Table 1.
Participant Characteristics by Treatment Group
| BP (n = 112) | SC (n = 53) | |
|---|---|---|
| Age (years) | ||
| Mean ± SD | 12 ± 3 | 12 ± 3 |
| 6 to <12, n (%) | 47 (42) | 23 (43) |
| 12 to <18, n (%) | 65 (58) | 30 (57) |
| Range | 6–17 | 6–17 |
| Diabetes duration (years) | ||
| Mean ± SD | 6 ± 4 | 7 ± 4 |
| Range | 1–15 | 1–16 |
| HbA1c level at randomization (%) | ||
| Mean ± SD | 8.1 ± 1.2 | 7.8 ± 1.1 |
| ≤7.0%, n (%) | 18 (16) | 12 (23) |
| 7.1–7.9%, n (%) | 34 (30) | 19 (36) |
| 8.0–8.9%, n (%) | 33 (29) | 15 (28) |
| ≥9.0%, n (%) | 27 (24) | 7 (13) |
| Range | 6.1–12.2 | 5.8–10.6 |
| Sex—Female, n (%) | 55 (49) | 15 (28) |
| Race/Ethnicity group, n (%) | ||
| White non-Hispanic | 72 (64) | 36 (68) |
| Black non-Hispanic | 13 (12) | 3 (6) |
| Hispanic or Latino | 16 (14) | 8 (15) |
| Asian | 2 (2) | 2 (4) |
| American Indian/Alaskan Native | 1 (<1) | 0 (0) |
| More than one race | 6 (5) | 4 (8) |
| Unknown | 2 (2) | 0 (0) |
| Annual household income, n (%) | ||
| <$25,000 | 3 (3) | 1 (2) |
| $25,000–<$35,000 | 4 (4) | 1 (2) |
| $35,000–<$50,000 | 7 (6) | 2 (4) |
| $50,000–<$75,000 | 8 (7) | 5 (9) |
| $75,000–<$100,000 | 18 (16) | 8 (15) |
| $100,000–<$200,000 | 35 (31) | 17 (32) |
| ≥$200,000 | 31 (28) | 11 (21) |
| Unknown | 6 (5) | 8 (15) |
| Education,a n (%) | ||
| <Bachelor's | 37 (33) | 16 (30) |
| Bachelor's | 36 (32) | 17 (32) |
| >Bachelor's | 38 (34) | 18 (34) |
| Unknown | 1 (<1) | 2 (4) |
| Health insurance, n (%) | ||
| Private | 90 (80) | 40 (75) |
| Medicare/Medicaid | 16 (14) | 8 (15) |
| Other Government Insurance | 6 (5) | 4 (8) |
| None | 0 (0) | 0 (0) |
| Unknown | 0 (0) | 1 (2) |
| BMI | ||
| Percentileb (%), mean ± SD | 74% ± 24% | 66% ± 27% |
| <5th percentile, n (%) | 0 (0) | 2 (4) |
| 5th to <85th percentile, n (%) | 64 (57) | 37 (70) |
| 85th to <95th percentile, n (%) | 26 (23) | 8 (15) |
| ≥95th percentile, n (%) | 22 (20) | 6 (11) |
| Insulin/CGM device use, n (%) | ||
| MDI without CGM | 7 (6) | 0 (0) |
| MDI with CGM | 30 (27) | 21 (40) |
| Pump without CGM | 0 (0) | 1 (2) |
| Pump with CGM (without automation) | 45 (40) | 13 (25) |
| Pump with predictive low glucose suspend | 3 (3) | 3 (6) |
| HCL system | 27 (24) | 15 (28) |
| Currently using CGM, n (%) | 105 (94) | 52 (98) |
| c-Peptide (ng/mL)b | ||
| Mean ± SD | 0.039 ± 0.115 | 0.042 ± 0.098 |
| <0.007, n (%) | 77 (79) | 34 (72) |
| Total daily insulin (U/kg/day), median (IQR) | 0.90 (0.75, 1.14) | 0.87 (0.70, 1.10) |
| Time since most recent SH event,c n (%) | ||
| Never had an event | 93 (83) | 40 (75) |
| <3 months ago | 1 (<1) | 0 (0) |
| 3 to <6 months ago | 1 (<1) | 1 (2) |
| ≥6 months ago | 17 (15) | 12 (23) |
| Time since last DKA event, n (%) | ||
| Never had an event | 65 (58) | 29 (55) |
| <3 months ago | 0 (0) | 1 (2) |
| 3 to <6 months ago | 1 (<1) | 0 (0) |
| ≥6 months ago | 46 (41) | 23 (43) |
| Non-insulin blood sugar control medications taken, n (%) | ||
| Metformin | 1 (<1) | 0 (0) |
a
Highest education level of parent or guardian.
b
c-Peptide at randomization missing for 15 BP participants and 6 SC participants.
c
A severe hypoglycemic event is defined as a hypoglycemic event that (1) required assistance of another person due to altered consciousness and (2) required another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
BMI, body mass index; BP, bionic pancreas; CGM, continuous glucose monitoring; DKA, diabetic ketoacidosis; HCL, hybrid closed loop; IQR, interquartile range; SC, standard care; SD, standard deviation; SH, severe hypoglycemia.