Diabetes affects 25.6 million individuals in the United States aged 21 years and older, or 11.3% of this population. Diabetes causes high blood glucose, which often results in serious health problems including blindness, heart disease, stroke, and amputations of the foot and toes. While diet and exercise can lower blood glucose, most individuals with diabetes need medications such as pills or insulin, proper diet and exercise, and at-home glucose testing. There are many factors that influence how well patients are able to comply with these requirements including age, education, income, and cultural and lifestyle issues. Often, the way an individual responds to treatment, in terms of negative side effects and the burden of the treatment, impacts compliance. In addition, persons with diabetes might also be depressed or have other diseases and conditions that make treatment with a particular medication or regimen more difficult. While diabetes patients act and respond differently to treatment due to many reasons, healthcare providers often cannot advise patients as to how they might respond given their personal characteristics simply because they do not have the required information. While drug research studies can tell us on the average how effective a particular treatment will be in terms of lowering blood glucose, they cannot tell us how any one individual will respond. Moreover, while they can tell us how variable the response in blood glucose lowering is for different patients, they do not identify why patients respond differently. The reason for this is that typically no one clinical study can separate out the results by all the patient characteristics that might affect treatment. In addition, clinical drug trials have not typically measured how patients feel or how satisfied they are with their assigned treatment. In most clinical trials, the “true voice” of the patient is usually silent.
During the past 25 years, we have asked patients in clinical trials to tell us how they feel during their treatment. For our proposed research, we have combined the strengths of our pooled diabetes clinical trials quality-of-life database and one of the largest and most comprehensive healthcare electronic medical records databases in existence in an attempt to predict patient-centered characteristics that impact diabetes treatment effectiveness. The purpose of our study is to compare the quality of life and treatment satisfaction responses to different therapies, and determine to what extent factors such as age, gender, employment status, education, income, race, language, ethnicity, clinical characteristics, and other conditions impact these responses. We will incorporate the results of our analysis into a web-based application that will allow clinicians to predict how likely a patient will be to respond given their individual characteristics, and allow patients and physicians to benchmark their progress against others with similar characteristics to improve the quality of care.