Minding the Gap: From Idea to Innovation in Diabetes

My 56-year-old patient with type 2 diabetes recently sat across from me and said, “I’m sorry I forgot to bring my log book and meter. I know what I need to do, and I really try to check my sugars, exercise, eat right, and do all the other right things, but it’s not easy with working and all that I have to deal with.”

Sadly, his experience is all too common, and this encounter sparked my thinking about gaps — gaps between where we are and where we could be. We know that landmark clinical trials such as the United Kingdom Prospective Diabetes Study (UKPDS)¹ and the Diabetes Control and Complications Trial (DCCT)² have demonstrated that tight glycemic control can greatly reduce the risk for diabetes complications. However, data from the National Health and Nutrition Examination Survey (NHANES) from 2007 to 2010 revealed that only 52.5% of adults with diagnosed diabetes achieved an HbA1c lower than 7.0%; 51.1% had a blood pressure lower than 130/80 mm Hg; and 56.2% attained an LDL cholesterol level lower than 100 mg/dL.³ Moreover, only 18.8% of people with diabetes reached all 3 goals.³

Unfortunately, multiple barriers, ranging from socioeconomic issues to the disease itself, prevent the application of evidence from clinical trials to patient care. ⁴

Seventeen years is the average time it takes for clinical research findings to reach clinical practice, studies suggest,⁵ but translational research aims to shorten the distance between discovery and application.

In a paper published in the Journal of the American Medical Association in 2003, Sung et al describe 2 continuous phases in translational research: 1) “from bench to bedside,” or from breakthroughs in the lab to their application in clinical research,⁶ such as the development of diabetes medications like metformin, insulin, or a sodium glucose co-transporter 2 (SGLT2) inhibitor, which are then studied in clinical trials; and 2) “from bedside to community,” or from clinical trials to clinical practice.⁷

The gaps may be closing, though not completely, and we still have much room to improve.

Can we even replicate what they accomplished with our patients in clinics in our communities? If so, how? Here are 3 potential solutions to explore further.

1. Break down barriers. Here are 2 examples of how to combat obstacles.

   On a larger scale, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) supports Centers for Diabetes Translational Research (CDTR). “The purpose of the CDTRs is to enhance the efficiency, productivity, effectiveness, and multidisciplinary nature of diabetes translation research. Centers are intended to improve the quality and multidisciplinary nature of research of diabetes translational research through shared access to specialized technical expertise,” according to their website. These centers conduct translational research on issues from health disparities to community engagement to applying technology.

   On a more local level, I have the privilege of volunteering about once a month at the University of California, San Diego (UCSD) Student-Run Free Clinic. I serve as an attending physician in the Diabetes Clinic and attend staff patient presentations by UCSD students from all 4 years of medical school. There are barriers abound. Our medication options, for instance, are usually only metformin, glipizide, or insulin. Without this clinic and others like it, more individuals would lack any of the key components to good health and quality of life.

2. Encourage and facilitate translational research efforts.

   Beyond speeding up the process of converting an idea to innovation that is widely used clinically to improve health, a key step involves optimizing all aspects of translational research — from patient involvement to new technologies. My institution, UCSD, is home to a Clinical and Translational Research Institute (CTRI). The CTRI is part of a national consortium of 62 similar medical research facilities with this shared mission. This resource provides multiple grants, ranging from those for pilot projects to ones that encourage collaboration between disciplines, such as medicine and engineering. Training in translational research as well as a physical space to conduct clinical studies are also provided.

   The UCSD CTRI recently received a $52 million Clinical and Translational Science Award to advance these and other efforts. The director of the UCSD CTRI, Gary S. Firestein, MD, stated that one of the goals of CTRI moving forward involves a paradigm shift.

   “Rather than rely upon the traditional method of studying large numbers of patients, we’re moving toward massive data collection on individual patients. The goal is to integrate diverse approaches and disciplines to find new drugs and therapies and advance individualized treatments,” he said in a press release.

3. Enhance communications between community clinicians and academic investigators, and between investigators and laypeople.

   “Sometimes progress takes the time and effort of many different members of society,” UCSD CTRI Director of Community Engagement Howard Taras, MD, who was honored as a “Health Hero” by Combined Health Agencies of San Francisco, noted in a UCSD announcement of his award.

   Dr Taras and his team help the academic community reach out to the community to facilitate a deeper understanding by both groups. To many, clinical research is still prone to misconceptions about how extensively putative new medications are initially tested.

How often do clinical investigators seek input from community clinicians who do not conduct research? Like Dr Taras’ group, we must also engage with clinicians in the community who are delivering and explaining the treatments and tests that are developed at academic institutions.

The world has become increasingly specialized. While we need this level of expertise, we should also not lose sight of the strength of collaboration across specialties. Much as caring for a patient with diabetes takes the combined efforts of a multidisciplinary team that includes nurses, dietitians, certified diabetes educators, and physicians, this cross-talk can only drive progress forward, bring fresh perspectives and insights to the table, and spark new connections and ideas that can potentially provide innovative solutions to our challenges in diabetes care.

Edward C. Chao, DO, practices at the VA San Diego Healthcare System and is associate clinical professor of medicine at the University of California, San Diego.

References

1. United Kingdom Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352(9131):837-853. [Erratum, Lancet. 1999;354(9178):602.]
2. The Diabetes Control and Complications Trial (DCCT) Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993;329(14):977-986.
3. Stark Casagrande S, Fradkin JE, Saydah SH, Rust KF, Cowie CC. The prevalence of meeting A1C, blood pressure, and LDL goals among people with diabetes, 1988-2010. Diabetes Care. 2013;36(8):2271–2279.
4. Hiss RG. The concept of diabetes translation: addressing barriers to widespread adoption of new science into clinical care. Diabetes Care. 2001;24(7):1293–1296.
5. Balas EA, Boren SA. Managing clinical knowledge for health care improvement. In: Bemmel J, McCray AT, eds. Yearbook of Medical Informatics 2000: Patient-Centered Systems. Stuttgart, Germany: Schattauer Verlagsgesellschaft mbH; 2000:65-70.
6. Sung NS, Crowley WF Jr, Genel M, et al. Central challenges facing the national clinical research enterprise. JAMA. 2003;289(10):1278–1287.
7. Narayan KM, Gregg EW, Engelgau MM, Moore B, Thompson TJ, Williamson DF, Vinicor F. Translation research for chronic disease: the case of diabetes. Diabetes Care. 2000;23(12):1794–1798.