NCT00279318

Brief Summary

The long-term goal of the TEDDY study is the identification of infectious agents, dietary factors, or other environmental agents, including psychosocial factors which trigger T1DM in genetically susceptible individuals or which protect against the disease. Identification of such factors will lead to a better understanding of disease pathogenesis and result in new strategies to prevent, delay or reverse T1DM.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,667

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2004

Longer than P75 for all trials

Geographic Reach
4 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2006

Completed
19.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

September 22, 2025

Status Verified

August 1, 2025

Enrollment Period

20.8 years

First QC Date

January 17, 2006

Last Update Submit

September 19, 2025

Conditions

Type 1 Diabetes Mellitus

Keywords

EnvironmentExposuresDietToxinsPsychosocialInfectious AgentsBacterialViralImmunizationsAutoantibody

Outcome Measures

Primary Outcomes (1)

  • Appearance of one or more islet cell autoantibodies: GADA, IAA, or IA-2A confirmed at two consecutive visits.

    September 2025

Secondary Outcomes (1)

  • Development of T1DM

    September 2025

Study Arms (1)

General Population, First Degree Relative

Newborns with high risk HLA in the general population or having a first-degree relative affected with T1DM.

Eligibility Criteria

Age0 Months - 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Childen up to 4 months of age with specified HLA are enrolled and followed longitudnally until 15 years of age

You may qualify if:

  • Newborns with high risk HLA in the general population or having a first- degree relative affected with T1DM
  • Newborns are less than 4 months of age

You may not qualify if:

  • Have an illness or birth defect that precludes long-term follow-up or involves use of treatment that may alter the natural history of diabetes (e.g. steroids or insulin)
  • Refuses to have blood and stool samples stored at the NIDDK Repository

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Colorado Health Sciences Center

Denver, Colorado, 80262, United States

Location

Augusta University

Gainesville, Florida, 32608, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Pacific Northwest Research Institute

Seattle, Washington, 98122, United States

Location

Wellbeing Services County of Southwest Finland

Turku, 20520, Finland

Location

Diabetes Research Institute

Munich, 80804, Germany

Location

Lund University

Malmo, 20502, Sweden

Location

Related Publications (12)

  • Kyronniemi A, Valtanen T, Koskenniemi J, Vahasalo P, Harkonen T, Ilonen J, Toppari J, Knip M, Veijola R. Extremely Early Appearance of Islet Autoantibodies in Genetically Susceptible Children. Pediatr Diabetes. 2023 Dec 11;2023:9973135. doi: 10.1155/2023/9973135. eCollection 2023.

    PMID: 40303239DERIVED

  • Gesualdo P, Melin J, Karban R, Crouch C, Killian M, Hopkins D, Adamsson A, Stock J, Johnson SB, Baxter J; TEDDY Study Group. Structures and strategies for retaining an international pediatric cohort from birth: Lessons from The Environmental Determinants of Diabetes in the Young (TEDDY) study. Contemp Clin Trials Commun. 2025 Jan 23;44:101405. doi: 10.1016/j.conctc.2024.101405. eCollection 2025 Apr.

    PMID: 40027280DERIVED

  • Euren A, Lynch K, Lindfors K, Parikh H, Koletzko S, Liu E, Akolkar B, Hagopian W, Krischer J, Rewers M, Toppari J, Ziegler A, Agardh D, Kurppa K; TEDDY Study Group. Risk of celiac disease autoimmunity is modified by interactions between CD247 and environmental exposures. Sci Rep. 2024 Oct 26;14(1):25463. doi: 10.1038/s41598-024-75496-w.

    PMID: 39462122DERIVED

  • Gesualdo P, Melin J, Karban R, Crouch C, Killian M, Hopkins D, Adamsson A, Stock J, Johnson SB, Baxter J. Structures and Strategies for Retaining an International Pediatric Cohort from Birth: Lessons from The Environmental Determinants of Diabetes in the Young (TEDDY) Study. Res Sq [Preprint]. 2024 Jun 6:rs.3.rs-4421364. doi: 10.21203/rs.3.rs-4421364/v1.

    PMID: 38883796DERIVED

  • Melin J, Lynch KF, Lundgren M, Aronsson CA, Larsson HE, Johnson SB. Factors assessed in the first year of a longitudinal study predict subsequent study visit compliance: the TEDDY study. Eur J Med Res. 2023 Dec 15;28(1):592. doi: 10.1186/s40001-023-01563-z.

    PMID: 38102669DERIVED

  • Krischer JP, Liu X, Lernmark A, Hagopian WA, Rewers MJ, She JX, Toppari J, Ziegler AG, Akolkar B; TEDDY Study Group. Predictors of the Initiation of Islet Autoimmunity and Progression to Multiple Autoantibodies and Clinical Diabetes: The TEDDY Study. Diabetes Care. 2022 Oct 1;45(10):2271-2281. doi: 10.2337/dc21-2612.

    PMID: 36150053DERIVED

  • Melin J, Lynch KF, Lundgren M, Aronsson CA, Larsson HE, Johnson SB; TEDDY Study Group. Is staff consistency important to parents' satisfaction in a longitudinal study of children at risk for type 1 diabetes: the TEDDY study. BMC Endocr Disord. 2022 Jan 10;22(1):19. doi: 10.1186/s12902-021-00929-w.

    PMID: 35012530DERIVED

  • Krischer JP, Liu X, Lernmark A, Hagopian WA, Rewers MJ, She JX, Toppari J, Ziegler AG, Akolkar B; TEDDY Study Group. Characteristics of children diagnosed with type 1 diabetes before vs after 6 years of age in the TEDDY cohort study. Diabetologia. 2021 Oct;64(10):2247-2257. doi: 10.1007/s00125-021-05514-3. Epub 2021 Jul 22.

    PMID: 34291312DERIVED

  • Johnson RK, Tamura R, Frank N, Uusitalo U, Yang J, Niinisto S, Andren Aronsson C, Ziegler AG, Hagopian W, Rewers M, Toppari J, Akolkar B, Krischer J, Virtanen SM, Norris JM; TEDDY Study Group. Maternal food consumption during late pregnancy and offspring risk of islet autoimmunity and type 1 diabetes. Diabetologia. 2021 Jul;64(7):1604-1612. doi: 10.1007/s00125-021-05446-y. Epub 2021 Mar 30.

    PMID: 33783586DERIVED

  • Frank NM, Lynch KF, Uusitalo U, Yang J, Lonnrot M, Virtanen SM, Hyoty H, Norris JM; TEDDY Study Group. The relationship between breastfeeding and reported respiratory and gastrointestinal infection rates in young children. BMC Pediatr. 2019 Sep 18;19(1):339. doi: 10.1186/s12887-019-1693-2.

    PMID: 31533753DERIVED

  • Hippich M, Beyerlein A, Hagopian WA, Krischer JP, Vehik K, Knoop J, Winker C, Toppari J, Lernmark A, Rewers MJ, Steck AK, She JX, Akolkar B, Robertson CC, Onengut-Gumuscu S, Rich SS, Bonifacio E, Ziegler AG; TEDDY Study Group; Teddy Study Group. Genetic Contribution to the Divergence in Type 1 Diabetes Risk Between Children From the General Population and Children From Affected Families. Diabetes. 2019 Apr;68(4):847-857. doi: 10.2337/db18-0882. Epub 2019 Jan 17.

    PMID: 30655385DERIVED

  • Hagopian WA, Erlich H, Lernmark A, Rewers M, Ziegler AG, Simell O, Akolkar B, Vogt R Jr, Blair A, Ilonen J, Krischer J, She J; TEDDY Study Group. The Environmental Determinants of Diabetes in the Young (TEDDY): genetic criteria and international diabetes risk screening of 421 000 infants. Pediatr Diabetes. 2011 Dec;12(8):733-43. doi: 10.1111/j.1399-5448.2011.00774.x. Epub 2011 May 12.

    PMID: 21564455DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, PBMCs, stool, urine, saliva, nasal swabs, nail clippings, water, teeth

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jeffrey P. Krischer, PhD

    University of South Florida

    PRINCIPAL INVESTIGATOR

  • Marian J. Rewers, MD, PhD

    University of Colorado Health Science Center

    PRINCIPAL INVESTIGATOR

  • William A. Hagopian, MD, PhD

    Pacific Northwest Research Institute

    PRINCIPAL INVESTIGATOR

  • Ake Lernmark, MD, PhD

    Lund University

    PRINCIPAL INVESTIGATOR

  • Jorma Toppari, MD, PhD

    Wellbeing Services County of Southwest Finland

    PRINCIPAL INVESTIGATOR

  • Richard McIndoe, PhD

    Augusta University Research Institute, Inc.

    PRINCIPAL INVESTIGATOR

  • Anette G. Ziegler, MD

    Diabetes Research Institute

    PRINCIPAL INVESTIGATOR

  • Beena Akolkar, PhD

    National Institutes of Diabetes and Digestive Kidney Diseases

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2006

First Posted

January 19, 2006

Study Start

September 1, 2004

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

September 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Data are available at the NIDDK Central Repository https://repository.niddk.nih.gov/studies/teddy/?query=teddy

More information

Locations

US(4)DE(1)FI(1)SE(1)