More than 2,000 trials in diabetes therapy and technology are currently listed on ClinicalTrials.gov; nearly 80,000 patients are enrolled in ongoing diabetes cardiovascular outcomes trials alone. A number of challenges associated with trials hinder optimal participation and reporting, including lack of enrollment information provided to patients, barriers to accessibility, and/or the workload and time commitments involved in trial participation. The clinical trial environment often fails to fully reflect patients’ real-world experiences, and studies have found that the hemoglobin A1c reductions and other benefits observed in phase 3 trials for glucose lowering therapies can exceed the effects observed in the real world – and vice versa. Patients enrolled in a clinical trial often have different financial and time-related considerations compared to those in the real world. Furthermore, clinical trials often do not reflect the diversity of diabetes patients across demographics, including age, ethnicity, socioeconomic status, and gender.
Using outcomes beyond A1c could help clinical trials glean more valuable information for healthcare providers and patients. Greater use of standardized patient reported outcomes could improve understanding of the ways in which diabetes therapies affect patients; they could also help HCPs understand which patients are best suited to which therapies. Technologies such as continuous glucose monitoring (CGM) can improve our insights into time spent “in range” or “out of range,” which could also help HCPs better personalize treatments. Finally, patient input could be solicited more systematically in the study design process as well as in the drafting of regulatory policy regarding clinical trials for diabetes therapies.
Authors: Manu Venkat1,2, Helen Gao1, and Kelly Close1
Affiliations: 1. Close Concerns, San Francisco, CA; 2. UCSF Medical School, San Francisco, CA