Introduction and Objective: The FreeDM2 randomized controlled trial (NCT05944432) demonstrated that real-time continuous glucose monitoring (CGM) with FreeStyle Libre 3 led to a significant improvement in A1c at 16 weeks, compared to self-monitoring of blood glucose (SMBG). This analysis assessed whether benefits are consistent across type 2 diabetes (T2DM) characteristics. Methods: The primary outcome, mean change from baseline in A1c at 16 weeks, was evaluated by age (60 vs ≥60 years), sex, BMI (30 vs ≥30 kg/m2), baseline A1c (≤9% vs 9% and ≤8% vs 8%), baseline time in range (TIR) (≤70% vs 70%) and the UK Index of Multiple Deprivation (IMD) by including treatment-subgroup interaction in the linear mixed model. Results: In total, 303 participants were randomized (mean±SD age 60.7±9.8 years, BMI 31.1±5.6 kg/m2, 67.3% male). Baseline A1c levels were 8.8±1.0% and 8.8±1.1% in the CGM and control groups, respectively, decreasing to 8.0±0.9% and 8.7±1.1% at 16 weeks (adjusted difference -0.6%; 95% CI −0.8, -0.3; p0.001). Improvements occurred regardless of age, sex, BMI and baseline A1c ≤9% vs 9% (Figure). No trends were observed across IMD deciles. Those with baseline A1c 9% had a greater reduction in A1c than those with A1c ≤9% (1.1% vs 0.4% respectively, p=0.0020). There were no other statistically significant interactions. Conclusion: These results support the efficacy of CGM across a broad range of T2DM characteristics. Disclosure L. Leelarathna: Research Support; Current; Abbott Diabetes. Speaker's Bureau; Current; Abbott Diabetes, Insulet Corporation. Consultant; Ended; Insulet Corporation. Advisory Panel; Ended; Vertex Pharmaceuticals Incorporated. P.J. Moore: None. T. Sathyapalan: Research Support; Current; Abbott. Advisory Panel; Current; Rhythm Pharmaceuticals, Inc., Eli Lilly and Company. P. Choudhary: Advisory Panel; Current; Medtronic. Speaker's Bureau; Current; Medtronic. Research Support; Current; Medtronic. Consultant; Current; Medtronic. Speaker's Bureau; Current; Abbott. Advisory Panel; Current; Abbott. Research Support; Current; Abbott. Speaker's Bureau; Current; Dexcom, Inc. Advisory Panel; Current; Dexcom, Inc. Research Support; Current; Dexcom, Inc. Consultant; Current; Dexcom, Inc. Speaker's Bureau; Current; Insulet Corporation. Advisory Panel; Current; Insulet Corporation. Research Support; Current; Insulet Corporation. Consultant; Current; Insulet Corporation. Speaker's Bureau; Current; Sanofi. Consultant; Current; Sanofi. Speaker's Bureau; Current; Lilly. Advisory Panel; Current; Lilly. Consultant; Current; Lilly. Advisory Panel; Current; Ypsomed AG. Advisory Panel; Ended; Embecta. Speaker's Bureau; Current; Roche Diabetes Care. Research Support; Current; Roche Diabetes Care. Consultant; Current; Roche Diabetes Care. Advisory Panel; Current; Vertex Pharmaceuticals Incorporated. Consultant; Current; Glooko, Inc., Cambridge Mechatronics Ltd, vTv Therapeutics. J. Lim: None. S. Neupane: Speaker's Bureau; Ended; Abbott Diabetes. Other - Paid to the employing National Health Service (NHS) Hospital Trust to run the research study.; Current; Abbott Diabetes. Other - Travel support to attend meeting; Ended; Novo Nordisk. A. Iqbal: Research Support; Current; Abbott Diabetes, Dexcom, Inc. Advisory Panel; Current; Sanofi. Speaker's Bureau; Current; Sanofi, Daiichi Sankyo, Eli Lilly and Company. M. Evans: Other - Triallist, speaker, advisory board; Current; Abbott Diabetes. Other - Research support, speaker, advisory board; Current; Novo Nordisk A/S. Other - Triallist, advisory board, speaker; Current; Sanofi. Other - Triallist, speakers fees; Current; Eli Lilly and Company. Other - Triallist, advisory board; Current; Medtronic. Other - Advisory board; Current; Dexcom, Inc. Advisory Panel; Current; Zucara Therapeutics, vTv Therapeutics. Other - Advisory panel, triallist; Current; Pila Pharma. G. Rayman: Research Support; Current; Abbott Diabetes. Speaker's Bureau; Ended; Eli Lilly and Company. H. Price: Other - Speaker fees; Ended; AstraZeneca. Other - Speaker fees; Current; Lilly, Novo Nordisk. R. Ajjan: Research Support; Current; Abbott Diabetes. Advisory Panel; Current; Abbott Diabetes. Speaker's Bureau; Current; Abbott Diabetes. Advisory Panel; Ended; Dexcom, Inc. Advisory Panel; Current; Eli Lilly and Company, Insulet Corporation. Speaker's Bureau; Ended; Boehringer Ingelheim International GmbH. Y.S. Cheah: Research Support; Current; Abbott Diabetes, Sanofi. A.N. Lumb: Research Support; Current; Abbott Diabetes. Research Support; Ended; Novo Nordisk A/S. Advisory Panel; Ended; Abbott Diabetes. Speaker's Bureau; Ended; Abbott Diabetes, Dexcom, Inc., Lilly Diabetes, Menarini Group, Novo Nordisk A/S, Sanofi. Advisory Panel; Ended; Dexcom, Inc., Insulet Corporation. Advisory Panel; Current; Medtronic, Roche Diabetes Care. S. Mostafa: None. I. Malik: None. I.C. Cranston: Advisory Panel; Current; Abbott Diabetes, Eli Lilly and Company. Advisory Panel; Ended; Glooko, Inc. Speaker's Bureau; Ended; Novo Nordisk. Advisory Panel; Current; Roche Diabetes Care. T. Min: None. E.B. Jude: Speaker's Bureau; Ended; Sanofi. Research Support; Ended; Abbott Diabetes. D. Sennik: Speaker's Bureau; Ended; AstraZeneca. J. McLaren: None. K. Barnard-Kelly: Research Support; Current; Abbott Diabetes, Dexcom, Inc. R.A. Elliott: None. T. Yates: None. E. Wilmot: Advisory Panel; Current; Abbott Diabetes. Speaker's Bureau; Current; Dexcom, Inc., Eli Lilly and Company. Advisory Panel; Current; Insulet Corporation. Consultant; Current; Roche Diabetes Care. Speaker's Bureau; Ended; Sanofi, Novo Nordisk. Advisory Panel; Ended; Medtronic. Speaker's Bureau; Ended; Ypsomed AG. Advisory Panel; Ended; Tandem Diabetes Care, Inc. Speaker's Bureau; Current; Abbott Diabetes. Research Support; Current; Abbott Diabetes. Speaker's Bureau; Current; Insulet Corporation. Research Support; Current; Insulet Corporation. Advisory Panel; Ended; Sanofi. Research Support; Current; Novo Nordisk. Consultant; Ended; Embecta. Research Support; Ended; Embecta. Advisory Panel; Ended; Sinocare. Funding The study was sponsored by Abbott Diabetes Care.
Leelarathna et al. (Sat,) studied this question.