Abbott (NYSE:ABT) said today that new data show its FreeStyle Libre continuous glucose monitoring (CGM) system significantly reduces hemoglobin A1c (HbA1c) levels in certain adults with type 2 diabetes.
Presented as a late-breaker at American Diabetes Association (ADA) annual conference in San Francisco, the data represent what Abbott termed the first evaluation of real-world evidence from FreeStyle Libre users who need multiple insulin injections daily.
Researchers evaluated de-identified records of 363 individuals across France, Germany and Austria, assessing their HbA1c levels over three to six months. The people, who averaged about 63 years in age, had used insulin multiple times a day for an average of more than eight years.
The results showed an association of lower HbA1c levels with the use of Abbott’s technology after at least three months of use. (HbA1c levels reflect a person’s average blood sugar over a period of three months). The nearly 1% drop (-0.9% or -9.7 mmol/mol) in HbA1c represents a significant reduction of glucose levels toward the ADA’s recommended A1c goal of 7% for adults with diabetes (not including women who are pregnant), the company said.
The average HbA1c was 8.9% (73.3 mmol/mol) before FreeStyle Libre system use and 8.0% (63.6 mmol/mol) after. Researchers detected no differences based on age group, gender, body mass index or duration of insulin use, which the company said indicates the findings apply to the broad population of people with type 2 diabetes and not just a particular subset.
“These real-world findings highlight how Abbott’s FreeStyle Libre system can fundamentally change how people manage their diabetes, especially for people living with type 2 diabetes,” said study co-author Dr. Helene Hanaire of University Hospital Center of Toulouse in Toulouse, France, in a news release. “By using the real-time results, trends and patterns from the technology right at their fingertips, people with diabetes are becoming more actively engaged in making better decisions to control their glucose levels and improve their own health.”
In February, Abbott presented real-world data showing that use of its FreeStyle Libre glucose monitoring system reduced prolonged hypoglycemia and helped users achieve better glucose control.
“Doctors tell us that FreeStyle Libre is changing the course of care for people with diabetes, and the combination of these real-world data and clinical research is further proof that our technology delivers significant reductions in HbA1c in people with Type 2 diabetes,” said Dr. Mahmood Kazemi, Abbott’s divisional vice president, global medical and scientific affairs for diabetes care. “This adds to growing evidence from more than half a million users in real-world settings showing time after time, use of FreeStyle Libre is associated with improved glucose control and better health outcomes.”
Abbott is seeking FDA clearance for its next-generation FreeStyle Libre system, which eliminates the need for finger sticks and features optional alarms that users can customize, according to the medtech company. The system won CE Mark clearance in the European Union in October last year.