Table 2.
Changes in Glycemic Control and Youth and Parent Person-Reported Outcome Measures During the 6-Month Intervention
| Baseline | Study period |
Change* | P ** | ||
|---|---|---|---|---|---|
| 3 Months | 6 Months | ||||
| Time in range (%) (70–180 mg/dL) | 12.3 (6.3, 27.1) | 43.4 (37.5, 46.9) | 23.7 (95% CI 16.9 to 30.5) | P < 0.001 | |
| HbA1c (%) | 11.7 (10.8, 13.0) | 9.0 (8.2, 9.6) | 9.0 (8.4, 10.6) | Baseline–3 months: −2.5% (95% CI −3.1% to −2.0%) | Baseline–3 months: P < 0.001 |
| Baseline–6 months: −2.1 (95% CI −3.1% to −1.1%) | Baseline–6 months: P < 0.001 | ||||
| Mean glucose (mg/dL) | 297 (255, 336) | 207 (199, 220) | −78 (95% CI −104 to −52) | P < 0.001 | |
| Coefficient of variation (%) | 30.3 (22.1, 33.4) | 39.0 (35.6, 40.9) | 9.8 (95% CI 4.1 to 15.6) | P < 0.001 | |
| Time above range (%) (>300 mg/dL) | 49.1 (39.4, 71.0) | 16.7 (9.8, 21.4) | −33.5 (95% CI −45.3 to −21.7) | P < 0.001 | |
| Time above range (%) (>250 mg/dL) | 69.4 (51.6, 84.0) | 30.1 (22.0, 38.1) | −33.9 (95% CI −44.8 to −23.1) | P < 0.001 | |
| Time above range (%) (>180 mg/dL) | 86.5 (70.5, 93.6) | 55.6 (52.5, 61.7) | −23.9 (95% CI −31.0 to −16.8) | P < 0.001 | |
| Time below range (%) (<70 mg/dL) | 0.2 (0.0, 0.8) | 0.7 (0.5, 1.2) | 0.2 (95% CI −0.5 to 0.9) | P = 0.63 | |
| Time below range (%) (<54 mg/dL) | 0.1 (0.0, 0.3) | 0.2 (0.1, 0.3) | 0.1 (95% CI −0.2 to 0.4) | P = 0.62 | |
| Time in HCL (%) | — | 78.3 (59.7, 87.3) | — | — | |
| Boluses per day | — | 10.1 (9.2, 11.9) | — | — | |
| User-initiated boluses (%) | — | 28.3 (20.7, 36.2) | — | — | |
| System-initiated boluses (%) | — | 71.7 (63.8, 79.3) | — | — | |
| T1DAL | |||||
| Parent | 59.2 (55.0, 68.2) | 73.4 (60.7, 78.1) | 72.2 (62.0, 81.2) | Baseline–3 months: 10.0 (95% CI 3.7 to 16.2) | Baseline–3 months: P = 0.002 |
| Baseline–6 months: 9.3 (95% CI 4.5 to 14.1) | Baseline–6 months: P < 0.001 | ||||
| Youth | 58.7 (58.3, 67.3) | 65 (58.3, 68.5) | 68.5 (58.7, 72.8) | Baseline–3 months: 5.2 (95% CI 0.4 to 9.9) | Baseline–3 months: P = 0.04 |
| Baseline–6 months: 8.1 (95% CI 2.6 to 13.7) | Baseline–6 months: P = 0.004 | ||||
| PAID | |||||
| Parent | 73.3 (65.0, 76.3) | 45.0 (30.4, 67.7) | 45.0 (22.7, 73.3) | Baseline–3 months: −19.7 (95% CI −29.6 to −9.8) | Baseline–3 months: P < 0.001 |
| Baseline–6 months: −22.8 (95% CI −34.8 to −10.8) | Baseline–6 months: P < 0.001 | ||||
| Youth | 44.3 (27.1, 58.6) | 24.3 (21.4, 47.1) | 22.9 (9.1, 34.3) | Baseline–3 months: −11.1 (95% CI −19.1 to −3.1) | Baseline–3 months: P = 0.006 |
| Baseline–6 months: −17.7 (95% CI −30.1 to −5.4) | Baseline–6 months: P = 0.005 | ||||
| INSPIRE | |||||
| Parent | 95.2 (73.7, 100) | 83.7 (73.7, 97.2) | 81.3 (70.3, 95.2) | Baseline–3 months: −2.9 (95% CI −9.6 to 3.8) | Baseline–3 months: P = 0.40 |
| Baseline–6 months: −5.3 (95% CI −11.7 to 1.2) | Baseline–6 months: P = 0.11 | ||||
| Youth | 77.9 (73.5, 88.2) | 79.4 (70.6, 84.4) | 79.4 (71.1, 80.9) | Baseline–3 months: −2.6 (95% CI −7.3 to 2.2) | Baseline–3 months: P = 0.29 |
| Baseline–6 months: −1.2 (95% CI −9.0 to 6.6) | Baseline–6 months: P = 0.76 | ||||
| DMQ | |||||
| Parent | 58.8 (51.3, 73.8) | 73.1 (65.0, 80.6) | 72.5 (61.9, 77.5) | Baseline–3 months: 9.1 (95% CI 1.0 to 17.3) | Baseline–3 months: P = 0.03 |
| Baseline–6 months: 5.8 (95% CI −3.1 to 14.7) | Baseline–6 months: P = 0.20 | ||||
| Youth | 63.8 (53.8, 70) | 70.0 (63.1, 78.1) | 67.5 (61.3, 72.5) | Baseline–3 months: 9.2 (95% CI 1.8 to 16.7) | Baseline–3 months: P = 0.02 |
| Baseline–6 months: 7.8 (95% CI −0.7 to 16.2) | Baseline–6 months: P = 0.08 | ||||
Note: Values for each timepoint reported as median (IQR).
*
Change reported as coefficient and 95% CI for multilevel mixed-effects regression analyses.
**
P-values reported reflect differences between baseline and the 90-day study period unless otherwise noted.
CI, confidence interval; DMQ, Diabetes Management Questionnaire; HbA1c, hemoglobin A1c; HCL, hybrid closed loop; INSPIRE, insulin delivery systems: perceptions, ideas, reflections, and expectations; PAID, problem areas in diabetes; T1DAL, Type 1 Diabetes and Life.