Clinical trial NCT03205865: Diabetes Autoimmunity Study in the Young
Official title: Natural History of Pre-Diabetic Autoimmunity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 2700
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnosis of Type 1 Diabetes
timeFrame: From date of birth until the date of first documentation of type 1 diabetes up to 30 years of age.
Secondary outcomes:
measure: Detection of Islet Autoantibodies
timeFrame: From date of birth until the date of first documentation of Islet auto-antibodies up to 20years of age.
Other outcomes:
measure: Detection of Transglutaminase Antibodies
timeFrame: From date of birth until the date of first documentation of Transglutaminase auto-antibodies up to 18 years of age.
Locations:
Study officials:
affiliation: Executive Director-Barbara Davis Center for Diabetes, Professor
name: Marian J Rewers, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: