FreeDM2 Trial Links Real-Time Cgm To Better HbA1c In Type 2 Diabetes

Key Takeaways

• Greater HbA1c reduction was reported with real-time CGM than with finger-prick monitoring at 16 and 32 weeks.
• The randomized comparison included 303 participants with type 2 diabetes treated with basal insulin plus SGLT2 inhibitors, GLP-1 receptor agonists, or dual GIP/GLP-1 receptor agonists.
• Participants were described as gaining new self-management insights from near real-time glucose data, while cost-effectiveness remained to be clarified.

The open-label, multicenter, parallel-design randomized controlled trial compared monitoring strategies during everyday diabetes self-management across 24 UK centers. It followed a 16-week self-management period and a further 16 weeks with clinician support. Greater HbA1c reduction was reported with CGM at both 16 and 32 weeks. The lead finding was an observed glycemic advantage with CGM rather than a practice recommendation.

The enrolled group consisted of adults with type 2 diabetes treated with basal insulin plus SGLT2 inhibitors, GLP-1 receptor agonists, or dual GIP/GLP-1 receptor agonists. One group received real-time CGM, while the other continued standard finger-prick glucose monitoring. The comparison unfolded across two phases rather than a single uninterrupted intervention period. Participants first used their assigned monitoring approach during 16 weeks of self-management, then entered another 16 weeks with clinician support, during which new therapies were introduced. That structure defined the trial frame and kept interpretation tied to the reported population.

Investigators reported significantly greater HbA1c reductions with real-time CGM than with finger-prick monitoring at both 16 and 32 weeks. The benefit was reported at the end of self-management and again after clinician involvement. The available text did not provide a numeric effect size for that difference. Researchers also said participants gained new insights into diabetes management, and early improvement was suggested to be related to sensor feedback rather than added medications or insulin. In the clinician-supported second phase, further improvements were reported after new therapies were introduced. The report tied the glycemic result to a self-management experience shaped by continuous glucose information.

CGM was described as less painful than finger-prick testing and as a way to deliver near real-time glucose readings. It also said alarms could warn users when glucose moved too high or too low. Diabetes UK also linked continuous feedback to fewer repeated finger-prick checks during day-to-day management. The findings were published in The Lancet Diabetes & Endocrinology and presented at the Diabetes UK Professional Conference in Liverpool. Diabetes UK said the results strengthened the case for wider CGM use for some people with type 2 diabetes, while noting that cost-effectiveness still needs analysis.

Support for the work included NIHR Imperial and Cambridge Biomedical Research Centres and NHS institutions in the East of England. Abbott Diabetes Care funded the trial, according to the report. Safety analyses reported similar non-device-related adverse events between groups, one death in the CGM group due to ischemic heart disease, and two severe hypoglycemia events in one control-group participant. Device-related adverse events were also reported. No serious adverse events were related to the study device or study procedures.