Table 2.
Glucose outcomes overall and by time of day
| 24 H (n = 39) |
Daytimea (n = 39) |
Nighttimea (n = 39) |
Awakeb (n = 38) |
Asleep overnightb (n = 38) |
|
|---|---|---|---|---|---|
| H of CGM data, mean ± SD | 205.6 ± 68.6 | 136.2 ± 45.6 | 69.4 ± 23.1 | 102.5 ± 37.3 | 87.2 ± 28.3 |
| Range | 79.5-425.1 | 55.5-281.1 | 24.0-144.0 | 37.2-232.7 | 30.2-189.8 |
| Overall glucose distribution, mean ± SD | |||||
| Mean glucose, mg/dL | 103 ± 8 | 106 ± 9 | 97 ± 8 | 107 ± 9 | 99 ± 8 |
| Glucose SD, mg/dL | 17 ± 3 | 18 ± 3 | 12 ± 3 | 18 ± 3 | 14 ± 3 |
| Glucose coefficient of variation, % | 17% ± 3% | 17% ± 3% | 12% ± 3% | 17% ± 3% | 14% ± 3% |
| % of sensor values, median (IQR) | |||||
| % time in range 70-120 mg/dL | 86% (75%-89%) |
81% (70%-86%) |
93% (88%-97%) |
80% (68%-87%) |
90% (86%-94%) |
| % time in range 70-140 mg/dL | 96% (92%-97%) |
94% (90%-96%) |
98% (96%-99%) |
94% (90%-96%) |
97% (95%-99%) |
| % time in range 60-140 mg/dL | 96% (93%-98%) |
95% (91%-97%) |
99% (98%-100%) |
95% (90%-97%) |
98% (97%-99%) |
| % time < 70 mg/dL | 0.44% (0.13%-1.02%) |
0.21% (0.07%-0.78%) |
0.65% (0.00%-1.53%) |
0.18% (0.00%-0.88%) |
0.52% (0.00%-1.18%) |
| % time < 60 mg/dL | 0.10% (0.00%-0.22%) | 0.00% (0.00%-0.13%) |
0.15% (0.00%-0.54%) |
0.00% (0.00%-0.00%) |
0.14% (0.00%-0.47%) |
| % time < 54 mg/dL | 0.02% (0.00%, 0.15%) | 0.00% (0.00%-0.00%) |
0.00% (0.00%-0.40%) |
0.00% (0.00%-0.00%) |
0.00% (0.00%-0.33%) |
| % time > 120 mg/dL | 13.0% (10.1%-23.1%) |
17.5% (12.7%-30.2%) |
4.9% (1.4%-9.1%) |
19.1% (12.7%-31.4%) |
8.1% (3.9%-13.2%) |
| % time > 140 mg/dL | 3.35% (2.20%-6.15%) |
5.05% (2.68%-8.56%) |
0.58% (0.00%-1.63%) |
5.50% (2.88%-9.17%) |
1.70% (0.35%-3.37%) |
| % time > 160 mg/dL | 0.79% (0.40%-1.79%) |
1.16% (0.54%-2.68%) |
0.00% (0.00%-0.00%) |
1.19% (0.46%-2.50%) |
0.20% (0.00%-0.55%) |
| % time > 180 mg/dL | 0.14% (0.00%-0.49%) |
0.21% (0.00%-0.75%) |
0.00% (0.00%-0.00%) |
0.21% (0.00%-0.78%) |
0.00% (0.00%-0.08%) |
| Participants with ≥ 1 hypoglycemic event c | 9 (23%) | 0 (0%) | 9 (23%) | 0 (0%) | 9 (24%) |
| Duration of hypoglycemic events for participants with ≥ 1 hypoglycemic event, min c , d | n = 13 events |
n = 0 events |
n = 13 events |
n = 0 events |
n = 12 events |
| Median (IQR) | 45 (35-50) | – | 45 (35-50) | – | 43 (35-50) |
Abbreviations: CGM, continuous glucose monitoring; IQR, interquartile range.
a Daytime is from 6 am to 9:59 pm. Nighttime is from 10 pm to 5:59 am.
b The parent or caregiver was asked to record the participant’s bedtime and morning wake time in a daily log. These logs were used to identify the periods of sensor data when participants were awake vs asleep overnight. Nap times are considered awake.
c A hypoglycemic event is defined as at least 2 sensor values less than 54 mg/dL that are 15 or more minutes apart with no intervening values greater than 54 mg/dL. An event ends when there are at least 2 sensor values greater than 70 mg/dL that are 15 or more minutes apart with no intervening values less than 70 mg/dL. Participant becomes eligible for a new event as soon as the aforementioned criteria for ending the previous event have been met.
d Based on an event level.