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It's complicated

How complications from diabetes impacts trial design, delivery and overall standards of care
Diabetes is fast becoming a global healthcare epidemic. The number of people with diabetes rose from 108 million in 1980 to 422 million in 2014, with related deaths projected to rise by more than 50 percent in the next 10 years (http://www.who.int/mediacentre/factsheets/fs312/en/). 

Lack of awareness and access to proper treatment can also lead to serious complications, such as blindness, amputation and kidney failure. And while the healthcare industry is effective at managing diabetes as a disease, physicians and patients could be doing more to test for early warning signs that indicate that these complications are emerging. 

The need for early diagnosis and better monitoring is the theme of this year’s World Diabetes Day, on November 14. The annual event, created by the International Diabetes Federation (IDF) and the World Health Organization (WHO), in response to growing concerns about the escalating health threat posed by diabetes, will focus on promoting the importance of screening to ensure early diagnosis of type 2 diabetes and treatment to reduce the risk of serious complications.  

As a clinical researcher and someone living with diabetes, I am particularly concerned about the need for more consistent testing as part of the broader diabetes care environment. Despite clear standards of care laid out by the American Diabetes Association, which call for regular medical testing to identify and prevent complications, many physicians forgo some of these practices until these complications begin to present themselves. For example, physicians may closely monitor their patients’ glucose levels, but fail to check their feet or recommend that they visit a podiatrist to detect signs of diabetic neuropathy or peripheral vascular disease – both of which are complications of diabetes that damage the feet. Another example would be a physician failing to make sure patients are having their eyes checked for signs of retinopathy, which is the most common cause of vision loss among people with diabetes and the leading cause of vision impairment and blindness among working-age adults. 

Another standard practice is to regularly check patients’ urine for the presence of microalbuminuria, which indicates the beginning stages of kidney disease. When kidney disease is diagnosed early, there are several treatments, including the use of Angiotensin Converting Enzyme (ACE) inhibitors, that may keep the condition from getting worse, yet when physicians fail to regularly conduct these tests, they put patients at unnecessary risk. 

Impact of clinical research
Such testing is equally important in the clinical environment, both for diabetes drug trials and trials that may recruit diabetes patients. These patients are vulnerable, and sponsors need to be sure that every aspect of the trial plan and implementation takes into account their risk for these conditions. 

Whenever we work on a trial that involves diabetes patients, we review protocols with a group of diabetes experts along with our scientific review committee to make sure the trial design will meet the requirements of evidence-based medicine and address all patient safety concerns, including any risk of complications related to their overall care. Then, we choose trial sites and physicians who have been shown to closely follow diabetes standards of care in their practice, and we regularly review case report forms (CRF) to ensure every patients’ care in our trials adheres to the protocol and standard practices to keep them safe. We also assess every patient at the outset of the trial to establish a baseline for their health and identify any potential risks for complications, to make sure that the treatment won’t exacerbate any underlying conditions. This kind of attention-to-detail is critical for patients and sponsors, as it not only makes sure trial participants are adequately protected and cared for, it also gives researchers the data they need to better identify trends in the research, and to more quickly identify risk factors among certain patient populations that may impact label claims and trial outcomes.

Avoiding adverse events is vital to the success of any trial, which is why sponsors pursuing diabetes research or recruiting diabetes patients to related trials, should seek partners who understand how to address these concerns at every stage of the drug development lifecycle, to deliver the highest quality research and patient care.

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