Table 3.
Module names and items | Conceptual framework domain | Completion timepoints (‘check-ins’) | ||
Morning | Afternoon | Evening | ||
Sleep quality module (two items) | ||||
1. How well did you sleep? | Sleep quality | x | ||
2. When you woke up how did you feel? | Sleep quality | x | ||
General well-being module (seven items) | ||||
3. How is your mood right now? | Mood | x | x | x |
4. How anxious do you feel right now? | Anxiety | x | x | x |
5. How is your energy level right now? | Energy levels | x | x | x |
6. How irritable do you feel right now? | Mood | x | x | x |
7. How alert do you feel right now? | Cognitive function | x | x | x |
8. How easy was if for you to remember things today? | Cognitive function | x | ||
9. How well are you able to concentrate right now? | Cognitive function | x | x | x |
Fear of hypoglycaemia/hyperglycaemia module (four items) | ||||
10. How worried are you about having a hypo later today? | Fear | x | x | |
11. How worried are you about having high blood glucose later today? | Fear | x | x | |
12. How worried are you about having a hypo while asleep? | Fear | x | ||
13. How worried are you about having high blood glucose while asleep? | Fear | x | ||
Social interactions module (one item) | ||||
14. How well did you get along with other people today? | Social interactions | x | ||
Work and productivity module (four items) | ||||
15. How many hours did you work today? | Work/productivity | x | ||
16. How many hours did you miss from work for ANY reason today?(this includes health issues, vacation, holiday, etc.) | Work/productivity | x | ||
17. How many hours did you miss from activities other than work today for ANY reason (eg, study, housework, shopping, family or leisure activities)? | Leisure activities | x | ||
18. How productive were you while working today? | Work/productivity | x | ||
Self-report of hypos while asleep module* (eight items) | ||||
19. During the night, did you have a hypo OR take action to prevent a hypo that was about to happen?† | NA | x | ||
20. How many hypos did you have? | NA | x | ||
21. At what time did this happen? | NA | x | ||
22. How did you detect your hypo or a hypo that was about to happen? (Select all that apply) | NA | x | ||
23. What happened? (Select all that apply) | NA | x | ||
24. Overall: How bothersome was hypoglycaemia for you last night? | Burden | x | ||
25. Overall: How much sleep did you lose due to hypoglycaemia? | Sleep quality | x | ||
26. Overall: How worried were you about going back to sleep? | Sleep quality | x | ||
Self-report of daytime hypos module* (seven items) | ||||
27. Today, did you have a hypo OR take action to prevent a hypo that was about to happen?† | NA | x | ||
20.1 How many hypos did you have? | NA | x | ||
21.1 At what time did this happen? | NA | x | ||
22.1 How did you detect your hypo or a hypo that was about to happen? | NA | x | ||
23.1 What happened? | NA | x | ||
28. Overall: How bothersome was hypoglycaemia for you today? | Burden | x | ||
29. Overall: How long was it before you were feeling your ‘usual self’ again? | Daily living/usual activities | x |
*Several of these items are not part of the conceptual framework, but were included to capture details about the hypoglycaemic episodes
†These items have branching: if a hypo is reported, the items below are presented to the participant for completion.