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Diabetes Study of Children of Diverse Ethnicity and Race: Study design
Maria J Redondo1, Kylie K Harrall2,3, Deborah H Glueck2,3
1Diabetes and Endocrinology Division, Department of Pediatrics, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas, USA.
Insights
Accurate diabetes classification in children is challenging. The DISCOVER study aims to improve models for differentiating type 1 and type 2 diabetes in youth, aiding early clinical management.
Area of Science:
- Pediatric Endocrinology
- Metabolic Disorders
- Clinical Research
Background:
- Distinguishing between type 1 diabetes (T1D) and type 2 diabetes (T2D) in children is increasingly complex due to overlapping clinical features.
- The DISCOVER program, funded by the NIH, is a multicenter, prospective, observational study designed to address this diagnostic challenge in diverse pediatric populations.
Purpose of the Study:
- To develop and validate enhanced predictive models for accurate differentiation of T1D and T2D in youth.
- To improve the classification of diabetes type in children with unclear presentations at diagnosis.
Main Methods:
- Utilizing a combination of T1D genetic risk scores, islet autoantibody data, and clinical parameters at diabetes onset.
- Employing low non-fasting serum C-peptide levels (<0.6 nmol/L) 3-10 years post-diagnosis as a biomarker for T1D.
- Enrolling youth (<19 years) with recent-onset or established diabetes for cross-sectional model development and longitudinal validation.
Main Results:
- The study is expected to yield improved models for classifying diabetes type in a significant and growing subset of pediatric patients.
- Enhanced diagnostic capabilities will assist in identifying children with ambiguous diabetes forms at initial presentation.
Conclusions:
- Accurate and timely diabetes type classification is crucial for initiating appropriate and effective clinical management strategies.
- Improved diagnostic tools will lead to better patient outcomes through early and correct treatment initiation.
Aims:
Determining diabetes type in children has become increasingly difficult due to an overlap in typical characteristics between type 1 diabetes (T1D) and type 2 diabetes (T2D). The Diabetes Study in Children of Diverse Ethnicity and Race (DISCOVER) programme is a National Institutes of Health (NIH)-supported multicenter, prospective, observational study that enrols children and adolescents with non-secondary diabetes. The primary aim of the study was to develop improved models to differentiate between T1D and T2D in diverse youth.
Materials And Methods:
The proposed models will evaluate the utility of three existing T1D genetic risk scores in combination with data on islet autoantibodies and other parameters typically available at the time of diabetes onset. Low non-fasting serum C-peptide (<0.6 nmol/L) between 3 and 10 years after diabetes diagnosis will be considered a biomarker for T1D as it reflects the loss of insulin secretion ability. Participating centres are enrolling youth (<19 years old) either with established diabetes (duration 3-10 years) for a cross-sectional evaluation or with recent onset diabetes (duration 3 weeks-15 months) for the longitudinal observation with annual visits for 3 years. Cross-sectional data will be used to develop models. Longitudinal data will be used to externally validate the best-fitting model.
Results:
The results are expected to improve the ability to classify diabetes type in a large and growing subset of children who have an unclear form of diabetes at diagnosis.
Conclusions:
Accurate and timely classification of diabetes type will help establish the correct clinical management early in the course of the disease.
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