Type 1 Diabetes MellitusT1DESNCT02734277
Type 1 Diabetes Extension Study
An observational study of Type 1 Diabetes Mellitus and T1DM, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 35 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, T1DM, T1D
- How many people
- 111 participants
- Where
- 12 sitesUnited States
- Study dates
- 8 Jun 2016to Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Former participants in Immune Tolerance Network (ITN) new-onset Type 1 Diabetes Mellitus (T1DM) studies with immunomodulatory agents as the intervention.
Who may be able to join
- Prior participant in an Immune Tolerance Network (ITN) executive committee approved T1DM study.
- Ability to sign informed consent/assent (as applicable for children).
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 8 recruiting
- Withdrawn
Emory University
Atlanta, Georgia, 30322
- Recruiting
University of Colorado School of Medicine: Barbara Davis Center for Diabetes
Aurora, Colorado, 80045
Mara Kinney, (303) 724-8272, MARA.KINNEY@ucdenver.edu
Peter Gottlieb, MD
- Recruiting
Joslin Diabetes Center
Boston, Massachusetts, 02215
Site Public Contact, 888-813-8669, T1DTrials@joslin.harvard.edu
Jason Gaglia, MD
- Recruiting
Indiana University Riley Hospital for Children
Indianapolis, Indiana, 46202
Ellie Ryan, 317-278-7037, elmryan@iu.edu
Maria Spall, 317-278-7034, malnicho@iu.edu
- Recruiting
University of Iowa Health Care Division of Pediatric Endocrinology
Iowa City, Iowa, 52242
Joanne Cabbage, 319-356-4035, joanne-cabbage@uiowa.edu
Michael Tansey, MD
- Completed
Children's Mercy Hospital
Kansas City, Missouri, 64108
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55454
Anne Street, 612-625-9709, stree065@umn.edu
Antoinette Moran, MD
- Completed
Yale University
New Haven, Connecticut, 06519
- Recruiting
UCSF School of Medicine
San Francisco, California, 94143
Rebecca Wesch, 415-476-5984, rebecca.wesch@ucsf.edu
Stephen Gitelman, MD
- Recruiting
Benaroya Research Institute
Seattle, Washington, 98101
Katie Bennett, (206) 341-8945, kbennett@benaroyaresearch.org
Sandra Lord, MD
- Completed
Sanford Research
Sioux Falls, South Dakota, 57104
- Recruiting
Stanford University
Stanford, California, 94305
Trudy Esrey, 650-498-4450, tesrey@stanford.edu
Darrell Wilson, MD
About this study
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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus, T1DM, T1D
- Keywords
- Insulin, Glucose Intolerance
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Visit 0) to Month 60 (Year 5)
Secondary outcomes (6)
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.
Measured: Baseline (Visit 0) to Month 60 (Year 5)
Change in HbA1C
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.
Measured: 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.
Measured: 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.
Measured: 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:
- 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).
Measured: 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:
- 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).
Measured: Baseline (Visit 0) to Month 60 (Year 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study start8 Jun 2016
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN)
- Responsible party
- Sponsor
- Investigators
- Linda A. DiMeglio, MD, MPH,MA, Study chair, Riley Hospital for Children at Indiana University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734277
- Sponsor's protocol ID
- DAIT ITN066AI
- Other IDs
- NIAID CRMS ID#: 20722
- Acronym
- T1DES
- Status last verified
- Sep 2026
- First submitted
- 6 Apr 2016
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 23835333Rigby 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.
PubMed 26193635Rigby 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.
PubMed 24622414
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 1 Diabetes Extension Study
- ClinicalTrials.gov ID
- NCT02734277
- Acronym / sponsor ID
- T1DES / DAIT ITN066AI
- Conditions
- Type 1 Diabetes Mellitus, T1DM, T1D
- Keywords
- Insulin, Glucose Intolerance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN)
- Study start
- 8 Jun 2016 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 8 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Former participants in Immune Tolerance Network (ITN) new-onset Type 1 Diabetes Mellitus (T1DM) studies with immunomodulatory agents as the intervention.
Key inclusion criteria (2 listed)
- Prior participant in an Immune Tolerance Network (ITN) executive committee approved T1DM study.
- Ability to sign informed consent/assent (as applicable for children).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Change in Insulin Use in Units per Kilogram Body Weight Per Day
Time frame: Baseline (Visit 0) to Month 60 (Year 5)
Change in HbA1C
Time frame: Baseline (Visit 0) to Month 60 (Year 5)
Count of Participant-Reported Major Hypoglycemic Events
Time frame: Baseline (Visit 0) to Month 60 (Year 5)
Time to Undetectable C-Peptide
Time frame: Baseline (Visit 0) to Month 60 (Year 5)
Frequency of Grade 3 or Higher Adverse Events (AEs) of Interest
Time frame: Baseline (Visit 0) to Month 60 (Year 5)
Severity of Grade 3 or Higher Adverse Events (AEs) of Interest
Time frame: Baseline (Visit 0) to Month 60 (Year 5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Background: PubMed 23835333Herold 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.
- Background: PubMed 26193635Rigby 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.
- Background: PubMed 24622414Rigby 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.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University of Colorado School of Medicine: Barbara Davis Center for Diabetes
Aurora, United States
Linda A. DiMeglio, MD, MPH,MA study chair
Riley Hospital for Children at Indiana University Health
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus and T1DM, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02734277, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.