Table 1.
Participant Characteristics
| Overall |
<7 years |
7–<14 years |
14–<25 years |
25–<50 years |
≥50 years |
|
|---|---|---|---|---|---|---|
| n = 558 | n = 67 | n = 169 | n = 87 | n = 192 | n = 43 | |
| Age at enrollment (years), n | 558 | 67 | 169 | 87 | 192 | 43 |
| Mean ± SD | 23 ± 16 | 5 ± 1 | 10 ± 2 | 18 ± 3 | 35 ± 7 | 57 ± 5 |
| Range | 1–71 | 1–6 | 7–13 | 14–24 | 25–49 | 50–71 |
| Female | 310/547 (57%) | 31/65 (48%) | 80/163 (49%) | 51/86 (59%) | 122/190 (64%) | 26/43 (60%) |
| Race | ||||||
| White | 484/531 (91%) | 51/64 (80%) | 144/156 (92%) | 79/84 (94%) | 168/184 (91%) | 42/43 (98%) |
| Black/African American | 5/531 (<1%) | 2/64 (3%) | 0/156 (0%) | 2/84 (2%) | 1/184 (<1%) | 0/43 (0%) |
| Hispanic or Latino | 21/531 (4%) | 4/64 (6%) | 7/156 (4%) | 2/84 (2%) | 7/184 (4%) | 1/43 (2%) |
| Asian | 9/531 (2%) | 2/64 (3%) | 3/156 (2%) | 1/84 (1%) | 3/184 (2%) | 0/43 (0%) |
| More than one race | 12/531 (2%) | 5/64 (8%) | 2/156 (1%) | 0/84 (0%) | 5/184 (3%) | 0/43 (0%) |
| BMI (kg/m2), na | 266 | — | — | 34 | 190 | 42 |
| Mean ± SD | 26 ± 5 | — | — | 26 ± 5 | 27 ± 5 | 26 ± 4 |
| BMI percentile, nb | 268 | 60 | 157 | 51 | — | — |
| Median (quartiles) | 75% (51%, 89%) | 84% (69%, 96%) | 74% (50%, 86%) | 61% (32%, 82%) | — | — |
| Age at diabetes diagnosis (years), n | 543 | 63 | 162 | 85 | 190 | 43 |
| Mean ± SD | 11 ± 10 | 3 ± 1 | 6 ± 3 | 10 ± 5 | 16 ± 10 | 22 ± 13 |
| Duration of T1D (years), n | 543 | 63 | 162 | 85 | 190 | 43 |
| Median (quartiles) | 8 (4, 20) | 2 (2, 4) | 5 (3, 7) | 7 (4, 12) | 20 (12, 26) | 37 (26, 45) |
| Highest level of educationc | ||||||
| Less than high school | 5/544 (<1%) | 1/65 (2%) | 3/164 (2%) | 1/84 (1%) | 0/188 (0%) | 0/43 (0%) |
| High school graduate/some college | 71/544 (13%) | 2/65 (3%) | 15/164 (9%) | 21/84 (25%) | 26/188 (14%) | 7/43 (16%) |
| Bachelor's degree | 220/544 (40%) | 15/65 (23%) | 65/164 (40%) | 34/84 (40%) | 93/188 (49%) | 13/43 (30%) |
| Master's degree | 164/544 (30%) | 33/65 (51%) | 50/164 (30%) | 18/84 (21%) | 50/188 (27%) | 13/43 (30%) |
| Professional/doctorate degree | 84/544 (15%) | 14/65 (22%) | 31/164 (19%) | 10/84 (12%) | 19/188 (10%) | 10/43 (23%) |
| Annual household income | ||||||
| <$25,000 | 6/498 (1%) | 0/59 (0%) | 0/156 (0%) | 1/73 (1%) | 4/177 (2%) | 1/33 (3%) |
| $25,000–<50,000 | 27/498 (5%) | 0/59 (0%) | 2/156 (1%) | 9/73 (12%) | 11/177 (6%) | 5/33 (15%) |
| $50,000–<75,000 | 40/498 (8%) | 4/59 (7%) | 9/156 (6%) | 4/73 (5%) | 18/177 (10%) | 5/33 (15%) |
| $75,000–<100,000 | 77/498 (15%) | 15/59 (25%) | 16/156 (10%) | 8/73 (11%) | 34/177 (19%) | 4/33 (12%) |
| $100,000 or more | 348/498 (70%) | 40/59 (68%) | 129/156 (83%) | 51/73 (70%) | 110/177 (62%) | 18/33 (55%) |
| Type of insurance | ||||||
| Private health insurance | 513/546 (94%) | 59/65 (91%) | 158/164 (96%) | 81/84 (96%) | 180/190 (95%) | 35/43 (81%) |
| Public health insurance | 31/546 (6%) | 6/65 (9%) | 5/164 (3%) | 3/84 (4%) | 9/190 (5%) | 8/43 (19%) |
| Other | 2/546 (<1%) | 0/65 (0%) | 1/164 (<1%) | 0/84 (0%) | 1/190 (<1%) | 0/43 (0%) |
| Pump used with Loop | ||||||
| Medtronic Minimed | 36/558 (6%) | 2/67 (3%) | 1/169 (<1%) | 2/87 (2%) | 23/192 (12%) | 8/43 (19%) |
| Insulet Omnipod | 502/558 (90%) | 64/67 (96%) | 166/169 (98%) | 82/87 (94%) | 157/192 (82%) | 33/43 (77%) |
| Both | 20/558 (4%) | 1/67 (1%) | 2/169 (1%) | 3/87 (3%) | 12/192 (6%) | 2/43 (5%) |
| Severe hypo events in the previous 3 months (baseline, before Loop) | ||||||
| Total events | 247 | 53 | 92 | 24 | 43 | 35 |
| Experienced at least 1 event | 97/545 (18%) | 16/65 (25%) | 32/163 (20%) | 12/85 (14%) | 24/189 (13%) | 13/43 (30%) |
| Events per participant | ||||||
| 0 | 448 (82%) | 49 (75%) | 131 (80%) | 73 (86%) | 165 (87%) | 30 (70%) |
| 1 | 51 (9%) | 5 (8%) | 19 (12%) | 7 (8%) | 14 (7%) | 6 (14%) |
| 2 | 17 (3%) | 2 (3%) | 3 (2%) | 2 (2%) | 7 (4%) | 3 (7%) |
| ≥3 | 29 (5%) | 9 (14%) | 10 (6%) | 3 (4%) | 3 (2%) | 4 (9%) |
| DKA events in the previous 3 months (baseline, before Loop) | ||||||
| Total events | 23 | 1 | 8 | 3 | 8 | 3 |
| Experienced at least 1 event | 13/537 (2%) | 1/63 (2%) | 4/158 (3%) | 3/85 (4%) | 3/189 (2%) | 2/42 (5%) |
| Events per participant | ||||||
| 0 | 524 (98%) | 62 (98%) | 154 (97%) | 82 (96%) | 186 (98%) | 40 (95%) |
| 1 | 8 (1%) | 1 (2%) | 2 (1%) | 3 (4%) | 1 (<1%) | 1 (2%) |
| 2 | 1 (<1%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (2%) |
| ≥3 | 4 (<1%) | 0 (0%) | 2 (1%) | 0 (0%) | 2 (1%) | 0 (0%) |
| Follows a low-carb diet | 85/545 (16%) | 7/64 (11%) | 7/163 (4%) | 5/86 (6%) | 49/189 (26%) | 17/43 (40%) |
| Previously used automated insulin delivery system | 53/547 (10%) | 1/65 (2%) | 9/164 (5%) | 11/86 (13%) | 21/189 (11%) | 11/43 (26%) |
| Systems used in the past | ||||||
| Medtronic 670G | 37/53 (70%) | 0/1 (0%) | 5/9 (56%) | 7/11 (64%) | 18/21 (86%) | 7/11 (64%) |
| OpenAPS | 8/53 (15%) | 0/1 (0%) | 2/9 (22%) | 2/11 (18%) | 2/21 (10%) | 2/11 (18%) |
| AndroidAPS | 1/53 (2%) | 0/1 (0%) | 1/9 (11%) | 0/11 (0%) | 0/21 (0%) | 0/11 (0%) |
| Other | 10/53 (19%) | 1/1 (100%) | 3/9 (33%) | 2/11 (18%) | 2/21 (10%) | 2/11 (18%) |
| Type of insulin currently using | ||||||
| Apidra (glulisine) | 8/526 (2%) | 1/63 (2%) | 3/158 (2%) | 1/82 (1%) | 2/180 (1%) | 1/43 (2%) |
| Fiasp (rapid aspart) | 46/526 (9%) | 5/63 (8%) | 8/158 (5%) | 9/82 (11%) | 21/180 (12%) | 3/43 (7%) |
| Humalog (lispro) | 255/526 (48%) | 32/63 (51%) | 79/158 (50%) | 35/82 (43%) | 83/180 (46%) | 26/43 (60%) |
| Novolog (aspart) | 216/526 (41%) | 25/63 (40%) | 67/158 (42%) | 37/82 (45%) | 74/180 (41%) | 13/43 (30%) |
| Regular insulin | 1/526 (<1%) | 0/63 (0%) | 1/158 (<1%) | 0/82 (0%) | 0/180 (0%) | 0/43 (0%) |
| Bolus calculation method | ||||||
| Bolus calculator | 234/547 (43%) | 25/65 (38%) | 67/164 (41%) | 37/86 (43%) | 84/189 (44%) | 21/43 (49%) |
| Count carbohydrates | 226/547 (41%) | 31/65 (48%) | 83/164 (51%) | 34/86 (40%) | 69/189 (37%) | 9/43 (21%) |
| Experience | 68/547 (12%) | 4/65 (6%) | 7/164 (4%) | 12/86 (14%) | 32/189 (17%) | 13/43 (30%) |
| Other | 19/547 (3%) | 5/65 (8%) | 7/164 (4%) | 3/86 (3%) | 4/189 (2%) | 0/43 (0%) |
| GLP1-analog inhibitor use | 19/555 (3%) | 0/67 (0%) | 1/168 (<1%) | 2/87 (2%) | 14/190 (7%) | 2/43 (5%) |
| SGLT2-inhibitor use | 13/555 (2%) | 0/67 (0%) | 0/168 (0%) | 1/87 (1%) | 12/190 (6%) | 0/43 (0%) |
| Baseline HbA1c, n | 378 | 43 | 110 | 54 | 135 | 36 |
| Mean ± SD, % (mmol/mol) | 6.8 ± 1.0 (51 ± 10.9) | 6.8 ± 0.8 (51 ± 8.7) | 7.0 ± 0.8 (53 ± 8.7) | 7.1 ± 1.3 (54 ± 14.2) | 6.7 ± 1.0 (50 ± 10.9) | 6.6 ± 0.8 (49 ± 8.7) |
a
Reported for subjects 18 years of age or older.
b
Reported for subjects younger than 18 years of age.
c
For subjects younger than 18, indicates highest parental education.
APS, artificial pancreas system; BMI, body mass index; DKA, diabetic ketoacidosis; GLP-1, glucagon-like peptide 1; SD, standard deviation; SGLT2, sodium-glucose cotransporter-2; T1D, type 1 diabetes.