Diabetes Care Volume 42, Supplement 1, January 2019 S1

Introduction: Standards of Medical

Care in Diabetesd2019
Diabetes Care 2019;42(Suppl. 1):S1–S2 | https://doi.org/10.2337/dc19-SINT01

Diabetes is a complex, chronic illness The ADA strives to improve and update updates the Standards of Care annually.
requiring continuous medical care with the Standards of Care to ensure that However, the Standards of Care is a
multifactorial risk-reduction strategies clinicians, health plans, and policy makers “living” document, where notable up-
beyond glycemic control. Ongoing pa- can continue to rely on them as the most dates are incorporated online should
tient self-management education and authoritative and current guidelines for the PPC determine that new evidence or
support are critical to preventing acute diabetes care. To improve access, the regulatory changes (e.g., drug approvals,
complications and reducing the risk of Standards of Care is now available label changes) merit immediate inclusion.
long-term complications. Significant ev- through ADA’s new interactive app, along More information on the “living Standards”

INTRODUCTION
idence exists that supports a range of with tools and calculators that can help can be found on DiabetesPro at profes-
interventions to improve diabetes out- guide patient care. To download the app, sional.diabetes.org/content-page/living-
comes. please visit professional.diabetes.org/ standards. The Standards of Care
The American Diabetes Association’s SOCapp. Readers who wish to com- supersedes all previous ADA position
(ADA’s) “Standards of Medical Care in ment on the 2019 Standards of Care statementsdand the recommendations
Diabetes,” referred to as the Standards of are invited to do so at professional. thereindon clinical topics within the
Care, is intended to provide clinicians, diabetes.org/SOC. purview of the Standards of Care; ADA
patients, researchers, payers, and other position statements, while still con-
interested individuals with the compo- ADA STANDARDS, STATEMENTS, taining valuable analysis, should not be
nents of diabetes care, general treat- REPORTS, and REVIEWS considered the ADA’s current position.
ment goals, and tools to evaluate the The ADA has been actively involved in the The Standards of Care receives annual
quality of care. The Standards of Care development and dissemination of di- review and approval by the ADA Board
recommendations are not intended to abetes care standards, guidelines, and of Directors.
preclude clinical judgment and must be related documents for over 25 years. The ADA Statement
applied in the context of excellent ADA’s clinical practice recommendations An ADA statement is an official ADA
clinical care, with adjustments for in- are viewed as important resources for point of view or belief that does not
dividual preferences, comorbidities, health care professionals who care for contain clinical practice recommenda-
and other patient factors. For more people with diabetes. tions and may be issued on advocacy,
detailed information about manage-
policy, economic, or medical issues re-
ment of diabetes, please refer to Med- Standards of Care
lated to diabetes.
ical Management of Type 1 Diabetes This document is an official ADA posi-
ADA statements undergo a formal
(1) and Medical Management of Type 2 tion, is authored by the ADA, and pro-
review process, including a review by
Diabetes (2). vides all of the ADA’s current clinical
the appropriate national committee,
The recommendations include screen- practice recommendations.
ADA mission staff, and the ADA Board
ing, diagnostic, and therapeutic act- To update the Standards of Care, the
of Directors.
ions that are known or believed to ADA’s Professional Practice Committee
favorably affect health outcomes of (PPC) performs an extensive clinical di- Consensus Report
patients with diabetes. Many of these abetes literature search, supple- A consensus report of a particular topic
interventions have also been shown to mented with input from ADA staff and contains a comprehensive examination
be cost-effective (3). the medical community at large. The PPC and is authored by an expert panel (i.e.,

“Standards of Medical Care in Diabetes” was originally approved in 1988. Most recent review/revision: December 2018.
© 2018 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit,
and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.
S2 Introduction Diabetes Care Volume 42, Supplement 1, January 2019

Table 1—ADA evidence-grading system for “Standards of Medical Care in Diabetes” that forms the basis for the recommen-
Level of evidence Description
dations. ADA recommendations are as-
signed ratings of A, B, or C, depending on
A Clear evidence from well-conducted, generalizable randomized controlled
the quality of evidence. Expert opinion
trials that are adequately powered, including
E is a separate category for recommen-
c Evidence from a well-conducted multicenter trial
c Evidence from a meta-analysis that incorporated quality ratings in the
dations in which there is no evidence
analysis from clinical trials, in which clinical trials
Compelling nonexperimental evidence, i.e., “all or none” rule developed by may be impractical, or in which there
the Centre for Evidence-Based Medicine at the University of Oxford is conflicting evidence. Recommenda-
Supportive evidence from well-conducted randomized controlled trials that tions with an A rating are based on large
are adequately powered, including well-designed clinical trials or well-done
c Evidence from a well-conducted trial at one or more institutions meta-analyses. Generally, these recom-
c Evidence from a meta-analysis that incorporated quality ratings in the mendations have the best chance of
analysis improving outcomes when applied to
B Supportive evidence from well-conducted cohort studies the population to which they are ap-
c Evidence from a well-conducted prospective cohort study or registry
propriate. Recommendations with lower
c Evidence from a well-conducted meta-analysis of cohort studies
levels of evidence may be equally im-
Supportive evidence from a well-conducted case-control study
portant but are not as well supported.
C Supportive evidence from poorly controlled or uncontrolled studies Of course, evidence is only one com-
c Evidence from randomized clinical trials with one or more major or three
ponent of clinical decision making. Clini-
or more minor methodological flaws that could invalidate the results
cians care for patients, not populations;
c Evidence from observational studies with high potential for bias (such as
case series with comparison with historical controls) guidelines must always be interpreted
c Evidence from case series or case reports
with the individual patient in mind. In-
Conflicting evidence with the weight of evidence supporting the dividual circumstances, such as comorbid
recommendation and coexisting diseases, age, education,
E Expert consensus or clinical experience disability, and, above all, patients’ values
and preferences, must be considered
and may lead to different treatment tar-
gets and strategies. Furthermore, con-
consensus panel) and represents the by invited experts. The scientific review ventional evidence hierarchies, such as
panel’s collective analysis, evaluation, may provide a scientific rationale for the one adapted by the ADA, may miss
and opinion. clinical practice recommendations in the nuances important in diabetes care. For
The need for a consensus report arises Standards of Care. The category may also example, although there is excellent
when clinicians, scientists, regulators, include task force and expert committee evidence from clinical trials supporting
and/or policy makers desire guidance reports. the importance of achieving multiple
and/or clarity on a medical or scientific risk factor control, the optimal way to
issue related to diabetes for which the GRADING OF SCIENTIFIC EVIDENCE achieve this result is less clear. It is dif-
evidence is contradictory, emerging, or ficult to assess each component of such
Since the ADA first began publishing
incomplete. Consensus reports may also a complex intervention.
practice guidelines, there has been con-
highlight gaps in evidence and propose
siderable evolution in the evaluation of
areas of future research to address these
scientific evidence and in the develop- References
gaps. A consensus report is not an ADA
ment of evidence-based guidelines. In 1. American Diabetes Association. Medical
position and represents expert opinion Management of Type 1 Diabetes. 7th ed.
2002, the ADA developed a classification
only but is produced under the auspices Wang CC, Shah AC, Eds. Alexandria, VA, American
system to grade the quality of scientific
of the Association by invited experts. Diabetes Association, 2017
evidence supporting ADA recommen- 2. American Diabetes Association. Medical
A consensus report may be developed
dations. A 2015 analysis of the evi- Management of Type 2 Diabetes. 7th ed.
after an ADA Clinical Conference or Re-
dence cited in the Standards of Care Burant CF, Young LA, Eds. Alexandria, VA,
search Symposium. American Diabetes Association, 2012
found steady improvement in quality
3. Li R, Zhang P, Barker LE, Chowdhury FM,
Scientific Review over the previous 10 years, with the Zhang X. Cost-effectiveness of interventions to
A scientific review is a balanced review 2014 Standards of Care for the first prevent and control diabetes mellitus: a sys-
and analysis of the literature on a scien- time having the majority of bulleted tematic review. Diabetes Care 2010;33:1872–
tific or medical topic related to diabetes. recommendations supported by A- or 1894
A scientific review is not an ADA po- B-level evidence (4). A grading system 4. Grant RW, Kirkman MS. Trends in the ev-
idence level for the American Diabetes As-
sition and does not contain clinical prac- (Table 1) developed by the ADA and sociation’s “Standards of Medical Care in
tice recommendations but is produced modeled after existing methods was Diabetes” from 2005 to 2014. Diabetes Care
under the auspices of the Association used to clarify and codify the evidence 2015;38:6–8