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Type 1 Diabetes Extension Study (T1DES)

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ClinicalTrials.gov Identifier: NCT02734277
Recruitment Status : Recruiting
First Posted : April 12, 2016
Last Update Posted : November 16, 2018
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
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).

Condition or disease
Type 1 Diabetes Diabetes Mellitus

Detailed Description:

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.


Study Type : Observational
Estimated Enrollment : 100 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 2027
Estimated Study Completion Date : March 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Group/Cohort
Detectable C-peptide by MMTT

This cohort includes participants with a detectable C-peptide by 4-hour mixed-meal tolerance test (MMTT) during their last study visit:

  • at week 104, in prior Immune Tolerance Network (ITN) studies ITN027AI (AbATE) or -045AI (T1DAL) -Reference ClinicalTrials.gov study IDs NCT00129259 and NCT00965458
  • in the ITN027AI (AbATE) follow-up study (NCT02067923) and
  • in this study, ITN066AI (T1DES).

Detectable C-peptide is defined as any value during a MMTT of ≥0.15 ng/mL.

Undetectable C-peptide by MMTT

This cohort includes participants with undetectable C-peptide by 4-hour mixed-meal tolerance test (MMTT):

  • during their last study visit at week 104, in prior Immune Tolerance Network (ITN) studies ITN027AI (AbATE) or ITN045AI (T1DAL) -Reference ClinicalTrials.gov study IDs NCT00129259 and NCT00965458
  • after two undetectable C-peptide results by MMTT in the current study, ITN066AI (T1DES).

Undetectable C-peptide is defined as any value during a MMTT of <0.15 ng/mL.




Primary Outcome Measures :
  1. Change in Beta Cell Function by MMTT-Stimulated Mean 4-hour C-peptide 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 4-hour 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 4.0), or clinically: involving seizure(s) or involving loss of consciousness (coma), or requiring assistance from another individual in order to recover.


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


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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
Participants in selected completed Immune Tolerance Network (ITN) new-onset Type 1 Diabetes (T1D) studies with immunomodulatory agents.
Criteria

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.

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
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: American Newnum    317-278-7052    anewnum@iu.edu   
Contact: Robin Hufferd    317-278-0528    rhufferd@iu.edu   
Principal Investigator: Linda DiMeglio, MD, MPH         
United States, Iowa
University of Iowa Health Care Division of Pediatric Endocrinology Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact: Joanne Cabbage    319-356-4035    joanne-cabbage@uiowa.edu   
Principal Investigator: Eva Tsalikian, MD         
United States, Massachusetts
Joslin Diabetes Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Suzanne Krishfield    617-309-4493    Suzanne.Krishfield@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: Marli M Olson    206-342-6943    marli@benaroyaresearch.org   
Principal Investigator: Carla Greenbaum, MD         
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN)
Investigators
Study Chair: Linda DiMeglio, MD, MPH Indiana University Riley Hospital for Children

Additional Information:
Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02734277     History of Changes
Other Study ID Numbers: DAIT ITN066AI
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
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
Prior ITN027AI Study Participants-NCT00129259
Prior ITN045AI Study Participants-NCT00965458

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases