clinical and real-world evidence in type 1 and type 2 ...€¦ · a rwd study of the effect of the...

FLASH GLUCOSE MONITORING SYSTEM

Simulated data for illustrative purposes only. Not real patient or data. 1. Scanning the sensor does not require lancets. This material is specific for the EASD meeting. Product availability may vary by country. Not all features are available in all markets. If you require product information for a specific country, please refer to your local Abbott website.

CLINICAL AND REAL-WORLD EVIDENCE IN TYPE 1 AND TYPE 2 DIABETES PATIENTS

1

FACTS SPEAK FOR THEMSELVES

The FreeStyle Libre system is proven to result in better clinical outcomes

ImprovesQuality of Life4

Decreases Work Absenteeism4 Decreases A1c3

Reduces Hypoglycaemia1,2

IncreasesTime In Range1

Product image for illustrative purposes only. Not real patient data. 1. Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kröger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016;388(10057):2254-2263. 2. Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. 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 Ther. 2017;8(1): 55-73. 3. Yaron M, Roitman E, Aharon-Hananel G, et al. Effect of flash glucose monitoring technology on glycemic control and treatment satisfaction in patients with type 2 diabetes. Diabetes Care. 2019;42(7):1178-1184. 4. Fokkert M, van Dijk P, Edens M, et al. Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4). BMJ Open Diab Res Care. 2019. https://doi:10.1136/bmjdrc-2019-000809. 5. Charleer S, De Block C, Van Huffel L, et al. 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. 2020;43(2):389-397. This material is specific for the EASD meeting. Product availability may vary by country. Not all features are available in all markets. If you require product information for a specific country, please refer to your local Abbott website. 2

A1c

Decreases Hospital Admissions4,5

The FreeStyle Libre system significantly increases Time In Range1

RCT=randomised controlled trial; T1D=type 1 diabetes; SMBG=self-monitored blood glucose.1. Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kröger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016;388(10057):2254-2263. 2. Battelino T, Danne T, Bergenstal RM, et al. Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range. Diabetes Care. 2019;42(8):1593-1603. This material is specific for the EASD meeting. Product availability may vary by country. Not all features are available in all markets. If you require product information for a specific country, please refer to your local Abbott website.

Every 5% (~1 hour per day) increase in Time In Range is associated with clinically significant benefits2

A RCT in 328 well-controlled T1D patients (with baseline A1c ≤7.5%) proves the FreeStyle Libre system safely and successfully replaces SMBG

Clinicallysignificant increasein Time In Range(3.9–10.0 mmol/L) vs SMBG (p=0.0006)

1.0HOUR

3

1DTYPE IMPACT STUDY1

Real-world data reinforce more frequent use of the FreeStyle Libre system increases Time In Range1

TIR=Time In Range. 1. Lang J, Jangam S, Dunn T, Hayter G. Expanded real-world use reaffirms strong correlation between scanning frequency of flash glucose monitoring and glucose control [Poster 972]. Diabetes. 2019;68(suppl 1). https://doi.org/10.2337/db19-972-P. 2. Comparing 2 groups from lowest to highest scan rate (3.6 and 39.5 scans/day). This material is specific for the EASD meeting. Product availability may vary by country. Not all features are available in all markets. If you require product information for a specific country, please refer to your local Abbott website.

Comparing 2 groups

from lowest to highest

scan rate,2 patients

who scanned more

frequently using the

FreeStyle Libre system

spent 43% more Time

In Range

4

1.71 43%

BILLION HOURS OF GLUCOSE READINGS

5.8 MILLION FREESTYLE LIBRE SENSORS

MORETIME IN RANGE(70-180 mg/dL) from 11.7 to 16.8 hours per day1 (p<0.001)

TIR

1D REAL-WORLD STUDY1TYPE 2DTYPE

Frequent use of the FreeStyle Libre system also resulted in patients spending 26% less Time Below Range (<3.0 mmol/L)1

A 6-month RCT in 328 well-controlled T1D patients (with baseline A1c ≤7.5%) proves the FreeStyle Libre system safely and successfully replaces SMBG

1D IMPACT STUDY1

RCT=randomised controlled trial; SMBG=self-monitored blood glucose; T1D=type 1 diabetes mellitus. 1. Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kröger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016;388(10057):2254-2263.This material is specific for the EASD meeting. Product availability may vary by country. Not all features are available in all markets. If you require product information for a specific country, please refer to your local Abbott website.

The FreeStyle Libre system is clinically proven to significantly reduce hypoglycaemia in T1D patients1

5

40%

50%

Reduces nocturnal hypoglycaemia(<3.9 mmol/L, time in hour, from 11:00 pm to 6:00 am)

(p<0.0001)

Reduces serious hypoglycaemia(<3.1 mmol/L, time in hour, within 24 hours)

(p<0.0001)

Min

ute

s/d

ay

240

180

120

60

0FreeStyle Libre systemSMBG (Control)

196

122

Min

ute

s/d

ay

80

60

40

20


65

37

(p=0.0006) (p<0.0001)

-38% -43%

Significantly reduces time spent in hypoglycaemia (<3.9 mmol/L)

TYPE

A 6-month RCT in 224 T2D patients on intensive insulin therapy proves the FreeStyle Libre system safely and successfully replaces SMBG

2D REPLACE STUDY1

RCT=randomised controlled trial; SMBG=self-monitored blood glucose; T2D=type 2 diabetes mellitus. 1. Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. 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 Ther. 2017;8(1):55-73. This material is specific for the EASD meeting. Product availability may vary by country. Not all features are available in all markets. If you require product information for a specific country, please refer to your local Abbott website.

The FreeStyle Libre system is clinically proven to significantly reduce hypoglycaemia in T2D patients1

6

53%

54%

Reduces nocturnal hypoglycaemia(<3.9 mmol/L, time in hour, from 11:00 pm to 6:00 am)

(p=0.0001)

Reduces serious hypoglycaemia(<3.1 mmol/L, time in hour, within 24 hours)

(p=0.0014)

Min

ute

s/d

ay

240

180

120

60


196

122

Min

ute

s/d

ay

80

60

40

20


65

37

(p=0.0006) (p<0.0001)

-38% -43%

TYPE

Significantly reduces time spent in hypoglycaemia (<3.9 mmol/L)

In a 10-week RCT, T2D patients on MDI (n=101) using the FreeStyle Libre system saw a significant A1c reduction compared to SMBG (0.82% vs 0.33%, respectively)

RCT=randomised controlled trial; T2D=type 2 diabetes mellitus; MDI=multiple daily insulin injections; SMBG=self-monitored blood glucose.1. Yaron M, Roitman E, Aharon-Hananel G, et al. Effect of flash glucose monitoring technology on glycemic control and treatment satisfaction in patients with type 2 diabetes. Diabetes Care. 2019;42(7):1178-1184.This material is specific for the EASD meeting. Product availability may vary by country. Not all features are available in all markets. If you require product information for a specific country, please refer to your local Abbott website.

The FreeStyle Libre system demonstrates clinically significant A1c reductions1

A1c

(p=0.005)

0.82%

7

More than 2X as many patients using the FreeStyle Libre system reduced their A1c by 0.5% at week 10 versus SMBG

68.6%30.2%

FreeStyle Libre system SMBG

vs

(p<0.001)

2D CLINICAL STUDY BY YARON1TYPE

The FreeStyle Libre system reduces A1c without increasing the frequency of hypoglycaemia1

META-ANALYSIS1

T1D=type 1 diabetes mellitus; T2D=type 2 diabetes mellitus.1. Evans E, Welsh Z, Ells S, Seibold A. 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 Ther. 2020;11(1):83-95. 2. NOTE: statistically significant A1c reduction based on the confidence interval range. This material is specific for the EASD meeting. Product availability may vary by country. Not all features are available in all markets. If you require product information for a specific country, please refer to your local Abbott website.

This A1c reduction was observed at 2-4 months and sustained at month 12 in adults and children with T1D and adults with T2D

29 1723

0.55%

CLINICAL AND REAL-WORLD STUDIES

PATIENTS

AVERAGEREDUCTION IN A1C2

A1c

A1c reduction is sustained with the FreeStyle Libre system1

8

1DTYPE 2DTYPE

FLARE STUDY1

A RWD study of the effect of the FreeStyle Libre system on 1365 T1D and T2D patients on insulin over 1 year: endpoints included A1c, hypoglycaemia, and patient-reported outcomes

RWD=real-world data/observational study; T1D=type 1 diabetes mellitus; T2D=type 2 diabetes mellitus.1. Fokkert M, van Dijk P, Edens M, et al. Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4). BMJ Open Diab Res Care. 2019. https://doi:10.1136/bmjdrc-2019-000809.This material is specific for the EASD meeting. Product availability may vary by country. Not all features are available in all markets. If you require product information for a specific country, please refer to your local Abbott website.

Real-world data show that the use of the FreeStyle Libre system improves quality of life1

9

1DTYPE 2DTYPE

95%

92%

80%

37%

report a better understanding of their glucose fluctuations

find it easier to regulate their glucose around a meal

adjust insulin doses more frequently

report engaging in physical activity more frequently

FLARE STUDY1 FUTURE STUDY1


A RWD study of the effect of the FreeStyle Libre system on 1913 T1D patients at 6 months and 1 year: endpoints included quality of life, number of hospital admissions, and hypoglycaemia

RWD=real-world data/observational study; T1D=type 1 diabetes mellitus; T2D=type 2 diabetes mellitus; DKA=diabetic ketoacidosis; hypo=hypoglycaemia.1. Fokkert M, van Dijk P, Edens M, et al. Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4). BMJ Open Diab Res Care. 2019. https://doi:10.1136/bmjdrc-2019-000809. 2. Charleer S, De Block C, Van Huffel L, et al. 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. 2020;43(2):389-397. This material is specific for the EASD meeting. Product availability may vary by country. Not all features are available in all markets. If you require product information for a specific country, please refer to your local Abbott website. 10

Real-world data demonstrate that the use of the FreeStyle Libre system decreases diabetes-related hospital admissions1,2

66%reduction in hospital admissionsfrom 13.7% to 4.7% at 12 months(p<0.05)

33%reduction in DKA or hypo admissionsfrom 3.3% to 2.2% at 12 months(p=0.031)

1DTYPE 1DTYPE2DTYPE


RWD=real-world data/observational study; T1D=type 1 diabetes mellitus; T2D=type 2 diabetes mellitus.1. Fokkert M, van Dijk P, Edens M, et al. Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4). BMJ Open Diab Res Care. 2019. https://doi:10.1136/bmjdrc-2019-000809.This material is specific for the EASD meeting. Product availability may vary by country. Not all features are available in all markets. If you require product information for a specific country, please refer to your local Abbott website.

A similar reduction in work absenteeism was observed

in patients under 65 years from 20.4% to 8.3% (p<0.001)

11

reduction in work absenteeismfrom 18.5% to 7.7%at 12 months

(p<0.05)

58%

Real-world data demonstrate that the use of the FreeStyle Libre system decreases work absenteeism1

FLARE STUDY11DTYPE 2DTYPE

FreeStyle Libre system is the #1 sensor-based glucose monitoring system worldwide1,2

Product image for illustrative purposes only. Not real patient data. T1D=type 1 diabetes mellitus; T2D=type 2 diabetes mellitus.1. Data based on the number of users worldwide for the FreeStyle Libre system compared to the number of users for other leading personal use sensor-based glucose monitoring systems. 2. Data on file, Abbott Diabetes Care, Inc. 3. Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kröger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016;388(10057):2254-2263. 4. Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. 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 Ther. 2017;8(1):55-73. 5. Yaron M, Roitman E, Aharon-Hananel G, et al. Effect of flash glucose monitoring technology on glycemic control and treatment satisfaction in patients with type 2 diabetes. Diabetes Care. 2019;42(7):1178-1184. 6. Fokkert M, van Dijk P, Edens M, et al. Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4). BMJ Open Diab Res Care. 2019. https://doi:10.1136/bmjdrc-2019-000809. 7. Charleer S, De Block C, Van Huffel L, et al. 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. 2020;43(2):389-397.This material is specific for the EASD meeting. Product availability may vary by country. Not all features are available in all markets. If you require product information for a specific country, please refer to your local Abbott website. © 2020 Abbott. FreeStyle, Libre, and related brand marks are marks of Abbott. ADC-27046 V1.0. 09/20. 12

Increases Time In Range3

Reduces Hypoglycaemia3,4

Decreases A1c5 A1c

Improves Quality of Life6

DecreasesHospital Admissions6,7

DecreasesWork Absenteeism6

FLASH GLUCOSE MONITORING SYSTEM

Recommend the FreeStyle Libre system to all T1D and T2D patients using insulin

FACTS SPEAK FOR THEMSELVES

clinical and real-world evidence in type 1 and type 2 ...€¦ · a rwd study of the effect of the...

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