What is being screened for?

If you were recently diagnosed with Type 1 diabetes, you may be eligible to join the AIDA study.

You may be considered eligible for the AIDA study if you:

• Are diagnosed with Type 1 diabetes according to WHO 1999 criteria
• Have positive GAD auto-antibodies
• Are 18-35 years of age at the onset of diabetes
• Your first symptoms (that is thirst or frequent urination) of diabetes have occurred for less than 12 weeks
• Peak C-peptide more than or equal to 200 pM after a standardized mixed meal test (Boost) at a test carried out when the subject is metabolically stable, i.e. after resolution of any polyuria, polydypsia or ketoacidosis.
  

You will not be eligible for the AIDA study if you:

• Have severe liver or renal disease (creatinine > 100 μmol/L, ASAT/ALAT > 2* ULN, alkaline phosphatase > 2 * ULN)
• Have a history of heart disease, signs of cardiac failure or abnormal ECG
• Have a present or previous malignancy
• Are pregnant or fail to comply with contraceptional planning, or breast-feeding. (Safe contraceptive methods include birth control pills, IUD, injection of gestagen, subdermal implantation, hormonal vaginal ring, and transdermal patch).
• Have plans of pregnancy within 2 years.
• Participate in other clinical intervention studies
• Are receiving anti-inflammatory therapy (except aspirin ≤ 100 mg/d)
• Have any active infections (CRP>30), and/or a history of recurrent infection or predisposition to infections
• Have neutropenia (ANC < 1.5*10/L) or anemia (Hemoglobin < 8.0 g/dL) 
• Are receiving Immune-suppressive treatment or have immune-deficiency
• Have presence of late diabetic complications at diagnosis
• Have received concurrent vaccination with live vaccine.
• Have a known need for live vaccinations within 2 years.
• Have used Etanercept within 6 months before screening or during the double-blinded study period
• Have hypersensitivity to E. coli-derived proteins, anakinra or any components of the product
  
• Are under the age of 18

There will be no exclusion on the basis of gender, race or ethnicity. These subjects are contacted for the first time in their disease course and there are thus no considerations of previous guarantees of confidentiality in the contact process.