Table 2

Inclusion and exclusion criteria

Summary of eligibility criteria
  1. Type 1 diabetes (diagnosis consistent with American Diabetes Association Classification of Diabetes Mellitus) diagnosed at least 1 year ago.

  2. Fasting C peptide <0.1 nmol/L (in the absence of hypoglycaemia).

  3. Insulin regimen either: multiple daily injections (MDI)≥4 injections per day (≥3 rapid-acting insulin and ≥1 long-acting insulin), or insulin pump therapy (CSII) established for >3 months.

  4. Aged 12–<25 years.

  5. HbA1c ≤10.5% (91 mmol/mol).

  6. Living in an area with internet and cellular phone coverage.

  7. English speaking.

Summary of exclusion criteria
  1. Chronic kidney disease (eGFR <45 mL/min/1.73 m2).

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

  3. Oral or injected steroid use within the past 3 months.

  4. Pregnancy or planned pregnancy within the study period.

  5. Uncontrolled coeliac disease (not following a gluten-free diet), or other untreated malabsorptions.

  6. Uncontrolled thyroid disease.

  7. Clinically significant gastroparesis.

  8. Uncontrolled hypertension (DBP >100 mm Hg and/or SBP >160 mm Hg).

  9. History of myocardial infarction, severe uncontrolled heart failure, unstable angina, transient ischaemic attack (TIA), stroke or thromboembolic disease in the past 3 months.

  10. Poor visual acuity precluding use of the investigational technology.

  11. Inability or unwillingness to meet protocol requirements (including carbohydrate counting, CGM use as per allocated study group only).

  12. Severe or unstable medical or psychological condition which, in the opinion of the investigator, would compromise the ability to meet protocol requirements.

  • CGM, continuous glucose monitor; DBP, diastolic blood pressure; eGFR, estimated glomerular filtration rate; HbA1c, haemoglobin A1c; SBP, systolic blood pressure.