Diabetes Autoimmunity Study in the Young

Type 1 Diabetes Mellitus Clinical Trial

— DAISY  

Official title:

Natural History of Pre-Diabetic Autoimmunity

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03205865
• Other study ID #: 92-080
• Status: Enrolling by invitation
• Start date: December 6, 1993
• Est. completion date: April 30, 2025

Study information

• Verified date: March 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The study will evaluate environmental risk factors for development of islet autoimmunity and progression to T1D.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2700
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 30 Years

Eligibility

Inclusion Criteria:

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 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

Exclusion Criteria:

• 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:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Detection of Transglutaminase Antibodies	At annual clinic visits, using a validated assay, detection of a Celiac Disease related antibody, transglutaminase indicates seroconversion and isolates a period of time in which a change in the immune response, targeting the small intestine.	From date of birth until the date of first documentation of Transglutaminase auto-antibodies up to 18 years of age.
Primary	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.	From date of birth until the date of first documentation of type 1 diabetes up to 30 years of age.
Secondary	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.	From date of birth until the date of first documentation of Islet auto-antibodies up to 20years of age.