Table 1.
Characteristics at baseline of the study participants in the modified intention-to-treat data set
| Characteristic | Children (age 6–13.9 years) | Adults (age 14–70 years) |
|---|---|---|
| n | 112 | 128 |
| Age (years) | 10.3 ± 2.2 (6.0, 14.0#) | 36.9 ± 13.9 (14.5, 69.8) |
| Duration of diabetes (years) | 4.7 ± 2.6 (0.6, 11.6) | 17.9 ± 11.6 (1.0, 51.0) |
| BMI (kg/m2) | 18.6 ± 3.2 (13.7, 32.4) | 26.6 ± 4.7 (18.9, 41.4) |
| Female sex, n (%) | 60 (53.6) | 78 (60.9) |
| Race/ethnicity, n (%)‡ | ||
| White | 104 (92.9) | 117 (91.4) |
| Hispanic or Latino | 8 (7.1) | 6 (4.7) |
| Not Hispanic or Latino | 96 (85.7) | 111 (86.7) |
| Black or African American, White | 3 (2.7) | — |
| Black or African American | 2 (1.8) | 5 (3.9) |
| Hispanic or Latino | — | 1 (0.8) |
| Not Hispanic or Latino | 2 (1.8) | 4 (3.1) |
| Asian | — | 2 (1.6) |
| Asian, White | 2 (1.8) | — |
| Asian, Native Hawaiian or Pacific Islander, White | 1 (0.9) | — |
| American Indian or Alaska Native, White | — | 1 (0.8) |
| American Indian or Alaska Native | — | 3 (2.3) |
| Hispanic or Latino | — | 3 (2.3) |
| Not Hispanic or Latino | — | 0 (0.0) |
| HbA1c (%)§ | 7.67 ± 0.95 (5.80, 10.30) | 7.16 ± 0.86 (5.20, 9.80) |
| HbA1c (mmol/mol)§ | 60 ± 10.4 (40, 89) | 55 ± 9.4 (33, 84) |
| Daily insulin dose (units/kg)ǁ | 0.85 ± 0.24 (0.25, 1.47) | 0.61 ± 0.22 (0.16, 1.31) |
| Previous¶ or current CGM use, n (%) | 108 (96.4) | 126 (98.4) |
| Previous¶ or current pump use, n (%) | 100 (89.3) | 115 (89.8) |
| Use of multiple daily injections as standard therapy method, n (%) | 13 (11.6) | 20 (15.6) |
Data are mean ± SD (minimum, maximum) unless otherwise indicated.
Age was determined at the date of informed consent. The birth date of one participant fell immediately after the informed consent date, resulting in inclusion in the children cohort despite the age being 14.0 years after rounding.
Race and ethnicity were reported by the participants and are displayed exactly as reported. As shown, several participants chose more than one racial category. Ethnicity delineation is shown for racial categories where at least one person identified as Hispanic or Latino.
Participant eligibility for the study was determined using a point-of-care HbA1c measurement performed at screening, which in some cases differed from the laboratory assessment displayed here and used for analysis.
Baseline total daily insulin dose was determined from data collected during the standard therapy phase.
Previous use is defined as having used the device for any duration in the past.