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Table 3 Measures

From: A cognitive behavioral therapy intervention to reduce fear of hypoglycemia in young adults with type 1 diabetes (FREE): study protocol for a randomized controlled trial

Variables

Measure

Frequency

Demographic, health, and literacy information

Demographic, health questionnaire, Hypoglycemia Patient Questionnaire [2]

Health Literacy Screener (Newest Vital Sign) [55]

Week 0

Aim 1

 Recruitment

Number recruited, screened, eligible, consented

Weekly

 Retention

Attendance rate; completion rate

Weekly

 Acceptability

Participant evaluation survey and interview (Appendix P4)

Week 8

Advisory panel

End of study

Aim 2

 FOH

Hypoglycemia Fear Scale-II (HFS-II [52])

Weeks 0, 4, 8,12

Glycemic measures

 Glycemic control

A1C (A1C Now®)

Weeks 0, 8, 12

 Glycemic variability

RT-CGM (Dexcom®): daily glucose standard deviation (GlucSD), continuous net glycemic action (CONGA), coefficient of variation (CV%), interquartile range (IQR), time spent in hypo- and hyperglycemia and time in range

Weeks 0–8

Diabetes self-management

Diabetes Self-Management Questionnaire [54]

Weeks 0, 8, 12