Type 1 Diabetes MellitusDAISYNCT03205865
Diabetes Autoimmunity Study in the Young
An observational study of Type 1 Diabetes Mellitus, run by University of Colorado, Denver.
Trial summary
Type 1 diabetes (T1D) affects 1.4 million people in the U.S. and its incidence has doubled over the past 20 years. The Diabetes Autoimmunity in the Young Study (DAISY) will estimate overall burden of T1D and other autoimmune diseases in the general population by age 30. Read more about this study
- Who is it for?
- Ages 1 month to 30 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 2,700 participants
- Where
- No sites listed yet
- Study dates
- 6 Dec 1993to 30 Apr 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 1 month to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population was selected from among the eligible population in the Denver Metropolitan are as described in the section above. Approximately 50% of the participants are female. The ethnic distribution in the general population newborn cohort is representative of the general Denver Metro area population: 7% African American, 30% Hispanic, 56% non-Hispanic white, and the remaining of biracial or other ethnicity. The ethnic distribution of the sibling/offspring cohort is representative of T1D in the general U.S. population: 5% African American, 10% Hispanic and 85% non-Hispanic white.
Who may be able to join
- General Population Genetic Screening to determine Enrollment Eligibility for the Follow-Up Study Criteria
- Child born at St. Joseph Hospital between 1/1/1993 and 6/30/2006
- Informed consent for genetic screening obtained
- Cord blood sample available
- No other severe co-existent condition
- At least one parent/guardian speaks English
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- General Population Follow Up Study Criteria
- Informed consent for Follow Up obtained
- Initial telephone interview at 3 months of age, initial blood draw at 9 months of age
- High or moderate risk of T1D, as determined from genetic screening (300 low risk children also enrolled as a control group)
- Sibling/offspring Follow Up Criteria
- Informed consent for follow up obtained
- Age < 4 yrs (< 7 yrs prior to 1997)
- No other severe co-existent condition
- At least one parent/guardian speaks English
- Family Members Follow Up Criteria
- Informed consent obtained
- First degree relative of either a sibling/offspring participant or general population newborn participant
- No other severe co-existent condition
- Ages 12 months to 65 years
- One clinic visit to obtain blood for genetic marker determination and islet autoantibody screening
- TEDDY Grad participants
- Completed the TEDDY protocol
- TEDDY home center is Colorado, Washington, Georgia
- Upon completion of the TEDDY protocol, persistently positive for islet autoantibodies at 13.5 yrs of age or older
- Not diagnosed with T1D
- Informed Consent obtained
Who cannot join
- Cord blood was not available for genetic screening,
- Other severe co-morbidities were indicated,
- Parents refused consent to screening or follow-up,
- At least one parent or legal guardian did not speak English, or
- If T1D had been diagnosed.
- Individuals were not eligible to be enrolled into the DAISY study under the Sibling/offspring criteria if:
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- They did not have a first degree relative with T1D,
- Other severe co-morbidities were indicated,
- They were older than 4 years of age (older than 7 years of age, before 1997),
- Parents refused consent to follow-up,
- At least one parent or legal guardian did not speak English, or
- T1D had been diagnosed.
- Individuals do not agree to the long-term storage of data and specimen samples.
About this study
Official title: Natural History of Pre-Diabetic Autoimmunity
Type 1 diabetes (T1D) affects 1.4 million people in the U.S. and its incidence has doubled over the past 20 years. The Diabetes Autoimmunity in the Young Study (DAISY) will estimate overall burden of T1D and other autoimmune diseases in the general population by age 30. The study will evaluate environmental risk factors for development of islet autoimmunity and progression to T1D.
Read the detailed description
Children determined to be at an increased risk for development of type 1 diabetes, either due to known genetic markers or due to family history of T1D, are followed from birth and monitored for development of T1D-related autoimmunity, on an annual basis. At annual clinic visits, participants are tested for development of these autoantibodies and data is collected related to environmental exposures. In addition to blood collection for determination of autoantibodies, serum and plasma are frozen, and stored for future analyses. Other biological samples collected for further future analysis include: throat swabs, rectal swabs, saliva, and urine. If T1D-related autoantibodies are detected, the participant is asked to increase the frequency of clinic visits to 2-4 visits per year in order to more closely monitor for onset of disease. The endpoint of the study is diagnosis of T1D per the American Diabetes Association (ADA) criteria.
- Conditions
- Type 1 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of Type 1 Diabetes
Children determined to be at an increased risk for development of type 1 diabetes (T1D), either due to known genetic markers or due to family history of T1D, are followed from birth and monitored for development of T1D-related autoimmunity, on an annual basis. The endpoint of the study is diagnosis of T1D per the American Diabetes Association (ADA) criteria.
Measured: From date of birth until the date of first documentation of type 1 diabetes up to 30 years of age.
Secondary outcomes (1)
Detection of Islet Autoantibodies
At annual clinic visits, participants are tested for development of these auto-antibodies and data is collected related to environmental exposures. In addition to blood collection for determination of auto-antibodies, serum and plasma are frozen, and stored for future analyses.
Measured: From date of birth until the date of first documentation of Islet auto-antibodies up to 20years of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start6 Dec 1993
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- 2,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marian J Rewers, MD, PhD, MPH, Principal investigator, Executive Director-Barbara Davis Center for Diabetes, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205865
- Sponsor's protocol ID
- 92-080
- Acronym
- DAISY
- Status last verified
- Mar 2023
- First submitted
- 8 Jun 2017
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available through the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) repository following manuscript publication which includes such data in the analysis.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Pre-Diabetic Autoimmunity
- ClinicalTrials.gov ID
- NCT03205865
- Acronym / sponsor ID
- DAISY / 92-080
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,700 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 6 Dec 1993 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 2 Jul 2017 (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.
Type 1 diabetes (T1D) affects 1.4 million people in the U.S. and its incidence has doubled over the past 20 years. The Diabetes Autoimmunity in the Young Study (DAISY) will estimate overall burden of T1D and other autoimmune diseases in the general population by age 30. The study will evaluate environmental risk factors for development of islet autoimmunity and progression to T1D.
Detailed description
Children determined to be at an increased risk for development of type 1 diabetes, either due to known genetic markers or due to family history of T1D, are followed from birth and monitored for development of T1D-related autoimmunity, on an annual basis. At annual clinic visits, participants are tested for development of these autoantibodies and data is collected related to environmental exposures. In addition to blood collection for determination of autoantibodies, serum and plasma are frozen, and stored for future analyses. Other biological samples collected for further future analysis include: throat swabs, rectal swabs, saliva, and urine. If T1D-related autoantibodies are detected, the participant is asked to increase the frequency of clinic visits to 2-4 visits per year in order to more closely monitor for onset of disease. The endpoint of the study is diagnosis of T1D per the American Diabetes Association (ADA) criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population was selected from among the eligible population in the Denver Metropolitan are as described in the section above. Approximately 50% of the participants are female. The ethnic distribution in the general population newborn cohort is representative of the general Denver Metro area population: 7% African American, 30% Hispanic, 56% non-Hispanic white, and the remaining of biracial or other ethnicity. The ethnic distribution of the sibling/offspring cohort is representative of T1D in the general U.S. population: 5% African American, 10% Hispanic and 85% non-Hispanic white.
Key inclusion criteria (27 listed)
- General Population Genetic Screening to determine Enrollment Eligibility for the Follow-Up Study Criteria
- Child born at St. Joseph Hospital between 1/1/1993 and 6/30/2006
- Informed consent for genetic screening obtained
- Cord blood sample available
- No other severe co-existent condition
Key exclusion criteria (13 listed)
- Cord blood was not available for genetic screening,
- Other severe co-morbidities were indicated,
- Parents refused consent to screening or follow-up,
- At least one parent or legal guardian did not speak English, or
- If T1D had been diagnosed.
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
Diagnosis of Type 1 Diabetes
Time frame: From date of birth until the date of first documentation of type 1 diabetes up to 30 years of age.
Children determined to be at an increased risk for development of type 1 diabetes (T1D), either due to known genetic markers or due to family history of T1D, are followed from birth and monitored for development of T1D-related autoimmunity, on an annual basis. The endpoint of the study is diagnosis of T1D per the American Diabetes Association (ADA) criteria.
1 secondary outcome
Detection of Islet Autoantibodies
Time frame: From date of birth until the date of first documentation of Islet auto-antibodies up to 20years of age.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: Yes. Data will be made available through the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) repository following manuscript publication which includes such data in the analysis.
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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.
Marian J Rewers, MD, PhD, MPH principal investigator
Executive Director-Barbara Davis Center for Diabetes, Professor
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by University of Colorado, Denver.
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 27 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Diagnosis of Type 1 Diabetes (time frame: From date of birth until the date of first documentation of type 1 diabetes up to 30 years of age.). 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 14 Mar 2023.