Clinical examination | Cardiovascular/respiratory/gastrointestinal/nervous system/feet |
Blood pressure and heart rate | |
Height, weight, waist circumference | |
Body fat content (bioimpedance) | |
Non-fasting blood | HbA1c |
FBC | |
Liver/renal function | |
GAD, IA-2 and zinc transporter autoantibodies (6-month assessment only) | |
C peptide (baseline only) | |
Questionnaires | Clarke'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 diaries | Blood glucose monitoring diary |
Insulin monitoring diary | |
Activity diary | |
Activity monitor | Small electronic device worn on wrist for 7 days. Measures physical activity by continually monitoring and recording movements of the body. |
Hypoglycemia | 4-week download of blood glucose monitor |
Continuous glucose monitor | Wearing a monitor on stomach that continuously records glucose every 5 min for 7 days (optional) |
Telephone call | Participants telephoned to inform them which treatment arm they had been allocated to |
Clinical review | Review by nurse, dietitian and doctor to ensure no changes need to be made to insulin dosages or medication |
Participant postcard | Postcard 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.