Psychosocial Outcomes with the Omnipod® 5 Automated Insulin Delivery System in Children and Adolescents with Type 1 Diabetes and Their Caregivers
Table 1
Characteristics of participants at baseline.
Characteristics
Children (6–11.9 years)
Adolescents (12–17.9 years)
N
83†
42
Age (years), [range]‡
9.4 ± 1.7 [6.0, 12.0]
14.0 ± 1.7 [12.0, 18.0]
Duration of diabetes (years)
4.3 ± 2.3 [0.6, 10.7]
6.7 ± 3.5 [1.1, 13.8]
Body-mass index (kg/m2), [range]§
17.8 ± 2.5 [13.7, 31.6]
21.4 ± 3.7 [16.0, 32.4]
Female sex-no. (%)
44 (53.0)
22 (52.4)
Race/Ethnicity-no. (%)¶
White
78 (94.0)
39 (92.9)
Hispanic or latino
8 (9.6)
0 (0.0)
Not hispanic or latino
70 (84.3)
39 (92.9)
Black or African American, white
2 (2.4)
1 (2.4)
Black or African American
2 (2.4)
—
Asian, white
1 (1.2)
1 (2.4)
Asian, native Hawaiian or pacific islander, white
—
1 (2.4)
Time in range (TIR) 70–180 mg/dL (%)
55.1 ± 14.8
49.6 ± 16.2
TIR >70%-no. (%)
16 (19.3)
6 (14.3)
HbA1c (%), [range]††
7.5 ± 0.9 [5.8, 9.8]
7.9 ± 1.0 [5.8, 10.3]
HbA1c (mmol/mol), [range]††
58 ± 9.8 [40, 84]
63 ± 10.9 [40, 89]
HbA1c <7.0%-no. (%)
23 (27.8)
7 (16.7)
Previous‡‡ or current continuous glucose monitor use-no. (%)
82 (98.8)
39 (92.9)
Baseline standard therapy, MDI-no. (%)
8 (9.6)
7 (16.7)
Baseline standard therapy, pump-no. (%)
75 (90.4)
35 (83.3)
Tubeless pump
60 (72.3)
28 (66.7)
Tubed pump
With low glucose suspend capabilities
2 (2.4)
2 (4.8)
With predictive low glucose suspend capabilities
2 (2.4)
1 (2.4)
With hybrid closed-loop capabilities
7 (8.4)
4 (9.5)
Data are mean ± SD and range [minimum, maximum] or n (%). †One participant was removed from further psychosocial outcomes analysis due to a medical condition that removed them from the study. ‡Age was determined at the date of informed consent. §Body-mass index is the weight in kilograms divided by the square of the height in meters. ¶Race and ethnicity were reported by the participants and were not mutually exclusive. ††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. ‡‡Previous use is defined as having used the device for any duration in the past.
