Objective: To determine perceptions of the impact of Control-IQ™ technology (CIQ) on psychosocial functioning and quality of life (QoL) in children/ youth with T1D and their parents, using patient and parent reported outcome measures (PROMs) .
Research Design and Methods: Single-center prospective real-world study of 6-18 year olds with T1D using the t:slim X2™ insulin pump, who were initiating CIQ. Youth (≥ 8years) and parents completed validated PROMs at baseline and end of study (16 weeks) . INSPIRE (INsulin delivery Systems: Perceptions, Ideas, Reflections and Expectations) end of study scores were the primary outcome with a score > 60 considered to indicate a perceived benefit of CIQ on psychosocial functioning and QoL. Glycemic control measures were recorded at baseline and every 4 weeks.
Results: In total, 65 children/youth with T1D participated; 50.8% female, median (IQR) age 13.9 (11.1, 15.7) years and T1D duration 6.2 (3.1, 8.4) years. INSPIRE end of study mean (SD) scores were 73.0 (11.6) for youth (n=49) and 70.7 (12.2) for parents (n=45) , both significantly > 60 (p < 0.001) . Diabetes Impact and Devices Satisfaction - Device Satisfaction subscale score increased by a mean (95% CI) of 0.43 (0.11, 0.74) in youth (p = 0.01) and 0.58 (0.31, 0.85) in parents (p<0.001) . WHO-5 well-being index median (IQR) score increased from 60 (48, 76) to 72 (60, 80) (p=0.25) in youth, and from 68 (55, 76) to 76 (68, 80) (p=0.002) in parents. Hypoglycemia Fear Survey mean (SD) score improved from 1.7 (0.6) to 1.4 (0.5) (p=0.01) in youth and from 2.0 (0.7) to 1.7 (0.6) (p<0.001) in parents. Time in range improved from 50.8% (baseline) to 62.2% (4 weeks) , with mean difference (95% CI) 9.62 (7.01, 12.23) , p<0.001; this was sustained to 16 weeks.
Conclusions: Initiation of CIQ in a real-world setting significantly improved measures of psychosocial functioning and QoL in children/youth with T1D and their parents. The change tended to be greater for parents than youth.
C.S.Zuijdwijk: Other Relationship; Medtronic, Research Support; Tandem Diabetes Care, Inc. J.Courtney: None. N.Mitsakakis: None. L.Hayawi: None. S.E.Lawrence: Advisory Panel; Pfizer Inc., Research Support; Tandem Diabetes Care, Inc.
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