Table 1 Inclusion and exclusion criteria for participation in Managing Diabetes in a ‘Flash’
Inclusion criteria | Exclusion criteria |
|---|---|
• Aged 13 to 20 years (inclusive) | • Any severe diabetes related complications (nephropathy on treatment, retinopathy with associated visual loss – milder degrees will not be excluded) |
• Mean HbA1c over previous 6 months ≥75 mmol/mol (≥9%) | |
• Diagnosed with T1D for at least 12 months | • Other severe uncontrolled medical or psychiatric co-morbidity/severe mental illness |
• Prescribed > 0.5 units of insulin/kg/day (with no restrictions based on insulin regimen) | |
• Planned to continue with routine clinical care during the initial 6-month RCT | • Currently using a CGM or FGM device or has used one continuously (other than for intermittent hospital use) within the previous 4 months |
• Resident in and expecting to remain in regions affiliated with the Canterbury, Capital and Coast, and Southern District Health Boards for the following year | • Participation in another device or drug study that could affect glucose measurements during the study period |
• Pregnant, lactating, or plan to become pregnant | |
• Ability to understand study procedures, including English language proficiency, and to comply with them for the entire length of the study | |
• Inability of individual (for those aged 16 years and older) or legal guardian (for those aged 13–15 years) to give written informed consent |