Clinical study summaries

Reduced HbA1c*†‡1-7

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

A prospective, single arm, non-inferiority multicenter study among 76 children and teenagers was conducted to evaluate efficacy of the FreeStyle Libre portfolio. Subjects between the ages of 4-17 years with type 1 diabetes who had been on their current insulin regimen for ≥2 months, testing with SMBG ≥2 times per day were included. Outcomes demonstrated reduction in HbA1c by 0.4%, from 7.9 ±1.0% at baseline to 7.5 ±0.9% at study end (P<0.0001). Additionally, Time in Range improved by 0.9 ±2.8 h/d mean from 10.1 ±3.0 h/d to 11.1 ±3.3, P=0.005. Improvement in treatment satisfaction for parents and teenagers was observed.

 

 

“Marked improvement in HbA1c following commencement of flash glucose monitoring in people with type 1 diabetes”*†2

A prospective, observational, multicenter study among 900 individuals with T1D was conducted to evaluate efficacy of the FreeStyle Libre portfolio. Outcomes demonstrated median reduction in HbA1c by 0.4%, from 7.9% to 7.5% (P<0.001). Additionally, reductions in diabetic ketoacidosis admissions were also observed (P=0.043).

 

 

“Three European retrospective real-world chart review studies to determine the effectiveness of flash glucose monitoring on HbA1c in adults with type 2 diabetes”*†3

A prospective, observational, multicenter study among 363 individuals with T2D treated with basal-bolus insulin regimens was conducted to evaluate efficacy of the FreeStyle Libre portfolio. Outcomes demonstrated an average reduction in HbA1c by 0.9% (P<0.0001), from baseline of 8.9% ±0.9 to 8.0% ±1.0.

 

 

“Use of flash continuous glucose monitoring is associated with A1C reduction in people with type 2 diabetes treated with basal insulin or noninsulin therapy”*†4

A retrospective, observational study using US-based IBM Explorys dataset was conducted in a cohort of 1,034 T2D individuals treated with basal-only or non-insulin regimens to evaluate the efficacy of the FreeStyle Libre portfolio. Outcomes demonstrated an average reduction in HbA1c of 1.5% (10.1% to 8.6%; P<0.001) in the full cohort. The reductions in HbA1c in the basal-only and non-insulin regimen subgroups were 1.1% (P<0.001) and 1.6% (P<0.001), respectively.

 

 

“Reductions in HbA1c with Flash Glucose Monitoring Are Sustained for up to 24 Months: A Meta-Analysis of 75 Real-World Observational Studies”*†5

A meta-analysis, consisting of 30,478 patients across 75 studies observed an overall mean reduction in HbA1c of 0.53% and 0.45% among people with T1D and T2D respectively at 3-4 months of FreeStyle Libre systems use. Reduction in HbA1c was about 0.42% and 0.59% among people with T1D and T2D respectively at 4.5-7.5 months. Additionally, the reductions in HbA1c were sustained for 24 months and 12 months for people with T1D and T2D respectively. Lastly, in children and adolescents, HbA1c reductions of 0.54% were observed after 1 month with the effect lessening up to 15 months, followed by stabilization through 24 months.

Reduced avoidable resource utilization*†8-13

“Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4)”*†9

A 12-month prospective, nationwide registry study (conducted independently of Abbott Diabetes Care) enrolled 1,365 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 patients experiencing a diabetes-related hospital admission decreased from 13.7% to 4.7% over 12 months (P<0.001). 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<0.001). Additionally, an average reduction in HbA1c (0.4%; P<0.001) was observed.

 

 

“Flash CGM is associated with reduced diabetes events and hospitalizations in insulin-treated type 2 diabetes”*†10

A retrospective, observational analysis of IBM Watson MarketScan™ commercial claims and Medicare Supplemental databases on a US patient population of 2,463 subjects (age 54.2 ±9.6 years; 52.9% male) over 6 months, analyzed pre- and post-CGM use outcomes 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 0.420 to 0.283 events/patient-year (HR: 0.68 [0.59-0.78]; P<0.001). Acute diabetes events reduced from 0.180 to 0.072 events/patient-year (HR: 0.39 [95% CI: 0.30-0.51]; P<0.001]).

Reduced number of hypoglycemic events*†14,15

“Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, nonmasked, randomized controlled trial”*†14

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)]; than patients using SMBG (n = 120) [(< 55 mg/dL); 0.92(0.73); at 6 months: 0.92 (0.74)], which translated to a 41% reduction in hypoglycemic events (<55mg/dL; P<0.0001).

 

 

“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”*†15

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 insulin ≥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 (0.50); at 6 months: 0.14 (0.24)] than subjects using SMBG [(<55 mg/dL): 0.27 (0.44); at 6 months: 0.24 (0.36)], which translated to a 44% reduction in hypoglycemic events (<55 mg/dL; P=0.0017).

Reduced work absenteeism*†8,9

“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 realworld cohort study”*†8

A 12-month prospective, observational, real-world study for 1,913 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). 

 

 

“Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4)”*†9

A 12-month prospective, nationwide registry study (conducted independently of Abbott Diabetes Care) enrolled 1,365 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 patients experiencing diabetes-related hospital admissions decreased from 13.7% to 4.7% over 12 months (P<0.001). 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<0.001). Additionally, an average reduction in HbA1c (0.4%; P<0.001) was observed.

* Data from this study was collected with the outside US version of the FreeStyle Libre 14 day system. FreeStyle Libre 3 has the same features as FreeStyle Libre 14 day system with real-time glucose alarms. Therefore the study data is applicable to both products.
† Data from this study was collected with the outside US version of the FreeStyle Libre 14 day system. FreeStyle Libre 2 has the same features as FreeStyle Libre 14 day system with optional real-time glucose alarms. Therefore the study data is applicable to both products.
‡ The FreeStyle Libre 2 system and FreeStyle Libre 3 system are indicated for patients ages 4 and older.

 

References: 1. Campbell, F. Pediatr Diabetes (2018): https://doi.org/10.1111/pedi.12735 2. Tyndall, V. Diabetologia (2019): https://doi.org/10.1007/s00125-019-4894-1 3. Kroger, J. Diabetes Therapy (2020): https://doi.org/10.1007/s13300-019-00741-9 4. Wright, E. Diabetes Spectr (2021): https://doi.org/10.2337/ds20-0069 5. Evans M, et al. Diabetes Therapy (2022): https://doi.org/10.1007/s13300-022-01253-9 6. Carlson AL, et al. BMJ Open Diabetes Res Care (2022): https://doi.org/10.1136/bmjdrc-2021-002590 7. Yaron, M. Diabetes Care (2019): https://doi.org/10.2337/dc18-0166 8. Charleer S, et al. Diabetes Care (2020): https://doi.org/10.2337/dc19-1610 9. Fokkert, M. BMJ Open Diabetes Res Care (2019): https://doi.org/10.1136/bmjdrc-2019-000809 10. Bergenstal, R. J Endocr Soc (2021): https://doi.org/10.1210/jendso/bvab013 11. Miller E, et al. AJMC (2021): https://doi.org/10.37765/ajmc.2021.88780 12. Kerr M, et al. Poster presented at the ATTD Conference, Madrid, Spain, February 19-22, 2020. https://doi.org/10.1089/dia.2020.2525.abstracts 13. Deshmukh, H. Diabetes Care (2020): https://doi.org/10.2337/dc20-0738 14. Bolinder, J. The Lancet (2016): https://doi.org/10.1016/s0140-6736(16)31535-5 15. Haak, T. Diabetes Ther (2017): https://doi.org/10.1007/s13300-016-0223-6

ADC-35219 v3.0 06/22