Status:
COMPLETED
Development of Predictive Biomarkers
Lead Sponsor:
Medical College of Wisconsin
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Benaroya Research Institute
Conditions:
Type1diabetes
Eligibility:
All Genders
5-17 years
Brief Summary
Investigators aim to further the understanding of the various factors that govern the progression of beta-cell death in individuals recently diagnosed with Type 1 diabetes (T1D). Specifically, the inv...
Eligibility Criteria
Inclusion
- Males and females 5-17 years of age with a clinical diagnosis of T1D
- T1D diagnosis date between 1-3 months at the time of study visit 2 (baseline visit)
- Treatment naïve of any immunomodulatory agent
- Receiving routine out-patient diabetes care at the CHW Diabetes Clinic
Exclusion
- Presence of severe, active disease that requires the use of chronic medication, with the exception of well-controlled autoimmune thyroiditis/hypothyroidism or celiac disease that is well-controlled on a gluten free diet.
- Diabetes other than T1D
- Chronic illness known to affect glucose metabolism
- Psychiatric impairment, with the exception of well-controlled depression or anxiety, that will affect the ability to participate in the study
- Female participants of child-bearing age with reproductive potential must not be knowingly pregnant
- Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results
Key Trial Info
Start Date :
October 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03423862
Start Date
October 1 2017
End Date
September 30 2021
Last Update
April 19 2024
Active Locations (1)
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1
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226