A 12-month prospective, nationwide registry study (conducted independently of Abbott Diabetes Care) enrolled 1365 subjects with type 1 and type 2 diabetes and assessed changes in HbA1c, hypoglycemia, health-related quality of life measures, patient-reported outcome measures, diabetes-related hospital admission rates, and work absenteeism rates. The percentage of diabetes-related hospital admissions decreased from 13.7% to 4.7% over 12 months (P<0.05). The number of patients with any work-associated period of absence in the prior 6 months decreased from 251 (18.5%) at baseline to 53 (7.7%) at 12 months (P<0.05). From baseline to 1 year, 78% of patients experienced less severe hypoglycemias; 95% reported a better understanding of his or her glucose fluctuations, while 92% found it easier to regulate glucose around meals.

This real-world evidence associates the FreeStyle Libre Portfolio among people with type 1 diabetes with higher treatment satisfaction, less severe hypoglycemia, and less work absenteeism, while maintaining quality of life and HbA1c.

Reference: 4. Fokkert, Marion, Peter van Dijk, Mireille Edens, Eglantine Barents, Jeanine Mollema, Robbert Slingerland, Reinold Gans, and Henk Bilo. “Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4).” BMJ Open Diabetes Research and Care 7, no. 1 (2019). https://doi.org/10.1136/bmjdrc-2019-000809.

A retrospective, observational analysis of IBM Watson MarketScan™ commercial claims and Medicare Supplemental databases on a US patient population of 1244 subjects (age 53.6 ±9.7 years; 53.8% male; 46.2% female) over 6 months, analyzed pre- and post-CGM use of the FreeStyle Libre Portfolio. The study evaluated the number of acute diabetes events as a primary diagnosis coded with hyper- or hypoglycemia. Secondary outcomes measured all-cause hospitalizations. Hospitalizations were reduced from 0.345 to 0.247 events/patient-year (HR: 0.72 [0.58-0.88]; P<0.002). Acute diabetes events reduced from 0.158 to 0.077 events/patient-year (HR: 0.49 [95% CI: 0.34-0.69]; P<0.001]).

This observational study associates FreeStyle Libre continuous glucose monitor use with a reduction in acute diabetic events and hospitalizations.

Reference: 5. Bergenstal, Richard M., Matthew SD Kerr, Gregory J. Roberts, Diana Souto, Yelena Nabutovsky, and Irl B. Hirsch. “69-OR: Freestyle Libre System Use Is Associated with Reduction in Inpatient and Outpatient Emergency Acute Diabetes Events and All-Cause Hospitalizations in Patients with Type 2 Diabetes.” (2020). Diabetes 69, no. Supplement 1 (2020). https://doi.org/10.2337/db20-69-or.

This multicenter, prospective, non-masked, randomized controlled trial of adult patients (≥18 years) with well-controlled type 1 diabetes (HbA1c ≤7.5%) for ≥5 years on ≥3 SMBG tests daily. The study was conducted in 23 European sites across Sweden, Austria, Germany, Spain, and the Netherlands. The primary outcome was change in time in hypoglycemia (<70 mg/dL) between baseline and 6 months in the full analysis set. Subjects using the FreeStyle Libre Portfolio (n = 119) experienced a greater reduction in hypoglycemic events/24h from baseline [(< 55 mg/dL); 0.96 (0.65) to endpoint: 0.56 (0.55); (P<0.0001)] than patients using SMBG (n = 120) [(< 55 mg/dL); 0.92(0.73); at 6 months: 0.92 (0.74); (P<0.0001)].

The IMPACT study demonstrated the significant reduction in time and incidence of hypoglycemia, a common barrier to optimal glucose control.

Reference: 6. Bolinder, Jan, Ramiro Antuna, Petronella Geelhoed-Duijvestijn, Jens Kröger, and Raimund Weitgasser. “Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial.” The Lancet 388, no. 10057 (2016): 2254-2263.

An open-label, randomized controlled study across 26 European sites in France, Germany, and the UK enrolled adult participants (149 intervention, 75 controls) age ≥18 years with type 2 diabetes who used SMBG ≥10 tests per week and who had been on MDI or CSII ≥6 months. The primary outcome was difference in HbA1c at 6 months in the full analysis set. Prespecified secondary outcomes included time in hypoglycemia, effect of age, and patient satisfaction. Subjects using the FreeStyle Libre Portfolio experienced a greater reduction in hypoglycemic events/24h from baseline [(<55 mg/dL): 0.34 (50); at 6 months: 0.14 (0.24); P=0.0017] than subjects using SMBG [(<55 mg/dL): 0.27 (44); at 6 months: 0.24 (36); P=0.0017].

Results from this study further demonstrated that the FreeStyle Libre Portfolio is a safe and effective replacement for SMBG in the management of insulin-using patients with type 2 diabetes.

Reference: 7. Haak, Thomas, Hélène Hanaire, Ramzi Ajjan, Norbert Hermanns, Jean-Pierre Riveline, and Gerry Rayman. “Flash glucose-sensing technology as a replacement for blood glucose monitoring for the management of insulin-treated type 2 diabetes: a multicenter, open-label randomized controlled trial.” Diabetes Therapy 8, no. 1 (2017): 55-73.

A 12-month prospective, nationwide registry study (conducted independently of Abbott Diabetes Care) enrolled 1365 subjects with type 1 and type 2 diabetes and assessed changes in HbA1c, hypoglycemia, health-related quality of life measures, patient-reported outcome measures, diabetes-related hospital admission rates, and work absenteeism rates. The percentage of diabetes-related hospital admissions decreased from 13.7% to 4.7% over 12 months (P<0.05). The number of patients with any work-associated period of absence in the prior 6 months decreased from 251 (18.5%) at baseline to 53 (7.7%) at 12 months (P<0.05). From baseline to 1 year, 78% of patients experienced less severe hypoglycemias; 95% reported a better understanding of his or her glucose fluctuations, while 92% found it easier to regulate glucose around meals.

This real-world evidence associates the FreeStyle Libre Portfolio among people with type 1 diabetes with higher treatment satisfaction, less severe hypoglycemia, and less work absenteeism, while maintaining quality of life and HbA1c.

Reference: 4. Fokkert, Marion, Peter van Dijk, Mireille Edens, Eglantine Barents, Jeanine Mollema, Robbert Slingerland, Reinold Gans, and Henk Bilo. “Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4).” BMJ Open Diabetes Research and Care 7, no. 1 (2019). https://doi.org/10.1136/bmjdrc-2019-000809.

A 12-month prospective, observational, real-world study for 1913 patients with type 1 diabetes was conducted independently of Abbott Diabetes Care in 3 specialist diabetes centers in Belgium. The number of patients with any work-associated period of absence in the prior 6 months decreased from 111 (5.8%) at baseline to 49 (2.9%) at 12 months (P<0.0001).

This real-world evidence associates the FreeStyle Libre Portfolio among people with type 1 diabetes with higher treatment satisfaction, less severe hypoglycemia, and less work absenteeism, while maintaining quality of life and HbA1c.

Reference: 8. Charleer, Sara, Christophe De Block, Liesbeth Van Huffel, Ben Broos, Steffen Fieuws, Frank Nobels, Chantal Mathieu, and Pieter Gillard. “Quality of life and glucose control after 1 year of nationwide reimbursement of intermittently scanned continuous glucose monitoring in adults living with type 1 diabetes (FUTURE): a prospective observational real-world cohort study.” Diabetes Care 43, no. 2 (2020): 389-397.