Time (weeks) | Visit | Test/action | Usual care arm | Intervention arm |
1 | Consent, screening (medical history, clinical examination (height, weight, waist circumference, body fat and blood pressure), HbA1c, FBC, U+Es, LFTs, C peptide, fit activity monitor and continuous glucose monitor (if applicable), complete questionnaires (Hypoglycemia Fear Survey, Clarke’s Hypoglycemia Awareness, BAPAD, EQ-5D, PAID and T1-DDS). Provision of blood glucose and insulin diaries. | ✔ | ✔ | |
2 | Collection of activity monitor and continuous glucose monitor, and blood glucose monitor and insulin diaries. | ✔ | ✔ | |
Randomization by a researcher between visits 2 and 3 | ||||
0–8 | 3 | Education session 1 | ✔ | ✔ |
4 | Education session 2 | ✔ | ||
5 | Education session 3 | ✔ | ||
10–16 | 6 | Joint nurse, doctor and dietitian appointment | ✔ | ✔ |
26–33 | 7 | 6-month assessment, medical history, clinical examination (height, weight, waist circumference, body fat and blood pressure), HbA1c, FBC, U+Es, LFTs and diabetes-related autoantibodies, fit activity monitor and continuous glucose monitor (if applicable), complete questionnaires (Hypoglycemia Fear Survey, Clarke’s Hypoglycemia Awareness, BAPAD, EQ-5D, PAID and T1-DDS). Provision of blood glucose and insulin diaries. | ✔ | ✔ |
28–34 | 8 | Final visit. Collection of activity monitor and continuous glucose monitor (if applicable), and blood glucose monitor and insulin diaries. | ✔ | ✔ |
BAPAD, Barriers to Physical Activity in Type 1 Diabetes; EQ-5D, EuroQol-5 Dimension; FBC, full blood count; LFT, liver function tests; PAID, Problem Areas in Diabetes scale; T1-DDS, Diabetes Distress Scale for Adults with Type 1 Diabetes; U+E, urea and electrolytes .