Type 1 Diabetes MellitusNCT00279318
TEDDY - The Environmental Determinants of Diabetes in the Young
An observational study of Type 1 Diabetes Mellitus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 7 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 8,667 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 1 Sep 2004to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Childen up to 4 months of age with specified HLA are enrolled and followed longitudnally until 15 years of age
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
United States4 sites
Augusta University
Augusta, Georgia, 30912
University of Colorado Health Sciences Center
Denver, Colorado, 80262
Augusta University
Gainesville, Florida, 32608
Pacific Northwest Research Institute
Seattle, Washington, 98122
About this study
Official title: Consortium for Identification of Environmental Triggers of Type 1 Diabetes
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.
Read the detailed description
Epidemiologic patterns suggest that viruses, nutrition, toxic agents or socioeconomic psychosocial factors may contribute to the etiology alone or in combination. Elucidation is confounded by the long interval between exposure and onset of clinical disease, as well as the interaction of multiple genes and/or insults, which appear to interact in a complex manner. Numerous studies have investigated environmental influences but have yielded conflicting results. This may be in part due to the failure to account for genetic susceptibility, begin observation at early ages or in utero, and/or monitor subjects long term and frequently.
Hypotheses:
- Initiation of persistent beta-cell autoimmunity and progression from beta-cell autoimmunity to diabetes is increased with:
- Exposure to a trigger factor during pregnancy, such as infections, preeclampsia, blood incompatibility, or birth weight.
- Differences in the timing of the introduction and/or the type of dietary constituents that include exposure to cereals or gluten, exposure to cow's milk during infancy and/or childhood, and short duration of breast- feeding;
- Lower intake of serum 25 hydroxyvitamin D in early infancy, vitamin E, anti-oxidants (e.g., carotenoids, ascorbic acid, selenium, or omega-3 fatty acids);
- Higher frequency of specific (e.g., enterovirus, rotavirus, or bacterial) infections, or non-specific childhood infections including those that exhibit molecular mimicry;
- Increased exposure to routine childhood immunizations and their timing;
- Environmental factors that may be contained in drinking water (e.g., low concentrations of zinc or high concentrations of nitrates, or lower pH levels);
- Exposure to household pets, and various allergies;
- Excessive weight gain;
- Increased psychological stress.
- The risk of persistent beta-cell autoimmunity is lower in children from the general population than in offspring or siblings of T1DM patients when stratifying for the HLA DR-DQ genotype and exposure to environmental triggers.
- The interaction of HLA DR-DQ genotype with exposure to dietary or infectious factors leads to increased incidence of beta-cell autoimmunity and T1DM.
- We expect that in some families study participation will be associated with affective (anxiety, depression) and behavioral responses (e.g. actions to prevent possible T1DM).
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Environment, Exposures, Diet, Toxins, Psychosocial, Infectious Agents, Bacterial, Viral, Immunizations, Autoantibody
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| General Population, First Degree Relative | Newborns with high risk HLA in the general population or having a first-degree relative affected with T1DM. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appearance of one or more islet cell autoantibodies: GADA, IAA, or IA-2A confirmed at two consecutive visits.
Measured: September 2025
Secondary outcomes (1)
Development of T1DM
Measured: September 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study start1 Sep 2004
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,667 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Environmental Health Sciences (NIEHS), Juvenile Diabetes Research Foundation, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Jeffrey P. Krischer, PhD, Principal investigator, University of South FloridaMarian J. Rewers, MD, PhD, Principal investigator, University of Colorado Health Science CenterWilliam A. Hagopian, MD, PhD, Principal investigator, Pacific Northwest Research InstituteAke Lernmark, MD, PhD, Principal investigator, Lund UniversityJorma Toppari, MD, PhD, Principal investigator, Wellbeing Services County of Southwest FinlandRichard McIndoe, PhD, Principal investigator, Augusta University Research Institute, Inc.Anette G. Ziegler, MD, Principal investigator, Diabetes Research InstituteBeena Akolkar, PhD, Study director, National Institutes of Diabetes and Digestive Kidney Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279318
- Sponsor's protocol ID
- DK095300; DK100238; DK106955
- Other IDs
- 1UC4DK095300-01, 1UC4DK100238-01, 1UC4DK106955-01, 1UC4DK112243-01, 1UC4DK117483-01, 1U01DK124166-01, 1U01DK128847-01
- Status last verified
- Aug 2025
- First submitted
- 17 Jan 2006
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available at the NIDDK Central Repository https://repository.niddk.nih.gov/studies/teddy/?query=teddy
Publications
Mattila M, Mramba LK, Niinisto S, Erlund I, Liu X, Uusitalo U, Andren Aronsson C, Hummel S, Frohnert BI, Parikh HM, Rich SS, Hagopian W, Toppari J, Lernmark A, Ziegler AG, Rewers M, Krischer JP, Hakola L, Norris JM, Virtanen SM; TEDDY Study Group. Dietary vitamin C intake and the risk of islet autoimmunity and type 1 diabetes: The Environmental Determinants of Diabetes in the Young (TEDDY) Study. Eur J Nutr. 2026 Sep 24;65(7):262. doi: 10.1007/s00394-026-04116-2.
PubMed 42782404Melin J, Tamura R, O'Donnell H, Johnson SB; TEDDY study group. Child and mother study satisfaction in a longitudinal study of children at-risk for type 1 diabetes. BMC Pediatr. 2026 Jul 2;26(1):622. doi: 10.1186/s12887-026-07251-1.
PubMed 42393557Kyronniemi 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.
PubMed 40303239Gesualdo 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.
PubMed 40027280Euren 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.
PubMed 39462122Gesualdo 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.
PubMed 38883796Melin 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.
PubMed 38102669Krischer 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.
PubMed 36150053Melin 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.
PubMed 35012530Krischer 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.
PubMed 34291312Johnson 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.
PubMed 33783586Frank 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.
PubMed 31533753Hippich 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.
PubMed 30655385Hagopian 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.
PubMed 21564455
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consortium for Identification of Environmental Triggers of Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00279318
- Acronym / sponsor ID
- DK095300; DK100238; DK106955
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Environment, Exposures, Diet, Toxins, Psychosocial, Infectious Agents, Bacterial, Viral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,667 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Environmental Health Sciences (NIEHS), Juvenile Diabetes Research Foundation, Centers for Disease Control and Prevention
- Study start
- 1 Sep 2004 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 19 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Epidemiologic patterns suggest that viruses, nutrition, toxic agents or socioeconomic psychosocial factors may contribute to the etiology alone or in combination. Elucidation is confounded by the long interval between exposure and onset of clinical disease, as well as the interaction of multiple genes and/or insults, which appear to interact in a complex manner. Numerous studies have investigated environmental influences but have yielded conflicting results. This may be in part due to the failure to account for genetic susceptibility, begin observation at early ages or in utero, and/or monitor subjects long term and frequently.
Hypotheses:
- Initiation of persistent beta-cell autoimmunity and progression from beta-cell autoimmunity to diabetes is increased with:
- Exposure to a trigger factor during pregnancy, such as infections, preeclampsia, blood incompatibility, or birth weight.
- Differences in the timing of the introduction and/or the type of dietary constituents that include exposure to cereals or gluten, exposure to cow's milk during infancy and/or childhood, and short duration of breast- feeding;
- Lower intake of serum 25 hydroxyvitamin D in early infancy, vitamin E, anti-oxidants (e.g., carotenoids, ascorbic acid, selenium, or omega-3 fatty acids);
- Higher frequency of specific (e.g., enterovirus, rotavirus, or bacterial) infections, or non-specific childhood infections including those that exhibit molecular mimicry;
- Increased exposure to routine childhood immunizations and their timing;
- Environmental factors that may be contained in drinking water (e.g., low concentrations of zinc or high concentrations of nitrates, or lower pH levels);
- Exposure to household pets, and various allergies;
- Excessive weight gain;
- Increased psychological stress.
- The risk of persistent beta-cell autoimmunity is lower in children from the general population than in offspring or siblings of T1DM patients when stratifying for the HLA DR-DQ genotype and exposure to environmental triggers.
- The interaction of HLA DR-DQ genotype with exposure to dietary or infectious factors leads to increased incidence of beta-cell autoimmunity and T1DM.
- We expect that in some families study participation will be associated with affective (anxiety, depression) and behavioral responses (e.g. actions to prevent possible T1DM).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General Population, First Degree Relative | – | –Newborns with high risk HLA in the general population or having a first-degree relative affected with T1DM. |
Who may qualify
- Ages
- 0 to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Childen up to 4 months of age with specified HLA are enrolled and followed longitudnally until 15 years of age
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Appearance of one or more islet cell autoantibodies: GADA, IAA, or IA-2A confirmed at two consecutive visits.
Time frame: September 2025
1 secondary outcome
Development of T1DM
Time frame: September 2025
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Derived from this study: PubMed 42782404Mattila M, Mramba LK, Niinisto S, Erlund I, Liu X, Uusitalo U, Andren Aronsson C, Hummel S, Frohnert BI, Parikh HM, Rich SS, Hagopian W, Toppari J, Lernmark A, Ziegler AG, Rewers M, Krischer JP, Hakola L, Norris JM, Virtanen SM; TEDDY Study Group. Dietary vitamin C intake and the risk of islet autoimmunity and type 1 diabetes: The Environmental Determinants of Diabetes in the Young (TEDDY) Study. Eur J Nutr. 2026 Sep 24;65(7):262. doi: 10.1007/s00394-026-04116-2.
- Derived from this study: PubMed 42393557Melin J, Tamura R, O'Donnell H, Johnson SB; TEDDY study group. Child and mother study satisfaction in a longitudinal study of children at-risk for type 1 diabetes. BMC Pediatr. 2026 Jul 2;26(1):622. doi: 10.1186/s12887-026-07251-1.
- Derived from this study: PubMed 40303239Kyronniemi 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.
- Derived from this study: PubMed 40027280Gesualdo 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.
- Derived from this study: PubMed 39462122Euren 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.
- Derived from this study: PubMed 38883796Gesualdo 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.
- Derived from this study: PubMed 38102669Melin 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.
- Derived from this study: PubMed 36150053Krischer 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.
- Derived from this study: PubMed 35012530Melin 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.
- Derived from this study: PubMed 34291312Krischer 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.
- Derived from this study: PubMed 33783586Johnson 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.
- Derived from this study: PubMed 31533753Frank 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.
- TEDDY Study Public siteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data are available at the NIDDK Central Repository https://repository.niddk.nih.gov/studies/teddy/?query=teddy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey P. Krischer, PhD principal investigator
University of South Florida
Marian J. Rewers, MD, PhD principal investigator
University of Colorado Health Science Center
William A. Hagopian, MD, PhD principal investigator
Pacific Northwest Research Institute
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Finland, Germany, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appearance of one or more islet cell autoantibodies: GADA, IAA, or IA-2A confirmed at two consecutive visits. (time frame: September 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00279318, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.