ENABLE: Clinical validation of islet autoantibody measurement in self-collected dried blood spot specimens

Study Purpose: Clinical validation of islet autoantibody measurement in self-collected dried blood spot specimens.

To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if
you meet the following criteria:

Study Duration: 1 visit

Study Commitment: 1 visit including:
-1 blood collection
-2 fingersticks
-Post-sample collection survey

Age: >1 years old

Sex: Male & Female

Conditions/Eligibility: Control Participants: >1 year old, no first, second or third degree relatives with T1D; Willing to provide informed consent and adhere to the study protocol;Willing to allow collection of venous blood tubes for processing to serum and whole blood; Has not received any form of insulin therapy; Have been diagnosed with type 2 diabetes, celiac disease, thyroid diseases (e.g. Graves disease, Hashimoto disease), Addison disease, pancreatic cancer, neurological diseases (e.g. stiff person syndromes, limbic encephalitis epilepsy, cerebellar ataxia) or other autoimmune, metabolic, allergy disease
TID participants: >1 year old; ● Clinical diagnosis of diabetes mellitus, defined as fasting glucose >7.0 mmol/l (126 mg/dl) OR glucose >11 mmol/l (200mg/dl) at the 2-hour time point of an oral glucose tolerance test OR random glucose >11 mmol/l (200 mg/dl) with symptoms of diabetes OR HbA1c > 6.5% (48 mmol/mol);● Have one or more characteristics of type 1 diabetes: serological evidence of islet autoimmunity; history of thyroid autoimmunity or of coeliac disease; absence of overweight or obesity; history of ketoacidosis; C-peptide<0.5nmol/l. These testing data may be supplemented within 8 weeks post enrollment; Has not received any form of insulin or insulin-analog therapies more than 14 days prior to sample collection

Study Procedures: Informed Consent & eligibility confirmation
Blood collection
Capillary puncture (fingerstick)
Survey

Compensation: $50