Sensor-specific measures of glycemic control, adherence to advanced hybrid closed loop (a-HCL) use, insulin dose and basal-to-bolus ratio, meals and CHO intake, and a-HCL settings*
| . | Manual . | Auto Start . | PManual vs. Auto Start . | Auto 3M . | PManual vs. Auto 3M . | Auto 6M . | PManual vs. Auto 6M . | Auto 9M . | PManual vs. Auto 9M . | Auto 12M . | PManual vs. Auto 12M . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| n | 12 | 12 | 12 | 12 | 10 | 8 | |||||
| % TAR | 39.0 (35.0; 40.8) | 33.0 (25.0; 39.8) | 0.02 | 28.0 (19.3; 48.3) | NS | 32.5 (26.3; 38.0) | 0.01 | 34.5 (26.3; 37.5) | 0.02 | 30.5 (25.5; 40.3) | <0.01 |
| >250 mg/dL | 12.0 (10.0; 16.8) | 8.0 (5.0; 9.8) | 0.01 | 7.0 (2.8; 15.8) | NS | 9.5 (4.0; 11.0) | 0.02 | 8.0 (4.8; 12.3) | NS | 8.5 (3.3; 14.8) | 0.01 |
| 180–250 mg/dL | 25.0 (23.0; 29.5) | 26.0 (20.0; 26.0) | NS | 21.5 (16.0; 26.5) | NS | 23.5 (21.3; 26.3) | 0.01 | 22.5 (20.5; 25.0) | NS | 23.0 (19.5; 26.8) | 0.01 |
| % TIR | 57.0 (51.0; 62.8) | 65.5 (58.3; 71.3) | <0.01 | 67.0 (49.3; 76.5) | NS | 63.5 (58.8; 68.0) | <0.01 | 63.5 (60.0; 70.8) | 0.02 | 66.5 (57.3; 70.5) | <0.01 |
| % TBR | 4.0 (2.3; 5.0) | 2.5 (2.0; 3.8) | 0.01 | 4.0 (1.3; 4.8) | NS | 3.0 (1.0; 6.5) | NS | 3.0 (0.8; 4.3) | NS | 3.5 (1.3; 4.0) | 0.04 |
| 54–70 mg/dL | 3.0 (2.3; 4.0) | 2.0 (2.0; 3.0) | 0.04 | 3.0 (1.3; 3.8) | NS | 3.0 (1.0; 4.8) | NS | 2.0 (0.8; 3.0) | 0.04 | 2.5 (1.3; 3.0) | 0.01 |
| <54 mg/dL | 1.0 (0.0; 1.0) | 0.0 (0.0; 1.0) | NS | 1.0 (0.0; 1.0) | NS | 0.5 (0.0; 1.8) | NS | 0.5 (0.0; 1.0) | NS | 0.5 (0.0; 1.8) | NS |
| % time in Auto Mode | 98 (96; 100) | 99 (97; 100) | 100 (98; 100) | 100 (97; 100) | 99 (98; 100) | ||||||
| % time of sensor wear | 94 (73; 98) | 98 (95; 98) | 0.03 | 96 (93; 98) | NS | 95 (93; 97) | NS | 95 (94; 97) | NS | 96 (93; 97) | NS |
| Mean glucose sensor (mg/dL) | 166 (163; 173) | 160 (145; 166) | 0.02 | 151 (140; 185) | NS | 159 (149; 169) | 0.02 | 162 (146; 169) | NS | 159 (145; 174) | 0.02 |
| SD glucose sensor (mg/dL) | 68 (63; 77) | 58 (56; 62) | <0.01 | 58 (51; 65) | NS | 59 (54; 67) | 0.01 | 60 (53; 68) | 0.03 | 62 (52; 70) | <0.01 |
| CV (%) | 38.9 (32.5; 43.3) | 37.4 (35.4; 38.6) | 0.03 | 37.5 (33.5; 40.2) | 0.01 | 38.0 (35.2; 41.0) | NS | 38.6 (35.9; 41.2) | NS | 40.1 (36.0; 41.0) | NS |
| GMI (%) | 7.3 (6.6; 7.7) | 7.1 (6.8; 7.3) | NS | 7.0 (6.7; 7.8) | NS | 7.1 (6.8; 7.4) | NS | 7.2 (6.8; 7.3) | NS | 7.1 (6.8; 7.5) | NS |
| Total daily dose (units/day) | 8.9 (6.0; 10.7) | 8.7 (6.6; 11.6) | NS | 12.3 (7.2; 18.1) | NS | 13.7 (7.7; 20.0) | 0.03 | 16.7 (7.5; 21.3) | 0.03 | 17.8 (11.5; 23.9) | <0.01 |
| Total daily dose (units/kg/day) | 0.60 (0.38; 0.78) | 0.54 (0.43; 0.64) | NS | 0.65 (0.50; 0.77) | NS | 0.68 (0.49; 0.94) | NS | 0.78 (0.48; 0.93) | NS | 0.85 (0.61; 1.14) | NS |
| Bolus (%) | 50 (43; 58) | 57 (53; 61) | 0.03 | 62 (56; 64) | <0.01 | 60 (52; 62) | 0.04 | 57 (54; 60) | NS | 58 (54; 62) | NS |
| Correction (%) | 30 (19; 37) | 32 (14; 53) | 32 (19; 47) | 35 (19; 48) | 38 (28; 49) | ||||||
| Basal (%) | 50 (42; 57) | 44 (39; 47) | 0.03 | 39 (36; 44) | <0.01 | 41 (38; 48) | 0.04 | 43 (40; 46) | NS | 43 (38; 46) | NS |
| Meals per day | 3.4 (3.0; 3.9) | 3.9 (3.5; 4.5) | NS | 4.3(4,0; 5.6) | NS | 4.9 (3.7; 5.5) | NS | 5.0 (3.5; 5.8) | NS | 4.8 (4.4; 5.6) | <0.01 |
| CHO (g/day) | 119 (80; 139) | 131 (82; 160) | 0.03 | 116 (99; 160) | NS | 127 (98; 160) | NS | 122 (90; 140) | NS | 124 (97; 164) | 0.01 |
| SD CHO (g/day) | 26 (19; 33) | 20 (12; 24) | 0.03 | 28 (18; 33) | NS | 28 (22; 46) | NS | 30 (21; 45) | NS | 27 (17; 41) | NS |
| CHO (g/kg/day) | 6.40 (5.50; 7.98) | 6.35 (5.48; 7.95) | NS | 6.95 (5.75; 7.40) | NS | 6.45 (5.95; 7.93) | NS | 6.70 (5.15; 7.23) | NS | 6.40 (5.00; 7.40) | NS |
| Glycemic target (mg/dL) | 120 (103; 120) | 120 (110; 120) | 115 (110; 120) | 110 (100; 120) | 110 (100; 120) | ||||||
| 120 mg/dL | 67% | 58% | 17% | 30% | 37% | ||||||
| 110 mg/dL | 8% | 25% | 33% | 40% | 25% | ||||||
| 100 mg/dL | 25% | 17% | 50% | 30% | 37% | ||||||
| AIT (h) | 3.0 (2.6; 4.0) | 3.0 (2.5; 3.0) | 3.0 (2.5; 3.4) | 2.5 (2.0; 3.1) | 2.3 (2.0; 2.5) |
| . | Manual . | Auto Start . | PManual vs. Auto Start . | Auto 3M . | PManual vs. Auto 3M . | Auto 6M . | PManual vs. Auto 6M . | Auto 9M . | PManual vs. Auto 9M . | Auto 12M . | PManual vs. Auto 12M . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| n | 12 | 12 | 12 | 12 | 10 | 8 | |||||
| % TAR | 39.0 (35.0; 40.8) | 33.0 (25.0; 39.8) | 0.02 | 28.0 (19.3; 48.3) | NS | 32.5 (26.3; 38.0) | 0.01 | 34.5 (26.3; 37.5) | 0.02 | 30.5 (25.5; 40.3) | <0.01 |
| >250 mg/dL | 12.0 (10.0; 16.8) | 8.0 (5.0; 9.8) | 0.01 | 7.0 (2.8; 15.8) | NS | 9.5 (4.0; 11.0) | 0.02 | 8.0 (4.8; 12.3) | NS | 8.5 (3.3; 14.8) | 0.01 |
| 180–250 mg/dL | 25.0 (23.0; 29.5) | 26.0 (20.0; 26.0) | NS | 21.5 (16.0; 26.5) | NS | 23.5 (21.3; 26.3) | 0.01 | 22.5 (20.5; 25.0) | NS | 23.0 (19.5; 26.8) | 0.01 |
| % TIR | 57.0 (51.0; 62.8) | 65.5 (58.3; 71.3) | <0.01 | 67.0 (49.3; 76.5) | NS | 63.5 (58.8; 68.0) | <0.01 | 63.5 (60.0; 70.8) | 0.02 | 66.5 (57.3; 70.5) | <0.01 |
| % TBR | 4.0 (2.3; 5.0) | 2.5 (2.0; 3.8) | 0.01 | 4.0 (1.3; 4.8) | NS | 3.0 (1.0; 6.5) | NS | 3.0 (0.8; 4.3) | NS | 3.5 (1.3; 4.0) | 0.04 |
| 54–70 mg/dL | 3.0 (2.3; 4.0) | 2.0 (2.0; 3.0) | 0.04 | 3.0 (1.3; 3.8) | NS | 3.0 (1.0; 4.8) | NS | 2.0 (0.8; 3.0) | 0.04 | 2.5 (1.3; 3.0) | 0.01 |
| <54 mg/dL | 1.0 (0.0; 1.0) | 0.0 (0.0; 1.0) | NS | 1.0 (0.0; 1.0) | NS | 0.5 (0.0; 1.8) | NS | 0.5 (0.0; 1.0) | NS | 0.5 (0.0; 1.8) | NS |
| % time in Auto Mode | 98 (96; 100) | 99 (97; 100) | 100 (98; 100) | 100 (97; 100) | 99 (98; 100) | ||||||
| % time of sensor wear | 94 (73; 98) | 98 (95; 98) | 0.03 | 96 (93; 98) | NS | 95 (93; 97) | NS | 95 (94; 97) | NS | 96 (93; 97) | NS |
| Mean glucose sensor (mg/dL) | 166 (163; 173) | 160 (145; 166) | 0.02 | 151 (140; 185) | NS | 159 (149; 169) | 0.02 | 162 (146; 169) | NS | 159 (145; 174) | 0.02 |
| SD glucose sensor (mg/dL) | 68 (63; 77) | 58 (56; 62) | <0.01 | 58 (51; 65) | NS | 59 (54; 67) | 0.01 | 60 (53; 68) | 0.03 | 62 (52; 70) | <0.01 |
| CV (%) | 38.9 (32.5; 43.3) | 37.4 (35.4; 38.6) | 0.03 | 37.5 (33.5; 40.2) | 0.01 | 38.0 (35.2; 41.0) | NS | 38.6 (35.9; 41.2) | NS | 40.1 (36.0; 41.0) | NS |
| GMI (%) | 7.3 (6.6; 7.7) | 7.1 (6.8; 7.3) | NS | 7.0 (6.7; 7.8) | NS | 7.1 (6.8; 7.4) | NS | 7.2 (6.8; 7.3) | NS | 7.1 (6.8; 7.5) | NS |
| Total daily dose (units/day) | 8.9 (6.0; 10.7) | 8.7 (6.6; 11.6) | NS | 12.3 (7.2; 18.1) | NS | 13.7 (7.7; 20.0) | 0.03 | 16.7 (7.5; 21.3) | 0.03 | 17.8 (11.5; 23.9) | <0.01 |
| Total daily dose (units/kg/day) | 0.60 (0.38; 0.78) | 0.54 (0.43; 0.64) | NS | 0.65 (0.50; 0.77) | NS | 0.68 (0.49; 0.94) | NS | 0.78 (0.48; 0.93) | NS | 0.85 (0.61; 1.14) | NS |
| Bolus (%) | 50 (43; 58) | 57 (53; 61) | 0.03 | 62 (56; 64) | <0.01 | 60 (52; 62) | 0.04 | 57 (54; 60) | NS | 58 (54; 62) | NS |
| Correction (%) | 30 (19; 37) | 32 (14; 53) | 32 (19; 47) | 35 (19; 48) | 38 (28; 49) | ||||||
| Basal (%) | 50 (42; 57) | 44 (39; 47) | 0.03 | 39 (36; 44) | <0.01 | 41 (38; 48) | 0.04 | 43 (40; 46) | NS | 43 (38; 46) | NS |
| Meals per day | 3.4 (3.0; 3.9) | 3.9 (3.5; 4.5) | NS | 4.3(4,0; 5.6) | NS | 4.9 (3.7; 5.5) | NS | 5.0 (3.5; 5.8) | NS | 4.8 (4.4; 5.6) | <0.01 |
| CHO (g/day) | 119 (80; 139) | 131 (82; 160) | 0.03 | 116 (99; 160) | NS | 127 (98; 160) | NS | 122 (90; 140) | NS | 124 (97; 164) | 0.01 |
| SD CHO (g/day) | 26 (19; 33) | 20 (12; 24) | 0.03 | 28 (18; 33) | NS | 28 (22; 46) | NS | 30 (21; 45) | NS | 27 (17; 41) | NS |
| CHO (g/kg/day) | 6.40 (5.50; 7.98) | 6.35 (5.48; 7.95) | NS | 6.95 (5.75; 7.40) | NS | 6.45 (5.95; 7.93) | NS | 6.70 (5.15; 7.23) | NS | 6.40 (5.00; 7.40) | NS |
| Glycemic target (mg/dL) | 120 (103; 120) | 120 (110; 120) | 115 (110; 120) | 110 (100; 120) | 110 (100; 120) | ||||||
| 120 mg/dL | 67% | 58% | 17% | 30% | 37% | ||||||
| 110 mg/dL | 8% | 25% | 33% | 40% | 25% | ||||||
| 100 mg/dL | 25% | 17% | 50% | 30% | 37% | ||||||
| AIT (h) | 3.0 (2.6; 4.0) | 3.0 (2.5; 3.0) | 3.0 (2.5; 3.4) | 2.5 (2.0; 3.1) | 2.3 (2.0; 2.5) |
AIT, active insulin time; CHO, carbohydrates; CV, coefficient of variation; GMI, glucose management indicator; NS, not significant; SD, standard deviation; TAR, time above range; TIR, time in range; TBR, time below range.
From reports generated with CareLink Personal software with observation time frames of 2 weeks, at insulin pump start in Manual Mode (Manual), at the beginning of Auto Mode (Auto Start), and after 3 months (Auto 3M), 6 months (Auto 6M), 9 months (Auto 9M), and 12 months (Auto 12M) of treatment.