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Table 3 Measures

From: Sleep optimization to improve glycemic control in adults with type 1 diabetes: study protocol for a randomized controlled parallel intervention trial

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