Type 1 Diabetes Extension Study

Type 1 Diabetes Mellitus Clinical Trial

— T1DES  

Official title:

Type 1 Diabetes Extension Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02734277
• Other study ID #: DAIT ITN066AI
• Secondary ID: NIAID CRMS ID#:
• Status: Recruiting
• Start date: August 18, 2016
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 111
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• T1D
• T1DM
• Type 1 Diabetes Mellitus

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Colorado School of Medicine: Barbara Davis Center for Diabetes	Aurora	Colorado
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	Indiana University Riley Hospital for Children	Indianapolis	Indiana
United States	University of Iowa Health Care Division of Pediatric Endocrinology	Iowa City	Iowa
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	University of Minnesota	Minneapolis	Minnesota
United States	Yale University	New Haven	Connecticut
United States	UCSF School of Medicine	San Francisco	California
United States	Benaroya Research Institute	Seattle	Washington
United States	Sanford Research	Sioux Falls	South Dakota
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Immune Tolerance Network (ITN)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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)
Secondary	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.	Baseline (Visit 0) to Month 60 (Year 5)
Secondary	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)
Secondary	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)
Secondary	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).	Baseline (Visit 0) to Month 60 (Year 5)
Secondary	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).	Baseline (Visit 0) to Month 60 (Year 5)

External Links

•   ITN T1D Extended Study (T1DES) website