INS and type 1 diabetes mellitus: 1.   Have given written informed consent to participate or assent with parental consent   2.   Be aged 6–18 years (not reached 19th birthday) at randomisation   3.   Be diagnosed with T1D (at least one autoantibody positive), requiring insulin treatment   4.   Be within 6 weeks from diagnosis of T1D (at screening)   5.   Have a random C-peptide > 200 pmol/l   6.   Have a normal full blood count