Number of Subjects in Study Archive: 130
Study Design: Observational
Conditions: Diabetes Mellitus, Type 1
Division: DEM
Duration: 7/1/2011-12/1/2018
Treatment: None
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Data Package Version Number: 2 (Updated on: August 11, 2023)
DOI: 10.58020/scct-xr14
How to cite this dataset: Krischer, Jeffrey (2023). JDRF Follow-up of Children Diagnosed with Diabetes (V2) [Dataset]. NIDDK Central Repository. https://doi.org/10.58020/scct-xr14
Data availability statement: Data from the JDRF Follow-up of Children Diagnosed with Diabetes [(V2)/https://doi.org/10.58020/scct-xr14] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
The Environmental Determinants of Diabetes in the Young (TEDDY) study enrolled over 8,000 infants identified to have an increased genetic risk for type 1 diabetes (T1D) and were followed prospectively for 15 years for the development of T1D and islet cell antibodies. There were 400 children projected to develop T1D over the course of the study, and follow-up of these children stopped upon development of T1D. The JDRF Follow-up of Children Diagnosed with Diabetes (JDRF-TEDDY Follow-Up) study sought to understand whether these children were diagnosed at an earlier stage of T1D compared to children not enrolled in prospective studies, and to identify if they maintained the ability to produce C-peptide longer than children diagnosed through standard clinical care in the community. The JDRF-TEDDY Follow-Up study analyzed the preservation of C-peptide over time in children diagnosed with T1D through prospective studies and compared them to a group of age matched controls identified from the community. Furthermore, the JDRF-TEDDY Follow-Up study collected samples to investigate immunological changes occurring after diagnosis and how these changes may relate to earlier T1D diagnoses.
The purpose of the JDRF-TEDDY Follow-Up study was to better understand how early T1D diagnoses may impact disease course and outcomes in children through three primary aims:
The primary outcome measure was C-peptide levels over time from diagnosis of diabetes.
The secondary outcome measures included presence of DKA at onset, C-peptide, islet cell antibodies, hemoglobin A1c and insulin dose, glycemic control and glycemic variability, health-related quality of life and psychological functioning from children and their parents, T-cell activity and gene expression prior to antibody development, post antibody development, post diagnosis of T1D, and changes in human biome from stool samples as feasible.
Inclusion criteria for Case subjects:
Inclusion criteria for Control subjects:
Exclusion criteria:
The primary outcome of the study was the preservation of stimulated C-peptide over time in TEDDY subjects versus the community diagnosed children. Higher C-peptide levels persisted for at least 12 months following diabetes onset in TEDDY participants compared to community diagnosed children. Symptom-free diagnosis, reduction of DKA, and the potential for immune intervention with increased baseline C-peptide may portend additional long-term benefits of early diagnosis.