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Treatment for Diabetes Mellitus (T1DES Trial)

N/A
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (visit 0) to month 60 (year 5)
Awards & highlights

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.

Eligible Conditions
  • Diabetes Mellitus
  • Type 1 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (visit 0) to month 60 (year 5)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (visit 0) to month 60 (year 5) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Beta Cell Function by MMTT-Stimulated Mean C-peptide Area Under the Curve (AUC)
Secondary outcome measures
Change in HbA1C
Change in Insulin Use in Units per Kilogram Body Weight Per Day
Count of Participant-Reported Major Hypoglycemic Events
+3 more

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Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,302 Previous Clinical Trials
5,501,331 Total Patients Enrolled
28 Trials studying Diabetes Mellitus
11,981 Patients Enrolled for Diabetes Mellitus
Immune Tolerance Network (ITN)NETWORK
67 Previous Clinical Trials
7,819 Total Patients Enrolled
10 Trials studying Diabetes Mellitus
374 Patients Enrolled for Diabetes Mellitus
Linda A. DiMeglio, MD, MPH,MAStudy ChairRiley Hospital for Children at Indiana University Health
~5 spots leftby Mar 2025
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