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The Environmental Determinants of Diabetes in the Young (TEDDY): genetic criteria and international diabetes risk screening of 421 000 infants.

ABSTRACT: AIMS:The Environmental Determinants of Diabetes in the Young (TEDDY) study seeks to identify environmental factors influencing the development of type 1 diabetes (T1D) using intensive follow-up of children at elevated genetic risk. This study requires a cost-effective yet accurate screening strategy to identify the high-risk cohort. METHODS:The TEDDY cohort was identified through newborn screening using human leukocyte antigen (HLA) class II genes based on criteria established with pre-TEDDY data. HLA typing was completed at six international centers using different genotyping methods that can achieve >98% accuracy. RESULTS:TEDDY developed separate inclusion criteria for the general population (GP) and first-degree relatives (FDRs) of T1D patients. The FDR eligibility includes nine haplogenotypes (DR3/4, DR4/4, DR4/8, DR3/3, DR4/4b, DR4/1, DR4/13, DR4/9, and DR3/9) for broad HLA diversity, whereas the GP eligibility includes only the first four haplogenotypes with DRB1*0403 as an exclusion allele. TEDDY has screened 414 714 GP infants, of which 19 906 (4.8%) were eligible, whereas 1415 of the 6333 screened FDR infants (22.2%) were eligible. High-resolution confirmation testing of the eligible subjects indicated that the low-cost and low-resolution genotyping techniques employed at the screening centers yielded an accuracy of 99%. There were considerable variations in eligibility rates among the centers for GP (3.5-7.4%) and FDR (19-32%) subjects. The eligibility rates among US ethnic groups were 0.9, 1.3, 5.0, and 6.9% for Asians, Black, Caucasians, and Hispanics, respectively. CONCLUSIONS:Different low-cost and low-resolution genotyping methods are useful for the efficient and accurate identification of a high-risk cohort for follow-up based on the TEDDY HLA inclusion criteria.

SUBMITTER: Hagopian WA

PROVIDER: S-EPMC3315186 | biostudies-literature | 2011 Dec

REPOSITORIES: biostudies-literature

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The Environmental Determinants of Diabetes in the Young (TEDDY): genetic criteria and international diabetes risk screening of 421 000 infants.

Hagopian William A WA Erlich Henry H Lernmark Ake A Rewers Marian M Ziegler Anette G AG Simell Olli O Akolkar Beena B Vogt Robert R Blair Alan A Ilonen Jorma J Krischer Jeffrey J She JinXiong J

Pediatric diabetes 20110512 8

<h4>Aims</h4>The Environmental Determinants of Diabetes in the Young (TEDDY) study seeks to identify environmental factors influencing the development of type 1 diabetes (T1D) using intensive follow-up of children at elevated genetic risk. This study requires a cost-effective yet accurate screening strategy to identify the high-risk cohort.<h4>Methods</h4>The TEDDY cohort was identified through newborn screening using human leukocyte antigen (HLA) class II genes based on criteria established wit ...[more]

PMID: 21564455

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Project description:ObjectiveTo assess parents' opinions about their participation in the longitudinal, multicenter study - The Environmental Determinants of Diabetes in the Young (TEDDY) consortium.MethodsA survey was given to parents who had been in the study for ≥ 1 year. Parents rated the importance of different reasons for staying in TEDDY and how well different study components were working. Parents were also asked if they had suggestions for making TEDDY better and if they ever had thought of leaving TEDDY and if so, why.ResultsOut of the 3336 eligible families, 2000 completed the survey (59.1%); most (77.6%) were mothers. Survey completion was more common in European than US TEDDY sites and was associated with greater maternal education, more accurate perceptions about their child's risk of type 1 diabetes, longer participation in TEDDY and excellent attendance at TEDDY visits. "Having someone watching the child for development of T1DM" was most important reason given for staying in the study; other important reasons included "Helping science discover causes of diabetes" and "Getting child's antibody results". Most parents were very satisfied with the different components of TEDDY and had not thought of leaving the study. A minority (24%) of parents acknowledged some thoughts of leaving TEDDY and cited the blood draws, being too busy/not having enough time, the demanding protocol, and food diaries as their reasons for considering leaving.ConclusionsThe study highlights factors important for successful implementation of demanding, longitudinal protocols. Friendly, devoted, skilled and knowledgeable staff with continuity makes the family comfortable. Keeping parents involved and informed on study progress is essential as is making procedures as smooth and painless as possible. Although the study is international the survey results were convergent across countries suggesting that the results have relevance to other similar studies to retain study participants.

Dataset Information

The Environmental Determinants of Diabetes in the Young (TEDDY): genetic criteria and international diabetes risk screening of 421 000 infants.

Publications

The Environmental Determinants of Diabetes in the Young (TEDDY): genetic criteria and international diabetes risk screening of 421 000 infants.

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