Diabetes Autoimmunity Study in the Young (DAISY)

General Description

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 on an annual basis for development of T1D-related autoimmunity. At annual clinic visits, participants are tested for development of these autoantibodies and data are collected related to environmental exposures. In addition to blood collection for determination of autoantibodies, serum and plasma are frozen and stored for future analyses, along with other biological samples such as 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 monitor for the onset of disease more closely. The endpoint of the study is diagnosis of T1D per the American Diabetes Association (ADA) criteria.

Objectives

The primary objective of the study is to estimate the overall burden of T1D and other autoimmune diseases in the general population by age 30.

Outcome Measure

The primary outcome measure is the diagnosis of T1D through participant assessments from birth until the date of first documentation of T1D or up to 30 years of age. Other outcome measures include the detection of islet autoantibodies and transglutaminase antibodies.

Criteria

Inclusion criteria:

• General population genetic screening and follow-up
• Child born at St. Joseph Hospital between 1/1/1993 and 6/30/2006
• Informed consent obtained
• Cord blood sample available
• No other severe co-existent condition
• At least one parent/guardian speaks English
• 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)
• Family members
• Informed consent obtained
• Siblings age < 4 years (< 7 years prior to 1997)
• First degree relative of either a sibling/offspring participant or general population newborn participant ages 12 months to 65 years
• No other severe co-existent condition
• One clinic visit to obtain blood for genetic marker determination and islet autoantibody screening

Exclusion criteria:

• Cord blood not available for genetic screening
• Other severe co-morbidities indicated or T1D diagnosed
• Refused consent and long-term storage of data and specimen samples
• At least one parent or legal guardian did not speak English

Outcome

The study is ongoing.