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ADA

UPDATE -2019
Exclusive Highlights

79
SCIENTIFIC SESSIONS OF THE
TH

AMERICAN DIABETES ASSOCIATION


SAN FRANCISCO, CA

Daily Update
TH
7 JUNE 2019

An educational initiative by
79 TH SCIENTIFIC SESSIONS OF THE
AMERICAN DIABETES ASSOCIATION
SAN FRANCISCO, CA • JUNE 7 - 11 , 2019
TH TH

American Diabetes Asso- Diabetes), being presented Sunday, June 9 at


4:30 PM, and the CAROLINA trial (Cardiovas-
ciation 79th Scientific cular Safety of Linagliptin), being presented
Sessions: What To Expect Monday, June 10 at 4:30 PM.

Other notable presentations to look for at 79th


San Francisco, California, Friday 7th
Scientific Sessions:
June, 2019: The American Diabetes
Association (ADA) began its 79th Annual
The D2d study, launched in 2013, is the
Scientific Sessions in San Francisco,
largest ever clinical trial designed to explore
California, from Friday, June 7, through
the effects of vitamin D supplementation on
Tuesday, June 11, 2019.
delay of diabetes onset. Results will be
unveiled at ADA 2019 for the first time.
The American Diabetes Association's 79th
Scientific Sessions, the world's largest scientific
The TODAY2 Study, documenting the course of
meeting focused on diabetes research, preven-
type 2 diabetes and its comorbidities (renal,
tion and care, will be held June 7-11, 2019, at
cardiac, eye, nerve) in the transition from youth
the Moscone Center in San Francisco,
to young adulthood.
California. Nearly 15,000 leading physi-
cians, scientists, health care professionals and The PREVIEW study, a global trial that used
industry representatives from around the world meal replacements, diets of varying composi-
are expected to convene at the Scientific tions, and 2 physical activity strategies to gain
Sessions to unveil cutting-edge research, insights into weight loss maintenance and
treatment recommendations and advances diabetes prevention.
toward a cure for diabetes. During the five-day
meeting, attendees will receive exclusive TrialNet results, which will cover findings from
access to more than 850 presentations and the Teplizumab Prevention Trial of individuals
2,000 original research presentations, partici- with type 1 diabetes with multiple antibodies
pate in provocative and engaging exchanges and abnormal glucose tolerance. In addition,
with leading diabetes experts, and can earn data from 2 other TrialNet studies will be
Continuing Medical Education (CME) or presented.
Continuing Education (CE) credits for educa-
tional sessions. The DECLARE-TIMI 58 trial, which assessed
patients with diabetes and risk factors for
Amongst the new trial data being presented, atherosclerotic cardiovascular disease receiv-
some of the most highly anticipated findings ing dapagliflozin. The session at ADA 2019
are from cardiovascular disease risk preven- will cover renal end points and other safety
tion trials, including the REWIND trial (Re- aspects.
searching CV Events with a Weekly Incretin in

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79 TH SCIENTIFIC SESSIONS OF THE
AMERICAN DIABETES ASSOCIATION
SAN FRANCISCO, CA • JUNE 7 - 11 , 2019
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The CREDENCE and CARMELINA trials, for The PIONEER trial program, comparing the
which key findings will be reviewed and new efficacy and safety of orally administered
data analyses presented. These major trials peptide drugs with other antihyperglycemic
explored the effects of canagliflozin and agents.
linagliptin, respectively, in patients with type 2
diabetes at high risk for renal and cardiovascu-
lar complications.

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79 TH SCIENTIFIC SESSIONS OF THE
AMERICAN DIABETES ASSOCIATION
SAN FRANCISCO, CA • JUNE 7 - 11 , 2019
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evidence does not suggest an ideal


ADA Updates Cons- caloric carbohydrates, protein, and fat
ensus Report Rega- intake. Various combinations of food
groups are acceptable.
rding Personalized
Nutrition Therapy in Current eating patterns, metabolic
goals, and preferences should be
Type 2 Diabetes assessed in order to personalize
macronutrient distribution.
San Francisco, California, Friday 7th
June, 2019: The American Diabetes Management of weight was recom-
Association (ADA) published a new guidance mended as an essential component of
report regarding individualization of nutrition care in people with type 1 diabetes
goals in diabetes care, including strategies for (T1D) who are overweight or obese and
weight management and the prevention of subject to worsening of insulin resis-
diabetes complications today 7th June 2019at t a n c e , g l y c e m i c v a r i a b i l i t y,
the 79th Annual Scientific Sessions held at the microvascular disease complications,
Moscone Convention Centre. For the first time, and cardiovascular risk factors.
the updated report also includes nutrition
The panel emphasized that it is critical to
interventions for adults diagnosed with
maintain and sustain an eating plan that
prediabetes.
results in a deficit of energy, regardless
The panel reviewed more than 600 nutrition of macronutrient composition or eating
manuscripts published between 2014 and pattern to promote weight loss.
2018 for the update, which has been incorpo-
Healthcare providers are advised to
rated into the ADA's 2019 Standards of
focus on important dietary factors such
Medical Care.
as consuming nonstarchy vegetables;
A summary of the consensus recom- minimizing added sugars and refined
mendations follows. grains; and choosing whole, unpro-
cessed foods over processed foods.
There is no single recommended nutri-
tion plan for patients with diabetes.
The panel recommended replacing
Factors such as food availability, socio-
sugar-sweetened beverages with water
economic circumstances, and cultural
when possible. They also noted that
preferences must be taken into consider-
replacing sugar with sugar substitutes
ation due to the broad spectrum of
does not make an unhealthy option
people affected by diabetes.
healthy.

For people with or at risk for diabetes,

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79 TH SCIENTIFIC SESSIONS OF THE
AMERICAN DIABETES ASSOCIATION
SAN FRANCISCO, CA • JUNE 7 - 11 , 2019
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Saturated fat should be replaced with William Cefalu, MD, the ADA's Chief
unsaturated fat to reduce low-density Scientific, Medical, and Mission Officer,
lipoprotein cholesterol, total cholesterol, stated that the ADA “strongly encourages an
and the risk for cardiovascular disease. individualized approach that includes regular
review of nutrition status for all people living
Research indicates that reductions in with diabetes. Reassessment of an individual's
hemoglobin A1c with medical nutrition nutritional plan is particularly important during
therapy in type 2 diabetes (T2D) can be significant life and health status changes…
equal to or greater than reductions with Working with a team of health providers
medications. including a registered dietician or certified
diabetes educator is fundamental to effectively
Medical nutrition therapy can be
manage[ing] diabetes and prediabetes.”
important in the management and
prevention of diabetes complications
including gastroparesis, cardiovascular
disease, and chronic kidney disease.
Exercise, Behavioral
National data suggest that people with Treatment Improve
diabetes do not receive any formal
diabetes education, so referring adults Outcomes in Comor-
with T1D or T2D to personalized, diabe- bid T2D & Depression
tes-focused medical nutrition therapy
upon diagnosis and throughout life is an
San Francisco, California, Friday 7th
imperative component of care.
June, 2019: Exercise and/or behavioral
treatment interventions may provide clinically
For patients with prediabetes, the
meaningful improvements in depression
panel made the following recommen-
outcomes in adults with type 2 diabetes
dations.
(T2DM) and major depressive disorder
Referral to an intensive behavioral (MDD), according to a study presented today
lifestyle intervention program to improve 7th June 2019 at the 79th Scientific Sessions of
eating habits, increasing physical the ADA.
activity to at least 150 min/wk, and a
Mary de Groot, Ph.D., from Indiana University
7% to 10% loss of initial body weight if
in Indianapolis, and colleagues randomly
indicated.
assigned adults with T2DM for at least one
Counseling by healthcare providers year with coexisting MDD to cognitive behav-
should focus on prevention and diagno- ioral therapy (CBT; 10 sessions over 12 weeks;
sis and treatment of disordered eating. 36 patients), community-based exercise
(EXER; 12 weeks including six sessions with a

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79 TH SCIENTIFIC SESSIONS OF THE
AMERICAN DIABETES ASSOCIATION
SAN FRANCISCO, CA • JUNE 7 - 11 , 2019
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personal trainer; 34 patients), CBT+EXER extend the availability of depression treatment


(concurrent over a 12-week period; 34 options that are complementary to medical
patients), and usual care (UC; 36 patients). care for patients with T2DM to achieve
improvements in outcomes for both disorders,”
The researchers note that participants were the authors write.
mainly female (77 percent), white (71 per-
cent), and married (52 percent), with a mean
age of 56.0 years. The odds of achieving full T2D a Risk Factor for
MDD remission in the intervention groups were
5.0 to 6.8 times greater than in the UC group
Liver Fibrosis Pro
after controlling for education and antidepres- gression in Non-
sant use. Compared with UC, the CBT+EXER
group demonstrated improved hemoglobin
alcoholic Fatty Liver
A1c (HbA1c). After controlling for other Disease
variables, among participants with a baseline
HbA1c ≥7.0 percent, the CBT+EXER group San Francisco, California, Friday 7th
had a 1.1 percent improvement in HbA1c. June, 2019: : Type 2 diabetes mellitus
(T2DM) is a risk factor for progression of liver
“These interventions enable behavioral health
fibrosis in patients with nonalcoholic fatty liver
counselors and exercise professionals to
disease (NAFLD), according to a study pub-

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79 TH SCIENTIFIC SESSIONS OF THE
AMERICAN DIABETES ASSOCIATION
SAN FRANCISCO, CA • JUNE 7 - 11 , 2019
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lished presented today 7th June 2019 at the


79th Scientific Sessions of the ADA..
Elizabeth R. Seaquist,
MD, Receives the Ame-
Toshifumi Tada, M.D., from Ogaki Municipal
Hospital in Japan, and colleagues examined rican Diabetes Asso-
®
clinical risk factors for progression of liver
ciation's First Lois
fibrosis in patients with NAFLD. Data were
included for 1,562 patients with NAFLD (aged J o v a n o v i c Tr a n s -
36 to 64 years) and less severe liver fibrosis
(FIB-4 index, <1.3).
formative Woman in
Diabetes Award, pre-
The researchers found that 186 patients
progressed to advanced fibrosis (FIB-4 index, sented in collabora-
>2.67) during follow-up. For progression to
advanced fibrosis, the three-, five-, seven-, and
tion with Sansum
10-year cumulative incidence rates were 4.4, D i a b e t e s Re s e a r c h
6.7, 11.0, and 16.7 percent, respectively.
Age, albumin concentration, and T2DM were Institute
significantly associated with progression to
advanced fibrosis in the univariate analysis. San Francisco, California, Friday 7th
Age ≥50 years, albumin concentration <4.2 June, 2019: Elizabeth R. Seaquist, MD, has
g/dL, and presence of T2DM were independ- been selected to receive the American
ently associated with progression to advanced Diabetes Association's® (ADA's) first Lois
fibrosis (hazard ratios, 2.121, 1.802, and Jovanovic Transformative Woman in Diabetes
1.879, respectively) in multivariate analysis. Award. This new award in honor of Lois
For progression to advanced fibrosis, the three- Jovanovic, MD, an iconic scientist and physi-
, five-, seven-, and 10-year cumulative cian who passed away in September 2018,
incidence rates were 3.6, 5.0, 8.2, and 12.9 recognizes a woman who has made a signifi-
percent, respectively, in patients without T2DM cant impact in diabetes care, research, educa-
and 6.1, 10.4, 16.7, and 24.0 percent, tion or public health. Dr. Seaquist will be
respectively, in patients with T2DM. recognized with this award during the ADA's
79th Scientific Sessions, June 7–11, 2019, at
“Presence of T2DM was an independent risk the Moscone Convention Center in San
factor for progression to advanced liver fibrosis Francisco. Dr. Seaquist will give remarks at the
in addition to advanced age and low albumin Women's Interprofessional Network of the
concentration,” the authors write. American Diabetes Association (WIN ADA)
Reception on Friday evening, Dr. Seaquist
holds the Pennock Family Chair in Diabetes

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79 TH SCIENTIFIC SESSIONS OF THE
AMERICAN DIABETES ASSOCIATION
SAN FRANCISCO, CA • JUNE 7 - 11 , 2019
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receive this inaugural award. Dr. Seaquist has


conducted pioneering work, and she has
served as a model investigator for women
professionals in diabetes research and care, as
Dr. Jovanovic did, and her work has improved
health care of women with diabetes.

An internationally recognized researcher, Dr.


Seaquist has directed the University of
Minnesota sites for high-profile clinical trials on
the impact of diabetes and iatrogenic
hypoglycemia on cerebral metabolism,
structure and function including the Glycemia
Reduction Approaches in Diabetes: A
Comparative Effectiveness Study (GRADE)
study and the Researching Cardiovascular
Events with a Weekly Incretin in Diabetes
(REWIND) study. She was the site investigator
for the Action to Control Cardiovascular Risk in
Research and is Professor of Medicine, Diabetes (ACCORD) trial. Dr. Seaquist is also
Director of the Division of Endocrinology, the principal investigator on the National
Diabetes and Metabolism, and Vice Chair for Institutes of Health (NIH) T32 Research
Clinical Affairs in the Department of Medicine Training Grant for fellows in endocrinology
at the University of Minnesota. She is also and diabetes at the University of Minnesota.
Associate Director of the University's Medical Her scientific contributions focus on under-
Scientist Training Program, as well as Medical standing hypoglycemia and human brain
Director of the Medical Subspecialty Service glucose metabolism from the “bedside to
Line at MHealth Fairview. population” level.

“Congratulations, Dr. Seaquist, on this tremen- Dr. Seaquist has mentored female junior
dous achievement, and thank you for your faculty members who are actively involved in
significant contributions supporting women diabetes, obesity and insulin resistance
and health care providers and researchers in research. She has also served in numerous
diabetes,” said the ADA's Chief Scientific, mentorship and leadership positions with the
Medical and Mission Officer and President of ADA, including serving as the 2014 President
the ADA Research Foundation William T. of Medicine and Science, as a member of the
Cefalu, MD. “For those of us who knew and ADA's National Board of Directors and the
respected Dr. Jovanovic, I can't imagine Pathway to Stop Diabetes Mentor Advisory
anyone more rewarding than Dr. Seaquist to

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79 TH SCIENTIFIC SESSIONS OF THE
AMERICAN DIABETES ASSOCIATION
SAN FRANCISCO, CA • JUNE 7 - 11 , 2019
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Group. Dr. Seaquist's outstanding work has O u t c o m e s i n Ty p e 2 D i a b e t e s a n d


also been recognized with the ADA's Banting Nephropathy (CREDENCE) trial, published
Medal for Service and the Distinguished April 14, 2019, in the New England Journal of
Clinician Scientist Award. Medicine, which assessed the impact of
canagliflozin therapy on cardiorenal out-
comes in patients with diabetes-related chronic
American Diabetes kidney disease. CREDENCE found that use of
Association ® Issues canagliflozin by patients with type 2 diabetes
and chronic, diabetes-related kidney disease
Critical Updates to the lowered the risk of the primary composite
outcome (inclusive of end-stage kidney dis-
2019 Standards of ease, doubling of serum creatinine or death
Medical Care in from renal or cardiovascular diseases) by
30%. The relative risk of the renal-specific
Diabetes composite, which included end-stage kidney
disease, a doubling of the creatinine level, or
San Francisco, California, Friday 7th death from renal causes, was 34% lower in the
June, 2019: Today, the American Diabetes group receiving canagliflozin. The relative risk
Association® (ADA) issued important updates of end-stage kidney disease was lower by
to the 2019 Standards of Medical Care in 32%.
Diabetes (Standards of Care), in annotations
as the Living Standards of Care, focused on Canagliflozin was additionally found to have
improving cardiovascular and renal health in a lower risk for the composite of cardiovascu-
people with type 2 diabetes. The updates were lar death, myocardial infarction or stroke, as
informed by newly published research and well as lower risk of hospitalizations for heart
crafted and approved by the ADA's failure, and for the composite of cardiovascu-
Professional Practice Committee, which is lar death or hospitalization for heart failure. In
responsible for producing the annual terms of safety, no significant increase in lower-
Standards of Care. Updates to Section 10, limb amputations, fractures, acute kidney
Cardiovascular Disease and Risk injury or hyperkalemia were noted for
Management, have also been reviewed and c a n a g l i fl o z i n re l a t ive to p l a c e b o i n
approved by the American College of CREDENCE. An increased risk for diabetic
Cardiology, who also endorse this section. The ketoacidosis (DKA) was noted, however, with
Living Standards of Care are available immedi- canagliflozin.
ately online at Diabetes Care.
“The CREDENCE trial was the first sodium-
Sections 10 and 11 were updated based on glucose cotransporter 2 (SGLT2) inhibitor trial
findings from the Canagliflozin and Renal to assess renal-specific primary outcomes and

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79 TH SCIENTIFIC SESSIONS OF THE
AMERICAN DIABETES ASSOCIATION
SAN FRANCISCO, CA • JUNE 7 - 11 , 2019
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ended early due to efficacy. Incorporating ence includes adult and pediatric endocrinol-
these findings into the Standards of Care now ogy, epidemiology, public health, lipid
gives providers the latest evidence-based research, hypertension, preconception plan-
recommendations to treat people with type 2 ning and pregnancy care. For the 2019
diabetes and diabetes-related chronic kidney Standards of Care, two designated representa-
disease. Our Mission at the ADA is to improve tives from the American College of Cardiology
the lives of all those with diabetes and provid- (ACC) reviewed, provided feedback and
ing timely updates to our Standards of Care endorsed the recommendations for cardiovas-
can help achieve that goal. Improving care for cular disease and risk management on behalf
the millions of Americans living with diabetes of the ACC. The ACC designated representa-
cannot wait,” said the ADA's Chief Scientific, tives also reviewed and approved the updates
Medical and Mission Officer William T. made to the cardiovascular disease and risk
Cefalu, MD. management section. The PPC performs an
extensive, global clinical diabetes literature
The Standards of Care provide the latest in search each year for the annual Standards of
comprehensive, evidence-based recommenda- Care update, supplemented with input from
tions for the diagnosis and treatment of chil- ADA leaders and staff and the medical com-
dren and adults with type 1, type 2 or gesta- munity at-large. Members of the PPC must
tional diabetes; strategies to improve the disclose potential conflicts of interest with
prevention or delay of type 2 diabetes; and industry and/or relevant organizations; these
therapeutic approaches that reduce complica- disclosures are available on page S184 of the
tions and positively affect health outcomes. 2019 Standards of Care.
Beginning in 2018, the ADA updates and
revises the online version of the Standards of
Care throughout the year, with annotations for No Evidence of Legacy
new evidence or regulatory changes that merit
immediate incorporation. The online version of
Effect Seen for Inte-
the Standards of Care will include any nsive Glucose Lower-
research updates or policy changes that are
approved throughout 2019.
ing
Updates to the Standards of Care are estab- San Francisco, California, Friday 7th
lished and revised by the ADA's Professional June, 2019: There seems to be no evidence
Practice Committee (PPC). The committee is a of a legacy effect or mortality benefit for
multidisciplinary team of 14 leading U.S. intensive glucose control among military
experts in the field of diabetes care and veterans with type 2 diabetes, according to a
includes physicians, diabetes educators, study published in the June 6 issue of the New
registered dietitians and others whose experi- England Journal of Medicine.

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79 TH SCIENTIFIC SESSIONS OF THE
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Peter D. Reaven, M.D., from the Phoenix interval, 0.78 to 1.06; P = 0.23; hazard ratio
Veterans Affairs Health Care System, and for death, 1.02; 95 percent confidence
colleagues report 15-year follow-up for interval, 0.88 to 1.18). During an extended
intensive versus standard glucose lowering interval of separation of the glycated hemoglo-
following a trial involving 1,791 military bin curves, the risk for major cardiovascular
veterans with type 2 diabetes. disease outcomes was reduced (hazard ratio,
0.83; 95 percent confidence interval, 0.70 to
The separation of glycated hemoglobin curves 0.99). After equalization of the glycated
between the intensive- and standard-therapy hemoglobin levels, the benefit did not persist
groups averaged 1.5 points during the trial (hazard ratio, 1.26; 95 percent confidence
and declined after the trial ended. The interval, 0.90 to 1.75).
researchers found that the risks for major
cardiovascular events or death were not lower “A major implication of the Veterans Affairs
in the intensive-therapy group versus the Diabetes Trial follow-up study is that older
standard-therapy group during a period of 15 patients with advanced diabetes should not
years of follow-up (active treatment plus post- expect long-term cardiovascular benefits from
trial observation; hazard ratio for primary intensive glycemic control,” write the authors of
outcome, 0.91; 95 percent confidence an accompanying editorial.

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79
SCIENTIFIC SESSIONS
TH

OF THE AMERICAN DIABETES


ASSOCIATION

An educational initiative by

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