Type1diabetesNCT03648918
Genetics Of Autoimmunity In Type I Diabetes
An observational study of Type1diabetes and Diabetes Mellitus, Type 1, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The purpose of this study is to gain more information about the step-by-step process that causes someone to develop type 1 diabetes. Scientists think that a person's own immune system, directed by genetic and environmental factors play a major role in its development. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type1diabetes, Diabetes Mellitus, Type 1, Type1 Diabetes Mellitus
- What is being tested?
- Blood Collection
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Jan 2050
- How long will I take part?
- 10 Years
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with T1D seen at clinics at the Children's Wisconsin (n~1500) and Froedtert Hospital (n~800) will be targeted. In families with a child proband, siblings will be asked to join the study. If the diabetic child has an aunt, uncle, or cousin with T1D, then siblings in that nuclear family will also be recruited. Adult proband families will include the adult affected by T1D and their children. Adult proband families must include children <17 years of age. If the adult proband has a sibling, niece, or nephew with T1D, siblings in that nuclear family will be recruited as well. The age-of-diagnosis criterion for the proband will be less than 39 years and insulin therapy started within 5 years of diagnosis.
Who may be able to join
- Families where at least one first-degree family member has type 1 diabetes
- The diabetic proband in the family was diagnosed before the age of 39
- Family members must be at least 2 years old to participate
- No family history of type 1 diabetes or other autoimmune conditions
- Age 2 or older
Who cannot join
- Families with no history of type 1 diabetes
- Families with a history of diabetes that is not type 1 (LADA, MODY, type 2 etc.)
- Personal or family history of autoimmune disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Martin Hessner, PhD, 414-955-4903, t1dinfo@mcw.edu
About this study
The purpose of this study is to gain more information about the step-by-step process that causes someone to develop type 1 diabetes. Scientists think that a person's own immune system, directed by genetic and environmental factors play a major role in its development. Participation involves a blood draw, a brief medical history questionnaire and measurements of height and weight. Some participants will be asked to return for annual follow-up visits for 10 years.
Read the detailed description
The goal of this project is to gain knowledge about the development of Type 1 diabetes (T1D), as T1D is one of the most common chronic diseases in children. There has been a rise in the number of cases diagnosed as well as a decrease in the age of diagnosis. This project aims to understand the disease progression as seen in the immune system and to define the genetic and environmental factors that affect inflammation and regulation, which could determine disease progression or nonprogression. Families that include a family member with T1D will be recruited, as well as unrelated, healthy controls as a comparison group.
Participants will have height and weight measured, complete a social \& medical history questionnaire, and have blood drawn for analysis for HLA haplotype (a genetic sequence related to type 1 diabetes susceptibility)diabetes, blood glucose, immune system response, complete blood count, and autoantibody measurements. Some family members may return for follow-up visits for up to 10 years.
- Being tested
- Blood Collection
- Keywords
- Family, Healthy Controls, Siblings
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood CollectionOther
Blood will be collected via venipuncture and analyzed. Blood samples will be analyzed for HLA haplotype (a genetic sequence related to type 1 diabetes susceptibility), plasma-induced signature, diabetes autoantibodies, complete blood count with differential, and serum and plasma for storage. For family members with diabetes, blood will also be tested for A1c.
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of Type 1 diabetes
The primary outcome is the development of diabetes as defined by the American Diabetes Association (ADA) based on the presence of symptoms and unequivocal hyperglycemia.
Measured: Up to 10 years
Autoantibody Measurement
Presence or absence of the autoantibodies related to type 1 diabetes: IA-2 (islet antigen), GAD65 (pancreatic islet cell autoantibody), IAA (insulin autoantibody), ZnT8 (zinc transporter 8)
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study startAug 2001
- Primary completionJan 2050 (estimated)
- Study completionJan 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Benaroya Research Institute, Indiana University
- Responsible party
- Principal investigator, Martin Hessner, Medical College of Wisconsin
- Investigators
- Martin Hessner, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648918
- Sponsor's protocol ID
- 142618
- Other IDs
- McGee Sibling Study
- Status last verified
- Mar 2026
- First submitted
- 16 Apr 2018
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Unidentified samples and data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics Of Autoimmunity In Type I Diabetes
- ClinicalTrials.gov ID
- NCT03648918
- Acronym / sponsor ID
- 142618
- Keywords
- Family, Healthy Controls, Siblings
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Benaroya Research Institute, Indiana University
- Study start
- Aug 2001 (actual)
- Primary completion
- Jan 2050 (estimated)
- Study completion
- Jan 2050 (estimated)
- First posted
- 28 Aug 2018 (actual)
- 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 purpose of this study is to gain more information about the step-by-step process that causes someone to develop type 1 diabetes. Scientists think that a person's own immune system, directed by genetic and environmental factors play a major role in its development. Participation involves a blood draw, a brief medical history questionnaire and measurements of height and weight. Some participants will be asked to return for annual follow-up visits for 10 years.
Detailed description
The goal of this project is to gain knowledge about the development of Type 1 diabetes (T1D), as T1D is one of the most common chronic diseases in children. There has been a rise in the number of cases diagnosed as well as a decrease in the age of diagnosis. This project aims to understand the disease progression as seen in the immune system and to define the genetic and environmental factors that affect inflammation and regulation, which could determine disease progression or nonprogression. Families that include a family member with T1D will be recruited, as well as unrelated, healthy controls as a comparison group.
Participants will have height and weight measured, complete a social \& medical history questionnaire, and have blood drawn for analysis for HLA haplotype (a genetic sequence related to type 1 diabetes susceptibility)diabetes, blood glucose, immune system response, complete blood count, and autoantibody measurements. Some family members may return for follow-up visits for up to 10 years.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with T1D seen at clinics at the Children's Wisconsin (n~1500) and Froedtert Hospital (n~800) will be targeted. In families with a child proband, siblings will be asked to join the study. If the diabetic child has an aunt, uncle, or cousin with T1D, then siblings in that nuclear family will also be recruited. Adult proband families will include the adult affected by T1D and their children. Adult proband families must include children <17 years of age. If the adult proband has a sibling, niece, or nephew with T1D, siblings in that nuclear family will be recruited as well. The age-of-diagnosis criterion for the proband will be less than 39 years and insulin therapy started within 5 years of diagnosis.
Key inclusion criteria (5 listed)
- Families where at least one first-degree family member has type 1 diabetes
- The diabetic proband in the family was diagnosed before the age of 39
- Family members must be at least 2 years old to participate
- No family history of type 1 diabetes or other autoimmune conditions
- Age 2 or older
Key exclusion criteria (3 listed)
- Families with no history of type 1 diabetes
- Families with a history of diabetes that is not type 1 (LADA, MODY, type 2 etc.)
- Personal or family history of autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood CollectionBlood will be collected via venipuncture and analyzed. Blood samples will be analyzed for HLA haplotype (a genetic sequence related to type 1 diabetes susceptibility), plasma-induced signature, diabetes autoantibodies, complete blood count with differential, and serum and plasma for storage. For family members with diabetes, blood will also be tested for A1c. | Other | – |
Primary outcome
Onset of Type 1 diabetes
Time frame: Up to 10 years
The primary outcome is the development of diabetes as defined by the American Diabetes Association (ADA) based on the presence of symptoms and unequivocal hyperglycemia.
Autoantibody Measurement
Time frame: Up to 10 years
Presence or absence of the autoantibodies related to type 1 diabetes: IA-2 (islet antigen), GAD65 (pancreatic islet cell autoantibody), IAA (insulin autoantibody), ZnT8 (zinc transporter 8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Undecided. Unidentified samples and data will be shared with other researchers.
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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.
Martin Hessner, PhD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type1diabetes and Diabetes Mellitus, Type 1, run by Medical College of Wisconsin at 1 site in United States.
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 5 inclusion and 3 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 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 Martin Hessner, PhD (414-955-4903, t1dinfo@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset of Type 1 diabetes (time frame: Up to 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2026.