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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