Diabetes Research and Clinical Practice - Volume 120 - Supplement 1

observed from EMPA-REG OUTCOME, more and more studies

will be implemented to confirm the potential benefits and

safety in patients with cardiovascular and renal disease.

LN09-2

EMPA-REG OUTCOME

: Macrovascular and microvascular

outcomes

Ele FERRANNINI

1,2

University of Pisa School of Medicine and CNR

(National Research Council) Institute of Clinical Physiology, Pisa,

Italy;

University of Texas Health Science Center, San Antonio, Texas,

USA

People with type 2 diabetes (T2D) are at increased risk of

vascular morbidity and mortality. Cardiovascular (CV) disease

remains a major complication and is the leading cause of

death associated with diabetes. While intensive glucose

control reduces the risk of microvascular complications, its

relationship to CV outcomes remains unclear. The manage-

ment of T2D is therefore complex and necessitates treatment

considerations beyond glycaemic control.

In the context of these current challenges, Professor Ele

Ferrannini from the University of Pisa, Italy, and the University

of Texas Health Science Center in San Antonio, USA, will

provide an overview of EMPA-REG OUTCOME

, the first CV

outcomes trial in T2D to demonstrate improved CV outcomes

in patients at high CV risk. In EMPA-REG OUTCOME

, the

SGLT2 inhibitor empagliflozin was found to significantly

reduce CV death compared with placebo in patients with

T2D and established cardiovascular disease.

Professor Ferrannini will begin by outlining the baseline

characteristics of the trial population, background standard

of care and trial endpoints. He will then explore the CV

outcomes, heart failure outcomes and renal findings from the

study. The trial safety findings, including those relevant to

patients with renal impairment or heart failure at baseline,

will also be reviewed during his presentation. Finally, Professor

Ferrannini will consider the wider clinical implications of

the EMPA-REG OUTCOME

trial results for future diabetes care.

Reference

1. Zinman B

et al.

Empagliflozin, cardiovascular outcomes,

and mortality in type 2 diabetes.

N Engl J Med

2015;373:2117.

Lunch Seminar

–

Takeda

LN10-1

Collaborations & combinations: Spotlight on high CV risk and

T2D patients in Asia

Cardiovascular outcome trials (CVOT) are increasing our

understanding of how we can optimize the way we manage

type 2 diabetes (T2D) patients.

We want to have a conversation about what this means for

endocrinologists and cardiologists treating high CV risk and

hypertensive patients with T2D mellitus in Asia.

This unique symposium will look at the challenges

–

and

discuss the potential solutions

–

to help improve and optimize

the treatment of specific patient populations in Asia.

Professor Fen-Yu Tseng and Professor Bob Chilton will talk

about the importance of collaboration from the perspective of

endocrinologists and cardiologists

–

including strategies to

help optimize multidisciplinary collaboration.

We will spotlight the epidemiology of high CV risk and

hypertensive patients, focus on CVOTs and discuss why they

are important. We will present the individual trials in detail

–

including EXAMINE, LEADER, EMPA-REG and PROactive. We

will then look at what these clinical datamean for patients and

clinicians.

Professor Bob Chilton and Professor Stefano Genovese will

discuss the azilsartan and alogliptin treatment families. We

will examine the clinical data and look at the specific patient

populations for whom these treatments and treatment

combinations are most appropriate.

Now is the time to have a conversation about how we improve

and optimize the management of high CV risk patients with

T2D in Asia.

Please come join us and collaborate in this symposium.

Lunch Seminar

–

Ascensia

LN11-1

Accuracy and user performance evaluation as key factors in

self-monitoring in diabetes patients

Guido FRECKMANN

Institute for Diabetes-Technology Research

and Development Corporation, Germany

For people with diabetes, self-monitoring of blood glucose

(SMBG) is an essential part in the maintenance of glycemic

control. Particularly for patients with intensified insulin

therapy or insulin pump therapy, the availability of reliable

and accurate glucose results is crucial to adequately adjust

insulin doses.

The international standard ISO (International Organization

for Standardization) 15197 defines various requirements for

SMBG systems, concerning safety and reliability, analytical

performance (e.g. system accuracy), information supplied by

the manufacturer and performance in the hand of lay-users.

The currently applicable version of the standard is ISO

15197:2013, its predecessor was ISO 15197:2003.

Regarding system accuracy, ISO 15197:2013 describes the

following minimum criteria: Criterion A: At least 95% of a

system

’

s measurement results shall fall within ±15 mg/dL of

the comparison measurement results at blood glucose (BG)

concentrations <100 mg/dL and within ±15% at BG concen-

trations

≥

100 mg/dL. Criterion B: At least 99% of individual

measurement results shall fall within Consensus Error

Grid zones A and B. Criterion A is also applicable for user

performance evaluation.

A number of accuracy evaluation studies performed in recent

years have reported that not all available SMBG systems

show sufficient measurement quality to comply with ISO

15197 requirements. However, there are qualitative differences

even among SMBG systems that comply with ISO 15197

requirements. Simulation studies show that higher accuracy

leads to clinical benefit. User performance evaluation studies

showed that SMBG systems showing high accuracy when used

by trained professionals do not necessarily also showed

high accuracy in the hands of lay-users. This underlines the

importance of patient education and training, not only to avoid

meter-independent factors like contamination of hands, but

also to highlight meter-specific details. A reliable and accurate

SMBG system is an important aspect in optimizing insulin-

dependent patients

’

therapies.

Lunch Seminar

–

AstraZeneca

LN14-1

Is there a unifying hypothesis to explain the cardio-renal

benefit of SGLT2 inhibitors?

–

Spotlight on the role of ketone

bodies

Sunder MUDALIAR

1,2,3

University of California,

Director

Diabetes Clinic, VA San Diego Healthcare System,

Director Special

Diagnostic and Treatment Unit, VA San Diego Healthcare System,

San Diego, CA, USA

Speech Abstracts / Diabetes Research and Clinical Practice 120S1 (2016) S1

–

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S37