Abbott has announced landmark findings from the FreeDM2 randomized controlled trial, demonstrating that FreeStyle Libre continuous glucose monitoring (CGM) technology significantly improves glucose management outcomes in people with Type 2 diabetes on basal insulin therapy. The groundbreaking research, presented at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD), provides compelling evidence that real-time glucose visibility enables patients to achieve better glucose control through self-directed adjustments to diet, insulin dosing, and physical activity.
Significant Clinical Improvements Achieved Through Real-Time Glucose Monitoring
The FreeDM2 trial, conducted across 24 clinical sites in the United Kingdom and involving 303 participants, compared the effectiveness of FreeStyle Libre continuous glucose monitoring with traditional self-monitoring of blood glucose (SMBG) using fingersticks in people with Type 2 diabetes using basal insulin therapy.
Key Results at Four Months
| Clinical Outcome | Results |
|---|---|
| HbA1c Reduction | 0.6% greater reduction vs. fingersticks (p<0.001) |
| Time in Healthy Glucose Range | 2.5 additional hours daily in 70-180 mg/dL range (10.4% increase) |
| Population Studied | Type 2 diabetes patients on basal insulin with SGLT2 inhibitor or GLP-1 receptor agonist |
| Study Sites | 24 clinical research centers across the United Kingdom |
The Role of Self-Management in Achieving Better Outcomes
A critical aspect of the FreeDM2 findings is that improvements were achieved through participant-led self-management, guided by real-time glucose readings from the FreeStyle Libre system. Patients used the continuous glucose data to make informed adjustments to their diet, basal insulin dosing, and activity levels throughout the day.
Italian Real-World Study Confirms FreeDM2 Findings
A complementary interventional study from Italy, also presented at ATTD, strengthens the evidence base for FreeStyle Libre in Type 2 diabetes management. This real-world study followed 88 adults with Type 2 diabetes using basal insulin in everyday clinical practice settings over three months.
Italian Cohort Improvements
- Better average glucose levels: Improved overall glycemic control across the study period.
- Increased time spent in healthy glucose range: More hours daily with glucose levels in the target 70-180 mg/dL range.
- Improved quality of life: Patients reported enhanced satisfaction with diabetes management and reduced disease burden.
The consistency of results between the controlled FreeDM2 trial and the real-world Italian study reinforces that benefits derive from the fundamental advantage of continuous glucose monitoring itself, rather than any single device feature or specific intervention protocol.
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Addressing the Type 2 Diabetes Management Gap
The FreeDM2 study addresses a significant unmet need in diabetes management. Currently, approximately 63 million people worldwide rely on insulin to manage Type 2 diabetes. However, real-world evidence indicates that only 18-30% of those using basal insulin therapy successfully achieve their HbA1c targets. This management gap contributes to an estimated $217 billion in annual diabetes-related healthcare costs.
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Implications for CGM Reimbursement and Access
Currently, continuous glucose monitoring reimbursement across Europe and many other regions primarily focuses on patients using multiple daily insulin injections, leaving many patients on basal insulin therapy without coverage. The FreeDM2 and Italian study findings provide strong clinical evidence supporting broader reimbursement policies for CGM in basal insulin users.
With clinically significant improvements in HbA1c reduction and time in range demonstrated in a rigorous randomized controlled trial, these results make a compelling case for expanding CGM access to this large population of Type 2 diabetes patients. Such expanded access could help millions of basal insulin users achieve their glucose control targets and reduce long-term diabetes-related complications.
The evidence base from FreeDM2 strengthens healthcare policy arguments for:
- Expanded CGM reimbursement eligibility for basal insulin users in Europe and other regions.
- Integration of CGM into standard care guidelines for Type 2 diabetes with basal insulin.
- Insurance coverage policies that recognize CGM as a clinically necessary intervention.
- Patient access programs to support those without reimbursement coverage.
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