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Background/objective: The main objective of this study is to evaluate the incremental cost-effectiveness (ICER) of the Cambridge hybrid closed-loop automated insulin delivery (AID) algorithm versus usual care for children and adolescents with type 1 diabetes (T1D)., Methods: This multicenter, binational, parallel-controlled trial randomized 133 insulin pump using participants aged 6 to 18 years to either AID (n = 65) or usual care (n = 68) for 6 months. Both within-trial and lifetime cost-effectiveness were analyzed. Analysis focused on the treatment subgroup (n = 21) who received the much more reliable CamAPS FX hardware iteration and their contemporaneous control group (n = 24). Lifetime complications and costs were simulated via an updated Sheffield T1D policy model., Results: Within-trial, both groups had indistinguishable and statistically unchanged health-related quality of life, and statistically similar hypoglycemia, severe hypoglycemia, and diabetic ketoacidosis (DKA) event rates. Total health care utilization was higher in the treatment group. Both the overall treatment group and CamAPS FX subgroup exhibited improved HbA 1C (-0.32%, 95% CI: -0.59 to -0.04; P = .02, and -1.05%, 95% CI: -1.43 to -0.67; P < .001, respectively). Modeling projected increased expected lifespan of 5.36 years and discounted quality-adjusted life years (QALYs) of 1.16 (U.K. tariffs) and 1.52 (U.S. tariffs) in the CamAPS FX subgroup. Estimated ICERs for the subgroup were £19 324/QALY (United Kingdom) and -$3917/QALY (United States). For subgroup patients already using continuous glucose monitors (CGM), ICERs were £10 096/QALY (United Kingdom) and -$33 616/QALY (United States). Probabilistic sensitivity analysis generated mean ICERs of £19 342/QALY (95% CI: £15 903/QALY to £22 929/QALY) (United Kingdom) and -$28 283/QALY (95% CI: -$59 607/QALY to $1858/QALY) (United States)., Conclusions: For children and adolescents with T1D on insulin pump therapy, AID using the Cambridge algorithm appears cost-effective below a £20 000/QALY threshold (United Kingdom) and cost saving (United States)., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: MT reports receiving speaking and advisory fees from Eli Lilly, Novo Nordisk, Medtronic, and Abbott. RPW reports receiving grant support from MannKind, and Novo Nordisk, grant support and lecture fees from Dexcom, grant support, and advisory board fees from Eli Lilly, and grant support, travel support, and lecture fees from Tandem Diabetes Care. BAB reports receiving grant support, donated supplies, and advisory board fees from ConvaTec, grant support from Dexcom, grant support and honoraria from Insulet, grant support and advisory board fees from Medtronic MiniMed, and grant support from Tandem Diabetes Care. LADM reports grants from Medtronic. NM reports receiving grant support for devices from Medtronic. REJB reports receiving speaking honoraria from Eli Lilly and Springer Healthcare. SAW reports receiving consulting fees from Eli Lilly, Sanofi US Services, and Zealand, speaker honoraria from Dexcom, Insulet, Medtronic, and Tandem Diabetes Care, and grant support to his institution from Abbott and Medtronic. LK reports receiving grant support from Tandem Diabetes Care. CK reports receiving grant support from Tandem Diabetes Care. RWB reports receiving grant support and donated supplies from Abbott Diabetes Care, Ascensia Diabetes Care US, Beta Bionics, and Roche Diabetes Care, grant support, donated supplies, and consulting fees from Dexcom, Novo Nordisk, and Tandem Diabetes Care, grant support and consulting fees from Bigfoot Biomedical, and consulting fees from Eli Lilly and Insulet. RH reports receiving speaker honoraria from Eli Lilly, Dexcom and Novo Nordisk, receiving license fees from B. Braun and Medtronic; patents related to closed-loop, and being director at CamDiab. MEW reports patents related to closed-loop and being a consultant at CamDiab. JW reports receiving speaker honoraria from Ypsomed and Novo Nordisk. KKH reports receiving consulting fees from Cecelia Health and Havas Health. CKB reports receiving consultancy fees from CamDiab and speaker honoraria from Ypsomed, JMA, AT, JS, LD, FC, ND, AG, and DSF declare no competing financial interests exist.

Objective: We aimed to assess whether percentage of time spent in hypoglycemia during closed-loop insulin delivery differs by age group and time of day. Methods: We retrospectively analyzed data from hybrid closed-loop studies involving young children (2-7 years), children and adolescents (8-18 years), adults (19-59 years), and older adults (≥60 years) with type 1 diabetes. Main outcome was time spent in hypoglycemia <3.9 mmol/L (<70 mg/dL). Eight weeks of data for 88 participants were analyzed. Results: Median time spent in hypoglycemia over the 24-h period was highest in children and adolescents (4.4% [interquartile range 2.4-5.0]) and very young children (4.0% [3.4-5.2]), followed by adults (2.7% [1.7-4.0]), and older adults (1.8% [1.2-2.2]); P  < 0.001 for difference between age groups. Time spent in hypoglycemia during nighttime (midnight-05:59) was lower than during daytime (06:00-23:59) across all age groups. Conclusion: Time in hypoglycemia was highest in the pediatric age group during closed-loop insulin delivery. Hypoglycemia burden was lowest overnight across all age groups.

Aim: To examine changes in the lived experience of type 1 diabetes after use of hybrid closed loop (CL), including the CamAPS FX CL system., Materials and Methods: The primary study was conducted as an open-label, single-period, randomized, parallel design contrasting CL versus insulin pump (with or without continuous glucose monitoring). Participants were asked to complete patient-reported outcomes before starting CL and 3 and 6 months later. Surveys assessed diabetes distress, hypoglycaemia concerns and quality of life. Qualitative focus group data were collected at the completion of the study., Results: In this sample of 98 youth (age range 6-18, mean age 12.7 ± 2.8 years) and their parents, CL use was not associated with psychosocial benefits overall. However, the subgroup (n = 12) using the CamAPS FX system showed modest improvements in quality of life and parent distress, reinforced by both survey (p < .05) and focus group responses. There were no negative effects of CL use reported by study participants., Conclusions: Closed loop use via the CamAPS FX system was associated with modest improvements in aspects of the lived experience of managing type 1 diabetes in youth and their families. Further refinements of the system may optimize the user experience., (© 2022 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)