Type 1 Diabetes National Screening Pilot: Feasibility and Acceptability Study

BRIEF NAME & WHY: The Type 1 Diabetes National Screening Pilot: Feasibility and Acceptability Study is a cluster-controlled implementation study comparing the feasibility, acceptability, and costs of three different screening models to identify the most appropriate strategy for type 1 diabetes screening in the paediatric general population in Australia. WHAT (MATERIALS & PROCEDURES): MATERIALS: Parents/guardians of all participating children will be provided with a hard-copy/electronic Participant Information Statement. Cohort 2 (infants aged 6–12 months) will receive a saliva swab self-sampling kit and instructions, and Cohort 3 (children aged 2, 6 or 10 years) will receive a capillary blood (finger prick) self-sampling kit and instructions. These resources will also be available to participating Primary Care Providers within the catchment areas should the parent/guardian require assistance from them in obtaining a sample from their child. In-school screening by a Registered Nurse will be offered to children in Cohort 3 (Kindergarten or Year 4) attending a participating school. Parent/guardians will also be provided with any relevant information relating to their child’s screening result e.g. explanation of the result, and/or recommendations for follow-up or specialist referral. PROCEDURES Cohort 1: Genetic screening (polygenic risk score) using newborn dried bloodspots (heel prick) with autoantibody follow-up of at-risk children at 12 months of age. Cohort 2: Genetic screening (polygenic risk score) using saliva at 6-12 months of age with autoantibody follow-up of at-risk children at 12 months of age. Cohort 3: Autoantibody screening using a capillary dried bloodspot (finger prick) in children aged 2, 6 or 10 years old OR in Kindergarten or Year 4. WHO DELIVERED/PROVIDED THE INTERVENTION & WHERE: Cohort 1 (newborns): The ‘intervention’ (i.e. dried bloodspot sampling for genetic analysis) will be performed by a research midwife, postnatal midwife, or hospital blood collector with pre-existing training in newborn heel prick blood spot collection. Cohort 2 (6-12 month old infants): The ‘intervention’ (i.e. saliva swab sampling for genetic analysis) can be performed in two ways according to participant preference. The saliva testing kits will be posted to registered families who can choose: 1) ‘self-sampling’ at home (i.e. the parent/guardian collects the sample from the infant); or 2) the parent/guardian can take the test kit to their Primary Care Provider who can perform the sample collection. Alternatively, selected Primary Care Providers will have test kits in their clinic, and they can screen and consent the participant and perform the swab during a routine consultation. Participating Primary Care Providers will have pre-existing training in saliva swab sample collection, and will receive protocol-specific training for sample collection. Cohort 3 (2, 6 and 10yr old children): The ‘intervention’ (i.e. dried capillary bloodspot sampling for autoantibody testing) can be performed in two ways according to participant preference. The finger prick blood test kits will be posted to registered families who can choose: 1) ‘self-sampling’ at home (i.e. the parent/guardian collects the sample from the infant); or 2) the parent/guardian can take the test kit to their Primary Care Provider who can perform the sample collection. Alternatively, selected Primary Care Providers will have test kits in their clinic, and they can screen and consent the participant and perform the blood spot collection during a routine consultation. Participating Primary Care Providers will have pre-existing training in finger prick blood spot sample collection, and will receive protocol-specific training for sample collection. Cohort 3 (children in Kindergarten or Year 4): The ‘intervention’ (i.e. dried capillary bloodspot sampling for autoantibody testing) will be performed in-school by a visiting registered nurse with pre-existing training in finger prick blood spot sample collection.