FreeDM2 trial results show outstanding outcomes

Some readers may remember Abbott’s FreeDM2 randomised controlled trial (RCT). We ran a couple of recruitment articles in the magazine, so some readers may have taken part.

It’s newly released results show that people using FreeStyle Libre (FSL) continuous glucose monitoring (CGM) technology had better glucose outcomes than those using traditional finger pricking. Improvements were achieved through participant-led self-management, guided by real-time CGM insights. Findings were presented at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in early March 2026 in Barcelona.

The FreeDM2 randomised controlled trial was designed to determine whether real-time continuous glucose monitoring (CGM) can help people using basal insulin improve their glucose management.  Conducted across 24 clinical sites in the UK and involving 303 participants, the study compared the effectiveness of CGM with traditional self‑monitoring of blood glucose (SMBG) in people with Type 2 diabetes using basal insulin.

Significant

At four months, participants using an Abbott FreeStyle Libre system for continuous glucose monitoring had a significantly greater reduction in HbA1c than the group using traditional finger-pricking. They also spent about 2.5 more hours a day (10.4% increase) in a healthy glucose range (3.9-10.0 mmol/L). Participants were on basal insulin with either an SGLT2 inhibitor or a GLP‑1 receptor agonist, indicating meaningful benefit even for people already on advanced glucose-lowering therapies.

“This study demonstrates the power of real-time glucose information for people with Type 2 diabetes treated with basal insulin,” said Emma Wilmot, MBChB, BSc (hons), PhD., FRCP, Associate Professor, University of Nottingham, School of Medicine, Nottingham, U.K. and co-lead investigator of the FreeDM2 study.

“Even when people with Type 2 diabetes are already receiving advanced therapies, such as SGLT2 inhibitors or GLP‑1 receptor agonists, adding real‑time glucose visibility delivered meaningful improvements. People were able to proactively use the insights CGM provided to adjust their diet, basal insulin and activity to deliver better outcomes,” added Lala Leelarathna, MBBS, MSc, Ph.D., FRCP, Associate Professor, Imperial College London and co-lead investigator of the FreeDM2 study.

A separate interventional study from Italy, also presented at ATTD, followed 88 adults with Type 2 diabetes using basal insulin in everyday clinical practice with an Abbott FreeStyle Libre system. After 3 months, participants had better average glucose levels, more time in a healthy glucose range, and improved quality of life.3

“Across both studies, real‑time glucose visibility gives people the understanding they need to make small, informed adjustments throughout the day,” said Mahmood Kazemi, chief medical officer for Abbott’s diabetes care business. “In the FreeDM2 study, people made these adjustments on their own. Seeing similar patterns in the Italian study reinforces that the value comes from continuous access to glucose information itself, rather than from any single device feature.”

Broader access

The evidence from the FreeDM2 and Italian studies demonstrates that people with Type 2 diabetes on basal insulin therapy can achieve clinically meaningful improvements through continuous glucose monitoring technology, strengthening the case for broader reimbursement of CGM for this population.

www.freestyle-libre.co.uk

 

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