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Diabetes Mellitus, Type 1NCT00097292

TrialNet Pathway to Prevention of T1D

An observational study of Diabetes Mellitus, Type 1, run by University of South Florida at 22 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Rationale: The accrual of data from the laboratory and from epidemiologic and prevention trials has improved the understanding of the etiology and pathogenesis of type 1 diabetes mellitus (T1DM). Read more about this study

Who is it for?
Ages 2 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 1
How many people
75,000 participants
Where
22 sitesin 6 countries
Study dates
1 Feb 2004to 31 Jul 2030
Phase
Observational
Are there results?
Not yet: the study is under way

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 2 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: First and second/third degree relatives of individuals with type 1 diabetes.

Who may be able to join

  • Individuals 2 to 45 years old who have an immediate family member with type 1 diabetes (such as a child, parent, or sibling)
  • Individuals 2-20 years old who have an extended family member with type 1 diabetes (such as a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)
  • Those aged 2 years to 45 years who are not family members and are known to have 1 or more islet antibodies

Who cannot join

  • To be eligible a person must not:
  • Have diabetes already
  • Have previous or current use of medications for the control of hyperglycemia/diabetes.
  • Currently be using immunosuppressive or immunomodulatory agents (topical and inhaled agents are acceptable)
  • Have known severe active diseases, and/or diseases which are likely to limit life expectancy or lead to the use of chronic immunosuppressive or immunomodulatory therapies during the course of the study

Trial locations and contacts

22 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

TrialNet Central Information Center general info contact

1-800-425-8361

22 sites in 6 countries

United States17 sites, 17 recruiting

  • Emory Children's Center

    Atlanta, Georgia, 30322

    Xiaomiao Lan-Pidhainy, RN, 404-712-0051, xlanpid@emory.edu

    Andrew Muir, MD

    Recruiting

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

    Nora Bryant, 617-309-4141, nora.bryant@joslin.harvard.edu

    Jason Gaglia, MD

    Recruiting

  • University of Texas Medical Center at Dallas

    Dallas, Texas, 75390-8858

    Lindsay Harter, 214-648-4725, Lindsay.Harter@UTSouthwestern.edu

    Perrin White, MD

    Recruiting

  • Barbara Davis Center for Childhood Diabetes

    Denver, Colorado, 80262

    Brenda Bradfield, 303-724-8595, brenda.bradfield@CUANSCHUTZ.EDU

    Andrea Steck, MD

    Recruiting

  • University of Florida

    Gainesville, Florida, 32601-0296

    Jennifer Hosford, 352-294-5759, jennifer.hosford@peds.ufl.edu

    Michael Haller, MD

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Sandra Pena, 832-822-3380, sypena@texaschildrens.org

    Maria Redondo, MD

    Recruiting

  • Riley Hospital for Children, Indiana University

    Indianapolis, Indiana, 46202

    Maria Spall, 866-230-8486, malnicho@iu.edu

    Linda DeMeglio, MD

    Recruiting

  • The Children's Mercy Hospital

    Kansas City, Missouri, 64111

    Cassandra McClain, 816-960-8877, clmcclain@cmh.edu

    Wayne Moore, Md, PhD

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 58944

    Beth Pappenfus, 612-624-2922, papp0086@umn.edu

    Antoinette Moran, MD

    Recruiting

  • Vanderbilt University

    Nashville, Tennessee, 37232

    Faith Brendle, RN, 615-936-8638, faith.brendle@vanderbilt.edu

    William Russell, MD

    Recruiting

  • Yale University School of Medicine

    New Haven, Connecticut, 06519

    Lori Carria, 203-737-3595, lori.carria@yale.edu

    Jennifer Sherr, MD

    Recruiting

  • Columbia University

    New York, New York, 10032

    Jamie R Hyatt, 212-851-5425, jh4470@cumc.columbia.edu

    Robin S Goland, MD

    Recruiting

  • Childrens Hospital of Orange County

    Orange, California, 92868

    Marissa Erickson, 714-509-8613, merickson@choc.org

    Mark Daniels, MD

    Recruiting

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15213

    Kelli DeLallo, RN, 412-692-5210, kelli.delallo@chp.edu

    Dorothy Becker, MD

    Recruiting

  • University of California San Francisco

    San Francisco, California, 94143-0434

    Karen Ko, 844-813-8273, clinicalresearch@diabetes.ucsf.edu

    Stephen Gitelman, MD

    Recruiting

  • Benaroya Research Institute

    Seattle, Washington, 98101-2795

    Katie Bennett, 206-341-8945, diabetes@benaroyaresearch.org

    Carla Greenbaum, MD

    Recruiting

  • Stanford University Medical Center

    Stanford, California, 94305-5208

    Trudy Esrey, RD, 650-498-4450, tesrey@stanford.edu

    Darrell Wilson, MD

    Recruiting

Other trials in United States

Australia1 site, 1 recruiting

  • Walter and Eliza Hall Institute

    Parkville, Victoria, 3050

    Felicity Healy, 61-3-9342 7063, felicity.healy@mh.org.au

    Peter C Colman, MD

    Recruiting

Other trials in Australia

Canada1 site, 1 recruiting

  • The Hospital for Sick Children

    Toronto, Ontario, M5G-1x8

    Rebecca Stochinsky, (416) 813-7654 ext. 202634, rebecca.stochinsky@sickkids.ca

    Diane Wherrett, MD

    Recruiting

Other trials in Canada

Finland1 site

  • University of Turku

    Turku, FIN-20520

    Suspended

Other trials in Finland

Italy1 site

  • Vita-Salute San Raffaele University

    Milan, +39-02-2643 2818

    Suspended

Other trials in Italy

United Kingdom1 site

  • University of Bristol

    Bristol, BS10 5NB UK

    Suspended

Other trials in United Kingdom

About this study

Rationale:

The accrual of data from the laboratory and from epidemiologic and prevention trials has improved the understanding of the etiology and pathogenesis of type 1 diabetes mellitus (T1DM). Genetic and immunologic factors play a key role in the development of T1DM, and characterization of the early metabolic abnormalities in T1DM is steadily increasing. However, information regarding the natural history of T1DM remains incomplete. The TrialNet Natural History Study of the Development of T1DM (Pathway to Prevention Study) has been designed to clarify this picture, and in so doing, will contribute to the development and implementation of studies aimed at prevention of and early treatment in T1DM.

Read more

Purpose:

TrialNet is an international network dedicated to the study, prevention, and early treatment of type 1 diabetes. TrialNet sites are located throughout the United States, Canada, Finland, United Kingdom, Italy, Germany, Sweden, Australia, and New Zealand. TrialNet is dedicated to testing new approaches to the prevention of and early intervention for type 1 diabetes.

The goal of the TrialNet Natural History Study of the Development of Type 1 Diabetes is to enhance our understanding of the demographic, immunologic, and metabolic characteristics of individuals at risk for developing type 1 diabetes.

The Natural History Study will screen relatives of people with type 1 diabetes to identify those at risk for developing the disease. Relatives of people with type 1 diabetes have about a 5% percent chance of being positive for the antibodies associated with diabetes. TrialNet will identify adults and children at risk for developing diabetes by testing for the presence of these antibodies in the blood. A positive antibody test is an early indication that damage to insulin-secreting cells may have begun. If this test is positive, additional testing will be offered to determine the likelihood that a person may develop diabetes. Individuals with antibodies will be offered the opportunity for further testing to determine their risk of developing diabetes over the next 5 years and to receive close monitoring for the development of diabetes.

Read the detailed description

Detailed Description:

The Pathway to Prevention Study is conducted in two parts:

  • Screening
  • Monitoring (annual and semi-annual depending on risk)

In Screening , a simple blood test is done to screen for the presence of diabetes-related biochemical autoantibodies (GAD and mIAA). Additional autoantibodies ICA, IA-2A, and ZnT8A will also measured in individuals positive for mIAA. ICA, IA-2A, and ZnT8A will be measured in individuals positive for GAD. Participants can go to a TrialNet Clinical Center, Affiliate, or request a screening kit to have their blood drawn by a local physician or laboratory. Participants will be provided with their screening results within 4-6 weeks.

If autoantibodies are present, participants will be invited to have additional testing to determine their average risk of developing diabetes over the next 5 years. Participants that are single autoantibody positive will be re-tested annually for the development of multiple autoantibodies. Multiple autoantibody positive participants will undergo an eligibility visit which will include an Oral Glucose Tolerance Test (OGTT), re-testing for biochemical and islet cell autoantibodies if needed, and measurement of HbA1c.

Multiple autoantibody positive individuals with a normal glucose tolerance and an HbA1c < 6.0% will be asked to come for follow-up on annual basis; multiple autoantibody positive individuals with an abnormal glucose tolerance or an HbA1c ≥ 6.0%will be asked to come for follow-up visits on semi-annual basis.

Participants will be monitored for possible progression towards type 1 diabetes and may be offered the opportunity to enter into a prevention study such (e.g., Oral Insulin prevention study) or an early treatment study if they are diagnosed with type 1 diabetes while participating in the Natural History Study.

Keywords
"at risk" for developing type 1 diabetes, T1DM, T1D, juvenile diabetes, Type 1 Diabetes TrialNet, TrialNet
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 groups in NCT00097292
Study groupRoleWhat they receive
Annual Re-Testing/Annual Metabolic MonitoringParticipants will be monitored annually for risk of type 1 diabetes.
Semi-Annual Metabolic MonitoringParticipants will be monitored every six months for risk of type 1 diabetes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Development of type 1 diabetes

    The primary outcome is the development of diabetes as defined by the American Diabetes Association (ADA) based on glucose testing, or the presence of symptoms and unequivocal hyperglycemia.

    Measured: Monitoring is provided once or twice annually depending on risk level

Secondary outcomes (1)

  1. Metabolic and Autoantibody Assessments

    Oral Glucose Tolerance Test (OGTT) HbA1c Autoantibodies: ICA, IA-2A, GAD65A, mIAA, ZnT8A

    Measured: Metabolic and Autoantibody assessments are provided once or twice annually depending on risk level

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2004 (estimated)
  2. Study start1 Feb 2004
  3. Primary completion31 Jul 2030 (estimated)
  4. Study completion31 Jul 2030 (estimated)

Resources

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
75,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00097292
Sponsor's protocol ID
NHStudy (IND)
Other IDs
UC4DK117009, UC4DK106993
Status last verified
Jun 2025
First submitted
19 Nov 2004
Last updated
1 Jul 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Diabetes Prevention Trial--Type 1 Diabetes Study Group. Effects of insulin in relatives of patients with type 1 diabetes mellitus. N Engl J Med. 2002 May 30;346(22):1685-91. doi: 10.1056/NEJMoa012350.

    PubMed 12037147

  • Gale EA, Bingley PJ, Emmett CL, Collier T; European Nicotinamide Diabetes Intervention Trial (ENDIT) Group. European Nicotinamide Diabetes Intervention Trial (ENDIT): a randomised controlled trial of intervention before the onset of type 1 diabetes. Lancet. 2004 Mar 20;363(9413):925-31. doi: 10.1016/S0140-6736(04)15786-3.

    PubMed 15043959

  • Atkinson MA, Eisenbarth GS. Type 1 diabetes: new perspectives on disease pathogenesis and treatment. Lancet. 2001 Jul 21;358(9277):221-9. doi: 10.1016/S0140-6736(01)05415-0.

    PubMed 11476858

  • Verge CF, Gianani R, Kawasaki E, Yu L, Pietropaolo M, Jackson RA, Chase HP, Eisenbarth GS. Prediction of type I diabetes in first-degree relatives using a combination of insulin, GAD, and ICA512bdc/IA-2 autoantibodies. Diabetes. 1996 Jul;45(7):926-33. doi: 10.2337/diab.45.7.926.

    PubMed 8666144

  • Bingley PJ, Christie MR, Bonifacio E, Bonfanti R, Shattock M, Fonte MT, Bottazzo GF, Gale EA. Combined analysis of autoantibodies improves prediction of IDDM in islet cell antibody-positive relatives. Diabetes. 1994 Nov;43(11):1304-10. doi: 10.2337/diab.43.11.1304.

    PubMed 7926304

  • Martinenghi S, Merolla A, Grogan P, Bianconi E, Senni E, Goncharova A, Massara F, Ragogna F, Bazzigaluppi E, Pastore MR, Bonfanti R, Bosi E. Prevention of diabetic ketoacidosis in relatives screened for islet autoantibodies and followed up in the TrialNet Pathway to Prevention study at a single institution in Italy. Diabetologia. 2025 Sep;68(9):1889-1898. doi: 10.1007/s00125-025-06461-z. Epub 2025 May 29.

    PubMed 40439773

  • Triolo TM, Pyle L, Broncucia H, Armstrong T, Yu L, Gottlieb PA, Steck AK. Association of High-Affinity Autoantibodies With Type 1 Diabetes High-Risk HLA Haplotypes. J Clin Endocrinol Metab. 2022 Mar 24;107(4):e1510-e1517. doi: 10.1210/clinem/dgab853.

    PubMed 34850014

  • Evans-Molina C, Sims EK, DiMeglio LA, Ismail HM, Steck AK, Palmer JP, Krischer JP, Geyer S, Xu P, Sosenko JM; Type 1 Diabetes TrialNet Study Group. beta Cell dysfunction exists more than 5 years before type 1 diabetes diagnosis. JCI Insight. 2018 Aug 9;3(15):e120877. doi: 10.1172/jci.insight.120877. eCollection 2018 Aug 9.

    PubMed 30089716

  • Ferrara CT, Geyer SM, Evans-Molina C, Libman IM, Becker DJ, Wentworth JM, Moran A, Gitelman SE, Redondo MJ; Type 1 Diabetes TrialNet Study Group. The Role of Age and Excess Body Mass Index in Progression to Type 1 Diabetes in At-Risk Adults. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4596-4603. doi: 10.1210/jc.2017-01490.

    PubMed 29092051

  • Bosi E, Boulware DC, Becker DJ, Buckner JH, Geyer S, Gottlieb PA, Henderson C, Kinderman A, Sosenko JM, Steck AK, Bingley PJ; Type 1 Diabetes TrialNet Study Group. Impact of Age and Antibody Type on Progression From Single to Multiple Autoantibodies in Type 1 Diabetes Relatives. J Clin Endocrinol Metab. 2017 Aug 1;102(8):2881-2886. doi: 10.1210/jc.2017-00569.

    PubMed 28531305

  • Herold KC, Usmani-Brown S, Ghazi T, Lebastchi J, Beam CA, Bellin MD, Ledizet M, Sosenko JM, Krischer JP, Palmer JP; Type 1 Diabetes TrialNet Study Group. beta cell death and dysfunction during type 1 diabetes development in at-risk individuals. J Clin Invest. 2015 Mar 2;125(3):1163-73. doi: 10.1172/JCI78142. Epub 2015 Feb 2.

    PubMed 25642774

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 1, run by University of South Florida at 22 sites in 6 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, Australia, Canada, Finland, Italy and 1 more country. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact TrialNet Central Information Center general info (1-800-425-8361), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Development of type 1 diabetes (time frame: Monitoring is provided once or twice annually depending on risk level). 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 NCT00097292, which also lists 11 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 1 Jul 2025.

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