Table 2

Test/action/questionnaires conducted at baseline and 6 months

Clinical examinationCardiovascular/respiratory/gastrointestinal/nervous system/feet
Blood pressure and heart rate
Height, weight, waist circumference
Body fat content (bioimpedance)
Non-fasting bloodHbA1c
FBC
Liver/renal function
GAD, IA-2 and zinc transporter autoantibodies (6-month assessment only)
C peptide (baseline only)
QuestionnairesClarke's Hypoglycemia Awareness Questionnaire
The Hypoglycemia Fear Survey
Gold score, Edinburgh hypo survey, and hypoawareness score
Problem Areas in Diabetes (PAID) scale
Diabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS)
Barriers to Physical Activity in Type 1 Diabetes (BAPAD-1) scale
EQ-5D
Purpose-designed diariesBlood glucose monitoring diary
Insulin monitoring diary
Activity diary
Activity monitorSmall electronic device worn on wrist for 7 days. Measures physical activity by continually monitoring and recording movements of the body.
Hypoglycemia4-week download of blood glucose monitor
Continuous glucose monitorWearing a monitor on stomach that continuously records glucose every 5 min for 7 days (optional)
Telephone callParticipants telephoned to inform them which treatment arm they had been allocated to
Clinical reviewReview by nurse, dietitian and doctor to ensure no changes need to be made to insulin dosages or medication
Participant postcardPostcard given at last visit for participant to provide anonymous feedback on the study
  • EQ-5D, EuroQol-5 Dimension; FBC, full blood count; GAD, glutamic acid decarboxylase ; IA-2, islet tyrosine phosphate 2.