Clinical study summaries

Reduced HbA1c1-3,*

“An Evaluation of Self-Management of Diabetes Using FreeStyle Libre Flash Glucose Monitoring System in Young People”

A meta-analysis, consisting of 1723 total patients (1496 T1DM; 227 T2DM), across 29 studies, observed an overall mean reduction in HbA1c of 0.55% [95% CI; -0.70, -0.39] over a 12-month period. Greater reductions in HbA1c were observed in patients with higher baseline HbA1c. HbA1c reductions were observed without significant differences when comparing by study length, age, and between T1DM and T2DM.

This study supports the Freestyle Libre Portfolio in reducing HbA1c and improving patient outcomes for all patients.

Reference: 1. Evans, Mark, Zoë Welsh, Sara Ells, and Alexander Seibold. “The impact of flash glucose monitoring on glycaemic control as measured by HbA1c: a meta-analysis of clinical trials and real-world observational studies.” Diabetes Therapy 11, no. 1 (2020): 83-95.

 

 

“Effect of Flash Glucose Monitoring Technology on Glycemic Control and Treatment Satisfaction in Patients with Type 2 Diabetes”

A 10-week, open-label, randomized controlled trial assessed 101 patients with type 2 diabetes for ≥1 year (HbA1c 7.5%-10.0%) who had been on multiple daily injections of insulin for at least 6 months. Subjects were randomly assigned to either the FreeStyle Libre Portfolio (n=53) or the control group (SMBG) (n=48). Changes in HbA1c were –0.85% vs –0.32% in the intervention and control group, respectively (P=0.00015).

This study demonstrates a reduction in HbA1c in T2DM patients using the FreeStyle Libre Portfolio on intensive insulin without an increase in hypoglycemic events when compared to self-monitoring blood glucose.

Reference: 2. Yaron, Marianna, Eytan Roitman, Genya Aharon-Hananel, Zohar Landau, Tali Ganz, Ilan Yanuv, Aliza Rozenberg et al. “Effect of flash glucose monitoring technology on glycemic control and treatment satisfaction in patients with type 2 diabetes.” Diabetes Care 42, no. 7 (2019): 1178-1184.

 

 

“Outcomes of using flash glucose monitoring technology by children and young people with type 1 diabetes in a single arm study”

A prospective, single arm, non-inferiority multicenter study among 75 children and teenagers demonstrated equivalence of time in range [70-180 mg/dL) by comparing 14-day masked sensor wear of the FreeStyle Libre Portfolio with self-monitored blood glucose (SMBG) testing. Subjects ages 4-17 with type 1 diabetes had been on their current insulin regimen for ≥2 months, testing with SMBG ≥2 times per day. During the study, HbA1c reduced by 0.4%, from 7.9 ±1.0% at baseline to 7.5 ±0.9% at study end (P<0.0001) with reductions across all age subgroups (4-6, 7-12, and 13-17 years).

This study demonstrates the efficacy of the FreeStyle Libre Portfolio in reducing HbA1c in children who have T1DM.

Reference: 3. Campbell, Fiona M., Nuala P. Murphy, Caroline Stewart, Torben Biester, and Olga Kordonouri. “Outcomes of using flash glucose monitoring technology by children and young people with type 1 diabetes in a single arm study.” Pediatric Diabetes 19, no. 7 (2018): 1294-1301.

Reduced avoidable resource utilization4,5,*

“Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4)”

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.

 

 

“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”

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.

Reduced number of hypoglycemic events6,7,*

“Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial”

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.

 

 

“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”

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.

Reduced work absenteeism4,8,*

“Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4)”

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.

 

 

“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”

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.

ADC-35219 v1.0 03/21