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Table 1 Participant inclusion and exclusion criteria

From: Study protocol for a randomised controlled trial of insulin delivery by continuous subcutaneous infusion compared to multiple daily injections

Inclusion criteria Exclusion criteria
Newly diagnosed type I diabetes mellitus using standard diagnostic practice Treated previously for diabetes
Age 7 months to 15 years (inclusive) Haemoglobinopathy
Parent or legal representative of the patient is willing to give consent for the study Co-existing pathology conditions likely to affect glycaemic control
Parent or legal representative of the patient is able to comply with the treatment regimen and study visits Psychological or psychiatric disorders, e.g. eating disorders
Patient aged 8 years and over and is able to adhere to the treatment regimen and study visits Receiving medication likely to affect glycaemic control
  Allergic to a component of insulin aspart or insulin glargine
  Thyroid in a non-euthyroid state
  Coeliac disease and unable to maintain a gluten-free diet