Guiding Principles for Diabetes Care

With the use of editorial commentaries over recent years, our editorial team has provided significant comments and updates at routine intervals regarding our progress as a leading diabetes journal. Many of the editorials were geared to addressing specific areas of science, providing discussion on clinical care or clinical research focus in a particular issue, or informing readers of new initiatives. With this issue of Diabetes Care, we want to provide comment on the process by which we acquire, gain, and put into practice recommendations based on new evidence, or when the evidence is not quite complete, how we make practice decisions based on the best evidence to date from consensus. Specifically, we are referring to the dissemination of recent updates from the American Diabetes Association (ADA) in the form of position statements, scientific statements, and consensus reports (proceedings from ADA Consensus Conferences). It has been a special privilege for our journal to publish these important narratives.

In this regard, this issue is particularly noteworthy as two comprehensive narratives (a consensus report and a scientific statement) are included that provide an enhanced focus on the advances in pathophysiology and pathways for development of therapies for type 1 diabetes. In addition, an ADA position statement provides an update on disease management and policy recommendations for students with diabetes in the elementary and secondary school settings. The updates in these particular areas not only provide important clinical information but also complement extremely well the special article collection in Diabetes Care (June 2015) entitled “Type 1 Diabetes at a Crossroads” (1). In that issue, the journal specifically focused on issues pertaining to type 1 diabetes and published articles that commented on the latest update from studies, opinions, and perspectives in the field.

The fact that this issue highlights three specific narratives from the ADA is not new or novel. The ADA has been actively involved in the development and dissemination of diabetes care standards, guidelines, and related documents for over 20 years that have regularly appeared in Diabetes Care. ADA position statements, scientific statements, and consensus reports are based on clinical and scientific research, expert opinions, and patient preferences. Generally, most readers are familiar with obtaining updated information from the ADA through the Standards of Medical Care in Diabetes recommendations published each January in Diabetes Care. The development of these Standards is extremely rigorous and based on the guiding principles listed in the Institute of Medicine’s Standards for Developing Trustworthy Clinical Practice Guidelines. In the January 2015 issue, the recommendations were examined and trends in the quality of evidence supporting the recommendations were ranked: higher evidence levels A and B versus lower levels C and E (expert opinion). As we stated in the January 2015 editorial and as outlined in the report, over the 9-year period spanning from 2005 to 2014, the proportion of recommendations from the ADA per year that were based on higher-level evidence increased from 39% to 51% (2,3). With these findings, it was clear that the process for review from the ADA is robust.

The Standards recommendations appear to be well known to most readers, but they may not precisely know the purpose for specific initiatives from the ADA as they appear in the current issue. As a case in point, the ADA position statement is an official ADA point of view or belief that contains clinical or research recommendations. Position statements are issued on scientific or medical issues related to diabetes. The position statement in this issue, “Diabetes Care in the School Setting: A Position Statement of the American Diabetes Association,” is a very good example (4).

The ADA scientific statement is an official ADA point of view or belief that may or may not contain clinical or research recommendations. A scientific statement contains a scholarly synopsis of a topic related to diabetes. In this issue, the scientific statement entitled “Staging Presymptomatic Type 1 Diabetes: A Scientific Statement of JDRF, the Endocrine Society, and the American Diabetes Association” is very representative for this format (5).

A consensus report is the proceedings from an ADA Consensus Conference and contains a comprehensive examination by an expert panel of a scientific or medical issue related to diabetes. It is not an ADA position and represents expert opinion only. The consensus report entitled “Defining Pathways for Development of Disease-Modifying Therapies in Children With Type 1 Diabetes: A Consensus Report” is presented in this issue (6). As would be expected, all ADA position statements, scientific statements, and consensus reports undergo a formal review by ADA’s Professional Practice Committee.

One can make the argument that such documents as position statements, scientific statements, and consensus reports can be considered as “guiding principles” of diabetes management. A standard definition of a “guiding principle” is “an idea that influences you very much when making a decision or considering a matter” (7). We clearly think that is appropriate for the intent of these updates from the ADA. Specifically, the three updates published in this issue provide concepts that may indeed influence you in the clinical decision-making process. For example, the ADA’s position statement by Jackson et al. (4) entitled “Diabetes Care in the School Setting: A Position Statement of the American Diabetes Association” provides a needed update in an important area. This narrative is a logical progression of the approach taken by the ADA last year when the ADA decided to separate out young children as their care is very different from school-aged students. Thus, in the October 2014 issue of Diabetes Care, we published “Care of Young Children With Diabetes in the Child Care Setting: A Position Statement of the American Diabetes Association” (8). We all recognize that diabetes is a common chronic disease in school-aged children. To effectively manage and monitor this condition so as to minimize the development of complications and to have children with diabetes participating in all school activities, there has to be proper coordination of care among the family, school, and diabetes health care provider. Thus, a comprehensive narrative about the needs of school-aged students and available resources are featured in this issue (4).

In addition, we are also featuring a scientific statement entitled “Staging Presymptomatic Type 1 Diabetes: A Scientific Statement of JDRF, the Endocrine Society, and the American Diabetes Association” (5). This article was the result of a collaborative effort of numerous organizations involved in type 1 diabetes research and clinical management. These organizations realized that there had been remarkable progress in the underlying pathophysiology of type 1 diabetes biology, but that the current classification did not represent the latest findings. The article represents a proposal of how we diagnose, manage, and approach future research in type 1 diabetes. The adoption of the staging classification system is endorsed by the American Association of Clinical Endocrinologists, the International Society for Pediatric and Adolescent Diabetes, and The Leona M. and Harry B. Helmsley Charitable Trust.

Finally, the consensus report appearing in this issue represents an incredible collaboration from multiple parties and results from recommendations from a Consensus Conference held in January 2015 by the ADA in conjunction with JDRF, the T1D Exchange, and the Benaroya Research Institute (6). Entitled “Defining Pathways for Development of Disease-Modifying Therapies in Children With Type 1 Diabetes: A Consensus Report,” this consensus report was initiated by clinical researchers in type 1 diabetes. The traditional paradigm is that research must first be conducted in adults before being considered in children. This approach may potentially deprive children of effective therapies. The Consensus Conference aimed to align researchers, regulators, advocacy groups, and policy makers in their understanding of type 1 diabetes in order to remove barriers so that effective medicines could be safely developed in children. This report is complemented extremely well by a thought-provoking perspective by Turner et al. (9) entitled “Alternate Approaches for Pediatric Type 1 Diabetes Drug Development and Potential Regulatory Approval: A Perspective.” The focus of the perspective is to provide comment on potential solutions to the challenges experienced in the goal to bring new drugs for pediatric type 1 diabetes to market.

Given the progress to date and knowledge gained in understanding the pathophysiology of type 1 diabetes, the unique needs of children with diabetes, and the evolving therapeutic landscape, updates to guide our thinking on management and approach to this patient cohort are continually needed. By featuring an updated position statement, scientific statement, consensus report, and perspective, it is our desire to continually bring new data, paradigm shifts, and, hopefully, consensus on these topics to our readers. Understanding the basis for the differences in diabetes presentation at earlier ages, the observations on disease progression, and the disease management approaches for this special population remains within our goal at Diabetes Care. Achieving goals of adequate management for this cohort requires collaboration at multiple levels including the patient, family, educator, and provider. The management of the cohort thus benefits from the incredible advances in research at the basic and clinical levels, in conjunction with the translational and population-based trials. All the research to date provides a wealth of information that will continue to benefit our most vulnerable patient populations. We remain honored that Diabetes Care continues to be the format by which these “guiding principles” are disseminated for the benefit of improved clinical care.