Glucose and Psychosocial Outcomes 12 Months Following Transition from Multiple Daily Injections to Advanced Hybrid Closed Loop in Youth with Type 1 Diabetes and Suboptimal Glycemia.

Objective: To investigate 12-month glycemic and psychosocial changes following transition from multiple daily injections (MDI) to advanced hybrid closed-loop (AHCL) therapy in youth (aged 13-25 years) with type 1 diabetes and suboptimal glycemia (glycated hemoglobin [HbA1c] ≥8.5% [69 mmol/mol]). Research Design and Methods: Prospective, single arm, dual-center study in 20 participants. Extension phase outcomes reported after 12 months, including HbA1c, time in glycemic ranges, AHCL system performance, and psychosocial questionnaires assessing quality of life, diabetes treatment, and sleep. Results: After 12 months, 19 out of 20 participants continued to use AHCL. Average time-in-range 70-180 mg/dL (3.9-10.0 mmol/L) improved from 27.6% ± 13.2% to 62.5% ± 11.4%. This translated to an average 2.5 percentage-point (27.1 mmol/mol) improvement in HbA1c from 10.5% ± 2.1% (91.2 mmol/mol) at baseline to 8.0% ± 0.9% (64.1 mmol/mol) at 12 months. Psychosocial questionnaires and very high HbA1c at study entry indicated significant diabetes-associated burden for both individuals and parents. After 12 months, improvements were observed in general and diabetes-specific health-related quality of life, as well as in diabetes treatment satisfaction. Safety data were reassuring with a diabetic ketoacidosis rate of 0.15 per participant-year after 12 months of AHCL (compared to 0.25 per participant-year in the 12 months before the study). Conclusions: After 12 months of AHCL usage, this study highlights the potential for substantial and sustained glycemic and psychosocial improvements among individuals experiencing considerable diabetes burden and suboptimal glycemia, following their switch from MDI to AHCL.

Effects of 12-Week Freestyle Libre 2.0 in Children with Type 1 Diabetes and Elevated HbA1c: A Multicenter Randomized Controlled Trial.

Objective: To investigate whether intermittently scanned continuous glucose monitoring (isCGM) reduced glycated hemoglobin (HbA1c) compared with capillary self-monitored capillary blood glucose (SMBG) in children with type 1 diabetes (T1D) and elevated glycemic control. Research Design and Methods: This multicenter 12-week 1:1 randomized, controlled, parallel-arm trial included 100 participants with established T1D aged 4-13 years (mean 10.9 ± 2.3 years) naive to isCGM and with elevated HbA1c 7.5%-12.2% [58-110 mmol/mol] [mean HbA1c was 9.05 (1.3)%] [75.4 (13.9) mmol/mol]. Participants were allocated to 12-week intervention (isCGM; FreeStyle Libre 2.0; Abbott Diabetes Care, Witney, United Kingdom) (n = 49) or control (SMBG; n = 51). The primary outcome was the difference in change of HbA1c from baseline to 12 weeks. Results: There was no evidence of a difference between groups for change in HbA1c at 12 weeks (0.23 [95% confidence interval; CI: -0.21 to 0.67], P = 0.3). However, glucose-monitoring frequency increased with isCGM +4.89/day (95% CI 2.97-6.81; P < 0.001). Percent time below range (TBR) <3.9 mmol/L (70-180 mg/dL) was reduced with isCGM -6.4% (10.6 to -4.2); P < 0.001. There were no differences in within group changes for Parent or Child scores of psychosocial outcomes at 12 weeks. Conclusions: For children aged 4-13 years with elevated Hba1c isCGM led to improvements in glucose testing frequency and reduced time below range. However, isCGM did not translate into reducing Hba1c or psychosocial outcomes compared to usual care over 12-weeks. The trial is registered within the Australian New Zealand Trial Registry on February 19, 2020 (ACTRN12620000190909p; ANZCTR.org.au) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1237-0090).