NCT02067923|Completed
AbATE Follow-Up Study
ITN0127AI Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes (AbATE) Follow-Up Study
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ITN0127AI Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes (AbATE) Follow-Up Study
Sponsor study identifier
observational
44
1 country
1
Study Start
February 2014
Actual (reported)Primary Completion
January 2016
Actual (reported)Study Completion
November 17, 2016
Actual (reported)This study proposes to conduct a non-interventional, multi-center trial that will look at C-peptide results from one or two Mixed Meal Tolerance Tests (MMTT) in participants who received anti-CD3 treatment or placebo on the Abate ITN027AI trial. Anti-CD3 monoclonal antibody is a humanized antibody that is commonly used to prevent organ rejection. It was give in order to determine whether anti-CD3 mAb treatment can halt the progression of newly diagnosed type 1 diabetes. The overall hypothesis of this study is there will be less change in c-peptide levels of the previously treated group versus the control group.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 17, 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2014
Actual (reported)February 18, 2014
Actual (reported)February 20, 2014
Actual (reported)January 2016
Actual (reported)November 17, 2016
Actual (reported)Mixed Meal Tolerance Test (MMTT) C-peptide levels
Labs will be obtained to assess beta cell function via c-peptide levels and glucose at 11 time points during the mixed meal tolerance test. Blood samples will be obtained prior to the start of the mixed meal tolerance test to assess auto-antibody status and HbA1c. Approximately 60 cc's of blood will also be obtained for PBMC's and future studies as related to the immunology and genetics of T1DM. A 4 hour urine sample during the MMTT will be collected for C-peptide and Creatinine measurement. We plan to determine the relationship between this measurement and the insulin secretory response.
1 Study Day
Safety experience
1 Study Day
This group of individuals received treatment in the original AbATE study.
During the original AbATE study these individuals received standard care.
The investigators will contact their patients who were originally on the ITN027AI (AbATE) study. Subjects will be contacted via email or phone to see if they would be interested in participating on this Abate follow-up study.
Church Street Research Unit
New Haven, Connecticut, 06519, United States
Perdigoto AL, Preston-Hurlburt P, Clark P, Long SA, Linsley PS, Harris KM, Gitelman SE, Greenbaum CJ, Gottlieb PA, Hagopian W, Woodwyk A, Dziura J, Herold KC; Immune Tolerance Network. Treatment of type 1 diabetes with teplizumab: clinical and immunological follow-up after 7 years from diagnosis. Diabetologia. 2019 Apr;62(4):655-664. doi: 10.1007/s00125-018-4786-9. Epub 2018 Dec 19.
blood urine
Kevan Herold, MD
Yale University
44 participants (actual enrollment reported by the registry).
First Submitted
February 18, 2014
First Posted
February 20, 2014
Study Start
February 2014
Actual (reported)Warming up to Sensors: Does Site Warming Improve Continuous Glucose Monitor Performance?
Contact the study team to confirm eligibility.
Primary Completion
January 2016
Actual (reported)Study Completion
November 17, 2016
Actual (reported)Last Updated
January 17, 2018
Record last verified: 2018-01
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Source: ClinicalTrials.gov.
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