months. Study visits may include:
- collection of medical history,
- physical exam,
- blood tests, and
- mixed meal tolerance test.
The study team stays in contact with the participant throughout the treatment period to help maintain good glucose control. This is an open label single-arm study. All participants receive study drug.
All visits take place in Seattle. If you’d like to participate, please call us at 800-888-4187 or email email@example.com.