Table 1.
Schedule of events.
Weeks | −1 | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
In Person Visit Number: | 1 | 2 | 3 | 4 | 5 | |||||||||
Study Window (days) | 1 | 3 | 3 | 3 | ||||||||||
Consent Completed | x | |||||||||||||
CGM Education Session | x | |||||||||||||
CGM Placed | x | |||||||||||||
Randomized | x | |||||||||||||
Dietary Education | x | |||||||||||||
Weekly phone calls: | x | x | x | x | x | x | x | x | x | |||||
Surveys | ||||||||||||||
Demographic information | x | |||||||||||||
Pediatric Quality of Life | x | x | x | x | x | |||||||||
Physical Activity | x | x | x | x | x | |||||||||
Binge Eating Disorder | x | x | x | x | x | |||||||||
Center for Epidemiological Studies Depression Scale | x | x | x | x | x | |||||||||
Perceived Stress Scale | x | x | x | x | x | |||||||||
Satisfaction Survey Teen | x | x | x | |||||||||||
NSDR: 24-h dietary recall (3 days: weekday, weekend, TLE day for Group 2/3) | x | x | x | |||||||||||
Anthropometrics: teen | x | x | x | x | x | |||||||||
Anthropometrics: family | x | x | ||||||||||||
Imaging: | ||||||||||||||
DEXA Scan: Total body fat % | x | x | ||||||||||||
CGM Data: | ||||||||||||||
Average fasting blood glucose | x | x | x | x | x | |||||||||
Time in range | x | x | x | x | x | |||||||||
Adherence to TLE-number of glycemic excursions of > 80 mg/dL during reported fasting periods | x | x | x | x | x | |||||||||
Labs: | ||||||||||||||
Metabolic biomarkers- Hemoglobin A1c, Insulin, c-peptide, Lipid Panel, Liver Function Tests, and Fasting glucose, c-reactive protein (CRP), uric acid, leptin | x | x | ||||||||||||
Compensation: | x | x | x | x | x |