With availability of advanced hybrid closed loop (aHCL) systems in Australia, there is a need to evaluate whether improvements reported in clinical trials (1) are reflected in real-world outcomes (2). The aims of this study were to measure glycaemic outcomes in youth commencing Control IQ (CIQ), and to evaluate the model of care for aHCL initiation.
Youth with Type 1 diabetes (T1D) starting CIQ from April 2022 were included. On-line education, baseline telehealth review with structured follow-up was provided until pre-defined benchmarks for system use were met. 2-week CGM metrics were collected prospectively at baseline (BL) and at 1 and 3 months post-CIQ start. Outcomes included time in range (TIR 3.9-10 mmol/l), time below range (TBR < 3.9 and <3 mmol/l), time above range (TAR 10.1-13.9 and >13.9 mmol/L) and number of reviews required to meet all benchmarks.
37 youth, mean (SD) age 13(2.7) years, diabetes duration 4.8 (3.2) years, HbA1c 7.4 (0.9)% were included. TIR increased from 60.5 (15.4)% at BL to 68.1 (11.1)% and 67.7 (14.2)% at 1 month (p<0.001) and 3 months (p = 0.009) respectively. TBR was unchanged (BL vs 3 months <3.9: 1.7% vs 1.5%, p=0.400, < 3.0: 0.4% vs 0.4%, p=0.844). TAR 10.1-13.9 reduced from 23 (5.9)% at BL to 19.4 (6.4)% and 19.0 (6.5)% at 1 and 3 months respectively (p = 0.004). TAR > 13.9 was 14.4 (11.8)% at baseline, 9.4 (6.9)% at 1 month (p=0.004) and 11.5 (10.5)% at 3 months (p = 0.162). 28/37 (76%) youth met all pre-defined benchmarks at the first post-CIQ review; 8/37 and 1/37 required 2 and 3 reviews respectively.
With structured education and follow-up, glycaemic outcomes in real-world use of CIQ technology approach those seen in clinical trials. Ongoing evaluation will be important to ensure results in early adopters are mirrored in subsequent cohorts.