Table 3.
Variables | Measures | Frequency |
---|---|---|
Demographic and health information, caffeine, and sleep aid use | Demographic, health questionnaire, hypoglycemia unawareness, Clark Scale [63], menopausal status (STRAW+10 in women≥40 years) [64], caffeine, sleep aid use | Week 0 |
Primary measures: Objective sleep indices Glycemic indices Glycemic control Glycemic variability |
Sleep duration, sleep variability, sleep and wake timing (Respironics Actiwatch Spectrum Plus®). Confirmed with sleep diary (bedtime, disruptions, wake time). A1C CGM (Abbott Libre® or Dexcom®): glucose variability, coefficient of variation (CV%), time-in-range [65, 66] |
Weeks 0, 6, 12, 24 |
Secondary measures: | Weeks 0, 6, 12, 24 | |
Diabetes distress Diabetes self-management Quality of life Fatigue Depressed mood Subjective sleep quality |
T1D Diabetes Distress Scale [67] Self-Management Questionnaire-R [68] Diabetes Quality of Life Scale (DQOL) [69] PROMIS Fatigue Scale [70] Center for Epidemiological Studies Depression Scale (CES-D) [71] Pittsburgh Sleep Quality Index [72] |
|
Important patient-related variables | Self-Efficacy for Diabetes Scale [73], General Anxiety Disorder – 7-item (GAD-7) [74], Hypoglycemia Fear Scale II [75], Epworth Sleepiness Scale [76], activity counts | Weeks 0, 6, 12, 24 |
Participant engagement | Number of sessions attended, length of coaching sessions, lessons viewed, Fitbit usage | Weeks 1–12 |