Type 1 Diabetes Extension Study



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:8 - 35
Updated:11/18/2018
Start Date:August 18, 2016
End Date:March 2027

Use our guide to learn which trials are right for you!

To further our understanding of the immunologic mechanisms underlying maintenance and loss of
beta cell function by evaluating the relationship between longitudinal changes in beta cell
function and changes over time in biomarkers known to be associated with a response to immune
modulating treatments which were used in prior clinical trials (Refer to ClinicalTrials.gov
records NCT00129259 and NCT00965458).

Type 1 diabetes mellitus (T1DM) is an autoimmune disease. This means that the immune system
(the part of the body that helps fight infections) mistakenly attacks the cells that produce
insulin (beta cells in the pancreas). As beta cells are destroyed by the immune cells, the
ability to produce insulin is decreased and diabetes develops. Insulin helps keep blood
glucose levels normal.

People with diabetes who have the ability to produce some of their own insulin (even though
they still need to take insulin) may be able to achieve better glucose control than people
who produce no insulin at all. Better glucose control has been shown to reduce the long-term
complications of diabetes.

Several Immune Tolerance Network (ITN) drug treatment studies have been completed and have
shown that some participants with new onset T1DM had partial disease remissions with therapy.
Prior participants in these trials, had measured insulin secretion, at six month intervals,
up to two years after diabetes diagnosis. It is unclear, however, if any of the interventions
have produced a continuing disease remission in patients. For persons who have completed drug
treatment trials, longer term follow-up is important for continued evaluation for effect of
therapy on insulin production.

Inclusion Criteria:

- Prior participation in protocol ITN027AI AbATE(NCT00129259) or protocol ITN045AI
T1DAL(NCT00965458) studies; and

- Ability to sign informed consent/assent (as applicable for children).

Exclusion Criteria:

- Any medical condition that in the opinion of the principal investigator would
interfere with safe completion of the trial; or

- Inability to comply with the study visit schedule and required assessments.
We found this trial at
12
sites
One Joslin Place
Boston, Massachusetts 02215
617-309-2400
Principal Investigator: Jason Gaglia, MD
Phone: 617-309-4493
Joslin Diabetes Center Joslin Diabetes Center, located in Boston, Massachusetts, is the world's largest diabetes...
?
mi
from
Boston, MA
Click here to add this to my saved trials
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Eric Felner, MD, MSCR
Phone: 404-727-5709
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Principal Investigator: Wayne Moore, MD, PhD
Phone: 816-760-5918
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Antoinette Moran, MD
Phone: 612-625-9709
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Aurora, Colorado 80045
Principal Investigator: Peter Gottlieb, MD
Phone: 303-724-8272
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Indianapolis, Indiana 46202
Principal Investigator: Linda DiMeglio, MD, MPH
Phone: 317-278-7052
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Iowa City, Iowa 52242
Principal Investigator: Eva Tsalikian, MD
Phone: 319-356-4035
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Kevan Herold, MD
Phone: 203-737-4510
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
San Francisco, California 94143
Principal Investigator: Stephen Gitelman, MD
Phone: 415-476-5984
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Seattle, Washington 98101
Principal Investigator: Carla Greenbaum, MD
Phone: 206-342-6943
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Sioux Falls, South Dakota 65104
Principal Investigator: Kurt Griffin, MD
Phone: 605-328-8741
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Darrell Wilson, MD
Phone: 650-498-4450
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
?
mi
from
Stanford, CA
Click here to add this to my saved trials