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Type 1 Diabetes Extension Study (T1DES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02734277
Recruitment Status : Recruiting
First Posted : April 12, 2016
Last Update Posted : May 19, 2023
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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Brief Summary:

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:

  • follow participants to determine how long they continue to produce insulin, and
  • will also assess how changes in the immune system over time relate to the ability to produce insulin.

This information could help design better therapies for type 1 diabetes in the future.


Condition or disease
Type 1 Diabetes Mellitus T1DM T1D

Detailed Description:

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:

  • Overall health assessments
  • Blood and urine collections
  • Mixed meal tolerance test (MMTTs) for certain participants, per protocol.
Study Design
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Study Type : Observational
Estimated Enrollment : 111 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Type 1 Diabetes Extension Study
Actual Study Start Date : August 18, 2016
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Groups and Cohorts
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Group/Cohort
Group 1: Detectable C-peptide by MMTT

Participants with detectable C-peptide at their:

  • Last Immune Tolerance Network (ITN) T1DM week 104 study visit,
  • Last AbATE (NCT00129259) follow-up visit, or
  • Last ITN066AI T1DES visit

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:

  • Last ITN T1DM week 104 study visit,
  • Last AbATE follow-up visit, or last
  • ITN066AI T1DES visit

Undetectable C-peptide is defined as a value below the lower limit of detection.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Beta Cell Function by MMTT-Stimulated Mean C-peptide Area Under the Curve (AUC) [ Time Frame: Baseline (Visit 0) to Month 60 (Year 5) ]

    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.



Secondary Outcome Measures :
  1. Change in Insulin Use in Units per Kilogram Body Weight Per Day [ Time Frame: Baseline (Visit 0) to Month 60 (Year 5) ]
    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.

  2. Change in HbA1C [ Time Frame: Baseline (Visit 0) to Month 60 (Year 5) ]
    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.

  3. Count of Participant-Reported Major Hypoglycemic Events [ Time Frame: Baseline (Visit 0) to Month 60 (Year 5) ]
    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.

  4. Time to Undetectable C-Peptide [ Time Frame: Baseline (Visit 0) to Month 60 (Year 5) ]
    To assess the longevity of beta cell function, time to undetectable C-peptide will be evaluated using Kaplan-Meier survival estimates.

  5. Frequency of Grade 3 or Higher Adverse Events (AEs) of Interest [ Time Frame: Baseline (Visit 0) to Month 60 (Year 5) ]

    Events of interest include but are not limited to:

    • Opportunistic and serious infections
    • Malignancy
    • Cardiovascular disease
    • Development of autoimmune disease(s)
    • Hypersensitivity reactions to unrelated allergens

    Reference for Grade 3 or higher AEs: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 (June 14, 2010).


  6. Severity of Grade 3 or Higher Adverse Events (AEs) of Interest [ Time Frame: Baseline (Visit 0) to Month 60 (Year 5) ]

    Events of interest include but are not limited to:

    • Opportunistic and serious infections
    • Malignancy
    • Cardiovascular disease
    • Development of autoimmune disease(s)
    • Hypersensitivity reactions to unrelated allergens

    Reference for Grade 3 or higher AEs: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 (June 14, 2010).



Biospecimen Retention:   Samples Without DNA
  • Blood or urine tests as needed to follow-up on potential long term safety concerns with a particular therapeutic agent
  • Blood and urine samples for additional studies related to your diabetes

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Former participants in Immune Tolerance Network (ITN) new-onset Type 1 Diabetes Mellitus (T1DM) studies with immunomodulatory agents as the intervention.
Criteria

Inclusion Criteria:

  • Prior participant in an Immune Tolerance Network (ITN) executive committee approved T1DM study.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734277


Locations
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United States, California
UCSF School of Medicine Recruiting
San Francisco, California, United States, 94143
Contact: Rebecca Wesch    415-476-5984    rebecca.wesch@ucsf.edu   
Principal Investigator: Stephen Gitelman, MD         
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Trudy Esrey    650-498-4450    tesrey@stanford.edu   
Principal Investigator: Darrell Wilson, MD         
United States, Colorado
University of Colorado School of Medicine: Barbara Davis Center for Diabetes Recruiting
Aurora, Colorado, United States, 80045
Contact: Mara Kinney    303-724-8272    MARA.KINNEY@ucdenver.edu   
Principal Investigator: Peter Gottlieb, MD         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06519
Contact: Linda Ryall    203-737-4510    linda.ryall@yale.edu   
Contact: Mikhail Smolgovsky    203-785-6248    mikhail.smolgovsky@yale.edu   
Principal Investigator: Kevan Herold, MD         
United States, Georgia
Emory University Withdrawn
Atlanta, Georgia, United States, 30322
United States, Indiana
Indiana University Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Ellie Ryan    317-278-7037    elmryan@iu.edu   
Contact: Maria Spall    317-278-7034    malnicho@iu.edu   
Principal Investigator: Linda DiMeglio, MD, MPH         
United States, Iowa
University of Iowa Health Care Division of Pediatric Endocrinology Recruiting
Iowa City, Iowa, United States, 52242
Contact: Joanne Cabbage    319-356-4035    joanne-cabbage@uiowa.edu   
Principal Investigator: Michael Tansey, MD         
United States, Massachusetts
Joslin Diabetes Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Site Public Contact    888-813-8669    T1DTrials@joslin.harvard.edu   
Principal Investigator: Jason Gaglia, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Anne Street    612-625-9709    stree065@umn.edu   
Principal Investigator: Antoinette Moran, MD         
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Marissa Beidelschies    816-760-5918    mkbeidelschies@cmh.edu   
Contact: Jennifer Dolan    (816) 760-8876    jldolan@cmh.edu   
Principal Investigator: Wayne Moore, MD, PhD         
United States, South Dakota
Sanford Research Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Christina Huber    605-328-8741    christina.huber@sanfordhealth.org   
Principal Investigator: Kurt Griffin, MD         
United States, Washington
Benaroya Research Institute Recruiting
Seattle, Washington, United States, 98101
Contact: Corinna Tordillos    206-341-8937    ctordillos@benaroyaresearch.org   
Principal Investigator: Carla Greenbaum, MD         
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN)
Investigators
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Study Chair: Linda A. DiMeglio, MD, MPH,MA Riley Hospital for Children at Indiana University Health
More Information
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Additional Information:

Publications:

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02734277    
Other Study ID Numbers: DAIT ITN066AI
NIAID CRMS ID#: 20722 ( Other Identifier: DAIT NIAID )
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: May 19, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Time Frame: After completion of the study.
Access Criteria: Will be available to the public.
URL: http://www.immport.org/immport-open/public/home/home
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Insulin
Glucose Intolerance
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases