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| ID | Type | Description | Link |
|---|---|---|---|
| NIAID CRMS ID#: 20722 | Other Identifier | DAIT NIAID |
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| Name | Class |
|---|---|
| Immune Tolerance Network (ITN) | NETWORK |
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This is a multi-center, prospective, non-interventional study that focuses on the long- term effects following participation in selected ITN new-onset Type1 Diabetes Mellitus studies with immunomodulatory agents (T1DM, T1D).
This observational study will:
This information could help design better therapies for type 1 diabetes in the future.
Depending upon a participant's level of insulin production, participation may be as short as one return visit or a maximum of five years. Evaluation visits will include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Detectable C-peptide by MMTT | Participants with detectable C-peptide at their:
Detectable C-peptide is defined as a value above the lower limit of detection. | ||
| Group 2:Undetectable C-peptide by MMTT | Participants without detectable C-peptide at their:
Undetectable C-peptide is defined as a value below the lower limit of detection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Beta Cell Function by MMTT-Stimulated Mean C-peptide Area Under the Curve (AUC) | Evaluation of changes in beta cell function over time will be measured by mixed-meal tolerance test (MMTT) -Stimulated mean C-Peptide area under the curve (AUC). C-peptide is released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. Detectable C-peptide is defined as any value during a MMTT of ≥0.15 ng/mL. | Baseline (Visit 0) to Month 60 (Year 5) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Insulin Use in Units per Kilogram Body Weight Per Day | The need to use exogenous insulin is an indication that the body is not producing enough endogenous insulin. Higher amounts of insulin use indicate higher disease activity. | Baseline (Visit 0) to Month 60 (Year 5) |
| Change in HbA1C |
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Inclusion Criteria:
Exclusion Criteria:
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Former participants in Immune Tolerance Network (ITN) new-onset Type 1 Diabetes Mellitus (T1DM) studies with immunomodulatory agents as the intervention.
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| Name | Affiliation | Role |
|---|---|---|
| Linda A. DiMeglio, MD, MPH,MA | Riley Hospital for Children at Indiana University Health | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF School of Medicine | Recruiting | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23835333 | Background | Herold KC, Gitelman SE, Ehlers MR, Gottlieb PA, Greenbaum CJ, Hagopian W, Boyle KD, Keyes-Elstein L, Aggarwal S, Phippard D, Sayre PH, McNamara J, Bluestone JA; AbATE Study Team. Teplizumab (anti-CD3 mAb) treatment preserves C-peptide responses in patients with new-onset type 1 diabetes in a randomized controlled trial: metabolic and immunologic features at baseline identify a subgroup of responders. Diabetes. 2013 Nov;62(11):3766-74. doi: 10.2337/db13-0345. Epub 2013 Jul 8. | |
| 26193635 |
| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | View source |
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The plan is to share data in: 1.)ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts that also provides data analysis tools that are available to researchers who register online and subsequently receive DAIT approval; and 2.)TrialShare, a clinical trials research portal developed by the Immune Tolerance Network that makes data from the consortium's clinical trials publicly available without charge.
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After completion of the study.
Will be available to the public.
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007333 | Insulin Resistance |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Glycosylated hemoglobin (HbA1c) is a measure of the average plasma concentration of blood sugar (glucose) over the previous three months and measures the level of optimal management of underlying disease. |
| Baseline (Visit 0) to Month 60 (Year 5) |
| Count of Participant-Reported Major Hypoglycemic Events | Major hypoglycemic events are defined as a glucose concentration <55 mg/dL (grades 2-5, NCI-CTCAE version 4.03), or clinically: involving seizure(s) or involving loss of consciousness (coma), or requiring assistance from another individual in order to recover. | Baseline (Visit 0) to Month 60 (Year 5) |
| Time to Undetectable C-Peptide | To assess the longevity of beta cell function, time to undetectable C-peptide will be evaluated using Kaplan-Meier survival estimates. | Baseline (Visit 0) to Month 60 (Year 5) |
| Frequency of Grade 3 or Higher Adverse Events (AEs) of Interest | Events of interest include but are not limited to:
Reference for Grade 3 or higher AEs: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 (June 14, 2010). | Baseline (Visit 0) to Month 60 (Year 5) |
| Severity of Grade 3 or Higher Adverse Events (AEs) of Interest | Events of interest include but are not limited to:
Reference for Grade 3 or higher AEs: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 (June 14, 2010). | Baseline (Visit 0) to Month 60 (Year 5) |
| Stanford University | Recruiting | Stanford | California | 94305 | United States |
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| University of Colorado School of Medicine: Barbara Davis Center for Diabetes | Recruiting | Aurora | Colorado | 80045 | United States |
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| Yale University | Completed | New Haven | Connecticut | 06519 | United States |
| Emory University | Withdrawn | Atlanta | Georgia | 30322 | United States |
| Indiana University Riley Hospital for Children | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| University of Iowa Health Care Division of Pediatric Endocrinology | Recruiting | Iowa City | Iowa | 52242 | United States |
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| Joslin Diabetes Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55454 | United States |
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| Children's Mercy Hospital | Completed | Kansas City | Missouri | 64108 | United States |
| Sanford Research | Completed | Sioux Falls | South Dakota | 57104 | United States |
| Benaroya Research Institute | Recruiting | Seattle | Washington | 98101 | United States |
|
| Background |
| Rigby MR, Harris KM, Pinckney A, DiMeglio LA, Rendell MS, Felner EI, Dostou JM, Gitelman SE, Griffin KJ, Tsalikian E, Gottlieb PA, Greenbaum CJ, Sherry NA, Moore WV, Monzavi R, Willi SM, Raskin P, Keyes-Elstein L, Long SA, Kanaparthi S, Lim N, Phippard D, Soppe CL, Fitzgibbon ML, McNamara J, Nepom GT, Ehlers MR. Alefacept provides sustained clinical and immunological effects in new-onset type 1 diabetes patients. J Clin Invest. 2015 Aug 3;125(8):3285-96. doi: 10.1172/JCI81722. Epub 2015 Jul 20. |
| 24622414 | Background | Rigby MR, DiMeglio LA, Rendell MS, Felner EI, Dostou JM, Gitelman SE, Patel CM, Griffin KJ, Tsalikian E, Gottlieb PA, Greenbaum CJ, Sherry NA, Moore WV, Monzavi R, Willi SM, Raskin P, Moran A, Russell WE, Pinckney A, Keyes-Elstein L, Howell M, Aggarwal S, Lim N, Phippard D, Nepom GT, McNamara J, Ehlers MR; T1DAL Study Team. Targeting of memory T cells with alefacept in new-onset type 1 diabetes (T1DAL study): 12 month results of a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Diabetes Endocrinol. 2013 Dec;1(4):284-94. doi: 10.1016/S2213-8587(13)70111-6. Epub 2013 Sep 23. |
| Division of Allergy, Immunology, and Transplantation (DAIT) | View source |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |
| D006943 | Hyperglycemia |