Trial Outcomes & Findings for Sleep Extension or Regularity to Reduce Diabetes Risk (NCT NCT06128265)

Sleep Extension or Regularity to Reduce Diabetes Risk

Change in sleep onset time (minutes from midnight). Sleep onset time was recorded in hh:mm:ss format and converted to minutes from midnight for analysis.

Change in wake time (minutes from midnight). Sleep wake time was recorded in hh:mm:ss format and converted to minutes from midnight for analysis.

Change in Sleep duration from baseline to day 24 measured in minutes by Wrist Actigraphy Monitoring.

SD of midpoint is a measurement of sleep regularity. Calculated as the standard deviation of sleep midpoint over multiple nights.

Change in sleep efficiency from baseline to day 24 measure by a percentage of total sleep time/time in bed from Wrist Actigraphy Monitoring.

The Matsuda Index of whole body insulin sensitivity, the homeostasis model assessment (HOMA) measures beta cell function and insulin resistance will be measured by Oral glucose tolerance test (OGTT).

This outcome includes two CGM-derived glucose variability metrics: Mean Absolute Glucose (MAG) and Standard Deviation (SD). All values are expressed in mg/dL. Change from Baseline to Day 24 was calculated.

CONGA was calculated from continuous glucose monitoring data as a measure of short-term glycemic variability. Values were expressed in mg/dL per minute. Change from Baseline to Day 24 was calculated.

AUC was derived from continuous glucose monitoring data to quantify total glycemic exposure over the monitoring period. Values were expressed in mg\*hr/dL. Change from Baseline to Day 24 was calculated.

TIR was calculated as the total number of minutes glucose values remained within the target glycemic range based on continuous glucose monitoring. Values were expressed in minutes. Change from Baseline to Day 24 was calculated.

This outcome includes CGM-derived glucose variability metric: Coefficient of Variation (CV) expressed in percentage of coefficient of variation. Change from Baseline to Day 24 was calculated.

Within-subject changes in sleep effects (sleepiness), appetite, mood, reported between baseline and Day 24. For sleepiness, the self-administered Epworth Sleepiness scale was used, participants rate the likelihood of falling asleep in eight common daily situations from 0 = never to 3 = high chance, scores range from 0 to 24, with higher scores denoting more sleepiness. Appetite and mood (vigor and affect) was administered via visual analog scale ranging from 0 to 10 on subscales. Appetite final score was the sum of 7 separate craving/food category assessments, with the total scoring ranging from 0-70 with higher scores denoting greater appetite. Vigor and affect are both derived from 4 different assessments, scores can range from 0-10. Vigor is calculated by subtracting sub-scales effort, weary, and sleepy from alert/4. Affect is calculated by subtracting sad and tense from the sum of happy and calm/4. For both, higher scores denote greater vigor and affect.

Changes in first phase insulin response (ARIg=mu.i\^-1.min) from baseline to Day 24 measured by oral glucose tolerance test (OGTT).

Changes in oral disposition index (DIo) from baseline to Day 24 measured in (SI x ARIg = \[(mu/l)\^-1.min\^-1\] \* \[mu.l\^-1.min\]) by oral glucose tolerance test (OGTT).

Changes in insulinogenic index (change in plasma insulin/change in plasma glucose from 0-30 minutes = (pmol/L)/(mg/dL)) from baseline to Day 24 measured by oral glucose tolerance test (OGTT).

The change in weight values will be measured by in laboratory anthropometrics measurements.