Table 2.

Baseline assessments

Demographic	Date of birth Ethnicity Gender Household income Highest education level attained (parent’s if applicable)
Auxological	Height Weight Body Mass Index (BMI)
Diabetic	Date of diagnosis Mean HbA1c (local laboratory value(s) over the previous six months prior to screening visit) Current HbA1c (measured using the DCA Vantage Analyzer) Number of episodes of severe hypoglycaemia (defined as coma or convulsion requiring assistance from others in the 12 months prior to screening visit) Total daily dose (TDD) of insulin, calculated as the mean of the previous 14 days Prior use of CGM/ intermittent/ Flash CGM (defined as use > 75% of the time prior to the baseline visit) Prior use of an AID system
Clinical	Comorbidities Adverse event (AE) collection and concomitant medication check will be recorded Urine pregnancy test for all post-menarcheal and pre-menopausal women Known allergies Seated blood pressure (BP) recorded as an average of 2 measurements at least 5 min apart
Lifestyle	Smoking status (tobacco as well as e cigarettes/ vaping devices)
Psychology Measures	Hypoglycaemia Fear Survey II (HFS II) Pittsburgh Sleep Quality Index (PSQI) Device-experience questionnaire (DTSQs) Health status (EuroQol 5-dimensional Questionnaire EQ-5D)