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Table 1 Eligibility

From: A pilot randomised controlled parallel arm trial evaluating treatment satisfaction with the Omnipod DASH® Insulin Management System compared with usual care in adults with type 1 diabetes in Australia: rationale, study design and methodologies

Inclusion criteria

Exclusion criteria

• Type 1 diabetes (as defined by the American Diabetes Association) [8] for at least 6 months

• Insulin regimen consisting of either MDI or IPT

• Age 18–70 years inclusive

• HbA1c < 10.0% (86 mmol/mol)

• Willing to perform at least four SMBG readings daily

• Willing to learn and apply carbohydrate counting skills

• Willing to use Omnipod DASH® Insulin Management System

• Access to a computer with internet access

• Proficient in English

• Suitable for remote education

• Current use of real-time CGM (defined as the use of real-time CGM > 25% of the time during the past 3 months, except Abbott Libre™ 1 ISGM)

• Use of any non-insulin glucose-lowering agent within the past 3 months

• Oral or injected corticosteroid use within the past 3 months

• An insulin requirement of more than 200 units of insulin every 2 days

• An episode of severe hypoglycaemia or diabetic ketoacidosis within the past 3 months

• Physical or intellectual disability precluding the use of IPT

• Severe renal impairment (eGFR < 15 mL/min/1.73m2)

• Haemoglobinopathy or haemolytic anaemia due to its interference with HbA1c assays

• Major life-threatening illness impacting immediate life expectancy

• Pregnancy, or planned pregnancy within the study period

• Uncontrolled thyroid disease

• Uncontrolled coeliac disease

• Uncontrolled hypertension