Table 2.
Glycemic Metrics Mean (Standard Deviation) Comparing Performance of the Automated Insulin Delivery System with Conventional Therapy (Sensor Augmented Pump/Predictive Low-Glucose Suspend) for the Entire Study Period, with Estimated Effect Calculated Using a Linear Mixed Effects Model with Adjustment for Treatment Period
| Metric | Conventional therapy (n = 10) | AID (n = 10) | Estimate (95% CI) | P |
|---|---|---|---|---|
| Day and night | ||||
| Mean CGM glucose | 150.7 (21.3) | 147.7 (18.5) | −3.0 (−11.9 to 6.0) | 0.47 |
| Median CGM glucose | 142.9 (20.1) | 139.2 (18.8) | −3.8 (−11.6 to 4.1) | 0.31 |
| SD CGM glucose | 54.2 (12.2) | 50.6 (10.5) | −3.6 (−10.2 to 2.9) | 0.25 |
| CV CGM glucose (%) | 35.7 (4.4) | 34.2 (5.0) | −1.6 (−4.1 to 0.9) | 0.18 |
| %Time <54 mg/dL | 0.6 (0.7) | 0.4 (0.4) | −0.2 (−0.5 to 0.1) | 0.20 |
| %Time <60 mg/dL | 1.3 (1.4) | 0.9 (1.0) | −0.4 (−0.9 to 0.0) | 0.07 |
| %Time <70 mg/dL | 3.5 (2.8) | 2.3 (1.9) | −1.2 (−2.1 to −0.2) | 0.02a |
| %Time 70–140 mg/dL | 46.3 (12.0) | 50.2 (11.5) | 3.9 (−1.5 to 9.3) | 0.14 |
| %Time 70–180 mg/dL | 70.6 (11.7) | 74.0 (11.2) | 3.4 (−2.3 to 9.1) | 0.22 |
| %Time >180 mg/dL | 25.9 (13.1) | 23.7 (11.9) | −2.2 (−7.9 to 3.5) | 0.40 |
| %Time >250 mg/dL | 7.1 (7.2) | 4.9 (6.1) | −2.1 (−5.8 to 1.6) | 0.23 |
| %Time >300 mg/dL | 2.1 (3.0) | 1.4 (2.5) | −0.7 (−2.6 to 1.3) | 0.48 |
| LBGI | 1.0 (0.7) | 0.7 (0.5) | −0.3 (−0.5 to −0.1) | 0.01a |
| HBGI | 6.0 (3.2) | 5.3 (2.8) | −0.7 (−2.2 to 0.8) | 0.31 |
| Overnight (12 am to 6 am) | ||||
| Mean CGM glucose | 159.6 (23.6) | 153.9 (22.7) | −5.8 (−20.2 to 8.6) | 0.39 |
| Median CGM glucose | 150.2 (25.1) | 148.6 (24.7) | −1.6 (−15.1 to 12.0) | 0.80 |
| SD CGM glucose | 57.8 (14.3) | 48.5 (14.4) | −9.3 (−19.8 to 1.2) | 0.08 |
| CV CGM glucose (%) | 36.2 (6.9) | 31.8 (8.9) | −4.5 (−9.7 to 0.8) | 0.09 |
| %Time <54 mg/dL | 0.6 (1.2) | 0.6 (1.1) | −0.0 (−0.9 to 0.9) | NS |
| %Time <60 mg/dL | 1.3 (1.6) | 1.2 (2.1) | −0.1 (−1.5 to 1.3) | 0.87 |
| %Time <70 mg/dL | 2.6 (2.5) | 2.8 (4.0) | 0.1 (−2.3 to 2.5) | 0.92 |
| %Time 70–140 mg/dL | 42.0 (13.9) | 43.4 (16.7) | 1.4 (−8.7 to 11.5) | 0.76 |
| %Time 70–180 mg/dL | 67.0 (15.5) | 70.4 (14.9) | 3.4 (−7.7 to 14.4) | 0.51 |
| %Time >180 mg/dL | 30.3 (16.8) | 26.9 (16.2) | −3.5 (−15.2 to 8.3) | 0.52 |
| %Time >250 mg/dL | 10.6 (10.0) | 5.5 (7.3) | −5.1 (−10.7 to 0.6) | 0.08 |
| %Time >300 mg/dL | 3.7 (5.5) | 1.9 (3.9) | −1.8 (−5.7 to 2.1) | 0.33 |
| LBGI | 0.8 (0.6) | 0.7 (0.9) | −0.1 (−0.6 to 0.4) | 0.60 |
| HBGI | 7.3 (3.8) | 5.9 (3.4) | −1.4 (−3.7 to 0.9) | 0.21 |
a
Denotes the estimated differences satisfying significance threshold of 0.05.
CGM, continuous glucose monitor; CV, coefficient of variation; HBGI, high blood glucose index; LBGI, low blood glucose index; SD, standard deviation; NS, not significant.