. 2020 May 30;19(2):1615–1629. doi: 10.1007/s40200-020-00547-8

Table 1.

Inclusion and exclusion criteria for participation in “CREATE”

Inclusion criteria	Exclusion criteria
• T1D diagnosed as per the American Diabetes Association classification for > 1 year prior to the screening visit • Aged 7–70 years inclusive at baseline • Currently on insulin pump therapy for > 6 months prior to the screening visit^a • Mean HbA1c < 10.5% (91 mmol/mol) within 6 months prior to the screening visit (minimum of one test)^b • Willing and able to adhere to the study protocol • Have daily access to a Wi-Fi network	• If a female is pregnant or plans to become pregnant while participating in the study. A positive urine pregnancy test at screening is exclusionary • Alcohol or drug dependence • Severe visual impairment that would impair use of the device • Any comorbid medical or psychological factors that would, on assessment by the investigators, make the person unsuitable for the study • A lack of English literacy that would, on assessment by the investigators, make the person unsuitable for the study • Allergic or intolerant to NovoRapid® insulin

Inclusion criteria

Exclusion criteria

• T1D diagnosed as per the American Diabetes Association classification for > 1 year prior to the screening visit

• Aged 7–70 years inclusive at baseline

• Currently on insulin pump therapy for > 6 months prior to the screening visit^a

• Mean HbA1c < 10.5% (91 mmol/mol) within 6 months prior to the screening visit (minimum of one test)^b

• Willing and able to adhere to the study protocol

• Have daily access to a Wi-Fi network

• If a female is pregnant or plans to become pregnant while participating in the study. A positive urine pregnancy test at screening is exclusionary

• Alcohol or drug dependence

• Severe visual impairment that would impair use of the device

• Any comorbid medical or psychological factors that would, on assessment by the investigators, make the person unsuitable for the study

• A lack of English literacy that would, on assessment by the investigators, make the person unsuitable for the study

• Allergic or intolerant to NovoRapid® insulin

^aSince carbohydrate counting is a requisite for obtaining an insulin pump, the assumption is made that all candidates are capable of carbohydrate counting.

^bThis reflects the New Zealand Pharmaceutical Management Agency (PHARMAC) criteria for funded access to insulin pump therapy in New Zealand.