FreeDM2 publication demonstrates A1c and TIR improvements with FreeStyle Libre 3 in basal insulin-treated T2D, with more insights on behavior –
Full publication reinforces ATTD 2026 readout; additional data highlights early behavioral drivers and strong patient engagement
The Lancet Diabetes & Endocrinology published full results from the FreeDM2 trial, led by Dr. Emma Wilmot (University of Nottingham, UK) and Dr. Lalantha Leelarathna (Imperial College London, UK) et al., evaluating CGM versus BGM in adults with T2D (n=303) on basal insulin alongside either SGLT-2 inhibitors or incretin-based therapy. This data was originally presented by Dr. Wilmot at ATTD 2026, where results showed significant A1c and Time in Range (TIR) improvements with FreeStyle Libre 3 compared to BGM.
The full publication reinforces these findings and adds important detail on behavioral mechanisms, patient-reported outcomes, and safety, offering a complete picture of how CGM drives benefit in this population.
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CGM delivers sustained glycemic improvements versus BGM across both self-management and clinician-supported phases
The primary outcomes are consistent with what was presented at ATTD 2026. Participants were randomized 2:1 to FreeStyle Libre 3 (n=198) or BGM (n=105) with usual care for 16 weeks. At 16 weeks, A1c declined from 8.8% to 8.0% in the CGM group versus 8.8% to 8.7% with BGM. By 32 weeks, A1c declined further to 7.8% with CGM versus 8.3%. Notably, improvements were observed early and lasted through the clinician-supported phase, suggesting that initial CGM-driven changes may be sustainable, even as therapy potentially intensifies.
CGM-based metrics reinforce these findings. TIR increased by ~10% (~2.5 hours/day) more with CGM than BGM; TIR improved from 40% to 54% with FreeStyle Libre 3 at 16 weeks versus an increase from 42% to 45% with BGM. This separation in TIR was maintained at 32 weeks (60% vs. 50%). Time below Range (TBR) remained low and similar between groups, and two severe hypoglycemia events were observed only in the control group. The availability of CGM data also influenced clinical decision-making, with higher rates of prandial insulin initiation in the CGM group during the clinician-supported phase, suggesting improved detection of postprandial hyperglycemia.
Early glycemic improvements may be driven by behavior changes
While behavioral trends were noted at ATTD, the full publication more explicitly frames these changes as a key driver of early glycemic improvement. During the initial 16-week self-management, there were no significant between-group differences in insulin dose or non-insulin medication adjustments, suggesting that early A1c and TIR improvements were not primarily pharmacologic.
Instead, CGM users demonstrated improved diet quality and increases in physical activity at 16 weeks, including ~12 additional minutes/day of light-intensity activity versus BGM. Although these differences were not sustained at 32 weeks, the pattern, combined with early increases in TIR, suggests that real-time glucose visibility may prompt immediate lifestyle adjustments that translate into early glycemic benefit.
High engagement and improved satisfaction reinforce CGM’s role in real-world management
The publication also provides additional detail on adherence and patient experience. CGM use was high throughout the study, with median wear time of ~98% across both phases, indicating strong engagement even in a largely self-managed setting. Participants using CGM reported greater satisfaction with glucose monitoring and improved confidence in avoiding hypoglycemia, reinforcing the role of CGM in both glycemic outcomes and for daily usability and decision-making.
Close Concerns Questions
- How durable are CGM-driven behavior changes beyond the 32-week study period?
- What level of patient education is required to replicate these outcomes in routine clinical practice?
- How should clinicians integrate CGM data into treatment decision-making to balance behavioral interventions versus earlier pharmacologic intensification?
-- by Riya Chatterjee, Jeremy Alkire, Monica Oxenreiter, and Kelly Close